Background: Capecitabine and irinotecan combination therapy(XELIRI) has been examined at various dose levels to treat metastatic colorectal cancer(m CRC). Recently, in the Association of Medical Oncology of the German...Background: Capecitabine and irinotecan combination therapy(XELIRI) has been examined at various dose levels to treat metastatic colorectal cancer(m CRC). Recently, in the Association of Medical Oncology of the German Cancer Society(AIO) 0604 trial, tri?weekly XELIRI plus bevacizumab, with reduced doses of irinotecan(200 mg/m^2 on day 1) and capecitabine(1600 mg/m^2 on days 1–14), repeated every 3 weeks, has shown favorable tolerability and eicacy which were comparable to those of capecitabine and oxaliplatin(XELOX) plus bevacizumab. The doses of capecit?abine and irinotecan in the AIO trial are considered optimal. In a phase I/II study, XELIRI plus bevacizumab(BIX) as second?line chemotherapy was well tolerated and had promising eicacy in Japanese patients.Methods: The Asian XELIRI Projec T(AXEPT) is an East Asian collaborative, open?labelled, randomized, phase Ⅲ clinical trial which was designed to demonstrate the non?inferiority of XELIRI with or without bevacizumab versus standard FOLFIRI(5?fluorouracil, leucovorin, and irinotecan combination) with or without bevacizumab as second?line chemo?therapy for patients with m CRC. Patients with 20 years of age or older, histologically conirmed m CRC, Eastern Coop?erative Oncology Group performance status 0–2, adequate organ function, and disease progression or intolerance of the irst?line regimen will be eligible. Patients will be randomized(1:1) to receive standard FOLFIRI with or with?out bevacizumab(5 mg/kg on day 1), repeated every 2 weeks(FOLIRI arm) or XELIRI with or without bevacizumab(7.5 mg/kg on day 1), repeated every 3 weeks(XELIRI arm). A total of 464 events were estimated as necessary to show non?inferiority with a power of 80% at a one?sided α of 0.025, requiring a target sample size of 600 patients. The 95% conidence interval(CI) upper limit of the hazard ratio was pre?speciied as less than 1.3.Conclusion: The Asian XELIRI Projec T is a multinational phase III trial being conducted to provide evidence for XELIRI with or without bevacizumab as a second?line treatment option of mCRC.展开更多
1文献来源Wolff AC,Lazar AA,Bondarenko I,et al.Randomized phase Ⅲ placebo-controlled trial of Letrozole plus oral Temsirolimus as first-line endocrine therapy in postmenopausal women with locally advanced or metastati...1文献来源Wolff AC,Lazar AA,Bondarenko I,et al.Randomized phase Ⅲ placebo-controlled trial of Letrozole plus oral Temsirolimus as first-line endocrine therapy in postmenopausal women with locally advanced or metastatic breast cancer[J].J Clin Oncol,2013,31（2）：195-202.2证据水平1a。展开更多
目的验证玄七健骨片治疗膝骨关节炎(KOA)筋脉瘀滞证的有效性及安全性。方法选取2012年12月-2015年2月7家医院476例KOA筋脉瘀滞证患者进行Ⅲ期临床研究,采用随机数字表法分为试验组和对照组。试验组予玄七健骨片,对照组予安慰剂,均4片/...目的验证玄七健骨片治疗膝骨关节炎(KOA)筋脉瘀滞证的有效性及安全性。方法选取2012年12月-2015年2月7家医院476例KOA筋脉瘀滞证患者进行Ⅲ期临床研究,采用随机数字表法分为试验组和对照组。试验组予玄七健骨片,对照组予安慰剂,均4片/次,3次/d,疗程28 d。比较2组中医证候疗效及疼痛消失情况,观察2组治疗前及治疗7、14、28 d西安大略和麦克马斯特大学骨关节炎指数(WOMAC)总分及疼痛、僵硬、日常活动评分,中医症状积分,监测2组安全性指标及试验期间出现的不良反应。结果共剔除10例患者,最终466例纳入分析数据集中的全分析集,2组一般资料比较差异无统计学意义(P>0.05),具有可比性。试验组临床控制率为24.86%(86/346),愈显率为50.00%(173/346),总有效率为89.60%(310/346),对照组临床控制率为0.00%(0/120),愈显率为4.17%(5/120),总有效率为29.17%(35/120),2组比较差异有统计学意义(P=0.000)。试验组治疗后107例患者疼痛消失(30.92%),对照组疼痛消失1例(0.83%),试验组疼痛消失率高于对照组(P<0.05)。与本组治疗前比较,2组治疗7、14、28 d WOMAC总分及疼痛、僵硬、日常活动评分,中医症状积分均显著改善(P<0.05);2组同时点比较,试验组治疗7、14、28 d WOMAC总分及疼痛、僵硬、日常活动评分,中医症状积分均低于对照组(P<0.05)。2组治疗后各相关症状均有所改善,且试验组对疼痛、活动不利、局部肿胀、局部压痛、关节僵硬、日常活动的改善显著优于对照组(P<0.05)。2组不良反应发生率差异无统计学意义(P>0.05)。结论玄七健骨片治疗KOA筋脉瘀滞证安全有效,其特点在于对患者疾病相关症状体征的改善作用。展开更多
基金funding from Chugai Pharmaceutical Co.Ltd.Roche Korea Co.Ltd.Roche Shanghai.Co.Ltd
文摘Background: Capecitabine and irinotecan combination therapy(XELIRI) has been examined at various dose levels to treat metastatic colorectal cancer(m CRC). Recently, in the Association of Medical Oncology of the German Cancer Society(AIO) 0604 trial, tri?weekly XELIRI plus bevacizumab, with reduced doses of irinotecan(200 mg/m^2 on day 1) and capecitabine(1600 mg/m^2 on days 1–14), repeated every 3 weeks, has shown favorable tolerability and eicacy which were comparable to those of capecitabine and oxaliplatin(XELOX) plus bevacizumab. The doses of capecit?abine and irinotecan in the AIO trial are considered optimal. In a phase I/II study, XELIRI plus bevacizumab(BIX) as second?line chemotherapy was well tolerated and had promising eicacy in Japanese patients.Methods: The Asian XELIRI Projec T(AXEPT) is an East Asian collaborative, open?labelled, randomized, phase Ⅲ clinical trial which was designed to demonstrate the non?inferiority of XELIRI with or without bevacizumab versus standard FOLFIRI(5?fluorouracil, leucovorin, and irinotecan combination) with or without bevacizumab as second?line chemo?therapy for patients with m CRC. Patients with 20 years of age or older, histologically conirmed m CRC, Eastern Coop?erative Oncology Group performance status 0–2, adequate organ function, and disease progression or intolerance of the irst?line regimen will be eligible. Patients will be randomized(1:1) to receive standard FOLFIRI with or with?out bevacizumab(5 mg/kg on day 1), repeated every 2 weeks(FOLIRI arm) or XELIRI with or without bevacizumab(7.5 mg/kg on day 1), repeated every 3 weeks(XELIRI arm). A total of 464 events were estimated as necessary to show non?inferiority with a power of 80% at a one?sided α of 0.025, requiring a target sample size of 600 patients. The 95% conidence interval(CI) upper limit of the hazard ratio was pre?speciied as less than 1.3.Conclusion: The Asian XELIRI Projec T is a multinational phase III trial being conducted to provide evidence for XELIRI with or without bevacizumab as a second?line treatment option of mCRC.
文摘1文献来源Wolff AC,Lazar AA,Bondarenko I,et al.Randomized phase Ⅲ placebo-controlled trial of Letrozole plus oral Temsirolimus as first-line endocrine therapy in postmenopausal women with locally advanced or metastatic breast cancer[J].J Clin Oncol,2013,31（2）：195-202.2证据水平1a。
文摘目的验证玄七健骨片治疗膝骨关节炎(KOA)筋脉瘀滞证的有效性及安全性。方法选取2012年12月-2015年2月7家医院476例KOA筋脉瘀滞证患者进行Ⅲ期临床研究,采用随机数字表法分为试验组和对照组。试验组予玄七健骨片,对照组予安慰剂,均4片/次,3次/d,疗程28 d。比较2组中医证候疗效及疼痛消失情况,观察2组治疗前及治疗7、14、28 d西安大略和麦克马斯特大学骨关节炎指数(WOMAC)总分及疼痛、僵硬、日常活动评分,中医症状积分,监测2组安全性指标及试验期间出现的不良反应。结果共剔除10例患者,最终466例纳入分析数据集中的全分析集,2组一般资料比较差异无统计学意义(P>0.05),具有可比性。试验组临床控制率为24.86%(86/346),愈显率为50.00%(173/346),总有效率为89.60%(310/346),对照组临床控制率为0.00%(0/120),愈显率为4.17%(5/120),总有效率为29.17%(35/120),2组比较差异有统计学意义(P=0.000)。试验组治疗后107例患者疼痛消失(30.92%),对照组疼痛消失1例(0.83%),试验组疼痛消失率高于对照组(P<0.05)。与本组治疗前比较,2组治疗7、14、28 d WOMAC总分及疼痛、僵硬、日常活动评分,中医症状积分均显著改善(P<0.05);2组同时点比较,试验组治疗7、14、28 d WOMAC总分及疼痛、僵硬、日常活动评分,中医症状积分均低于对照组(P<0.05)。2组治疗后各相关症状均有所改善,且试验组对疼痛、活动不利、局部肿胀、局部压痛、关节僵硬、日常活动的改善显著优于对照组(P<0.05)。2组不良反应发生率差异无统计学意义(P>0.05)。结论玄七健骨片治疗KOA筋脉瘀滞证安全有效,其特点在于对患者疾病相关症状体征的改善作用。
