Articles
Cisplatin plus gemcitabine versus paclitaxel plus gemcitabine as first-line therapy for metastatic triple-negative breast cancer (CBCSG006): a randomised, open-label, multicentre, phase 3 trial Xi-Chun Hu*, Jian Zhang*, Bing-He Xu, Li Cai, Joseph Ragaz, Zhong-Hua Wang, Bi-Yun Wang, Yue-E Teng, Zhong-Sheng Tong, Yue-Yin Pan, Yong-Mei Yin, Chang-Ping Wu, Ze-Fei Jiang, Xiao-Jia Wang, Gu-Yin Lou, Dong-Geng Liu, Ji-Feng Feng, Jian-Feng Luo, Kang Sun, Ya-Jia Gu, Jiong Wu, Zhi-Min Shao
Summary Lancet Oncol 2015; 16: 436–46 Published Online March 18, 2015 http://dx.doi.org/10.1016/ S1470-2045(15)70064-1 See Comment page 357 *Contributed equally Department of Medical Oncology (Prof X-C Hu MD, J Zhang MD, Z-H Wang MD, B-Y Wang MD), Department of Radiology (Prof Y-J Gu MD), Department of Breast Surgery (Prof J Wu MD, Prof Z-M Shao MD), Fudan University Shanghai Cancer Centre, Collaborative Innovation Centre for Cancer Medicine, Shanghai, China; Department of Oncology, Shanghai Medical College, (Prof X-C Hu, J Zhang, Z-H Wang, B-Y Wang, Prof Y-J Gu, Prof J Wu, Prof Z-M Shao); Department of Biostatistics, School of Public Health, Fudan University, Shanghai, China (J-F Luo PhD); Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, China (Prof B-H Xu MD); Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China (Prof L Cai MD); Faculty of Medicine, School of Population and Public Health, University of British Columbia, Vancouver, BC, Canada (Prof J Ragaz FRCP); Department of Medical Oncology, The First Hospital of China Medical University, Shenyang, China (Prof Y-E Teng MD); Tianjin Medical University Cancer Institute and Hospital, Tianjin, China (Prof Z-S Tong MD); Department of Medical Oncology, The First Hospital, Anhui Medical University, Hefei, China (Prof Y-Y Pan MD); Department of Oncology, The First Affiliated Hospital of
436
Background Platinum chemotherapy has a role in the treatment of metastatic triple-negative breast cancer but its full potential has probably not yet been reached. We assessed whether a cisplatin plus gemcitabine regimen was noninferior to or superior to paclitaxel plus gemcitabine as first-line therapy for patients with metastatic triple-negative breast cancer. Methods For this open-label, randomised, phase 3, hybrid-designed trial undertaken at 12 institutions or hospitals in China, we included Chinese patients aged 18–70 years with previously untreated, histologically confirmed metastatic triple-negative breast cancer, and an ECOG performance status of 0–1. These patients were randomly assigned (1:1) to receive either cisplatin plus gemcitabine (cisplatin 75 mg/m² on day 1 and gemcitabine 1250 mg/m² on days 1 and 8) or paclitaxel plus gemcitabine (paclitaxel 175 mg/m² on day 1 and gemcitabine 1250 mg/m² on days 1 and 8) given intravenously every 3 weeks for a maximum of eight cycles. Randomisation was done centrally via an interactive web response system using block randomisation with a size of eight, with no stratification factors. Patients and investigator were aware of group assignments. The primary endpoint was progression-free survival and analyses were based on all patients who received at least one dose of assigned treatment. The margin used to establish non-inferiority was 1·2. If non-inferiority of cisplatin plus gemcitabine compared with paclitaxel plus gemcitabine was achieved, we would then test for superiority. The trial is registered with ClinicalTrials.gov, number NCT01287624. Findings From Jan 14, 2011, to Nov 14, 2013, 240 patients were assessed for eligibility and randomly assigned to treatment (120 in the cisplatin plus gemcitabine group and 120 in the paclitaxel plus gemcitabine group). 236 patients received at least one dose of assigned chemotherapy and were included in the modified intention-to-treat analysis (118 per group). After a median follow-up of 16·3 months (IQR 14·4–26·8) in the cisplatin plus gemcitabine group and 15·9 months (10·7–25·4) in the paclitaxel plus gemcitabine group, the hazard ratio for progression-free survival was 0·692 (95% CI 0·523–0·915; pnon-inferiority
Cisplatin plus gemcitabine versus paclitaxel plus gemcitabine as first-line therapy for metastatic triple-negative breast cancer (CBCSG006): a randomised, open-label, multicentre, phase 3 trial Xi-Chun Hu*, Jian Zhang*, Bing-He Xu, Li Cai, Joseph Ragaz, Zhong-Hua Wang, Bi-Yun Wang, Yue-E Teng, Zhong-Sheng Tong, Yue-Yin Pan, Yong-Mei Yin, Chang-Ping Wu, Ze-Fei Jiang, Xiao-Jia Wang, Gu-Yin Lou, Dong-Geng Liu, Ji-Feng Feng, Jian-Feng Luo, Kang Sun, Ya-Jia Gu, Jiong Wu, Zhi-Min Shao
Summary Lancet Oncol 2015; 16: 436–46 Published Online March 18, 2015 http://dx.doi.org/10.1016/ S1470-2045(15)70064-1 See Comment page 357 *Contributed equally Department of Medical Oncology (Prof X-C Hu MD, J Zhang MD, Z-H Wang MD, B-Y Wang MD), Department of Radiology (Prof Y-J Gu MD), Department of Breast Surgery (Prof J Wu MD, Prof Z-M Shao MD), Fudan University Shanghai Cancer Centre, Collaborative Innovation Centre for Cancer Medicine, Shanghai, China; Department of Oncology, Shanghai Medical College, (Prof X-C Hu, J Zhang, Z-H Wang, B-Y Wang, Prof Y-J Gu, Prof J Wu, Prof Z-M Shao); Department of Biostatistics, School of Public Health, Fudan University, Shanghai, China (J-F Luo PhD); Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, China (Prof B-H Xu MD); Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China (Prof L Cai MD); Faculty of Medicine, School of Population and Public Health, University of British Columbia, Vancouver, BC, Canada (Prof J Ragaz FRCP); Department of Medical Oncology, The First Hospital of China Medical University, Shenyang, China (Prof Y-E Teng MD); Tianjin Medical University Cancer Institute and Hospital, Tianjin, China (Prof Z-S Tong MD); Department of Medical Oncology, The First Hospital, Anhui Medical University, Hefei, China (Prof Y-Y Pan MD); Department of Oncology, The First Affiliated Hospital of
436
Background Platinum chemotherapy has a role in the treatment of metastatic triple-negative breast cancer but its full potential has probably not yet been reached. We assessed whether a cisplatin plus gemcitabine regimen was noninferior to or superior to paclitaxel plus gemcitabine as first-line therapy for patients with metastatic triple-negative breast cancer. Methods For this open-label, randomised, phase 3, hybrid-designed trial undertaken at 12 institutions or hospitals in China, we included Chinese patients aged 18–70 years with previously untreated, histologically confirmed metastatic triple-negative breast cancer, and an ECOG performance status of 0–1. These patients were randomly assigned (1:1) to receive either cisplatin plus gemcitabine (cisplatin 75 mg/m² on day 1 and gemcitabine 1250 mg/m² on days 1 and 8) or paclitaxel plus gemcitabine (paclitaxel 175 mg/m² on day 1 and gemcitabine 1250 mg/m² on days 1 and 8) given intravenously every 3 weeks for a maximum of eight cycles. Randomisation was done centrally via an interactive web response system using block randomisation with a size of eight, with no stratification factors. Patients and investigator were aware of group assignments. The primary endpoint was progression-free survival and analyses were based on all patients who received at least one dose of assigned treatment. The margin used to establish non-inferiority was 1·2. If non-inferiority of cisplatin plus gemcitabine compared with paclitaxel plus gemcitabine was achieved, we would then test for superiority. The trial is registered with ClinicalTrials.gov, number NCT01287624. Findings From Jan 14, 2011, to Nov 14, 2013, 240 patients were assessed for eligibility and randomly assigned to treatment (120 in the cisplatin plus gemcitabine group and 120 in the paclitaxel plus gemcitabine group). 236 patients received at least one dose of assigned chemotherapy and were included in the modified intention-to-treat analysis (118 per group). After a median follow-up of 16·3 months (IQR 14·4–26·8) in the cisplatin plus gemcitabine group and 15·9 months (10·7–25·4) in the paclitaxel plus gemcitabine group, the hazard ratio for progression-free survival was 0·692 (95% CI 0·523–0·915; pnon-inferiority
