Objective： The aim of this prospective, single-arm phase II trial was to confirm the safety and efficacy of neoadjuvant chemotherapy（NAC） using oxaliplatin plus capecitabine（Cap OX） for patients with operable loc...Objective： The aim of this prospective, single-arm phase II trial was to confirm the safety and efficacy of neoadjuvant chemotherapy（NAC） using oxaliplatin plus capecitabine（Cap OX） for patients with operable locally advanced colon cancer（CC）.Methods： Patients with computed tomography-defined T4 or lymph node-positive CCs were enrolled. After radiological staging, patients were treated with at least 2 cycles of NAC consisting of 130 mg/m2 oxaliplatin on d 1,plus 1,000 mg/m2 capecitabine twice daily for 14 d every 3 weeks, followed by surgery, and then with the rest cycles of adjuvant chemotherapy. Radiological response was evaluated after 2 cycles of NAC. Tumor response, treatment toxicity, and surgical complications were recorded. The pathological response to therapy was evaluated according to the tumor regression grade（TRG） score. The primary endpoint was pathologic tumor response. This trial is registered in Clinical Trials.gov（No： NCT02415829）.Results： Forty-seven patients were enrolled in the study. Forty-two patients completed the planned treatments.The total radiological response rate was 68%（32/47）, including complete and partial response rates of 2%（1/47）and 66%（31/47）, respectively. Stable disease was observed in 32%（15/47） and progressive disease was observed in none. Complete pathologic response, major regression, and at least moderate regression were achieved in 1（2%）, 2（4%）, and 29（62%） patients, respectively. Four patients developed grade 3 treatment toxicities. One patient with wound infection occurred after operation（1/47, 2%）. There was no treatment-related death.Conclusions： Our results suggest that NAC with Cap OX is an effective and safe treatment option for patients with locally advanced CCs.展开更多
BACKGROUND Non-magnifying endoscopy with narrow-band imaging(NM-NBI)has been frequently used in routine screening of esophagus squamous cell carcinoma(ESCC).The performance of NBI for screening of early ESCC is,howeve...BACKGROUND Non-magnifying endoscopy with narrow-band imaging(NM-NBI)has been frequently used in routine screening of esophagus squamous cell carcinoma(ESCC).The performance of NBI for screening of early ESCC is,however,significantly affected by operator experience.Artificial intelligence may be a unique approach to compensate for the lack of operator experience.AIM To construct a computer-aided detection(CAD)system for application in NMNBI to identify early ESCC and to compare it with our previously reported CAD system with endoscopic white-light imaging(WLI).METHODS A total of 2167 abnormal NM-NBI images of early ESCC and 2568 normal images were collected from three institutions(Zhongshan Hospital of Fudan University,Xuhui Hospital,and Kiang Wu Hospital)as the training dataset,and 316 pairs of images,each pair including images obtained by WLI and NBI(same part),were collected for validation.Twenty endoscopists participated in this study to review the validation images with or without the assistance of the CAD systems.The diagnostic results of the two CAD systems and improvement in diagnostic efficacy of endoscopists were compared in terms of sensitivity,specificity,accuracy,positive predictive value,and negative predictive value.RESULTS The area under receiver operating characteristic curve for CAD-NBI was 0.9761.For the validation dataset,the sensitivity,specificity,accuracy,positive predictive value,and negative predictive value of CAD-NBI were 91.0%,96.7%,94.3%,95.3%,and 93.6%,respectively,while those of CAD-WLI were 98.5%,83.1%,89.5%,80.8%,and 98.7%,respectively.CAD-NBI showed superior accuracy and specificity than CAD-WLI(P=0.028 and P≤0.001,respectively),while CAD-WLI had higher sensitivity than CAD-NBI(P=0.006).By using both CAD-WLI and CAD-NBI,the endoscopists could improve their diagnostic efficacy to the highest level,with accuracy,sensitivity,and specificity of 94.9%,92.4%,and 96.7%,respectively.CONCLUSION The CAD-NBI system for screening early ESCC has higher accuracy and specificity than CAD-WLI.Endoscopists can achieve the best diagnostic efficacy using both CAD-WLI and CAD-NBI.展开更多
Objective:This study aims to analyze how changes in pathological diagnosis practice and molecular detection technology have affected clinical outcomes for colorectal cancer(CRC)patients in Fudan University Shanghai Ca...Objective:This study aims to analyze how changes in pathological diagnosis practice and molecular detection technology have affected clinical outcomes for colorectal cancer(CRC)patients in Fudan University Shanghai Cancer Center(FUSCC).Methods:This retrospective cohort study analyzed 21,141 pathologically confirmed CRC cases diagnosed at FUSCC from 2008 to 2020.Patients were divided into five groups for different analytical purposes:(1)the before vs.since 2014 groups to analyze the influence of the changes in the classification criteria of pT3 and pT4 staging on the survival of patients;(2)the partial vs.total mesorectal excision(TME)groups to analyze whether evaluation of completeness of the mesorectum have impact on the survival of patients;(3)the tumor deposit(TD)(+)N0 vs.TD(+)N1c groups to analyze the influence of the changes in the pN staging on the survival of patients with positive TD and negative regional lymph node metastasis(LNM);(4)the before vs.since 2013 groups to analyze the influence of the changes in the testing process of deficient mismatch repair on the survival of patients;and(5)the groups with vs.without RAS/BRAF gene mutation testing to analyze the influence of these testing on the survival of patients.Patients’clinicopathological parameters,including age at diagnosis,sex,tumor size,location,differentiation,mucinous subtype,TD,lymphovascular invasion,perineural invasion,tumor depth,LNM and distant metastasis,and tumor-node-metastasis(TNM)stage,were compared between groups.Kaplan-Meier analysis with log rank method was performed for patients’overall survival(OS)and disease-free survival(DFS)analyses.Results:In pathological reports,there were three parameter changes that impacted patient outcomes.Firstly,changes in the pT staging criteria led to a shift of the ratio of patients with stage pT3 to stage pT4 from 1:110.9 to 1:0.26.In comparison to patients admitted before 2014(n=4,754),a significant difference in prognosis between pT3 and pT4 stages was observed since 2014(n=9,965).Secondly,we began to evaluate the completeness of the mesorectum since 2016.As a result,91.0%of patients with low rectal cancer underwent TME(n=4,111)surgery,and patients with TME had significantly better OS compared with partial mesorectal excision(PME,n=409).Thirdly,we began to stage TD(+)LNM(-)as N1c since 2017.The results showed that N1c(n=127)but not N0(n=39)can improve the prognosis of patients without LNM and distal metastasis.In molecular testing,there have been three and five iterations of updates regarding mismatch repair(MMR)/microsatellite instability(MSI)status and RAS/BRAF gene mutation detection,respectively.The standardization of MMR status testing has sharply decreased the proportion of deficient MMR(dMMR)patients(from 32.5%to 7.4%)since 2013.The prognosis of patients underwent MMR status testing since 2013(n=867)were significantly better than patients before 2013(n=1,313).In addition,detection of RAS/BRAF gene mutation status(n=5,041)resulted in better DFS but not OS,for patients with stage I-III disease(n=16,557).Conclusion:Over the past few decades,updates in elements in pathological reports,as well as the development of standardized tests for MMR/MSI status and RAS/BRAF gene mutations have significantly improved patient outcomes.展开更多
基金supported by grants from the National Natural Science Foundation of China (Grant No. 81472620)Shanghai Science and Technology Planning Fund (No. 13140902100)+1 种基金Shanghai Combination Study Project for Major Diseases (No. 2014ZYJB0101)Shanghai Health and Family Planning Commission (No. JGY1404)
文摘Objective： The aim of this prospective, single-arm phase II trial was to confirm the safety and efficacy of neoadjuvant chemotherapy（NAC） using oxaliplatin plus capecitabine（Cap OX） for patients with operable locally advanced colon cancer（CC）.Methods： Patients with computed tomography-defined T4 or lymph node-positive CCs were enrolled. After radiological staging, patients were treated with at least 2 cycles of NAC consisting of 130 mg/m2 oxaliplatin on d 1,plus 1,000 mg/m2 capecitabine twice daily for 14 d every 3 weeks, followed by surgery, and then with the rest cycles of adjuvant chemotherapy. Radiological response was evaluated after 2 cycles of NAC. Tumor response, treatment toxicity, and surgical complications were recorded. The pathological response to therapy was evaluated according to the tumor regression grade（TRG） score. The primary endpoint was pathologic tumor response. This trial is registered in Clinical Trials.gov（No： NCT02415829）.Results： Forty-seven patients were enrolled in the study. Forty-two patients completed the planned treatments.The total radiological response rate was 68%（32/47）, including complete and partial response rates of 2%（1/47）and 66%（31/47）, respectively. Stable disease was observed in 32%（15/47） and progressive disease was observed in none. Complete pathologic response, major regression, and at least moderate regression were achieved in 1（2%）, 2（4%）, and 29（62%） patients, respectively. Four patients developed grade 3 treatment toxicities. One patient with wound infection occurred after operation（1/47, 2%）. There was no treatment-related death.Conclusions： Our results suggest that NAC with Cap OX is an effective and safe treatment option for patients with locally advanced CCs.
基金Supported by National Key R&D Program of China,No.2018YFC1315000,No.2018YFC1315005,No.2019YFC1315800,and No.2019YFC1315802National Natural Science Foundation of China,No.81861168036 and No.81702305+2 种基金Science and Technology Commission Foundation of Shanghai Municipality,No.19411951600,and No.19411951601Macao SAR Science and Technology Development Foundation,No.0023/2018/AFJDawn Program of Shanghai Education Commission,No.18SG08.
文摘BACKGROUND Non-magnifying endoscopy with narrow-band imaging(NM-NBI)has been frequently used in routine screening of esophagus squamous cell carcinoma(ESCC).The performance of NBI for screening of early ESCC is,however,significantly affected by operator experience.Artificial intelligence may be a unique approach to compensate for the lack of operator experience.AIM To construct a computer-aided detection(CAD)system for application in NMNBI to identify early ESCC and to compare it with our previously reported CAD system with endoscopic white-light imaging(WLI).METHODS A total of 2167 abnormal NM-NBI images of early ESCC and 2568 normal images were collected from three institutions(Zhongshan Hospital of Fudan University,Xuhui Hospital,and Kiang Wu Hospital)as the training dataset,and 316 pairs of images,each pair including images obtained by WLI and NBI(same part),were collected for validation.Twenty endoscopists participated in this study to review the validation images with or without the assistance of the CAD systems.The diagnostic results of the two CAD systems and improvement in diagnostic efficacy of endoscopists were compared in terms of sensitivity,specificity,accuracy,positive predictive value,and negative predictive value.RESULTS The area under receiver operating characteristic curve for CAD-NBI was 0.9761.For the validation dataset,the sensitivity,specificity,accuracy,positive predictive value,and negative predictive value of CAD-NBI were 91.0%,96.7%,94.3%,95.3%,and 93.6%,respectively,while those of CAD-WLI were 98.5%,83.1%,89.5%,80.8%,and 98.7%,respectively.CAD-NBI showed superior accuracy and specificity than CAD-WLI(P=0.028 and P≤0.001,respectively),while CAD-WLI had higher sensitivity than CAD-NBI(P=0.006).By using both CAD-WLI and CAD-NBI,the endoscopists could improve their diagnostic efficacy to the highest level,with accuracy,sensitivity,and specificity of 94.9%,92.4%,and 96.7%,respectively.CONCLUSION The CAD-NBI system for screening early ESCC has higher accuracy and specificity than CAD-WLI.Endoscopists can achieve the best diagnostic efficacy using both CAD-WLI and CAD-NBI.
基金supported by National Natural Science Foundation of China(grant numbers:82273370,82202899,82172702,81972249,81902430,82002543,82002946,U1932145)Shanghai Clinical Science and Technology Innovation Project of Municipal Hospital(grant number:SHDC12020102)+5 种基金Natural Science Foundation of Shanghai(grant numbers:22ZR1413000,21ZR1414900)Artificial Intelligence Medical Hospital Cooperation Project of Xuhui District(grant number:2021-017)Shanghai Science and Technology Development Fund(grant number:19MC1911000)Shanghai Municipal Key Clinical Specialty(grant number:shslczdzk01301)Science and Technology Commission of Shanghai Municipality(grant number:18401933402)“Chenguang Program”supported by Shanghai Education Development Foundation and Shanghai Municipal Education Commission(grant number:20CG08).
文摘Objective:This study aims to analyze how changes in pathological diagnosis practice and molecular detection technology have affected clinical outcomes for colorectal cancer(CRC)patients in Fudan University Shanghai Cancer Center(FUSCC).Methods:This retrospective cohort study analyzed 21,141 pathologically confirmed CRC cases diagnosed at FUSCC from 2008 to 2020.Patients were divided into five groups for different analytical purposes:(1)the before vs.since 2014 groups to analyze the influence of the changes in the classification criteria of pT3 and pT4 staging on the survival of patients;(2)the partial vs.total mesorectal excision(TME)groups to analyze whether evaluation of completeness of the mesorectum have impact on the survival of patients;(3)the tumor deposit(TD)(+)N0 vs.TD(+)N1c groups to analyze the influence of the changes in the pN staging on the survival of patients with positive TD and negative regional lymph node metastasis(LNM);(4)the before vs.since 2013 groups to analyze the influence of the changes in the testing process of deficient mismatch repair on the survival of patients;and(5)the groups with vs.without RAS/BRAF gene mutation testing to analyze the influence of these testing on the survival of patients.Patients’clinicopathological parameters,including age at diagnosis,sex,tumor size,location,differentiation,mucinous subtype,TD,lymphovascular invasion,perineural invasion,tumor depth,LNM and distant metastasis,and tumor-node-metastasis(TNM)stage,were compared between groups.Kaplan-Meier analysis with log rank method was performed for patients’overall survival(OS)and disease-free survival(DFS)analyses.Results:In pathological reports,there were three parameter changes that impacted patient outcomes.Firstly,changes in the pT staging criteria led to a shift of the ratio of patients with stage pT3 to stage pT4 from 1:110.9 to 1:0.26.In comparison to patients admitted before 2014(n=4,754),a significant difference in prognosis between pT3 and pT4 stages was observed since 2014(n=9,965).Secondly,we began to evaluate the completeness of the mesorectum since 2016.As a result,91.0%of patients with low rectal cancer underwent TME(n=4,111)surgery,and patients with TME had significantly better OS compared with partial mesorectal excision(PME,n=409).Thirdly,we began to stage TD(+)LNM(-)as N1c since 2017.The results showed that N1c(n=127)but not N0(n=39)can improve the prognosis of patients without LNM and distal metastasis.In molecular testing,there have been three and five iterations of updates regarding mismatch repair(MMR)/microsatellite instability(MSI)status and RAS/BRAF gene mutation detection,respectively.The standardization of MMR status testing has sharply decreased the proportion of deficient MMR(dMMR)patients(from 32.5%to 7.4%)since 2013.The prognosis of patients underwent MMR status testing since 2013(n=867)were significantly better than patients before 2013(n=1,313).In addition,detection of RAS/BRAF gene mutation status(n=5,041)resulted in better DFS but not OS,for patients with stage I-III disease(n=16,557).Conclusion:Over the past few decades,updates in elements in pathological reports,as well as the development of standardized tests for MMR/MSI status and RAS/BRAF gene mutations have significantly improved patient outcomes.
