Efficacy and safety of weekly nab-paclitaxel plus gemcitabine in Chinese patients with metastatic adenocarcinoma of the pancreas: a phase II study

BMC Cancer

Research Article

Jianming Xu¹  Damir Begic²  Mingyu Li²  Brian Lu²  Guanghai Dai³  Xianjun Yu⁴  Yanqiao Zhang⁵  Shujun Yang⁶  Jia Chen⁷  Lin Shen⁸  Liwei Wang⁹  Hongming Pan^1,10  Ruihua Xu^1,11  Jihui Hao^1,12  Guohong Han^1,13  Jieer Ying^1,14 

[1] 307 Hospital of the People’s Liberation Army, 100021, Beijing, China;Celgene Corporation, Summit, NJ, USA;Chinese People’s Liberation Army General Hospital No.28, Fuxing Road, Beijing, China;Fudan University Shanghai Cancer Center, No 270, Dongan Road, 200032, Shanghai, China;Harbin Medical University Cancer Hospital, Haping Road No.150, Harbin, China;Henan Cancer Hospital, 450003, Zhengzhou, China;Jiangsu Provincial Tumor Hospital, 300 Guangzhou Road, 210029, Nanjing, China;Peking University Cancer Hospital and Institute, No. 52 Fucheng Road, Haidian District, 100142, Beijing, China;Department of Gastrointestinal Oncology, Peking University Cancer Hospital and Institute, No. 52 Fucheng Road, Haidian District, 100142, Beijing, China;Renji Hospital, Shanghai Jiaotong University, 160 Pujian Lu, 200127, Shanghai, China;Sir Run Run Shaw Hospital, Zhejiang University, 3 East Qingchun Road, 310016, Hangzhou City, China;Sun Yat-sen University Cancer Center, 651 Dongfeng East Road, 510060, Guangzhou, China;Tianjin Cancer Hospital, Huan-Hu-Xi Road, 300060, Tianjin, China;Xijing Hospital, W Rd, Xi’an, 127, Changle, China;Zhejiang Cancer Hospital, 38 Guangji Road, Banshan Bridge, 310022, Hangzhou City, China;

关键词: nab;    Gemcitabine;    MPACT;    Pancreatic cancer;    Metastatic;    Chinese;   

DOI  :  10.1186/s12885-017-3887-z

 received in 2016-08-19, accepted in 2017-12-08,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundThis phase II bridging study assessed the safety and efficacy of nab-paclitaxel/gemcitabine (Metastatic Pancreatic Adenocarcinoma Clinical Trial [MPACT] regimen) in Chinese patients with metastatic pancreatic cancer (MPC).MethodsThis 3-part sequential study evaluated nab-paclitaxel 125 mg/m2 plus gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 4 weeks. Part 1 evaluated safety. Part 2 evaluated efficacy using Simon’s optimal 2-stage design: if >2 responses were observed in Stage 1 (n = 28), 54 additional patients would be enrolled in Stage 2. If >9 responses were observed, the study was complete. Otherwise, nab-paclitaxel/gemcitabine would be compared with gemcitabine alone in Part 3. The primary endpoint was overall response rate (ORR). Secondary endpoints included duration of response (DOR), overall survival (OS), and safety.ResultsEighty-three patients were treated. The prespecified primary endpoint was met: the independently assessed ORR in Stages 1 + 2 was 35% (95% CI, 24.8–46.2); therefore, Part 3 was not initiated. The median DOR was 8.9 months (95% CI, 6.01–8.94). The median OS and progression-free survival were 9.2 (95% CI, 7.6–11.1) and 5.5 (95% CI, 5.29–7.16) months, respectively. The 12-month OS rate was 30%. In an updated analysis, the median OS was 9.3 months and the 12-month OS rate was 32%. Longer OS was observed in patients with baseline neutrophil-to-lymphocyte ratio ≤ 5 vs > 5. The most common grade ≥ 3 adverse events were leukopenia (35%), neutropenia (34%), anemia (15%), thrombocytopenia (10%), and fatigue (13%). Grade 3 peripheral neuropathy occurred in 7% of patients (no grade 4 reported).ConclusionsThe MPACT regimen of nab-paclitaxel/gemcitabine is efficacious in Chinese patients with MPC. No new safety signals were observed.Trial registrationNCT02135822, May 8, 2014.

【 授权许可】

CC BY   
© The Author(s). 2017