Background: It remains controversial whether palliative primary tumor resection(PPTR) can provide survival benefits to the patients with metastatic colorectal cancer(m CRC) who have unresectable metastases. The aim of...Background: It remains controversial whether palliative primary tumor resection(PPTR) can provide survival benefits to the patients with metastatic colorectal cancer(m CRC) who have unresectable metastases. The aim of this study was to evaluate whether PPTR could improve the survival of patients with m CRC.Methods: We conducted a retrospective study on consecutive m CRC patients with unresectable metastases who were diagnosed at Sun Yat?sen University Cancer Center in Guangzhou, Guangdong, China, between January 2005 and December 2012. Overall survival(OS) and progression?free survival(PFS) after first?line chemotherapy failure were compared between the PPTR and non?PPTR patient groups.Results: A total of 387 patients were identified, including 254 who underwent PPTR and 133 who did not. The median OS of the PPTR and non?PPTR groups was 20.8 and 14.8 months(P < 0.001), respectively. The median PFS after first?line chemotherapy was 7.3 and 4.8 months(P < 0.001) in the PPTR and non?PPTR groups, respectively. A larger proportion of patients in the PPTR group(219 of 254, 86.2%) showed local progression compared with that of patients in the non?PPTR group(95 of 133, 71.4%; P < 0.001). Only patients with normal lactate dehydrogenase(LDH) levels and with carcinoembryonic antigen(CEA) levels <70 ng/m L benefited from PPTR(median OS, 22.2 months for the PPTR group and 16.2 months for the non?PPTR group; P < 0.001).Conclusions: For m CRC patients with unresectable metastases, PPTR can improve OS and PFS after first?line chemo?therapy and decrease the incidence of new organ involvement. However, PPTR should be recommended only for patients with normal LDH levels and with CEA levels <70 ng/m L.展开更多
Objective： To investigate the best surgical mode for the patients of nasopharyngeal carcinoma with recurrent and persistent lymph nodes after radiotherapy. Methods： The clinical data of 88 patients of nasopharyngeal...Objective： To investigate the best surgical mode for the patients of nasopharyngeal carcinoma with recurrent and persistent lymph nodes after radiotherapy. Methods： The clinical data of 88 patients of nasopharyngeal carcinoma with recurrent and persistent lymph nodes after radiotherapy were analyzed retrospectively. The levels of involved lymph nodes and the relationship among the levels were analyzed; the survival rate and recurrent rate of the surgical modes including radical neck dissection （RND）, modified radical neck dissection （MRND）, selective neck dissection （SND）, and lymph node resection （LNR） were analyzed; the role of postoperative radiotherapy was evaluated. Results： （1） The recurrent and persistent lymph nodes mainly located in level Ⅱ（55.6% and 58.6%, respectively）, next was level Ⅲ and rarely in level Ⅳ, Ⅴ, and Ⅰ, but the number of levels Ⅳ Ⅴ, and Ⅰ with cancer-bearing lymph nodes was relatively more than that of clinical measurement. （2） Patients with lymph nodes involved in level Ⅲ and Ⅳ, usually, have other levels involved simultaneously; the percentages were 63.6% and 88.9%, respectively. However, the lymph nodes in level Ⅱ and Ⅴ were mainly isolated. （3） The 5-year survival rate and recurrent rate of the whole group were 42.77% and 22.7%, respectively. （4） The 5-year survival rates of RND, MRND, SND, and LMR groups were 39.75%, 60.00%, 37.87%, and 44.10%, respectively; the differences were insignificant （Log-rank = 1.0, P = 0.8011）; the recurrent rate between the extensive and local surgery groups were insignificant （X^2 = 0.470, P = 0.493）. （5） The 5-year survival rates of the patients with and without postoperative radiotherapy were 39.06% and 45.26%, respectively; the difference was insignificant （Log-rank = 0.06, P = 0.8138）. Conclusion： The extensive surgery was recommended when the recurrent and persistent lymph nodes were more than one level involved or very large or immovable, otherwise, the SND should be performed and postoperative radiotherapy was important compensation if necessary.展开更多
Objective:Gemcitabine,used as single agent for elderly patients with non-small cell lung cancer (NSCLC),was demonstrated effective in this population based on phase II studies.The aim of this study was to summarize al...Objective:Gemcitabine,used as single agent for elderly patients with non-small cell lung cancer (NSCLC),was demonstrated effective in this population based on phase II studies.The aim of this study was to summarize all those phase II studies with the hope to get a comprehensive understanding of gemcitabine efficacy.Methods:The PubMed database was used to search all the papers on NSCLC associated with gemcitabine used as single agent in the first line setting till to March 31st,2010.And the medians and their 95% CI of overall response rate (ORR),disease control rate (DCR),progression free survival (PFS),and overall survival (OS) were calculated.Results:1.There were 7 papers including 410 patients with performance status (PS) ≤ 2 and advanced stage collected.2.The dose-intensities of gemcitabine were 843.75 mg/m 2 /week-1125 mg/m 2 /week in the 4-week schedule,and 666.7 mg/m 2 /week in the 3-week schedule.3.The median age was 73.8 (95% CI was 72.44,75.16) years old;36.1% (95% CI:31.4%,40.7%) of patients with stage IIIB and 60.5% (95% CI:55.8%,65.2%) of patients with stage IV;35.9% (95% CI:31.2%,40.5%) patients were adenocarcinomas and 43.7% (95% CI:38.9%,48.5%) patients were squamous cell carcinomas (SCCs).4.The ORR,DCR,PFS/TTP,and OS were 22.3% (95% CI:18.2%,26.5%),58.4% (95% CI:53.5%,63.4%),3.6 (95% CI:2.9,5.15) months and 6.68 (95% CI:5.4,8.11) months,respectively.Conclusion:Gemcitabine as single agent applied in this special population was effective and can be well tolerated under different doses and usage.展开更多
Objective： Male breast cancer （MBC） is a rare disease, and studies to compare the prognosis between the MBC and female breast cancer （FBC） available now were case-control studies and population-based studies, how...Objective： Male breast cancer （MBC） is a rare disease, and studies to compare the prognosis between the MBC and female breast cancer （FBC） available now were case-control studies and population-based studies, however, with controversial outcomes. To further investigate whether sex affects the prognosis of breast cancer, we performed a meta-analysis based on all the peered papers. Methods： The PubMed database was screened. Subsequently, the hazard ratios （HRs） for overall survival （OS） and disease special survival （DSS）, were pooled using the Review Manager 5.0 package. Results： This study comprised of 254 MBC and 733 FBC patients enrolled in six case-control studies. There was no statistically significant heterogeneity among the trials for either outcome variable. The pooled HR showed that there was no significant difference in 5-year or 10-year DSS （HR： 1.25, 95% CI： 0.76-2.08; HR： 1.04, 95% CI： 0.68-1.5g） and 5-year or 10-year OS （HR： 0.76, 95% CI： 0.51-1.14; HR： 0.74, 95% CI： 0.54-1.02） between MBCs and FBCs. Conclusion： MBC and FBC with similar prognosis are found in this meta-analysis based on only case-control studies which matched main potential prognostic factors such as age, clinical stage, and time at diagnosis.展开更多
Objective:The extremely low incidence of male breast cancer (MBC) leads to lack of prospective randomized phase III studies worldwide. Especially in China,all studies on Chinese patients with MBC were based on small s...Objective:The extremely low incidence of male breast cancer (MBC) leads to lack of prospective randomized phase III studies worldwide. Especially in China,all studies on Chinese patients with MBC were based on small sample size and single institute experience. The aim of this study was to provide overall view of characteristics of Chinese patients with MBC by means of summarizing all related papers published in Chinese journals. Methods: An online search was made in CBM,VIP,CNKI,and CBA databases to find all published articles of interest on Chinese patients with MBC. And eight subjects including the proportion of MBC in all breast cancer,age,tumor location,clinical stages,pathological subtypes,treatment modalities,ER/PR expression,and 5-year survival rate were selected to calculate the proportion and their 95% interval confidence. Results: There were 122 papers with 2584 patients enrolled. The basic features of Chinese patients with MBC included:(1) MBC only with a proportion of 1.06% of all the breast cancer; (2) The mean age at diagnosis was 57.6 years old; (3) Tumor mainly located in the areolar region (74.83%) with obvious nipple and/or skin involvement; (4) Nearly 62.62% patients were in early stage before accepting treatment; (5) Infiltrating ductal carcinoma accounted for 79.05% of all pathological subtypes; (6) ER/PR expression rate was 65.86%; (7) Radical resection was up to 86.06% in all surgical modalities; (8) The 5-year survival rate was 57.33%. Conclusion: The results showed in this study were an overall view of Chinese patients with MBC whose characteristics were similar to that reported in the West. Though this study provided a little bit stronger confidence than a single study collected in this paper,studies with more powerful evidence are urgently demanding in China.展开更多
Objective： Albumin-bound paclitaxel （abraxane, ABX） has more favorable efficacy and less toxicity than conventional taxanes. However, the data of ABX in advanced gastric cancer （AGC） treatment is unavailable. The...Objective： Albumin-bound paclitaxel （abraxane, ABX） has more favorable efficacy and less toxicity than conventional taxanes. However, the data of ABX in advanced gastric cancer （AGC） treatment is unavailable. The current study was designed to summarize our experience in treating AGC patients with ABX. Methods： The clinical data of patients with AGC who had received at least one cycle of ABX-based chemotherapy in Sun Yat-sen University Cancer Center from January 10th 2010 to May 14th 2012 was retrospectively analyzed. Results： A total of 47 cycles of ABX-containing regimens, with a median of 3 cycles （range： 1-8 cycles）, were administered to 14 patients. Five （35.7%） partial responses and 6 （42.9%） stable diseases were obtained, with a disease control rate （DCR） of 78.6%. The median progression free survival （PFS） and overall survival （OS） were 3.3 and 10.8 months, respectively. Interestingly, patients in the first-line setting achieved a DCR of 100% （8/8）. Neutropenia and thrombocytopenia were the main grade 3/4 adverse events with an incidence of 50% in the whole group. However, only 25% patients （2/8） experienced grade 3 neutropenia when ABX in combination with fluoropyrJmJdines. Conclusion： The activity of ABX-based regimens as first-line therapy for patients with AGC is remarkable, and the toxicity is mild when ABX combined with fluorepyrimidines. Further prospective clinical trials of ABX-based chemotherapy as first-line treatment for AGC are strongly anticipated.展开更多
Objective： The aim of this study was to investigate the efficacy and safety profiles of cetuximab, the commonly used monoclonal antibody of epidermal growth factor receptor, based on Chinese patients with colorectal ...Objective： The aim of this study was to investigate the efficacy and safety profiles of cetuximab, the commonly used monoclonal antibody of epidermal growth factor receptor, based on Chinese patients with colorectal cancer. Methods： All the papers studied on Chinese patients with gastrointestinal cancer treated by cetuximab and found in both databases of Chinese journal database for fulltext and PubMed were collected. The commonly used efficacy index such as disease control rate （CR ＋ PR ＋ SD） and response rate （CR ＋ PR） were analyzed, and the cetuximab related side effects such acne-like rash and nail change and hypersensitivity were analyzed too. Results： （1） There were 10 original papers contained total 152 patients with gastrointestinal cancer who were the candidates to analyze the safety profiles, and contained 130 patients with colorectal cancer who were candidates to analyze the efficacy. （2） The disease control rate and response rate in the whole group was 73.5% （95% CI： 65.5%-81.5%） and 29.1% （95% CI： 20.9%-37.3%）, respectively; In first-line setting group they were 70.0% （95% CI： 55%-85%） and 41.7% （95% CI： 25.6%-57.8%）, respectively; In non-first line setting group they were 71.6% （95% CI： 61.8%-81.4%） and 23.5% （95% CI： 14.3%-32.7%）, respectively. The disease control rate between the two line-setting groups was insignificant, but the response rate between the two line-setting groups was significant （P = 0.045）. （3） The incidence of acne-like rash was 72.0% （95% CI： 64.8%-79.2%）, the degree Ⅰ-Ⅱ and degree Ⅲ-Ⅳ account for 56.0% （95% CI： 48.1%-63.9%） and 16.0% （95% CI： 10.1%-21.9%）, respectively. No treatment related death, and the hypersensitivity was under control. Conclusion： This study is the first study to summarize the data of Chinese patients with colorectal cancer treated by cetuximab-contained regimen, it showed that the monoclonal antibody was effective and safe for Chinese patients as the West patients with colorectal cancer.展开更多
Objective:The combination of cetuximab with standard chemotherapy was not widely studied though it was recommended by NCCN 2009 to apply in non-small cell lung cancer(NSCLC)first-line setting.The aim of this study was...Objective:The combination of cetuximab with standard chemotherapy was not widely studied though it was recommended by NCCN 2009 to apply in non-small cell lung cancer(NSCLC)first-line setting.The aim of this study was to summary the efficacy and safety profiles of all the NSCLC patients available in openly published papers treated with above mentioned regimens.Methods:The PubMed database was used to search all the papers on NSCLC associated with cetuximab treatment,and only the clinical trails applied cetuximab combined with doublets cytotoxic chemotherapy in first-line setting till to 30 November 2009 were collected.And the medians and their 95%CI of objective response rate(ORR),progression free survival(PFS),overall survival(OS),and the common adverse events were calculated.Results:(1)Eight papers including 1032 patients were collected,and all cases were at advanced stage.(2)The ratio of male and female patients was 1.6,50.1%patients were adenocarcinoma and 28.2%patients were squamous cell carcinoma(SCC),90.0%patients were PS=0-1,and 78.2%patients were white ethnic.(3)The disease control rate(DCR),ORR,PFS,and OS were 65.2%(95%CI:60.7%-69.7%),33.2%(95%CI:30.3%-36.1%),5.0 months(95%CI:4.7-5.3)and 10.9 months(95%Cl:9.6-12.2),respectively.Conclusion:This is the first study to summarize the efficacy and safety profiles of cetuximab combined with chemotherapy in NSCLC first-line setting based on all available patients.The addition of cetuximab caused promising prognosis and acceptable side effects excepting higher incidence of neutropenia,and febrile neutropenia.展开更多
Objective: We aimed to evaluate the effect of bevacizumab in the palliative treatment of Chinese metastatic colorectal cancer(mCRC) and its efficacy in different lines. Methods: Patients of mCRC treated with bevacizum...Objective: We aimed to evaluate the effect of bevacizumab in the palliative treatment of Chinese metastatic colorectal cancer(mCRC) and its efficacy in different lines. Methods: Patients of mCRC treated with bevacizumab or not at Sun Yat-sen University Cancer Center from 2005 to 2013 were recruited as the study group and control group. The endpoints were objective response rate(ORR), disease control rate(DCR), overall survival(OS) and progression free survival(PFS). The OS and PFS of first-, second- and third-line treatment groups were compared between study group and control group. Results: The median PFS of the study and the control group were 8.2 months(7.0–9.4 months), 5.7 months(4.7–6.6 months), P = 0.001; OS were 26 months(5.4–130.5 months), 18 months(16.6–19.4 months), P < 0.001, respectively. The ORR and DCR of first-, second- and third-line were 30.3%(20/66), 20%(6/30), 17.6%(3/17) and 97%(64/66), 86.7%(26/30), 100%(17/17). In the first-line chemotherapy group, the OS of the study group and the control group were 22.9(5.4–96.7) months and 18(16.6–19.4) months(P < 0.001); PFS were 9.4(8.4–10.4) months and 5.7(4.7–6.6) months(P < 0.001), respectively. While in the second- and third-line setting, only OS were statistically different, PFS had no significant difference. Conclusion: The combination of bevacizumab and chemotherapy had a promising short-term and long-term efficacy in Chinese mCRC patients than those without bevacizumab regimens, and the effect could be better reflected in the first-line treatment.展开更多
Objective: The combination of hepatic arterial chemotherapy(HAIC) and systemic chemotherapy(SYC) has potential effect on colorectal cancer(CRC) patients with unresectable hepatic metastasis. The aim of this retrospect...Objective: The combination of hepatic arterial chemotherapy(HAIC) and systemic chemotherapy(SYC) has potential effect on colorectal cancer(CRC) patients with unresectable hepatic metastasis. The aim of this retrospective study was to investigate the efficacy and safety of this combined therapeutic regimen on Chinese patients based on single institute experiences. Methods: All 54 patients of this retrospective analysis were diagnosed with CRC with unresectable liver metastasis and received combined HAIC and SYC. Among the patients, 23 of them received HAIC plus SYC when they developed liver metastases as first-line treatment(Group 1), and 31 patients received HAIC plus SYC as non-first-line treatment(Group 2). The different efficacy in two groups was analyzed by SPSS 19.0. Results: The overall response rate(ORR) were 52.2% and 25.8% respectively in Groups 1 and 2(P = 0.047), and the disease control rate(DCR) were 65.2% and 35.5% respectively in Groups 1 and 2(P = 0.031). The median progression-free survival(PFS) were 6.8 and 3.3 months(P = 0.002), the median hepatic progression-free survival(H-PFS) were 8.8 and 3.7 months(P = 0.001), and the median overall survival(OS) were 18.8 and 13.7 months(P = 0.121) in Groups 1 and 2, respectively. No fatal reaction was observed and no significant difference of adverse reaction was found in two groups. Grade 3/4 toxic effects included neutropenia(9.7% in Group 2 only), gastrointestinal reaction(8.7% in Group 1 and 6.5% in Group 2), stomatitis(6.5% in Group 2 only) and hyperbilirubinemia(4.3% in Group 1 only). Conclusion: HAIC combined with SYC showed promising efficacy and safe profiles on CRC patients with unresectable liver metastases.展开更多
Objective： The aim of the study was to compare the efficacies and toxicities of non-platinum doublets （doublets group） with a non-platinum single agent （single-agent group） in previously untreated advanced non-sm...Objective： The aim of the study was to compare the efficacies and toxicities of non-platinum doublets （doublets group） with a non-platinum single agent （single-agent group） in previously untreated advanced non-small cell lung cancer （NSCLC） patients with elderly age and/or poor performance status （PS）. Methods： The PubMed database was screened. Subsequently, the hazard ratios （HRs） for overall survival （OS） and progression-free survival （PFS）, relative risks （RRs） for overall response rate （ORR） and one-year survival, and odds ratios （ORs） for the different types of toxicities were pooled using the Review Manager 5.0 package. Results： This study comprised of 1427 patients enrolled in four randomized controlled trials. The pooled HR showed that the doublet group could increase ORR （P = 0.002） with no heterogeneity （P = 0.64）, and might improve OS （P = 0.01 / P = 0.06） with heterogeneity （P 0.001）. There was no significant difference in PFS （P = 0.16） and one-year survival （P = 0.25） between two treatment groups. The doublet group led to more grade 3/4 neutropenia and thrombocytopenia than the single-agent group （P = 0.02 and P = 0.000, respectively）. The incidences of grade 3/4 anemia, vomiting, mucositis, constipation, diarrhea, neurotoxicity, allergy, and fatigue between the two treatment groups were insignificant. Conclusion： Except for neutropenia and thrombocytopenia, the non-platinum doublets could increase ORR, and might improve OS for NSCLC patients with elderly age and/or poor PS without addition of more side effects; however, the doublets showed an increased rate of neutropenia and thrombocytopenia. The addition of doublets may not improve PFS and one-year survival.展开更多
OBJECTIVE Data on the efficacy profiles of pemetrexed mono- therapy and pemetrexed plus platinum combination therapy in the non-first-line setting for patients with advanced non-small cell lung cancer （NSCLC） are li...OBJECTIVE Data on the efficacy profiles of pemetrexed mono- therapy and pemetrexed plus platinum combination therapy in the non-first-line setting for patients with advanced non-small cell lung cancer （NSCLC） are limited, and previous studies have reported contradictory results. This study investigated and compared the efficacy and toxicity profiles of these two regimens to provide a broader understanding of their dynamics. METHODS Previously treated patients with advanced and/or recurrent NSCLC who received pemetrexed monotherapy or peme- trexed plus platinum combination therapy between January 1, 2006, and December 31, 2009, at Sun Yat-sen University Cancer Center were evaluated. The primary endpoint of this study was progres- sion-free survival （PFS）, whereas the secondary endpoints were overall response rate （ORR）, disease control rate （DCR）, overall survival （OS）, and toxicity. Survival was analyzed using the Kaplan- Meier method. Univariate analysis was performed to identify the factors potentially influencing OS, and chi-square analysis was carried out to compare ORR and DCR. RESULTS Forty-six patients with advanced and/or recurrent NSCLC were analyzed; of these patients, 25 were given pemetrexed monotherapy and 21 received pemetrexed plus platinum combina- tion therapy. The following correspond to the rates recorded for the pemetrexed monotherapy group and the pemetrexed plus platinum group： median PFS, 1.97 and 2.3 months （P=0.565）; median OS, 30.93 and 30.33 months （P=0.877）; ORR, 8% （2/25） and 9.5% （2/21） （P=0.857）; and DCR, 32% （8/25） and 57.1% （12/21） （P=0.09）. Univariate analysis revealed that no factor was correlated with OS from NSCLC （P〉0.05 for all）. Gastrointestinal toxicity in the pemetrexed plus platinum group was modestly higher than that in the pemetrexed monotherapy group （P=0.034）, but other adverse events were similar between the groups. CONCLUSION Compared with pemetrexed monotherapy, peme- trexed plus platinum combination therapy causes more gastro- intestinal toxicities and does not exhibit improved efficacy, in terms of ORR, DCR, PFS, and OS, in the non-first-line setting for NSCLC. However, further research with a higher patient population is necessary to validate this finding.展开更多
Objective:Cetuximab combined with chemotherapy has been used to treat non-small cell lung cancer (NSCLC) in recent years, most of them were first line setting.This study was to summarize our experiences in treating NS...Objective:Cetuximab combined with chemotherapy has been used to treat non-small cell lung cancer (NSCLC) in recent years, most of them were first line setting.This study was to summarize our experiences in treating NSCLC patients with cetuximab in the non-first line setting.Methods:From October 1st 2006 to December 31st 2009, six NSCLC patients were treated with cetuximab combined standard chemotherapy as non-first line setting in Sun Yat-sen University Cancer Center, China.The short-term efficacies and safeties were analyzed.Results:1.A total of 18 cycles of cetuximab treatment, with a median of two cycles in the whole group.2.There were 6 patients treated as non-first line setting, overall response rate (ORR) was 33.3% (2/6), disease control rate (DCR) was 33.3% (2/6), median time to progression (TTP) was 3.5 (3-4) months, and median OS was 18 (4-28) months.3.There were 50% (3/6) patients occurred acne-like rash within three weeks, their ORR was 66.7% (2/3), and DCR was 66.7% (2/3), however, both of ORR and DCR in patients who didn't occurred acne-like rash were 0% (0/3), the differences of ORR, DCR between two groups were in significant different (P=0.143).4.There was no treatment-associated death and no cetuximab-associated discontinuation.The incidence of acne-like rash was 50% occurred within three weeks, there were two patients suffered side effects associated with chemotherapy.Conclusion:The data of cetuximab application in non-first line setting for patients with NSCLC were rare, and the addition of cetuximab in those population was safe.展开更多
Objective： Cetuximab is an effective medicine for colorectal cancer bearing wild type Kras. However, few studies of cetuximab on patients with noncolorectal gastrointestinal cancer were available now. The aim of this...Objective： Cetuximab is an effective medicine for colorectal cancer bearing wild type Kras. However, few studies of cetuximab on patients with noncolorectal gastrointestinal cancer were available now. The aim of this study was to summarize the efficacy and safety profiles base-on the experiences of 16 patients with noncolorectal gastrointestinal cancer accepted cetuximab-contained regimens treatment. Methods： The clinical data of all patients with noncolorectal gastrointestinal cancer treated by cetuximab combined with chemotherapy and/or radiotherapy from October 1st 2006 to Jun 30th 2009 in Sun Yat-sen University Cancer Center were collected. Results： （1） A total of 16 patients enrolled, including gastric cancer, esophageal carcinoma, pancreatic cancer and cholangiocarcinoma （8, 6, 1 and 1, respectively）. The cetuximab was administered 92 cycles totally with median cycle of 4. （2） PR, SD and PD obtained in 4, 3 and 2 patients respectively in cetuximab ＋ chemotherapy group. The disease control rate, median l-rP and median OS were 77.8% （7/9）, 3.5 months and 3.5 months, respectively. （3） Both of patients in cetuximab ＋ radiotherapy group achieved PR with median TTP of 4 months and 7 months, with median OS of 14 and 28 months, respectively. （4） in evaluable patients, 3 PR obtained in first-line setting, 1 PD and 1 SD achieved in second-line setting, 2 SD and 1 PD appeared in third-line and more than third-line setting. （5） The commonly side effect was neutropenia, however, rash and hypomagnesemia were the common side effects related to cetuximab. Conclusion： Cetuximab-contained regimens show a promising disease control rate, especially in first-line setting, in patients with noncolorectal gastrointestinal cancer, and the side effects both related to cytotoxic agents and related to cetuximab itself is tolerable and manageable. Of course, more phase Ⅲ clinical trails are needed urgently.展开更多
Objective: The aim of this study was to investigate the efficacy and safety profiles of bevacizumab, the commonly used monoclonal antibody and its safety profiles were challenging, based on Chinese cancer patients. Me...Objective: The aim of this study was to investigate the efficacy and safety profiles of bevacizumab, the commonly used monoclonal antibody and its safety profiles were challenging, based on Chinese cancer patients. Methods: All the papers studied on Chinese cancer patients treated by bevacizumab were found in both databases of Chinese journal database for fulltext and PubMed were collected. The commonly used efficacy index such as disease control rate (CR + PR + SD) and response rate (CR + PR) were analyzed, and the bevacizumab related side effects were analyzed too. Results: (1) There were ten original papers contained total 199 patients who were the candidates to analyze the safety profiles, and 115 patients with colorectal cancer in five papers who were candidates to analyze the efficacy. (2) Nine in ten papers set the dose of bevacizumab in 2.5 mg/kg/week - 5 mg/kg/week, and the biweekly was the standard chemotherapy interval. (3) The disease control rate and response rate in Chinese colorectal cancer patients were 85% (95% CI: 79%-92%) and 61% (95% CI: 52%-70%), respectively. (4) The side effects related to bevacizumab were rare and most of them were grades 1-2, and only one case with grade 4 bleeding was recorded and only two cases with discontinuation of bevacizumab since hemoplysis. Also, the grades 3-4 side effects related cytotoxic agents were not common. Conclusion: This study summarized the data of Chinese cancer patients treated by bevacizumab-contained regimens, and it showed that the monoclonal antibody was effective and safe for Chinese patients as the West patients.展开更多
Objective The standard therapy alter failure of the initial non-first line epidermal growth factor receptor tyrosine kinase inhibitor （EGFR-TK1） treatment in advanced non-small cell lung cancer （NSCLC） has not yet...Objective The standard therapy alter failure of the initial non-first line epidermal growth factor receptor tyrosine kinase inhibitor （EGFR-TK1） treatment in advanced non-small cell lung cancer （NSCLC） has not yet been established. The aim of the current study was to identify whether the 2nd TKI treatment or chemotherapy （paclitaxel-containing or non-paclitaxel regimen） is the appropriate treatment for patients with NSCLC based on the efficacy of the initial TKls. Methods Seventy-two advanced NSCLC patients who had accepted 2nd TKIs or chemotherapy immediately alter failure of the initial TKIs in non-first line setting from May 1, 2004 to January 31, 2010 at the Sun Yat-sen University Cancer Center were enrolled. The primary endpoint [2nd progression-free survival （PFS）] and the second endpoint loverall survival （OS）] were compared among the 2＇＇d TKI and chemotherapy groups as well as their subgroups. Results （1） Twenty-one patients were treated with 2 TKIs, and 51 patients were administered chemotherapy after failure of the initial non-first line TKI treatment. There was nonsignificant difference in the responses （P=0.900） [2nd PFS （P=0.833） and OS （P=0.369）] between the 2nd TKI and chemotherapy groups. （2） In tile 2nd TKI group, 9 patients exhibited PFS_〉7 months. The initial TKI treatment group exhibited a longer 2＂d PFS than the other 12 patients with an initial PFS〈7 months （7 months vs. 2 months, P=0.019）. However, these groups had nonsignificantly different OS （P=0.369）. （3） In the chemotherapy group, patients with PFS〈5 months exhibited longer 2＇1~ PFS than those with PFS 〉 5 months in the initial TKI treatment （3 months vs. 2 months, P=0.039）. （4） In the chemotherapy group, nd patients treated with paclitaxel-containing regimen showed longer 2 PFS than those treated with non-paclitaxel regimen （, months t,s. 2.3 months, P=0.043）. Conclusions Patients with PFS_〉7 months or 〈5 months under the initial TKI treatment potentially benefit from the 2nd TK1 treatment or chemotherapy immediately after failure of the non-first line TKIs. The paclitaxel-containing regimen may improve the 2na PFS. However, more patient samples are urgently needed to validate these findings.展开更多
Objective: Bevacizumab has been challenging in the treatment of metastatic breast cancer. To investigate its efficacy, optimal partner to combine with and maintenance therapy, we performed a retrospective study based ...Objective: Bevacizumab has been challenging in the treatment of metastatic breast cancer. To investigate its efficacy, optimal partner to combine with and maintenance therapy, we performed a retrospective study based on Chinese patients with metastatic breast cancer (MBC). Methods: Patients with MBC treated with bevacizumab-contained regimens at the Sun Yat-sen University Cancer Center from 2006 to 2010 were recruited to the study. The primary endpoints were overall survival (OS), time to progression (TTP), objective response rate (ORR), and disease control rate (DCR). These endpoints were analyzed using the Kaplan-Meier and Chi-squared tests, respectively. Results: (1) A total of 229 cycles of bevacizumab with a median cycle of 7 (1-34) were administered among 25 patients. (2) In the whole group, ORR and DCR were 60% (15/25) and 76% (19/25), respectively. The mTTP was 5 months (1-21), mOS from diagnosis was 48 months (13-172), mOS from bevacizumab administration was 24 months (1-45). (3) Both ORR (73.7% vs. 16.7%, P = 0.023) and DCR (94.7% vs. 33.3%, P = 0.005) were significant higher once patients treated with the combination of taxanes-based regimen and bevacizamab when compared with the combination with non-taxanes-based regimens. (4) In the taxanes-based group, no matter bevacizumab used in first line or non-first line, the differences of ORR (P = 0.637) and DCR (P = 0.316) were insignificant. However, the maintenance therapy with bevacizumab will bring more longer TTP (P < 0.001) than those without maintenance therapy. Conclusion: Taxanes-based regimens were the optimal candidate to combine with bevacizumab regardless the timing in palliative setting, however, the maintenance therapy with bevacizumab should be considered once indicated.展开更多
AIM To investigate the expression of G protein-coupled receptor 31 (GPR31) and its clinical significance in human colorectal cancer (CRC).METHODS To determine the association between the GPR31 expression and the progn...AIM To investigate the expression of G protein-coupled receptor 31 (GPR31) and its clinical significance in human colorectal cancer (CRC).METHODS To determine the association between the GPR31 expression and the prognosis of patients, we obtained paraffin-embedded pathological specimens from 466 CRC patients who underwent initial resection. A total of 321 patients from the First Affiliated Hospital of Sun Yat-sen University from January 1996 to December 2008 were included as a training cohort, whereas 145 patients from the Sixth Affiliated Hospital of Sun Yat-sen University from January 2007 to November 2008 were included as a validation cohort. We examined GPR31 expression levels in CRC tissues from two independent cohorts via immunohistochemical staining. All patients were categorized into either a GPR31 low expression group or a GPR31 high expression group. The clinicopathological factors and the prognosis of patients in the GPR31 low expression group and GPR31 high expression group were compared.RESULTS We compared the clinicopathological factors and the prognosis of patients in the GPR31 low expression group and GPR31 high expression group. Significant differences were observed in the number of patients in pM classification between patients in the GPR31 low expression group and GPR31 high expression group (P = 0.007). The five-year survival and tumor-free survival rates of patients were 84.3% and 82.2% in the GPR31 low expression group, respectively, and both rates were 59.7% in the GPR31 high expression group (P < 0.05). Results of the Cox proportional hazard regression model revealed that GPR31 upregulation was associated with shorter overall survival and tumor-free survival of patients with CRC (P < 0.05). Multivariate analysis identified GPR31 expression in colorectal cancer as an independent predictive factor of CRC patient survival (P < 0.05).CONCLUSION High GPR31 expression levels were found to be correlated with pM classification of CRC and to serve as an independent predictive factor of poor survival of CRC patients.展开更多
基金supported by grants from the Natural Science Foundation of Guangdong, China (2015A030313010)Science and Technology Program of Guangzhou, China (1563000305)National Natural Science Foundation of China (81272641 and 81572409)
文摘Background: It remains controversial whether palliative primary tumor resection(PPTR) can provide survival benefits to the patients with metastatic colorectal cancer(m CRC) who have unresectable metastases. The aim of this study was to evaluate whether PPTR could improve the survival of patients with m CRC.Methods: We conducted a retrospective study on consecutive m CRC patients with unresectable metastases who were diagnosed at Sun Yat?sen University Cancer Center in Guangzhou, Guangdong, China, between January 2005 and December 2012. Overall survival(OS) and progression?free survival(PFS) after first?line chemotherapy failure were compared between the PPTR and non?PPTR patient groups.Results: A total of 387 patients were identified, including 254 who underwent PPTR and 133 who did not. The median OS of the PPTR and non?PPTR groups was 20.8 and 14.8 months(P < 0.001), respectively. The median PFS after first?line chemotherapy was 7.3 and 4.8 months(P < 0.001) in the PPTR and non?PPTR groups, respectively. A larger proportion of patients in the PPTR group(219 of 254, 86.2%) showed local progression compared with that of patients in the non?PPTR group(95 of 133, 71.4%; P < 0.001). Only patients with normal lactate dehydrogenase(LDH) levels and with carcinoembryonic antigen(CEA) levels <70 ng/m L benefited from PPTR(median OS, 22.2 months for the PPTR group and 16.2 months for the non?PPTR group; P < 0.001).Conclusions: For m CRC patients with unresectable metastases, PPTR can improve OS and PFS after first?line chemo?therapy and decrease the incidence of new organ involvement. However, PPTR should be recommended only for patients with normal LDH levels and with CEA levels <70 ng/m L.
文摘Objective： To investigate the best surgical mode for the patients of nasopharyngeal carcinoma with recurrent and persistent lymph nodes after radiotherapy. Methods： The clinical data of 88 patients of nasopharyngeal carcinoma with recurrent and persistent lymph nodes after radiotherapy were analyzed retrospectively. The levels of involved lymph nodes and the relationship among the levels were analyzed; the survival rate and recurrent rate of the surgical modes including radical neck dissection （RND）, modified radical neck dissection （MRND）, selective neck dissection （SND）, and lymph node resection （LNR） were analyzed; the role of postoperative radiotherapy was evaluated. Results： （1） The recurrent and persistent lymph nodes mainly located in level Ⅱ（55.6% and 58.6%, respectively）, next was level Ⅲ and rarely in level Ⅳ, Ⅴ, and Ⅰ, but the number of levels Ⅳ Ⅴ, and Ⅰ with cancer-bearing lymph nodes was relatively more than that of clinical measurement. （2） Patients with lymph nodes involved in level Ⅲ and Ⅳ, usually, have other levels involved simultaneously; the percentages were 63.6% and 88.9%, respectively. However, the lymph nodes in level Ⅱ and Ⅴ were mainly isolated. （3） The 5-year survival rate and recurrent rate of the whole group were 42.77% and 22.7%, respectively. （4） The 5-year survival rates of RND, MRND, SND, and LMR groups were 39.75%, 60.00%, 37.87%, and 44.10%, respectively; the differences were insignificant （Log-rank = 1.0, P = 0.8011）; the recurrent rate between the extensive and local surgery groups were insignificant （X^2 = 0.470, P = 0.493）. （5） The 5-year survival rates of the patients with and without postoperative radiotherapy were 39.06% and 45.26%, respectively; the difference was insignificant （Log-rank = 0.06, P = 0.8138）. Conclusion： The extensive surgery was recommended when the recurrent and persistent lymph nodes were more than one level involved or very large or immovable, otherwise, the SND should be performed and postoperative radiotherapy was important compensation if necessary.
基金Support by a grant from Major Science and Technology Project of"National Significant New Drug Creation"(No. 2008ZX09312-002)
文摘Objective:Gemcitabine,used as single agent for elderly patients with non-small cell lung cancer (NSCLC),was demonstrated effective in this population based on phase II studies.The aim of this study was to summarize all those phase II studies with the hope to get a comprehensive understanding of gemcitabine efficacy.Methods:The PubMed database was used to search all the papers on NSCLC associated with gemcitabine used as single agent in the first line setting till to March 31st,2010.And the medians and their 95% CI of overall response rate (ORR),disease control rate (DCR),progression free survival (PFS),and overall survival (OS) were calculated.Results:1.There were 7 papers including 410 patients with performance status (PS) ≤ 2 and advanced stage collected.2.The dose-intensities of gemcitabine were 843.75 mg/m 2 /week-1125 mg/m 2 /week in the 4-week schedule,and 666.7 mg/m 2 /week in the 3-week schedule.3.The median age was 73.8 (95% CI was 72.44,75.16) years old;36.1% (95% CI:31.4%,40.7%) of patients with stage IIIB and 60.5% (95% CI:55.8%,65.2%) of patients with stage IV;35.9% (95% CI:31.2%,40.5%) patients were adenocarcinomas and 43.7% (95% CI:38.9%,48.5%) patients were squamous cell carcinomas (SCCs).4.The ORR,DCR,PFS/TTP,and OS were 22.3% (95% CI:18.2%,26.5%),58.4% (95% CI:53.5%,63.4%),3.6 (95% CI:2.9,5.15) months and 6.68 (95% CI:5.4,8.11) months,respectively.Conclusion:Gemcitabine as single agent applied in this special population was effective and can be well tolerated under different doses and usage.
基金Supported by a grant from the Major Science and Technology Project of "National Significant New Drug Creation" (No. 2008ZX09312-002)
文摘Objective： Male breast cancer （MBC） is a rare disease, and studies to compare the prognosis between the MBC and female breast cancer （FBC） available now were case-control studies and population-based studies, however, with controversial outcomes. To further investigate whether sex affects the prognosis of breast cancer, we performed a meta-analysis based on all the peered papers. Methods： The PubMed database was screened. Subsequently, the hazard ratios （HRs） for overall survival （OS） and disease special survival （DSS）, were pooled using the Review Manager 5.0 package. Results： This study comprised of 254 MBC and 733 FBC patients enrolled in six case-control studies. There was no statistically significant heterogeneity among the trials for either outcome variable. The pooled HR showed that there was no significant difference in 5-year or 10-year DSS （HR： 1.25, 95% CI： 0.76-2.08; HR： 1.04, 95% CI： 0.68-1.5g） and 5-year or 10-year OS （HR： 0.76, 95% CI： 0.51-1.14; HR： 0.74, 95% CI： 0.54-1.02） between MBCs and FBCs. Conclusion： MBC and FBC with similar prognosis are found in this meta-analysis based on only case-control studies which matched main potential prognostic factors such as age, clinical stage, and time at diagnosis.
文摘Objective:The extremely low incidence of male breast cancer (MBC) leads to lack of prospective randomized phase III studies worldwide. Especially in China,all studies on Chinese patients with MBC were based on small sample size and single institute experience. The aim of this study was to provide overall view of characteristics of Chinese patients with MBC by means of summarizing all related papers published in Chinese journals. Methods: An online search was made in CBM,VIP,CNKI,and CBA databases to find all published articles of interest on Chinese patients with MBC. And eight subjects including the proportion of MBC in all breast cancer,age,tumor location,clinical stages,pathological subtypes,treatment modalities,ER/PR expression,and 5-year survival rate were selected to calculate the proportion and their 95% interval confidence. Results: There were 122 papers with 2584 patients enrolled. The basic features of Chinese patients with MBC included:(1) MBC only with a proportion of 1.06% of all the breast cancer; (2) The mean age at diagnosis was 57.6 years old; (3) Tumor mainly located in the areolar region (74.83%) with obvious nipple and/or skin involvement; (4) Nearly 62.62% patients were in early stage before accepting treatment; (5) Infiltrating ductal carcinoma accounted for 79.05% of all pathological subtypes; (6) ER/PR expression rate was 65.86%; (7) Radical resection was up to 86.06% in all surgical modalities; (8) The 5-year survival rate was 57.33%. Conclusion: The results showed in this study were an overall view of Chinese patients with MBC whose characteristics were similar to that reported in the West. Though this study provided a little bit stronger confidence than a single study collected in this paper,studies with more powerful evidence are urgently demanding in China.
文摘Objective： Albumin-bound paclitaxel （abraxane, ABX） has more favorable efficacy and less toxicity than conventional taxanes. However, the data of ABX in advanced gastric cancer （AGC） treatment is unavailable. The current study was designed to summarize our experience in treating AGC patients with ABX. Methods： The clinical data of patients with AGC who had received at least one cycle of ABX-based chemotherapy in Sun Yat-sen University Cancer Center from January 10th 2010 to May 14th 2012 was retrospectively analyzed. Results： A total of 47 cycles of ABX-containing regimens, with a median of 3 cycles （range： 1-8 cycles）, were administered to 14 patients. Five （35.7%） partial responses and 6 （42.9%） stable diseases were obtained, with a disease control rate （DCR） of 78.6%. The median progression free survival （PFS） and overall survival （OS） were 3.3 and 10.8 months, respectively. Interestingly, patients in the first-line setting achieved a DCR of 100% （8/8）. Neutropenia and thrombocytopenia were the main grade 3/4 adverse events with an incidence of 50% in the whole group. However, only 25% patients （2/8） experienced grade 3 neutropenia when ABX in combination with fluoropyrJmJdines. Conclusion： The activity of ABX-based regimens as first-line therapy for patients with AGC is remarkable, and the toxicity is mild when ABX combined with fluorepyrimidines. Further prospective clinical trials of ABX-based chemotherapy as first-line treatment for AGC are strongly anticipated.
基金Supported by a grant from Major Science and Technology Project of "National Significant New Drug Creation" (No: 2008ZX09312–002)
文摘Objective： The aim of this study was to investigate the efficacy and safety profiles of cetuximab, the commonly used monoclonal antibody of epidermal growth factor receptor, based on Chinese patients with colorectal cancer. Methods： All the papers studied on Chinese patients with gastrointestinal cancer treated by cetuximab and found in both databases of Chinese journal database for fulltext and PubMed were collected. The commonly used efficacy index such as disease control rate （CR ＋ PR ＋ SD） and response rate （CR ＋ PR） were analyzed, and the cetuximab related side effects such acne-like rash and nail change and hypersensitivity were analyzed too. Results： （1） There were 10 original papers contained total 152 patients with gastrointestinal cancer who were the candidates to analyze the safety profiles, and contained 130 patients with colorectal cancer who were candidates to analyze the efficacy. （2） The disease control rate and response rate in the whole group was 73.5% （95% CI： 65.5%-81.5%） and 29.1% （95% CI： 20.9%-37.3%）, respectively; In first-line setting group they were 70.0% （95% CI： 55%-85%） and 41.7% （95% CI： 25.6%-57.8%）, respectively; In non-first line setting group they were 71.6% （95% CI： 61.8%-81.4%） and 23.5% （95% CI： 14.3%-32.7%）, respectively. The disease control rate between the two line-setting groups was insignificant, but the response rate between the two line-setting groups was significant （P = 0.045）. （3） The incidence of acne-like rash was 72.0% （95% CI： 64.8%-79.2%）, the degree Ⅰ-Ⅱ and degree Ⅲ-Ⅳ account for 56.0% （95% CI： 48.1%-63.9%） and 16.0% （95% CI： 10.1%-21.9%）, respectively. No treatment related death, and the hypersensitivity was under control. Conclusion： This study is the first study to summarize the data of Chinese patients with colorectal cancer treated by cetuximab-contained regimen, it showed that the monoclonal antibody was effective and safe for Chinese patients as the West patients with colorectal cancer.
基金Supported by the grant of Major Science and Technology Project of "National Significant New drug Creation" (No. 2008ZX09312-002)
文摘Objective:The combination of cetuximab with standard chemotherapy was not widely studied though it was recommended by NCCN 2009 to apply in non-small cell lung cancer(NSCLC)first-line setting.The aim of this study was to summary the efficacy and safety profiles of all the NSCLC patients available in openly published papers treated with above mentioned regimens.Methods:The PubMed database was used to search all the papers on NSCLC associated with cetuximab treatment,and only the clinical trails applied cetuximab combined with doublets cytotoxic chemotherapy in first-line setting till to 30 November 2009 were collected.And the medians and their 95%CI of objective response rate(ORR),progression free survival(PFS),overall survival(OS),and the common adverse events were calculated.Results:(1)Eight papers including 1032 patients were collected,and all cases were at advanced stage.(2)The ratio of male and female patients was 1.6,50.1%patients were adenocarcinoma and 28.2%patients were squamous cell carcinoma(SCC),90.0%patients were PS=0-1,and 78.2%patients were white ethnic.(3)The disease control rate(DCR),ORR,PFS,and OS were 65.2%(95%CI:60.7%-69.7%),33.2%(95%CI:30.3%-36.1%),5.0 months(95%CI:4.7-5.3)and 10.9 months(95%Cl:9.6-12.2),respectively.Conclusion:This is the first study to summarize the efficacy and safety profiles of cetuximab combined with chemotherapy in NSCLC first-line setting based on all available patients.The addition of cetuximab caused promising prognosis and acceptable side effects excepting higher incidence of neutropenia,and febrile neutropenia.
基金Supported by grants from the National Natural Science Foundation of China(No.81272641,81071872)
文摘Objective: We aimed to evaluate the effect of bevacizumab in the palliative treatment of Chinese metastatic colorectal cancer(mCRC) and its efficacy in different lines. Methods: Patients of mCRC treated with bevacizumab or not at Sun Yat-sen University Cancer Center from 2005 to 2013 were recruited as the study group and control group. The endpoints were objective response rate(ORR), disease control rate(DCR), overall survival(OS) and progression free survival(PFS). The OS and PFS of first-, second- and third-line treatment groups were compared between study group and control group. Results: The median PFS of the study and the control group were 8.2 months(7.0–9.4 months), 5.7 months(4.7–6.6 months), P = 0.001; OS were 26 months(5.4–130.5 months), 18 months(16.6–19.4 months), P < 0.001, respectively. The ORR and DCR of first-, second- and third-line were 30.3%(20/66), 20%(6/30), 17.6%(3/17) and 97%(64/66), 86.7%(26/30), 100%(17/17). In the first-line chemotherapy group, the OS of the study group and the control group were 22.9(5.4–96.7) months and 18(16.6–19.4) months(P < 0.001); PFS were 9.4(8.4–10.4) months and 5.7(4.7–6.6) months(P < 0.001), respectively. While in the second- and third-line setting, only OS were statistically different, PFS had no significant difference. Conclusion: The combination of bevacizumab and chemotherapy had a promising short-term and long-term efficacy in Chinese mCRC patients than those without bevacizumab regimens, and the effect could be better reflected in the first-line treatment.
基金Supported by grants of National Natural Science Foundation of China(No.81302141)Administration of Traditional Chinese Medicine of Guangdong Province,China(No.20111169)+1 种基金Science and Technology Planning Project of Guangdong Province,China(No.2010B031600317)the Sun Yat-sen University Young Teacher Training Project(No.12ykpy56)
文摘Objective: The combination of hepatic arterial chemotherapy(HAIC) and systemic chemotherapy(SYC) has potential effect on colorectal cancer(CRC) patients with unresectable hepatic metastasis. The aim of this retrospective study was to investigate the efficacy and safety of this combined therapeutic regimen on Chinese patients based on single institute experiences. Methods: All 54 patients of this retrospective analysis were diagnosed with CRC with unresectable liver metastasis and received combined HAIC and SYC. Among the patients, 23 of them received HAIC plus SYC when they developed liver metastases as first-line treatment(Group 1), and 31 patients received HAIC plus SYC as non-first-line treatment(Group 2). The different efficacy in two groups was analyzed by SPSS 19.0. Results: The overall response rate(ORR) were 52.2% and 25.8% respectively in Groups 1 and 2(P = 0.047), and the disease control rate(DCR) were 65.2% and 35.5% respectively in Groups 1 and 2(P = 0.031). The median progression-free survival(PFS) were 6.8 and 3.3 months(P = 0.002), the median hepatic progression-free survival(H-PFS) were 8.8 and 3.7 months(P = 0.001), and the median overall survival(OS) were 18.8 and 13.7 months(P = 0.121) in Groups 1 and 2, respectively. No fatal reaction was observed and no significant difference of adverse reaction was found in two groups. Grade 3/4 toxic effects included neutropenia(9.7% in Group 2 only), gastrointestinal reaction(8.7% in Group 1 and 6.5% in Group 2), stomatitis(6.5% in Group 2 only) and hyperbilirubinemia(4.3% in Group 1 only). Conclusion: HAIC combined with SYC showed promising efficacy and safe profiles on CRC patients with unresectable liver metastases.
基金Supported by a grant of Major Science and Technology Project of "National Significant New Drug Creation" (No. 2008ZX09312-002)
文摘Objective： The aim of the study was to compare the efficacies and toxicities of non-platinum doublets （doublets group） with a non-platinum single agent （single-agent group） in previously untreated advanced non-small cell lung cancer （NSCLC） patients with elderly age and/or poor performance status （PS）. Methods： The PubMed database was screened. Subsequently, the hazard ratios （HRs） for overall survival （OS） and progression-free survival （PFS）, relative risks （RRs） for overall response rate （ORR） and one-year survival, and odds ratios （ORs） for the different types of toxicities were pooled using the Review Manager 5.0 package. Results： This study comprised of 1427 patients enrolled in four randomized controlled trials. The pooled HR showed that the doublet group could increase ORR （P = 0.002） with no heterogeneity （P = 0.64）, and might improve OS （P = 0.01 / P = 0.06） with heterogeneity （P 0.001）. There was no significant difference in PFS （P = 0.16） and one-year survival （P = 0.25） between two treatment groups. The doublet group led to more grade 3/4 neutropenia and thrombocytopenia than the single-agent group （P = 0.02 and P = 0.000, respectively）. The incidences of grade 3/4 anemia, vomiting, mucositis, constipation, diarrhea, neurotoxicity, allergy, and fatigue between the two treatment groups were insignificant. Conclusion： Except for neutropenia and thrombocytopenia, the non-platinum doublets could increase ORR, and might improve OS for NSCLC patients with elderly age and/or poor PS without addition of more side effects; however, the doublets showed an increased rate of neutropenia and thrombocytopenia. The addition of doublets may not improve PFS and one-year survival.
文摘OBJECTIVE Data on the efficacy profiles of pemetrexed mono- therapy and pemetrexed plus platinum combination therapy in the non-first-line setting for patients with advanced non-small cell lung cancer （NSCLC） are limited, and previous studies have reported contradictory results. This study investigated and compared the efficacy and toxicity profiles of these two regimens to provide a broader understanding of their dynamics. METHODS Previously treated patients with advanced and/or recurrent NSCLC who received pemetrexed monotherapy or peme- trexed plus platinum combination therapy between January 1, 2006, and December 31, 2009, at Sun Yat-sen University Cancer Center were evaluated. The primary endpoint of this study was progres- sion-free survival （PFS）, whereas the secondary endpoints were overall response rate （ORR）, disease control rate （DCR）, overall survival （OS）, and toxicity. Survival was analyzed using the Kaplan- Meier method. Univariate analysis was performed to identify the factors potentially influencing OS, and chi-square analysis was carried out to compare ORR and DCR. RESULTS Forty-six patients with advanced and/or recurrent NSCLC were analyzed; of these patients, 25 were given pemetrexed monotherapy and 21 received pemetrexed plus platinum combina- tion therapy. The following correspond to the rates recorded for the pemetrexed monotherapy group and the pemetrexed plus platinum group： median PFS, 1.97 and 2.3 months （P=0.565）; median OS, 30.93 and 30.33 months （P=0.877）; ORR, 8% （2/25） and 9.5% （2/21） （P=0.857）; and DCR, 32% （8/25） and 57.1% （12/21） （P=0.09）. Univariate analysis revealed that no factor was correlated with OS from NSCLC （P〉0.05 for all）. Gastrointestinal toxicity in the pemetrexed plus platinum group was modestly higher than that in the pemetrexed monotherapy group （P=0.034）, but other adverse events were similar between the groups. CONCLUSION Compared with pemetrexed monotherapy, peme- trexed plus platinum combination therapy causes more gastro- intestinal toxicities and does not exhibit improved efficacy, in terms of ORR, DCR, PFS, and OS, in the non-first-line setting for NSCLC. However, further research with a higher patient population is necessary to validate this finding.
基金Supported by a grant of Major Science and Technology Project of "National Significant New Drug Creation" (No.2008ZX09312-002)
文摘Objective:Cetuximab combined with chemotherapy has been used to treat non-small cell lung cancer (NSCLC) in recent years, most of them were first line setting.This study was to summarize our experiences in treating NSCLC patients with cetuximab in the non-first line setting.Methods:From October 1st 2006 to December 31st 2009, six NSCLC patients were treated with cetuximab combined standard chemotherapy as non-first line setting in Sun Yat-sen University Cancer Center, China.The short-term efficacies and safeties were analyzed.Results:1.A total of 18 cycles of cetuximab treatment, with a median of two cycles in the whole group.2.There were 6 patients treated as non-first line setting, overall response rate (ORR) was 33.3% (2/6), disease control rate (DCR) was 33.3% (2/6), median time to progression (TTP) was 3.5 (3-4) months, and median OS was 18 (4-28) months.3.There were 50% (3/6) patients occurred acne-like rash within three weeks, their ORR was 66.7% (2/3), and DCR was 66.7% (2/3), however, both of ORR and DCR in patients who didn't occurred acne-like rash were 0% (0/3), the differences of ORR, DCR between two groups were in significant different (P=0.143).4.There was no treatment-associated death and no cetuximab-associated discontinuation.The incidence of acne-like rash was 50% occurred within three weeks, there were two patients suffered side effects associated with chemotherapy.Conclusion:The data of cetuximab application in non-first line setting for patients with NSCLC were rare, and the addition of cetuximab in those population was safe.
基金Supported by a grant from the Major Science and Technology Project of "National Significant New Drug Creation" (No. 2008ZX09312-002)
文摘Objective： Cetuximab is an effective medicine for colorectal cancer bearing wild type Kras. However, few studies of cetuximab on patients with noncolorectal gastrointestinal cancer were available now. The aim of this study was to summarize the efficacy and safety profiles base-on the experiences of 16 patients with noncolorectal gastrointestinal cancer accepted cetuximab-contained regimens treatment. Methods： The clinical data of all patients with noncolorectal gastrointestinal cancer treated by cetuximab combined with chemotherapy and/or radiotherapy from October 1st 2006 to Jun 30th 2009 in Sun Yat-sen University Cancer Center were collected. Results： （1） A total of 16 patients enrolled, including gastric cancer, esophageal carcinoma, pancreatic cancer and cholangiocarcinoma （8, 6, 1 and 1, respectively）. The cetuximab was administered 92 cycles totally with median cycle of 4. （2） PR, SD and PD obtained in 4, 3 and 2 patients respectively in cetuximab ＋ chemotherapy group. The disease control rate, median l-rP and median OS were 77.8% （7/9）, 3.5 months and 3.5 months, respectively. （3） Both of patients in cetuximab ＋ radiotherapy group achieved PR with median TTP of 4 months and 7 months, with median OS of 14 and 28 months, respectively. （4） in evaluable patients, 3 PR obtained in first-line setting, 1 PD and 1 SD achieved in second-line setting, 2 SD and 1 PD appeared in third-line and more than third-line setting. （5） The commonly side effect was neutropenia, however, rash and hypomagnesemia were the common side effects related to cetuximab. Conclusion： Cetuximab-contained regimens show a promising disease control rate, especially in first-line setting, in patients with noncolorectal gastrointestinal cancer, and the side effects both related to cytotoxic agents and related to cetuximab itself is tolerable and manageable. Of course, more phase Ⅲ clinical trails are needed urgently.
文摘Objective: The aim of this study was to investigate the efficacy and safety profiles of bevacizumab, the commonly used monoclonal antibody and its safety profiles were challenging, based on Chinese cancer patients. Methods: All the papers studied on Chinese cancer patients treated by bevacizumab were found in both databases of Chinese journal database for fulltext and PubMed were collected. The commonly used efficacy index such as disease control rate (CR + PR + SD) and response rate (CR + PR) were analyzed, and the bevacizumab related side effects were analyzed too. Results: (1) There were ten original papers contained total 199 patients who were the candidates to analyze the safety profiles, and 115 patients with colorectal cancer in five papers who were candidates to analyze the efficacy. (2) Nine in ten papers set the dose of bevacizumab in 2.5 mg/kg/week - 5 mg/kg/week, and the biweekly was the standard chemotherapy interval. (3) The disease control rate and response rate in Chinese colorectal cancer patients were 85% (95% CI: 79%-92%) and 61% (95% CI: 52%-70%), respectively. (4) The side effects related to bevacizumab were rare and most of them were grades 1-2, and only one case with grade 4 bleeding was recorded and only two cases with discontinuation of bevacizumab since hemoplysis. Also, the grades 3-4 side effects related cytotoxic agents were not common. Conclusion: This study summarized the data of Chinese cancer patients treated by bevacizumab-contained regimens, and it showed that the monoclonal antibody was effective and safe for Chinese patients as the West patients.
基金supported by grants from the National Natural Science Foundation of China(No.81071872)Guangdong Provincial Natural Science Foundation(No. 9151008901000102)
文摘Objective The standard therapy alter failure of the initial non-first line epidermal growth factor receptor tyrosine kinase inhibitor （EGFR-TK1） treatment in advanced non-small cell lung cancer （NSCLC） has not yet been established. The aim of the current study was to identify whether the 2nd TKI treatment or chemotherapy （paclitaxel-containing or non-paclitaxel regimen） is the appropriate treatment for patients with NSCLC based on the efficacy of the initial TKls. Methods Seventy-two advanced NSCLC patients who had accepted 2nd TKIs or chemotherapy immediately alter failure of the initial TKIs in non-first line setting from May 1, 2004 to January 31, 2010 at the Sun Yat-sen University Cancer Center were enrolled. The primary endpoint [2nd progression-free survival （PFS）] and the second endpoint loverall survival （OS）] were compared among the 2＇＇d TKI and chemotherapy groups as well as their subgroups. Results （1） Twenty-one patients were treated with 2 TKIs, and 51 patients were administered chemotherapy after failure of the initial non-first line TKI treatment. There was nonsignificant difference in the responses （P=0.900） [2nd PFS （P=0.833） and OS （P=0.369）] between the 2nd TKI and chemotherapy groups. （2） In tile 2nd TKI group, 9 patients exhibited PFS_〉7 months. The initial TKI treatment group exhibited a longer 2＂d PFS than the other 12 patients with an initial PFS〈7 months （7 months vs. 2 months, P=0.019）. However, these groups had nonsignificantly different OS （P=0.369）. （3） In the chemotherapy group, patients with PFS〈5 months exhibited longer 2＇1~ PFS than those with PFS 〉 5 months in the initial TKI treatment （3 months vs. 2 months, P=0.039）. （4） In the chemotherapy group, nd patients treated with paclitaxel-containing regimen showed longer 2 PFS than those treated with non-paclitaxel regimen （, months t,s. 2.3 months, P=0.043）. Conclusions Patients with PFS_〉7 months or 〈5 months under the initial TKI treatment potentially benefit from the 2nd TK1 treatment or chemotherapy immediately after failure of the non-first line TKIs. The paclitaxel-containing regimen may improve the 2na PFS. However, more patient samples are urgently needed to validate these findings.
文摘Objective: Bevacizumab has been challenging in the treatment of metastatic breast cancer. To investigate its efficacy, optimal partner to combine with and maintenance therapy, we performed a retrospective study based on Chinese patients with metastatic breast cancer (MBC). Methods: Patients with MBC treated with bevacizumab-contained regimens at the Sun Yat-sen University Cancer Center from 2006 to 2010 were recruited to the study. The primary endpoints were overall survival (OS), time to progression (TTP), objective response rate (ORR), and disease control rate (DCR). These endpoints were analyzed using the Kaplan-Meier and Chi-squared tests, respectively. Results: (1) A total of 229 cycles of bevacizumab with a median cycle of 7 (1-34) were administered among 25 patients. (2) In the whole group, ORR and DCR were 60% (15/25) and 76% (19/25), respectively. The mTTP was 5 months (1-21), mOS from diagnosis was 48 months (13-172), mOS from bevacizumab administration was 24 months (1-45). (3) Both ORR (73.7% vs. 16.7%, P = 0.023) and DCR (94.7% vs. 33.3%, P = 0.005) were significant higher once patients treated with the combination of taxanes-based regimen and bevacizamab when compared with the combination with non-taxanes-based regimens. (4) In the taxanes-based group, no matter bevacizumab used in first line or non-first line, the differences of ORR (P = 0.637) and DCR (P = 0.316) were insignificant. However, the maintenance therapy with bevacizumab will bring more longer TTP (P < 0.001) than those without maintenance therapy. Conclusion: Taxanes-based regimens were the optimal candidate to combine with bevacizumab regardless the timing in palliative setting, however, the maintenance therapy with bevacizumab should be considered once indicated.
基金Supported by National Key Clinical Disciplineand the Medical Scientific Research Foundation of Guangdong Province,No.A2016198the Science and Technology Planning Project of Guangdong Province,No.20160916,No.2015B020229001 and No.2014SC111
文摘AIM To investigate the expression of G protein-coupled receptor 31 (GPR31) and its clinical significance in human colorectal cancer (CRC).METHODS To determine the association between the GPR31 expression and the prognosis of patients, we obtained paraffin-embedded pathological specimens from 466 CRC patients who underwent initial resection. A total of 321 patients from the First Affiliated Hospital of Sun Yat-sen University from January 1996 to December 2008 were included as a training cohort, whereas 145 patients from the Sixth Affiliated Hospital of Sun Yat-sen University from January 2007 to November 2008 were included as a validation cohort. We examined GPR31 expression levels in CRC tissues from two independent cohorts via immunohistochemical staining. All patients were categorized into either a GPR31 low expression group or a GPR31 high expression group. The clinicopathological factors and the prognosis of patients in the GPR31 low expression group and GPR31 high expression group were compared.RESULTS We compared the clinicopathological factors and the prognosis of patients in the GPR31 low expression group and GPR31 high expression group. Significant differences were observed in the number of patients in pM classification between patients in the GPR31 low expression group and GPR31 high expression group (P = 0.007). The five-year survival and tumor-free survival rates of patients were 84.3% and 82.2% in the GPR31 low expression group, respectively, and both rates were 59.7% in the GPR31 high expression group (P < 0.05). Results of the Cox proportional hazard regression model revealed that GPR31 upregulation was associated with shorter overall survival and tumor-free survival of patients with CRC (P < 0.05). Multivariate analysis identified GPR31 expression in colorectal cancer as an independent predictive factor of CRC patient survival (P < 0.05).CONCLUSION High GPR31 expression levels were found to be correlated with pM classification of CRC and to serve as an independent predictive factor of poor survival of CRC patients.
