The efficacy and safety of bevacizumab with modified irinotecan,leucovorin bolus,and 5-fluorouracil intravenous infusion(mIFL) in the first-line treatment of metastatic colorectal cancer(mCRC) has not been well evalua...The efficacy and safety of bevacizumab with modified irinotecan,leucovorin bolus,and 5-fluorouracil intravenous infusion(mIFL) in the first-line treatment of metastatic colorectal cancer(mCRC) has not been well evaluated in randomized clinical trials in Chinese patients.We conducted a phrase Ⅲ trial in which patients with previously untreated mCRC were randomized 2:1 to the mIFL [irinotecan(125 mg/m2),leucovorin(20 mg/m2) bolus,and 5-fluorouracil intravenous infusion(500 mg/m2) weekly for four weeks every six weeks] plus bevacizumab(5 mg/kg every two weeks) group and the mIFL group,respectively.Co-primary objectives were progression-free survival(PFS) and 6-month PFS rate.In total,214 patients were enrolled.Our results showed that addition of bevacizumab to mIFL significantly improved median PFS(4.2 months in the mIFL group vs.8.3 months in the bevacizumab plus mIFL group,P < 0.001),6-month PFS rate(25.0% vs.62.6%,P < 0.001),median overall survival(13.4 months vs.18.7 months,P = 0.014),and response rate(17% vs.35%,P = 0.013).Grades 3 and 4 adverse events included diarrhea(21% in the mIFL group and 26% in the bevacizumab plus mIFL group) and neutropenia(19% in the mIFL group and 33% in the bevacizumab plus mIFL group).No wound-healing complications or congestive heart failure occurred.Our results suggested that bevacizumab plus mIFL is effective and well tolerated as first-line treatment for Chinese patients with mCRC.Clinical benefit and safety profiles were consistent with those observed in pivotal phase Ⅲ trials with mainly Caucasian patients.展开更多
AIM:To elucidate the prognostic value of age for gastric cancer and identify the optimal treatment for elderly gastric cancer patients.METHODS:We enrolled 920 patients with gastric cancer who underwent gastrectomy bet...AIM:To elucidate the prognostic value of age for gastric cancer and identify the optimal treatment for elderly gastric cancer patients.METHODS:We enrolled 920 patients with gastric cancer who underwent gastrectomy between January 2003and December 2007 in our center.Patients were categorized into three groups:younger group(age<50years),middle-aged group(50-69 years),and elderly group(≥70 years).Clinicopathological features were compared among the three groups and potential prognostic factors were analyzed.The log-rank test was used to assess statistical differences between curves.Independent prognostic factors were identified by the Cox proportional hazards regression model.Stratified analysis was used to investigate the impact of age on survival at each stage.Cancer-specific survival was also compared among the three groups by excluding deaths due to reasons other than gastric cancer.We analyzed the potential prognostic factors for patients aged≥70years.Finally,the impact of extent of lymphadenectomy and postoperative chemotherapy on survival for each age group was evaluated.RESULTS:In the elderly group,there was a male predominance.At the same time,cancers of the upper third of the stomach,differentiated type,and less-invasive surgery were more common than in the younger or middle-aged groups.Elderly patients were more likely to have advanced tumor-node-metastasis(TNM)stage and larger tumors,but less likely to have distant metastasis.Although 5-year overall survival(OS)rate specific to gastric cancer was not significantly different among the three groups,elderly patients demonstrated a significantly lower 5-year OS rate than the younger and middle-aged patients(elderly vs middle-aged vs younger patients=22.0%vs 36.6%vs 38.0%,respectively).In the TNM-stratified analysis,the differences in OS were only observed in patients withⅡandⅢtumors.In multivariate analysis,only surgical margin status,pT4,lymph node metastasis,M1 and sex were independent prognostic factors for elderly patients.The5-year OS rate did n展开更多
文摘The efficacy and safety of bevacizumab with modified irinotecan,leucovorin bolus,and 5-fluorouracil intravenous infusion(mIFL) in the first-line treatment of metastatic colorectal cancer(mCRC) has not been well evaluated in randomized clinical trials in Chinese patients.We conducted a phrase Ⅲ trial in which patients with previously untreated mCRC were randomized 2:1 to the mIFL [irinotecan(125 mg/m2),leucovorin(20 mg/m2) bolus,and 5-fluorouracil intravenous infusion(500 mg/m2) weekly for four weeks every six weeks] plus bevacizumab(5 mg/kg every two weeks) group and the mIFL group,respectively.Co-primary objectives were progression-free survival(PFS) and 6-month PFS rate.In total,214 patients were enrolled.Our results showed that addition of bevacizumab to mIFL significantly improved median PFS(4.2 months in the mIFL group vs.8.3 months in the bevacizumab plus mIFL group,P < 0.001),6-month PFS rate(25.0% vs.62.6%,P < 0.001),median overall survival(13.4 months vs.18.7 months,P = 0.014),and response rate(17% vs.35%,P = 0.013).Grades 3 and 4 adverse events included diarrhea(21% in the mIFL group and 26% in the bevacizumab plus mIFL group) and neutropenia(19% in the mIFL group and 33% in the bevacizumab plus mIFL group).No wound-healing complications or congestive heart failure occurred.Our results suggested that bevacizumab plus mIFL is effective and well tolerated as first-line treatment for Chinese patients with mCRC.Clinical benefit and safety profiles were consistent with those observed in pivotal phase Ⅲ trials with mainly Caucasian patients.
基金Supported by National Basic Research Program of China: 973 Program, No. 2010CB529301
文摘AIM:To elucidate the prognostic value of age for gastric cancer and identify the optimal treatment for elderly gastric cancer patients.METHODS:We enrolled 920 patients with gastric cancer who underwent gastrectomy between January 2003and December 2007 in our center.Patients were categorized into three groups:younger group(age<50years),middle-aged group(50-69 years),and elderly group(≥70 years).Clinicopathological features were compared among the three groups and potential prognostic factors were analyzed.The log-rank test was used to assess statistical differences between curves.Independent prognostic factors were identified by the Cox proportional hazards regression model.Stratified analysis was used to investigate the impact of age on survival at each stage.Cancer-specific survival was also compared among the three groups by excluding deaths due to reasons other than gastric cancer.We analyzed the potential prognostic factors for patients aged≥70years.Finally,the impact of extent of lymphadenectomy and postoperative chemotherapy on survival for each age group was evaluated.RESULTS:In the elderly group,there was a male predominance.At the same time,cancers of the upper third of the stomach,differentiated type,and less-invasive surgery were more common than in the younger or middle-aged groups.Elderly patients were more likely to have advanced tumor-node-metastasis(TNM)stage and larger tumors,but less likely to have distant metastasis.Although 5-year overall survival(OS)rate specific to gastric cancer was not significantly different among the three groups,elderly patients demonstrated a significantly lower 5-year OS rate than the younger and middle-aged patients(elderly vs middle-aged vs younger patients=22.0%vs 36.6%vs 38.0%,respectively).In the TNM-stratified analysis,the differences in OS were only observed in patients withⅡandⅢtumors.In multivariate analysis,only surgical margin status,pT4,lymph node metastasis,M1 and sex were independent prognostic factors for elderly patients.The5-year OS rate did n
