BACKGROUND No clear guidelines for long-term postoperative maintenance therapy have been established for patients with lung oligometastases from colorectal cancer(CRC)who achieve radiological no evidence of disease af...BACKGROUND No clear guidelines for long-term postoperative maintenance therapy have been established for patients with lung oligometastases from colorectal cancer(CRC)who achieve radiological no evidence of disease after radiofrequency ablation(RFA)treatment.We compared the outcomes of patients with lung oligometa-stases from CRC after RFA plus maintenance capecitabine with RFA alone.AIM To determine whether adding capecitabine to RFA improves prognosis compared with RFA alone.METHODS This multicenter retrospective study included consecutive patients from two tertiary cancer centers treated for pulmonary oligometastases from CRC between 2016 and 2023.Subjects were assigned to RFA plus capecitabine(combined)or RFA alone(only RFA)groups.Primary outcomes included overall survival(OS)and progression-free survival(PFS)survival and the secondary outcome was local tumor progression(LTP).The OS,PFS,and LTP rates were compared between the two groups.In addition,prognostic factors were identified using univariate and multivariate analyses.RESULTS Combination therapy(RFA+capecitabine,n=148)and RFA monotherapy(n=99)were compared in patients with CRC and lung metastases.The median OS was 37.8 months(22.4,50.3),the PFS was 18.7 months(13.0,36.5),and the LTP was 31.5 months(20.0,52.4)in the Only RFA group.The OS increased significantly(P=0.011)and the LTP decreased at all time points(P<0.001)in the combined group.The multivariate cox analysis revealed that combined chemotherapy significantly improved OS,with hazard ratios ranging from 0.29 to 0.35(all P<0.015)after adjusting for demographic,tumor,and treatment-related factors.The risk of death was consistently lower in the combination therapy group compared to RFA monotherapy.CONCLUSION RFA prolongs survival and local control in patients with CRC pulmonary oligometastases.Adjuvant capecitabine increases OS and reduces LTP compared to RFA alone,but PFS did not significantly change.展开更多
Objective： To investigate the efficacy and safety of capecitabine maintenance therapy（MT） after initial capecitabine plus docetaxel（XT） chemotherapy in patients with metastatic triple-negative breast cancer（m T...Objective： To investigate the efficacy and safety of capecitabine maintenance therapy（MT） after initial capecitabine plus docetaxel（XT） chemotherapy in patients with metastatic triple-negative breast cancer（m TNBC）.Methods： Fifty-five m TNBC patients treated with XT chemotherapy between May 2007 and June 2013 were retrospectively analyzed. When initial disease control was achieved by the combination chemotherapy, capecitabine was continued for 32 patients（MT）, while 23 patients remained without any treatment（nonMT）. We compared progression-free survival（PFS） and safety of both groups.Results： The median PFS of 55 patients was 8.1 months, overall median PFS time of 32 patients in the capecitabine MT group and 23 in the non-MT group was 10.1 vs. 6.7 months（P=0.032）, respectively. When compared PFS time of maintenance treatment, single-agent capecitabine prolonged PFS by 7.1 months, for non-MT patients, the PFS without any treatment was 3.1 months, and this between-group difference was statistically significant（P=0.003）. Adverse events, including of hematologic toxicity, gastrointestinal toxicities, hand-foot syndrome and abnormal liver function were not significantly different between two groups.Conclusions： After initial disease control was achieved with the XT combination chemotherapy, capecitabine MT can significantly prolong PFS time with a favorable safety profile in m TNBC patients.展开更多
BACKGROUND Infliximab was the first approved biologic treatment for moderate to severe Crohn's disease(MS-CD) in China. However, the cost-effectiveness of infliximab maintenance therapy(IMT) for MS-CD relative to ...BACKGROUND Infliximab was the first approved biologic treatment for moderate to severe Crohn's disease(MS-CD) in China. However, the cost-effectiveness of infliximab maintenance therapy(IMT) for MS-CD relative to conventional maintenance therapy remained unclarified.AIM To assess the cost-effectiveness of IMT for MS-CD in Chinese patients from the perspective of Chinese public insurance payer.METHODS A cohort of MS-CD patients managed in a Chinese tertiary care hospital was created to compare IMT with conventional maintenance therapy(CMT) for clinical outcomes and direct medical costs over a 1-year observation time using conventional regression analyses. A decision-analytic model with the generated evidence was constructed to assess the cost-effectiveness of IMT relative to CMT using reimbursed medical costs.RESULTS Based on the included 389 patients, IMT was associated with significantly higher disease remission chance [odds ratio: 4.060, P = 0.003], lower risk of developing new complications(odds ratio: 0.527, P = 0.010), higher utility value for quality of life(coefficient 0.822, P = 0.008), and lower total hospital costs related to disease management(coefficient-0.378, P = 0.008) than CMT. Base-case cost-effectiveness analysis estimated that IMT could cost Chinese health insurance payers $55260 to gain one quality-adjusted life year(QALY). The cost-effectiveness of IMT was mainly driven by the estimate of quality of life, treatment efficacy of maintenance therapy, mortality risk associated with active disease, and unit price of infliximab. The probability that IMT was cost-effective at a willingness-to-pay threshold of three times gross domestic product [2018 Chinese gross domestic product per capita(GDPPC)] was 86.4%.CONCLUSION IMT significantly improved real-world health outcomes and cost the Chinese public health insurance payers less than one GDPPC to gain one QALY in Chinese MS-CD patients.展开更多
Objective:To evaluate the efficacy and toxicity of capecitabine maintenance therapy in metastatic colorectal cancer(mCRC) patients.Methods:From June 2001 to November 2006,after they had achieved clinical response from...Objective:To evaluate the efficacy and toxicity of capecitabine maintenance therapy in metastatic colorectal cancer(mCRC) patients.Methods:From June 2001 to November 2006,after they had achieved clinical response from first-line chemotherapy,patients with mCRC in our hospital received two different treatment strategies.Thirty-three patients in maintenance group were treated with capecitabine 1000 mg/m2 po bid d1-14,q21d.Fifty-two patients in non-maintenance group did not receive any further chemotherapy.Results:Patients in maintenance group and non-maintenance group both received FOLFOX,FOLFIRI and XELOX as first-line therapy.The median chemotherapy cycles the two groups received were the same(6 vs 6).The response rates of first-line chemotherapy were 33.3% in maintenance group and 32.7% in non-maintenance group.Patients in maintenance group received 3-9 cycles of capecitabine therapy(median cycle 4).29/33(87.9%) patients in maintenance group and 47/52(90.4%) in non-maintenance group received following second-line chemotherapy,and no patients underwent targeted therapy.The median survival time and TTP were 40.4 months(95%CI:24.2-56.6) and 9.0 months(95%CI:6.7-11.3) in maintenance group,as compared with 21.5 months(95%CI:14.9-28.0,P=0.015) and 6.5 months(95%CI:4.4-8.5,P=0.007) in non-maintenance group.No severe adverse event was observed in the capecitabine maintenance group.Conclusion:mCRC patients could benefit from capecitabine maintenance therapy by prolonging survival time and TTP.展开更多
Objective： To investigate the efficacy and safety of gefitinib as maintenance therapy for advanced non-small cell lung cancer （NSCLC） patients who obtained disease control （DC） after first-line chemotherapy in Ch...Objective： To investigate the efficacy and safety of gefitinib as maintenance therapy for advanced non-small cell lung cancer （NSCLC） patients who obtained disease control （DC） after first-line chemotherapy in Chinese population. Methods： Chinese patients with advanced NSCLC treated with standard chemotherapy and obtained DC were assigned to receive gefitinib as maintenance treatment. The primary end point was overall survival time （OS）, the second end point was disease control rate （DCR） and progression-free survival time （PFS）. DCR included complete response （CR） plus partial response （PR） and plus stable disease （SD）. The impact of epidermal growth factor receptor （EGFR） mutation status on the treatment as exploratory point was also evaluated by denaturing high-performance liquid chromatography （DHPLC）. Results： Among 75 enrolled patients, the overall response rate was 37% and the DCR （CR ＋ PR ＋SD） was 66%. The median PFS and OS were 17.13 months and 26.13 months respectively, with 1- and 2-year survival rates 89.3% and 34.7%. Patients harboring somatic EGFR mutations obtained a prolonged median PFS and OS compared with EGFR wide type （25.1 vs. 13.0 months, P=0.019 and 33.37 vs. 25.57 months, P=0.014, respectively）. In COX regression model, only EGFR mutation status was the independently factor influencing both PFS and OS （P=0.029 and 0.017, respectively）, however, rash status was the predictor in terms of PFS （P=0.027）. Conclusion： Gefitinib produced encouraging survival when delivered as maintenance therapy in Chinese patients obtaining DC after first-line chemotherapy, especially for patients carrying somatic EGFR mutations. EGFR mutation is an independently predictive factor of survival.展开更多
BACKGROUND Previous reports have demonstrated that S-1 has remarkable effects in the maintenance treatment of advanced non-small-cell lung cancer(NSCLC),and has less toxic and side effects than conventional drugs.AIM ...BACKGROUND Previous reports have demonstrated that S-1 has remarkable effects in the maintenance treatment of advanced non-small-cell lung cancer(NSCLC),and has less toxic and side effects than conventional drugs.AIM To investigate the efficacy and safety of S-1 maintenance therapy in patients with advanced NSCLC.METHODS Ninety-four patients with NSCLC admitted to our hospital from September 2015 to April 2018 were included in the study and divided into the S-1 group(47 cases)and the gemcitabine group(47 cases)by random digital table method.The S-1 group was treated with S-1,while the gemcitabine group received gemcitabine treatment.The clinical efficacy and quality of life of the patients after treatment in the two groups were evaluated.RESULTS There was no significant difference in the total effectiveness rate between the two groups(P=0.519).The quality-of-life scores indicated that there was no significant difference between the two groups in terms of four dimensions of the GQOLI-74 questionnaire(P=0.518,0.094,0.338,0.418).The incidence of nausea and vomiting,granulocytopenia and diarrhea in the S-1 group was significantly lower than that in the gemcitabine group(P=0.001,0.001 and 0.001,respectively).There was no significant difference in the incidence of thrombocytopenia(P=0.366),the progression-free survival(P=0.064),and the survival between the two groups(P=0.050).CONCLUSION S-1 maintenance therapy shows a significant therapeutic effect in patients with advanced NSCLC.It has the same clinical efficacy as gemcitabine,but with less toxic and side effects than conventional drugs.展开更多
Objective： The purpose of this study was to observe the efficacy and toxicities of capecitabine-based chemotherapy and capecitabine monotherapy as maintenance therapy in the treatment of metastatic breast cancer（MBC...Objective： The purpose of this study was to observe the efficacy and toxicities of capecitabine-based chemotherapy and capecitabine monotherapy as maintenance therapy in the treatment of metastatic breast cancer（MBC）.Patients and methods： A total of 98 MBC patients were treated with capecitabine combined with vinorelbine（NX）. Results： The median number of treatment was 6 cycles（1-7 cycles）. There were two cases of complete remission（CR）, 58 partial remission, 27 stable disease（SD）, 11 progression disease. The overall response rate（ORR）（CR ＋ PR） was 61.2%. The clinical benefit rate（CBR） was 75.5%. Fifty of effective patients received with capecitabine monotherapy as maintenance therapy. The ORR（CR ＋ PR） was 4%. The CBR was 48%. The median progression-free survival（PFS） was 12 months. In maintenance therapy or not, the median post metastasis survival rate（MSR） was 63 and 28 months, respectively. In the combination therapy group, the major grade 3/4 toxicities included hand-foot syndrome（3.1%）, skin pigmentation（2.0%）, diarrhoea and abdominal distension（5.1%）, stomatitis（1.0%）, and leukopenia（20.4%）.Conclusions： Capecitabine-based combination therapy and single-agent capecitabine maintenance therapy were well tolerated and effective to MBC.展开更多
Objective The aim of the study was to evaluate the efficacy and safety of etoposide plus thalidomide as maintenance therapy for elderly patients with advanced non-small cell lung cancer（NSCLC） without disease progre...Objective The aim of the study was to evaluate the efficacy and safety of etoposide plus thalidomide as maintenance therapy for elderly patients with advanced non-small cell lung cancer（NSCLC） without disease progression after first-line chemotherapy.Methods After four to six cycles of platinum-based first-line therapy, 64 elderly patients with advanced NSCLC without disease progression who were treated in the General Hospital of Shenyang Military Region（China） from 2014 to 2016 were enrolled in this study. According to the different maintenance treatment methods, patients were divided as having received etoposide plus thalidomide therapy（treatment group, n = 32） and best supportive care（control group, n = 32）. Disease control and progression-free survival（PFS） were compared between the two groups. Results The recent curative effect objective response rates of the treatment group and the control group were 31.3% and 3.1%, respectively, and the disease control rates were 71.9% and 31.3%, respectively. The Kaplan-Meier survival curves of the two groups were significantly different（χ2 = 26.532, P = 0.001）. The median PFS for the treatment group and control group was 6.0 months [95% confidence interval（CI） = 4.3–7.9 months] and 3.2 months（95% CI = 2.6–3.8 months）, respectively. The side effects in the treatment group included hematologic abnormalities, gastrointestinal toxicity, and impaired liver function, which were relieved after symptomatic support therapy and drug withdrawal.Conclusion Etoposide plus thalidomide as maintenance therapy is associated with a significantly longer PFS with tolerable toxicity for elderly patients with advanced NSCLC.AcknowledgementThe authors would like to thank Liu Zhongzheng for his technical assistance.展开更多
Nowadays,advanced non-small cell lung cancer (NSCLC) is still an incurable disease.However,recent researches on maintenance therapy have led to considerable progress.Recently,pemetrexed and erlotinib have been approve...Nowadays,advanced non-small cell lung cancer (NSCLC) is still an incurable disease.However,recent researches on maintenance therapy have led to considerable progress.Recently,pemetrexed and erlotinib have been approved for maintenance chemotherapy by both the U.S.Food and Drug Administration and European Medicines Agency.However,there are not adequate data to support the maintenance therapy as the standard treatment for advanced NSCLC and there has been no conclusive predictor of who will get benefit from maintenance chemotherapy and what type of maintenance,continuation or switch,is preferred.This article reviews the main studies on maintenance therapy of advanced NSCLC and discusses the results available to date.展开更多
BACKGROUND Blastic plasmacytoid dendritic cell neoplasm(BPDCN)is a rare,highly invasive malignant neoplasm.There is no universally accepted standard of care because of its rarity and the dearth of prospective research...BACKGROUND Blastic plasmacytoid dendritic cell neoplasm(BPDCN)is a rare,highly invasive malignant neoplasm.There is no universally accepted standard of care because of its rarity and the dearth of prospective research.It is still challenging for some patients to achieve persistent clinical remission or cure,despite the success of allogeneic hematopoietic stem cell transplantation(allo-HSCT),indicating that there is still a significant recurrence rate.We report a case of prevention of BPDCN allograft recurrence by azacitidine maintenance therapy and review the relevant literature.CASE SUMMARY We report a 41-year-old man with BPDCN who was admitted to hospital due to skin sclerosis for>5 mo’duration.BPDCN was diagnosed by combined clinical assessment and laboratory examinations.Following diagnosis,the patients underwent induction consolidation chemotherapy to achieve the first complete remission,followed by bridging allo-HSCT.Post-transplantation,azacitidine(75 mg/m2 for 7 d)was administered as maintenance therapy,with repeat administration every 4–6 wk and appropriate extension of the chemotherapy cycle.After 10 cycles,the patient has been disease free for 26 mo after transplantation.Regular assessments of bone marrow morphology,minimal residual disease,full donor chimerism,Epstein–Barr virus,and cytomegalovirus all yielded normal results with no abnormalities detected.CONCLUSION Azacitidine may be a safe and effective maintenance treatment for BPDCN following transplantation because there were no overt adverse events during the course of treatment.展开更多
Background:Poly adenosine-diphosphate-ribose polymerase(PARP)inhibitors(PARPi)have been approved to act as first-line maintenance(FL-M)therapy and as platinum-sensitive recurrent maintenance(PSR-M)therapy for ovarian ...Background:Poly adenosine-diphosphate-ribose polymerase(PARP)inhibitors(PARPi)have been approved to act as first-line maintenance(FL-M)therapy and as platinum-sensitive recurrent maintenance(PSR-M)therapy for ovarian cancer in China for>5 years.Herein,we have analyzed the clinical-application characteristics of olaparib and niraparib in ovarian cancer-maintenance therapy in a real-world setting to strengthen our understanding and promote their rational usage.Methods:A retrospective chart review identified patients with newly diagnosed or platinum-sensitive recurrent ovarian cancer,who received olaparib or niraparib as maintenance therapy at Sichuan Cancer Hospital between August 1,2018,and December 31,2021.Patient medical records were reviewed.We grouped and analyzed patients based on the type of PARPi they used(the olaparib group and the niraparib group)and the line of PARPi maintenance therapy(the FL-M setting and the PSR-M setting).The primary endpoint was the 24-month progression-free survival(PFS)rate.Results:In total,131 patients(olaparib:n=67,51.1%;niraparib:n=64,48.9%)were enrolled.Breast cancer susceptibility genes(BRCA)mutations(BRCA m)were significantly less common in the niraparib group than in the olaparib group[9.4%(6/64)vs.62.7%(42/67),P<0.001],especially in the FL-M setting[10.4%(5/48)vs.91.4%(32/35),P<0.001].The 24-month progression-free survival(PFS)rates in the FL-M and PSR-M settings were 60.4%and 45.7%,respectively.In patients with BRCA m,the 24-month PFS rates in the FL-M and PSR-M settings were 62.2%and 72.7%,respectively.Conclusions:Olaparib and niraparib were effective in patients with ovarian cancer without any new safety signals except for skin pigmentation.In patients with BRCA m,the 24-month PFS of the PARPi used in the PSR-M setting was even higher than that used in the FL-M setting.展开更多
Objective To assess the efficacy and safety of thioamide as a maintenance therapy for peripheral T-cell lymphoma(PTCL).Methods This study retrospectively analyzed the data from 58 patients with PTCL who were treated i...Objective To assess the efficacy and safety of thioamide as a maintenance therapy for peripheral T-cell lymphoma(PTCL).Methods This study retrospectively analyzed the data from 58 patients with PTCL who were treated in the Department of Hematology at the First Affiliated Hospital of Nanjing Medical University from January 2015to July2022.Chidamidewas orally administered as a maintenance therapy after first-line or salvage treatment.Progression-free survival(PFS),overall survival(OS),and safety were analyzed.Results Among the 58 patients with PTCL,43 were males and 15 were females,and the median age was 66(range 29-83)years.Thirty-nine patients received thioamide as first-line maintenance therapy,and 19 patients received thioamide as maintenance therapyafter salvage treatment.The median maintenance therapy duration was 16 months(range 1-72 months),with a median PFS time of 33(2-74)months,and the median OS time had not tbeen reached.Patients who received first-line maintenance therapy withtthioamidedemonstrated superior PFS and OS outcomes compared with patients who received thioamide maintenance therapy after salvage treatment(median PFS time:not reached vs 7 months,P<0.001;median 0S time:not reached us 67 months,P=0.009).The most prevalent adverse reaction was a hematologic adverse reaction(77.6%).Twelve(20.7%)patients underwent a dose reduction and three patients discontinued treatment.Conclusion Patients receiving thioamide maintenance therapy demonstrate a promising PFS and OS with a manageable safety profile,especially as the first-line maintenance therapy.展开更多
0bjective To investigate frsty Chinese patent medicine Realgar-Indigo Naturalis Formula(RIF),which mainly contains tetra-arsenic tetra-sufide formula for the maintenance therapy of ovarian cancer.Methods We recruited ...0bjective To investigate frsty Chinese patent medicine Realgar-Indigo Naturalis Formula(RIF),which mainly contains tetra-arsenic tetra-sufide formula for the maintenance therapy of ovarian cancer.Methods We recruited all patients with ovarian epithelial cancer who were diagnosed at Peking University People's Hospital between January 2018 and January 2021.All these patients received standard chemotherapy and achieved complete remission.The patients took RIF(60 mg/kg daily in an oral divided dose)in a 4-week-on and 4-week-off regimen.The main fficacy indicators,including progresson-free interval(PFI)and overall survival(0S),were measured and evaluated regularly.Additionally,the safety and side effects were closely monitored.Results A total of 20 patients were included in this study.Regarding the treatment,patients received oral arsenic for 3--18 courses(the longest treatment interval was equivalent to 3 years).The median follow-up time was 43 months.Subsequently,data analysis was conducted,revealing that the median PFI was 23 months.P53 mutations were worse than P53 wild-type PFI,and the median PFI was 19.2 months(p=0.03).Regarding P53 wt status,the HR for disease progression or death was 0.25(95%CI 0.07 to 0.91).The 3-year OS was 89%,and the 5-year OS was 77%.The common side effects were abdominal pain and diarrhoea.Conclusions RIF compound proved to be an efctive Chinese patent medicine maintenance therapy for ovarian cancer,thus prolonging the PFI of patients and controllable side effects,in particular simple and convenient for the method of administration and better potency ratio.These findings need to be validated in multicentre research studies with large sample sizes.Trial registration number ChiCTR2400090349.展开更多
Objective:Maintenance treatment with rituximab has been used in some nodal lymphomas,such as follicular and diffuse large cell lymphoma.The aim of this study was to evaluate the survival of extra nodal lymphoma patien...Objective:Maintenance treatment with rituximab has been used in some nodal lymphomas,such as follicular and diffuse large cell lymphoma.The aim of this study was to evaluate the survival of extra nodal lymphoma patients under maintenance treatment.Materials and methods:From July 2008 to December 2017,after induction treatment in patients with extra nodal lymphoma,if the patients consented and the drug was available,they were treated with rituximab every 3 months for 2 years.Results:A total of 112 patients with extra nodal lymphoma met the inclusion criteria.Among them,89 patients had high-grade lymphomas and 23 patients were in the group of low-grade lymphomas.The group of patients with high-grade lymphoma who received the rituximab-containing regimen as a maintenance treatment had lower rates of recurrence and death compared to the group that received rituximab only in the induction phase.In patients with low-grade lymphoma,the recurrence rate and mortality were also lower in the group receiving maintenance treatment compared to other groups,but the difference was not statistically significant.Conclusion:The use of rituximab in patients with extra nodal lymphoma as maintenance can increase the survival of the patients.展开更多
Background:Capecitabine was previously used as a second-line or salvage therapy for metastatic nasopharyngeal carcinoma(NPC)and has shown satisfactory curative effect as maintenance therapy in other metastatic cancers...Background:Capecitabine was previously used as a second-line or salvage therapy for metastatic nasopharyngeal carcinoma(NPC)and has shown satisfactory curative effect as maintenance therapy in other metastatic cancers.This study aimed to explore the role of capecitabine as maintenance therapy in de novo metastatic NPC patients with different plasma Epstein-Barr virus(EBV)DNA levels before treatment.Methods:We selected de novo metastatic NPC patients treated with locoregional radiotherapy(LRRT)for this retrospective study.The propensity score matching(PSM)was applied to balance potential confounders between patients who underwent capecitabine maintenance therapy and those who did not with a ratio of 1:3.Overall survival(OS)was the primary endpoint.The association between capecitabine maintenance therapy and survival was assessed using the log-rank test and a Cox proportional hazard model.Results:Among all patients eligible for this study,64 received capecitabine maintenance therapy after LRRT.After PSM,192 patients were identified in the nonmaintenance group.In the matched cohort,patients treated with capecitabine achieved a higher 3-year OS rate compared with patients in the non-maintenance group(68.5%vs.61.8%,P=0.037).Multivariate analysis demonstrated that capecitabine maintenance therapy was an independent prognostic factor.In subgroup analysis,3-year OS rate was comparable between the maintenance and non-maintenance groups in patients with high pretreatment EBV DNA levels(˃30,000 copies/mL)(54.8%vs.45.8%,P=0.835),whereas patients with low pretreatment EBV DNA levels(≤30,000 copies/mL)could benefit from capecitabine maintenance therapy in OS(90.0%vs.68.1%,P=0.003).Conclusion:Capecitabine maintenance therapy may be superior to non-maintenance therapy in prolonging OS for de novo metastatic NPC patients with pretreatment EBV DNA≤30,000 copies/mL.groups in patients with high pretreatment EBV DNA levels(˃30,000 copies/mL)(54.8%vs.45.8%,P=0.835),whereas patients with low pretreatment EBV DNA levels(≤30,000 copies/mL)could benefit from capecitabine maintenance therapy in OS(90.0%vs.68.1%,P=0.003).Conclusion:Capecitabine maintenance therapy may be superior to non-maintenance therapy in prolonging OS for de novo metastatic NPC patients with pretreatment EBV DNA≤30,000 copies/mL.展开更多
Background:Erosive esophagitis(EE)is a gastroesophageal reflux disease characterized by mucosal breaks in the esophagus.Proton pump inhibitors are widely used as maintenance therapy for EE,but many patients still rela...Background:Erosive esophagitis(EE)is a gastroesophageal reflux disease characterized by mucosal breaks in the esophagus.Proton pump inhibitors are widely used as maintenance therapy for EE,but many patients still relapse.In this trial,we evaluated the noninferiority of vonoprazan vs.lansoprazole as maintenance therapy in patients with healed EE.Methods:We performed a double-blind,double-dummy,multicenter,phase 3 clinical trial among non-Japanese Asian adults with endoscopically confirmed healed EE from April 2015 to February 2019.Patients from China,South Korea,and Malaysia were randomized to vonoprazan 10 mg or 20 mg once daily or lansoprazole 15 mg once daily for 24 weeks.The primary endpoint was endoscopically confirmed EE recurrence rate over 24 weeks with a noninferiority margin of 10%using a two-sided 95%confidence interval(CI).Treatment-emergent adverse events(TEAEs)were recorded.Results:Among 703 patients,EE recurrence was observed in 24/181(13.3%)and 21/171(12.3%)patients receiving vonoprazan 10 mg or 20 mg,respectively,and 47/184(25.5%)patients receiving lansoprazole(differences:-12.3%[95%CI,-20.3%to-4.3%]and-13.3%[95%CI,-21.3%to-5.3%],respectively),meeting the primary endpoint of noninferiority to lansoprazole in preventing EE recurrence at 24 weeks.Evidence of superiority(upper bound of 95%CI<0%)was also observed.At 12 weeks,endoscopically confirmed EE recurrence was observed in 5/18,2/20,and 7/20 of patients receiving vonoprazan 10 mg,vonoprazan 20 mg,and lansoprazole,respectively.TEAEs were experienced by 66.8%(157/235),69.0%(156/226),and 65.3%(158/242)of patients receiving vonoprazan 10 mg,vonoprazan 20 mg,and lansoprazole,respectively.The most common TEAE was upper respiratory tract infection in 12.8%(30/235)and 12.8%(29/226)patients in vonoprazan 10 mg and 20 mg groups,respectively and 8.7%(21/242)patients in lansoprazole group.Conclusion:Vonoprazan maintenance therapy was well-tolerated and noninferior to lansoprazole for preventing EE recurrence in Asian patients with healed EE.Trial Registration:https://clinicaltrials.gov;NCT02388737.展开更多
Lung cancer is the leading cancer in terms of incidence and mortality in China and its incidence in China is predicted to increase in the next 20 years.1 The majority of the lung cancer patients are diagnosed with adv...Lung cancer is the leading cancer in terms of incidence and mortality in China and its incidence in China is predicted to increase in the next 20 years.1 The majority of the lung cancer patients are diagnosed with advanced stage disease,for which chemotherapy or targeted therapies are the mainstay palliative treatments.Before the identification of single-driver mutations,like the epidermal growth factor receptor （EGFR） mutation,platinum-based doublet was the standard first line treatment for advanced stage nonsmall cell lung cancer （NSCLC） patients with a good performance status （PS）.However,patient prognosis remains poor and the modest treatment efficacy seems to have reached a plateau despite newer generation of platinum doublets.2 The recommendation for the duration of first line platinum doublet treatment is 4-6 cycles.3 The paradigm was based on the fact that a protracted course of chemotherapy did not prolong survival but introduced cumulative toxicities.4,5 The use of maintenance therapy （MT）,defined by Grossi et al6 as the prolongation of chemotherapy with the administration of additional drugs at the end of a defined number of initial chemotherapy cycles after achieving maximum tumor response,was not considered as a standard option in the past.展开更多
Background Can single-agent maintenance therapy be considered as an ideal strategy for non-small cell lung cancer （NSCLC） treatment to achieve prolonged survival and tolerated toxicity？ A systematic review and meta...Background Can single-agent maintenance therapy be considered as an ideal strategy for non-small cell lung cancer （NSCLC） treatment to achieve prolonged survival and tolerated toxicity？ A systematic review and meta-analysis was performed to etuc（date this issue. Methods The electronic databases were searched for RCTs comparing single-agent maintenance therapy with placebo, best support care or observation. The required data for estimation of response, survival and toxicity were extracted from the publications and the combined data were calculated. Results Eleven RCTs involving 3686 patients were identified. We found a statistically significant higher probability of tumor response for patients with maintenance therapy versus control patients （OR： 2.80, 95% CI： 2.15-3.64）. Patients receiving maintenance therapy had significantly longer progression-free survival （PFS） （HR： 0.67, 95% CI： 0.62-0.71） and overall survival （OS） （HR： 0.84, 95% CI： 0.78-0.90）. However, maintenance therapy was associated with more severe toxicities （OR： 6.45, 95% CI： 4.61-9.01）. Conclusion In patients with advanced NSCLC, the use of single-agent maintenance therapy is associated with higher response rate and significantly prolongs PFS and OS despite of the risk of additional toxicity.展开更多
Although olaparib has demonstrated substantial clinical benefits as maintenance therapy in BRCA mutation-carrying women with newly diagnosed advanced ovarian cancer,its effectiveness in patients without BRCA mutations...Although olaparib has demonstrated substantial clinical benefits as maintenance therapy in BRCA mutation-carrying women with newly diagnosed advanced ovarian cancer,its effectiveness in patients without BRCA mutations remains poorly investigated.This study aims to provide the first evidence on the efficacy of mono-olaparib maintenance therapy in such context.Using real-world data from 11 high-volume tertiary care centers in China,a retrospective cohort study was conducted to assess the efficacy and safety of olaparib as first-line maintenance therapy in patients with BRCA wild-type ovarian cancer.The primary objective was 1-year progression-free survival rate.Safety was also evaluated.Fifty patients with a median age of 54 years were included,and all of them tested negative for BRCA mutations but positive for homologous recombination deficiency(HRD).The 1-year PFS rate was 75.2%(95%CI,63.4 to 89.2),and the median PFS was 21.0 months(95%CI,13.8 to 28.2).All the patients received olaparib at a starting dose of 300 mg twice daily,and none experienced serious adverse events(AEs).Eight(16%)patients had dose adjustment,but none discontinued olaparib treatment due to AEs.We provide the first evidence that mono-olaparib could be a safe and effective maintenance treatment option for patients newly diagnosed with HRD-positive/BRCA wild-type ovarian cancer.展开更多
Preventing the recurrence of lung oligometastases after local therapy in patients with colorectal cancer is an area requiring investigation.A recent article demonstrated that adding capecitabine maintenance therapy af...Preventing the recurrence of lung oligometastases after local therapy in patients with colorectal cancer is an area requiring investigation.A recent article demonstrated that adding capecitabine maintenance therapy after radiofrequency ablation improved the 5-year overall survival(88.7%vs 69.1%)and reduced local tumor progression(22.7%vs 49.0%)compared with radiofrequency ablation alone.Although progression-free survival did not differ significantly between the two treatments,multivariate analysis confirmed a robust survival benefit.These findings support the use of systemic maintenance to eradicate micrometastases after locoregional control and warrant validation in prospective randomized trials.展开更多
基金Supported by the National Natural Science Foundation of China,No.82072034。
文摘BACKGROUND No clear guidelines for long-term postoperative maintenance therapy have been established for patients with lung oligometastases from colorectal cancer(CRC)who achieve radiological no evidence of disease after radiofrequency ablation(RFA)treatment.We compared the outcomes of patients with lung oligometa-stases from CRC after RFA plus maintenance capecitabine with RFA alone.AIM To determine whether adding capecitabine to RFA improves prognosis compared with RFA alone.METHODS This multicenter retrospective study included consecutive patients from two tertiary cancer centers treated for pulmonary oligometastases from CRC between 2016 and 2023.Subjects were assigned to RFA plus capecitabine(combined)or RFA alone(only RFA)groups.Primary outcomes included overall survival(OS)and progression-free survival(PFS)survival and the secondary outcome was local tumor progression(LTP).The OS,PFS,and LTP rates were compared between the two groups.In addition,prognostic factors were identified using univariate and multivariate analyses.RESULTS Combination therapy(RFA+capecitabine,n=148)and RFA monotherapy(n=99)were compared in patients with CRC and lung metastases.The median OS was 37.8 months(22.4,50.3),the PFS was 18.7 months(13.0,36.5),and the LTP was 31.5 months(20.0,52.4)in the Only RFA group.The OS increased significantly(P=0.011)and the LTP decreased at all time points(P<0.001)in the combined group.The multivariate cox analysis revealed that combined chemotherapy significantly improved OS,with hazard ratios ranging from 0.29 to 0.35(all P<0.015)after adjusting for demographic,tumor,and treatment-related factors.The risk of death was consistently lower in the combination therapy group compared to RFA monotherapy.CONCLUSION RFA prolongs survival and local control in patients with CRC pulmonary oligometastases.Adjuvant capecitabine increases OS and reduces LTP compared to RFA alone,but PFS did not significantly change.
文摘Objective： To investigate the efficacy and safety of capecitabine maintenance therapy（MT） after initial capecitabine plus docetaxel（XT） chemotherapy in patients with metastatic triple-negative breast cancer（m TNBC）.Methods： Fifty-five m TNBC patients treated with XT chemotherapy between May 2007 and June 2013 were retrospectively analyzed. When initial disease control was achieved by the combination chemotherapy, capecitabine was continued for 32 patients（MT）, while 23 patients remained without any treatment（nonMT）. We compared progression-free survival（PFS） and safety of both groups.Results： The median PFS of 55 patients was 8.1 months, overall median PFS time of 32 patients in the capecitabine MT group and 23 in the non-MT group was 10.1 vs. 6.7 months（P=0.032）, respectively. When compared PFS time of maintenance treatment, single-agent capecitabine prolonged PFS by 7.1 months, for non-MT patients, the PFS without any treatment was 3.1 months, and this between-group difference was statistically significant（P=0.003）. Adverse events, including of hematologic toxicity, gastrointestinal toxicities, hand-foot syndrome and abnormal liver function were not significantly different between two groups.Conclusions： After initial disease control was achieved with the XT combination chemotherapy, capecitabine MT can significantly prolong PFS time with a favorable safety profile in m TNBC patients.
基金Supported by Zhejiang Medical and Health Science and Technology Project,No. 2020KY608Natural Science Foundation of Zhejiang Province,No. LQ19H030013。
文摘BACKGROUND Infliximab was the first approved biologic treatment for moderate to severe Crohn's disease(MS-CD) in China. However, the cost-effectiveness of infliximab maintenance therapy(IMT) for MS-CD relative to conventional maintenance therapy remained unclarified.AIM To assess the cost-effectiveness of IMT for MS-CD in Chinese patients from the perspective of Chinese public insurance payer.METHODS A cohort of MS-CD patients managed in a Chinese tertiary care hospital was created to compare IMT with conventional maintenance therapy(CMT) for clinical outcomes and direct medical costs over a 1-year observation time using conventional regression analyses. A decision-analytic model with the generated evidence was constructed to assess the cost-effectiveness of IMT relative to CMT using reimbursed medical costs.RESULTS Based on the included 389 patients, IMT was associated with significantly higher disease remission chance [odds ratio: 4.060, P = 0.003], lower risk of developing new complications(odds ratio: 0.527, P = 0.010), higher utility value for quality of life(coefficient 0.822, P = 0.008), and lower total hospital costs related to disease management(coefficient-0.378, P = 0.008) than CMT. Base-case cost-effectiveness analysis estimated that IMT could cost Chinese health insurance payers $55260 to gain one quality-adjusted life year(QALY). The cost-effectiveness of IMT was mainly driven by the estimate of quality of life, treatment efficacy of maintenance therapy, mortality risk associated with active disease, and unit price of infliximab. The probability that IMT was cost-effective at a willingness-to-pay threshold of three times gross domestic product [2018 Chinese gross domestic product per capita(GDPPC)] was 86.4%.CONCLUSION IMT significantly improved real-world health outcomes and cost the Chinese public health insurance payers less than one GDPPC to gain one QALY in Chinese MS-CD patients.
文摘Objective:To evaluate the efficacy and toxicity of capecitabine maintenance therapy in metastatic colorectal cancer(mCRC) patients.Methods:From June 2001 to November 2006,after they had achieved clinical response from first-line chemotherapy,patients with mCRC in our hospital received two different treatment strategies.Thirty-three patients in maintenance group were treated with capecitabine 1000 mg/m2 po bid d1-14,q21d.Fifty-two patients in non-maintenance group did not receive any further chemotherapy.Results:Patients in maintenance group and non-maintenance group both received FOLFOX,FOLFIRI and XELOX as first-line therapy.The median chemotherapy cycles the two groups received were the same(6 vs 6).The response rates of first-line chemotherapy were 33.3% in maintenance group and 32.7% in non-maintenance group.Patients in maintenance group received 3-9 cycles of capecitabine therapy(median cycle 4).29/33(87.9%) patients in maintenance group and 47/52(90.4%) in non-maintenance group received following second-line chemotherapy,and no patients underwent targeted therapy.The median survival time and TTP were 40.4 months(95%CI:24.2-56.6) and 9.0 months(95%CI:6.7-11.3) in maintenance group,as compared with 21.5 months(95%CI:14.9-28.0,P=0.015) and 6.5 months(95%CI:4.4-8.5,P=0.007) in non-maintenance group.No severe adverse event was observed in the capecitabine maintenance group.Conclusion:mCRC patients could benefit from capecitabine maintenance therapy by prolonging survival time and TTP.
基金supported by the grants from the National "863" High Technology Research and Development Program of China (No.2006AA02A401)the Capital Development Foundation of Beijing (No.30772472)
文摘Objective： To investigate the efficacy and safety of gefitinib as maintenance therapy for advanced non-small cell lung cancer （NSCLC） patients who obtained disease control （DC） after first-line chemotherapy in Chinese population. Methods： Chinese patients with advanced NSCLC treated with standard chemotherapy and obtained DC were assigned to receive gefitinib as maintenance treatment. The primary end point was overall survival time （OS）, the second end point was disease control rate （DCR） and progression-free survival time （PFS）. DCR included complete response （CR） plus partial response （PR） and plus stable disease （SD）. The impact of epidermal growth factor receptor （EGFR） mutation status on the treatment as exploratory point was also evaluated by denaturing high-performance liquid chromatography （DHPLC）. Results： Among 75 enrolled patients, the overall response rate was 37% and the DCR （CR ＋ PR ＋SD） was 66%. The median PFS and OS were 17.13 months and 26.13 months respectively, with 1- and 2-year survival rates 89.3% and 34.7%. Patients harboring somatic EGFR mutations obtained a prolonged median PFS and OS compared with EGFR wide type （25.1 vs. 13.0 months, P=0.019 and 33.37 vs. 25.57 months, P=0.014, respectively）. In COX regression model, only EGFR mutation status was the independently factor influencing both PFS and OS （P=0.029 and 0.017, respectively）, however, rash status was the predictor in terms of PFS （P=0.027）. Conclusion： Gefitinib produced encouraging survival when delivered as maintenance therapy in Chinese patients obtaining DC after first-line chemotherapy, especially for patients carrying somatic EGFR mutations. EGFR mutation is an independently predictive factor of survival.
文摘BACKGROUND Previous reports have demonstrated that S-1 has remarkable effects in the maintenance treatment of advanced non-small-cell lung cancer(NSCLC),and has less toxic and side effects than conventional drugs.AIM To investigate the efficacy and safety of S-1 maintenance therapy in patients with advanced NSCLC.METHODS Ninety-four patients with NSCLC admitted to our hospital from September 2015 to April 2018 were included in the study and divided into the S-1 group(47 cases)and the gemcitabine group(47 cases)by random digital table method.The S-1 group was treated with S-1,while the gemcitabine group received gemcitabine treatment.The clinical efficacy and quality of life of the patients after treatment in the two groups were evaluated.RESULTS There was no significant difference in the total effectiveness rate between the two groups(P=0.519).The quality-of-life scores indicated that there was no significant difference between the two groups in terms of four dimensions of the GQOLI-74 questionnaire(P=0.518,0.094,0.338,0.418).The incidence of nausea and vomiting,granulocytopenia and diarrhea in the S-1 group was significantly lower than that in the gemcitabine group(P=0.001,0.001 and 0.001,respectively).There was no significant difference in the incidence of thrombocytopenia(P=0.366),the progression-free survival(P=0.064),and the survival between the two groups(P=0.050).CONCLUSION S-1 maintenance therapy shows a significant therapeutic effect in patients with advanced NSCLC.It has the same clinical efficacy as gemcitabine,but with less toxic and side effects than conventional drugs.
文摘Objective： The purpose of this study was to observe the efficacy and toxicities of capecitabine-based chemotherapy and capecitabine monotherapy as maintenance therapy in the treatment of metastatic breast cancer（MBC）.Patients and methods： A total of 98 MBC patients were treated with capecitabine combined with vinorelbine（NX）. Results： The median number of treatment was 6 cycles（1-7 cycles）. There were two cases of complete remission（CR）, 58 partial remission, 27 stable disease（SD）, 11 progression disease. The overall response rate（ORR）（CR ＋ PR） was 61.2%. The clinical benefit rate（CBR） was 75.5%. Fifty of effective patients received with capecitabine monotherapy as maintenance therapy. The ORR（CR ＋ PR） was 4%. The CBR was 48%. The median progression-free survival（PFS） was 12 months. In maintenance therapy or not, the median post metastasis survival rate（MSR） was 63 and 28 months, respectively. In the combination therapy group, the major grade 3/4 toxicities included hand-foot syndrome（3.1%）, skin pigmentation（2.0%）, diarrhoea and abdominal distension（5.1%）, stomatitis（1.0%）, and leukopenia（20.4%）.Conclusions： Capecitabine-based combination therapy and single-agent capecitabine maintenance therapy were well tolerated and effective to MBC.
文摘Objective The aim of the study was to evaluate the efficacy and safety of etoposide plus thalidomide as maintenance therapy for elderly patients with advanced non-small cell lung cancer（NSCLC） without disease progression after first-line chemotherapy.Methods After four to six cycles of platinum-based first-line therapy, 64 elderly patients with advanced NSCLC without disease progression who were treated in the General Hospital of Shenyang Military Region（China） from 2014 to 2016 were enrolled in this study. According to the different maintenance treatment methods, patients were divided as having received etoposide plus thalidomide therapy（treatment group, n = 32） and best supportive care（control group, n = 32）. Disease control and progression-free survival（PFS） were compared between the two groups. Results The recent curative effect objective response rates of the treatment group and the control group were 31.3% and 3.1%, respectively, and the disease control rates were 71.9% and 31.3%, respectively. The Kaplan-Meier survival curves of the two groups were significantly different（χ2 = 26.532, P = 0.001）. The median PFS for the treatment group and control group was 6.0 months [95% confidence interval（CI） = 4.3–7.9 months] and 3.2 months（95% CI = 2.6–3.8 months）, respectively. The side effects in the treatment group included hematologic abnormalities, gastrointestinal toxicity, and impaired liver function, which were relieved after symptomatic support therapy and drug withdrawal.Conclusion Etoposide plus thalidomide as maintenance therapy is associated with a significantly longer PFS with tolerable toxicity for elderly patients with advanced NSCLC.AcknowledgementThe authors would like to thank Liu Zhongzheng for his technical assistance.
文摘Nowadays,advanced non-small cell lung cancer (NSCLC) is still an incurable disease.However,recent researches on maintenance therapy have led to considerable progress.Recently,pemetrexed and erlotinib have been approved for maintenance chemotherapy by both the U.S.Food and Drug Administration and European Medicines Agency.However,there are not adequate data to support the maintenance therapy as the standard treatment for advanced NSCLC and there has been no conclusive predictor of who will get benefit from maintenance chemotherapy and what type of maintenance,continuation or switch,is preferred.This article reviews the main studies on maintenance therapy of advanced NSCLC and discusses the results available to date.
文摘BACKGROUND Blastic plasmacytoid dendritic cell neoplasm(BPDCN)is a rare,highly invasive malignant neoplasm.There is no universally accepted standard of care because of its rarity and the dearth of prospective research.It is still challenging for some patients to achieve persistent clinical remission or cure,despite the success of allogeneic hematopoietic stem cell transplantation(allo-HSCT),indicating that there is still a significant recurrence rate.We report a case of prevention of BPDCN allograft recurrence by azacitidine maintenance therapy and review the relevant literature.CASE SUMMARY We report a 41-year-old man with BPDCN who was admitted to hospital due to skin sclerosis for>5 mo’duration.BPDCN was diagnosed by combined clinical assessment and laboratory examinations.Following diagnosis,the patients underwent induction consolidation chemotherapy to achieve the first complete remission,followed by bridging allo-HSCT.Post-transplantation,azacitidine(75 mg/m2 for 7 d)was administered as maintenance therapy,with repeat administration every 4–6 wk and appropriate extension of the chemotherapy cycle.After 10 cycles,the patient has been disease free for 26 mo after transplantation.Regular assessments of bone marrow morphology,minimal residual disease,full donor chimerism,Epstein–Barr virus,and cytomegalovirus all yielded normal results with no abnormalities detected.CONCLUSION Azacitidine may be a safe and effective maintenance treatment for BPDCN following transplantation because there were no overt adverse events during the course of treatment.
基金This work was supported by grants from the Natural Science Foundation of Sichuan Province(No.2023NSFSC0702)the Basic Research Business Fee Project of Central Universities at the University of Electronic Science and Technology of China(No.ZYGX2022J024).
文摘Background:Poly adenosine-diphosphate-ribose polymerase(PARP)inhibitors(PARPi)have been approved to act as first-line maintenance(FL-M)therapy and as platinum-sensitive recurrent maintenance(PSR-M)therapy for ovarian cancer in China for>5 years.Herein,we have analyzed the clinical-application characteristics of olaparib and niraparib in ovarian cancer-maintenance therapy in a real-world setting to strengthen our understanding and promote their rational usage.Methods:A retrospective chart review identified patients with newly diagnosed or platinum-sensitive recurrent ovarian cancer,who received olaparib or niraparib as maintenance therapy at Sichuan Cancer Hospital between August 1,2018,and December 31,2021.Patient medical records were reviewed.We grouped and analyzed patients based on the type of PARPi they used(the olaparib group and the niraparib group)and the line of PARPi maintenance therapy(the FL-M setting and the PSR-M setting).The primary endpoint was the 24-month progression-free survival(PFS)rate.Results:In total,131 patients(olaparib:n=67,51.1%;niraparib:n=64,48.9%)were enrolled.Breast cancer susceptibility genes(BRCA)mutations(BRCA m)were significantly less common in the niraparib group than in the olaparib group[9.4%(6/64)vs.62.7%(42/67),P<0.001],especially in the FL-M setting[10.4%(5/48)vs.91.4%(32/35),P<0.001].The 24-month progression-free survival(PFS)rates in the FL-M and PSR-M settings were 60.4%and 45.7%,respectively.In patients with BRCA m,the 24-month PFS rates in the FL-M and PSR-M settings were 62.2%and 72.7%,respectively.Conclusions:Olaparib and niraparib were effective in patients with ovarian cancer without any new safety signals except for skin pigmentation.In patients with BRCA m,the 24-month PFS of the PARPi used in the PSR-M setting was even higher than that used in the FL-M setting.
文摘Objective To assess the efficacy and safety of thioamide as a maintenance therapy for peripheral T-cell lymphoma(PTCL).Methods This study retrospectively analyzed the data from 58 patients with PTCL who were treated in the Department of Hematology at the First Affiliated Hospital of Nanjing Medical University from January 2015to July2022.Chidamidewas orally administered as a maintenance therapy after first-line or salvage treatment.Progression-free survival(PFS),overall survival(OS),and safety were analyzed.Results Among the 58 patients with PTCL,43 were males and 15 were females,and the median age was 66(range 29-83)years.Thirty-nine patients received thioamide as first-line maintenance therapy,and 19 patients received thioamide as maintenance therapyafter salvage treatment.The median maintenance therapy duration was 16 months(range 1-72 months),with a median PFS time of 33(2-74)months,and the median OS time had not tbeen reached.Patients who received first-line maintenance therapy withtthioamidedemonstrated superior PFS and OS outcomes compared with patients who received thioamide maintenance therapy after salvage treatment(median PFS time:not reached vs 7 months,P<0.001;median 0S time:not reached us 67 months,P=0.009).The most prevalent adverse reaction was a hematologic adverse reaction(77.6%).Twelve(20.7%)patients underwent a dose reduction and three patients discontinued treatment.Conclusion Patients receiving thioamide maintenance therapy demonstrate a promising PFS and OS with a manageable safety profile,especially as the first-line maintenance therapy.
基金supported by the thehorizontal project:Antitumor effects of Realgar-Indigo naturalis formula(RIF)combined with Apatinib on platinumresistant ovarian cancer Research(Project No.2022-Z-23).
文摘0bjective To investigate frsty Chinese patent medicine Realgar-Indigo Naturalis Formula(RIF),which mainly contains tetra-arsenic tetra-sufide formula for the maintenance therapy of ovarian cancer.Methods We recruited all patients with ovarian epithelial cancer who were diagnosed at Peking University People's Hospital between January 2018 and January 2021.All these patients received standard chemotherapy and achieved complete remission.The patients took RIF(60 mg/kg daily in an oral divided dose)in a 4-week-on and 4-week-off regimen.The main fficacy indicators,including progresson-free interval(PFI)and overall survival(0S),were measured and evaluated regularly.Additionally,the safety and side effects were closely monitored.Results A total of 20 patients were included in this study.Regarding the treatment,patients received oral arsenic for 3--18 courses(the longest treatment interval was equivalent to 3 years).The median follow-up time was 43 months.Subsequently,data analysis was conducted,revealing that the median PFI was 23 months.P53 mutations were worse than P53 wild-type PFI,and the median PFI was 19.2 months(p=0.03).Regarding P53 wt status,the HR for disease progression or death was 0.25(95%CI 0.07 to 0.91).The 3-year OS was 89%,and the 5-year OS was 77%.The common side effects were abdominal pain and diarrhoea.Conclusions RIF compound proved to be an efctive Chinese patent medicine maintenance therapy for ovarian cancer,thus prolonging the PFI of patients and controllable side effects,in particular simple and convenient for the method of administration and better potency ratio.These findings need to be validated in multicentre research studies with large sample sizes.Trial registration number ChiCTR2400090349.
文摘Objective:Maintenance treatment with rituximab has been used in some nodal lymphomas,such as follicular and diffuse large cell lymphoma.The aim of this study was to evaluate the survival of extra nodal lymphoma patients under maintenance treatment.Materials and methods:From July 2008 to December 2017,after induction treatment in patients with extra nodal lymphoma,if the patients consented and the drug was available,they were treated with rituximab every 3 months for 2 years.Results:A total of 112 patients with extra nodal lymphoma met the inclusion criteria.Among them,89 patients had high-grade lymphomas and 23 patients were in the group of low-grade lymphomas.The group of patients with high-grade lymphoma who received the rituximab-containing regimen as a maintenance treatment had lower rates of recurrence and death compared to the group that received rituximab only in the induction phase.In patients with low-grade lymphoma,the recurrence rate and mortality were also lower in the group receiving maintenance treatment compared to other groups,but the difference was not statistically significant.Conclusion:The use of rituximab in patients with extra nodal lymphoma as maintenance can increase the survival of the patients.
基金National Key R&D Program of China,Grant/Award Numbers:2016YFC0902003,2017YFC1309003,2017YFC0908500National Natural Science Foundation of China,Grant/Award Numbers:81425018,81672868,81602371+9 种基金Sun Yat-sen University Clinical Research 5010 Program,Grant/Award Numbers:201707020039,2014A020212103,16zxyc02Sci-Tech Project Foundation of Guangzhou City,Grant/Award Number:201707020039National Key Basic Research Program of China,Grant/Award Number:2013CB910304Special Support Plan of Guangdong Province,Grant/Award Number:2014TX01R145Sci-Tech Project Foundation of Guangdong Province,Grant/Award Number:2014A020212103Health&Medical Collaborative Innovation Project of Guangzhou City,Grant/Award Number:201400000001National Science&Technology Pillar Program during the Twelfth Five-year Plan Period,Grant/Award Number:2014BAI09B10PhD Start-up Fund of Natural Science Foundation of Guangdong Province,China,Grant/Award Number:2016A030310221cultivation foundation for the junior teachers in Sun Yat-sen University,Grant/Award Number:16ykpy28foundation for major projects and new cross subjects in Sun Yat-sen University,Grant/Award Number:16ykjc38。
文摘Background:Capecitabine was previously used as a second-line or salvage therapy for metastatic nasopharyngeal carcinoma(NPC)and has shown satisfactory curative effect as maintenance therapy in other metastatic cancers.This study aimed to explore the role of capecitabine as maintenance therapy in de novo metastatic NPC patients with different plasma Epstein-Barr virus(EBV)DNA levels before treatment.Methods:We selected de novo metastatic NPC patients treated with locoregional radiotherapy(LRRT)for this retrospective study.The propensity score matching(PSM)was applied to balance potential confounders between patients who underwent capecitabine maintenance therapy and those who did not with a ratio of 1:3.Overall survival(OS)was the primary endpoint.The association between capecitabine maintenance therapy and survival was assessed using the log-rank test and a Cox proportional hazard model.Results:Among all patients eligible for this study,64 received capecitabine maintenance therapy after LRRT.After PSM,192 patients were identified in the nonmaintenance group.In the matched cohort,patients treated with capecitabine achieved a higher 3-year OS rate compared with patients in the non-maintenance group(68.5%vs.61.8%,P=0.037).Multivariate analysis demonstrated that capecitabine maintenance therapy was an independent prognostic factor.In subgroup analysis,3-year OS rate was comparable between the maintenance and non-maintenance groups in patients with high pretreatment EBV DNA levels(˃30,000 copies/mL)(54.8%vs.45.8%,P=0.835),whereas patients with low pretreatment EBV DNA levels(≤30,000 copies/mL)could benefit from capecitabine maintenance therapy in OS(90.0%vs.68.1%,P=0.003).Conclusion:Capecitabine maintenance therapy may be superior to non-maintenance therapy in prolonging OS for de novo metastatic NPC patients with pretreatment EBV DNA≤30,000 copies/mL.groups in patients with high pretreatment EBV DNA levels(˃30,000 copies/mL)(54.8%vs.45.8%,P=0.835),whereas patients with low pretreatment EBV DNA levels(≤30,000 copies/mL)could benefit from capecitabine maintenance therapy in OS(90.0%vs.68.1%,P=0.003).Conclusion:Capecitabine maintenance therapy may be superior to non-maintenance therapy in prolonging OS for de novo metastatic NPC patients with pretreatment EBV DNA≤30,000 copies/mL.
文摘Background:Erosive esophagitis(EE)is a gastroesophageal reflux disease characterized by mucosal breaks in the esophagus.Proton pump inhibitors are widely used as maintenance therapy for EE,but many patients still relapse.In this trial,we evaluated the noninferiority of vonoprazan vs.lansoprazole as maintenance therapy in patients with healed EE.Methods:We performed a double-blind,double-dummy,multicenter,phase 3 clinical trial among non-Japanese Asian adults with endoscopically confirmed healed EE from April 2015 to February 2019.Patients from China,South Korea,and Malaysia were randomized to vonoprazan 10 mg or 20 mg once daily or lansoprazole 15 mg once daily for 24 weeks.The primary endpoint was endoscopically confirmed EE recurrence rate over 24 weeks with a noninferiority margin of 10%using a two-sided 95%confidence interval(CI).Treatment-emergent adverse events(TEAEs)were recorded.Results:Among 703 patients,EE recurrence was observed in 24/181(13.3%)and 21/171(12.3%)patients receiving vonoprazan 10 mg or 20 mg,respectively,and 47/184(25.5%)patients receiving lansoprazole(differences:-12.3%[95%CI,-20.3%to-4.3%]and-13.3%[95%CI,-21.3%to-5.3%],respectively),meeting the primary endpoint of noninferiority to lansoprazole in preventing EE recurrence at 24 weeks.Evidence of superiority(upper bound of 95%CI<0%)was also observed.At 12 weeks,endoscopically confirmed EE recurrence was observed in 5/18,2/20,and 7/20 of patients receiving vonoprazan 10 mg,vonoprazan 20 mg,and lansoprazole,respectively.TEAEs were experienced by 66.8%(157/235),69.0%(156/226),and 65.3%(158/242)of patients receiving vonoprazan 10 mg,vonoprazan 20 mg,and lansoprazole,respectively.The most common TEAE was upper respiratory tract infection in 12.8%(30/235)and 12.8%(29/226)patients in vonoprazan 10 mg and 20 mg groups,respectively and 8.7%(21/242)patients in lansoprazole group.Conclusion:Vonoprazan maintenance therapy was well-tolerated and noninferior to lansoprazole for preventing EE recurrence in Asian patients with healed EE.Trial Registration:https://clinicaltrials.gov;NCT02388737.
文摘Lung cancer is the leading cancer in terms of incidence and mortality in China and its incidence in China is predicted to increase in the next 20 years.1 The majority of the lung cancer patients are diagnosed with advanced stage disease,for which chemotherapy or targeted therapies are the mainstay palliative treatments.Before the identification of single-driver mutations,like the epidermal growth factor receptor （EGFR） mutation,platinum-based doublet was the standard first line treatment for advanced stage nonsmall cell lung cancer （NSCLC） patients with a good performance status （PS）.However,patient prognosis remains poor and the modest treatment efficacy seems to have reached a plateau despite newer generation of platinum doublets.2 The recommendation for the duration of first line platinum doublet treatment is 4-6 cycles.3 The paradigm was based on the fact that a protracted course of chemotherapy did not prolong survival but introduced cumulative toxicities.4,5 The use of maintenance therapy （MT）,defined by Grossi et al6 as the prolongation of chemotherapy with the administration of additional drugs at the end of a defined number of initial chemotherapy cycles after achieving maximum tumor response,was not considered as a standard option in the past.
文摘Background Can single-agent maintenance therapy be considered as an ideal strategy for non-small cell lung cancer （NSCLC） treatment to achieve prolonged survival and tolerated toxicity？ A systematic review and meta-analysis was performed to etuc（date this issue. Methods The electronic databases were searched for RCTs comparing single-agent maintenance therapy with placebo, best support care or observation. The required data for estimation of response, survival and toxicity were extracted from the publications and the combined data were calculated. Results Eleven RCTs involving 3686 patients were identified. We found a statistically significant higher probability of tumor response for patients with maintenance therapy versus control patients （OR： 2.80, 95% CI： 2.15-3.64）. Patients receiving maintenance therapy had significantly longer progression-free survival （PFS） （HR： 0.67, 95% CI： 0.62-0.71） and overall survival （OS） （HR： 0.84, 95% CI： 0.78-0.90）. However, maintenance therapy was associated with more severe toxicities （OR： 6.45, 95% CI： 4.61-9.01）. Conclusion In patients with advanced NSCLC, the use of single-agent maintenance therapy is associated with higher response rate and significantly prolongs PFS and OS despite of the risk of additional toxicity.
文摘Although olaparib has demonstrated substantial clinical benefits as maintenance therapy in BRCA mutation-carrying women with newly diagnosed advanced ovarian cancer,its effectiveness in patients without BRCA mutations remains poorly investigated.This study aims to provide the first evidence on the efficacy of mono-olaparib maintenance therapy in such context.Using real-world data from 11 high-volume tertiary care centers in China,a retrospective cohort study was conducted to assess the efficacy and safety of olaparib as first-line maintenance therapy in patients with BRCA wild-type ovarian cancer.The primary objective was 1-year progression-free survival rate.Safety was also evaluated.Fifty patients with a median age of 54 years were included,and all of them tested negative for BRCA mutations but positive for homologous recombination deficiency(HRD).The 1-year PFS rate was 75.2%(95%CI,63.4 to 89.2),and the median PFS was 21.0 months(95%CI,13.8 to 28.2).All the patients received olaparib at a starting dose of 300 mg twice daily,and none experienced serious adverse events(AEs).Eight(16%)patients had dose adjustment,but none discontinued olaparib treatment due to AEs.We provide the first evidence that mono-olaparib could be a safe and effective maintenance treatment option for patients newly diagnosed with HRD-positive/BRCA wild-type ovarian cancer.
文摘Preventing the recurrence of lung oligometastases after local therapy in patients with colorectal cancer is an area requiring investigation.A recent article demonstrated that adding capecitabine maintenance therapy after radiofrequency ablation improved the 5-year overall survival(88.7%vs 69.1%)and reduced local tumor progression(22.7%vs 49.0%)compared with radiofrequency ablation alone.Although progression-free survival did not differ significantly between the two treatments,multivariate analysis confirmed a robust survival benefit.These findings support the use of systemic maintenance to eradicate micrometastases after locoregional control and warrant validation in prospective randomized trials.
