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

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机构: [1]Sun Yat-sen University Cancer Center, 651 Dongfeng East Road, Guangzhou 510060, China. [2]Fudan University Shanghai Cancer Center, No 270, Dongan Road, Shanghai 200032, China. [3]Tianjin Cancer Hospital, Huan-Hu-Xi Road, Tianjin 300060, China. [4]Renji Hospital, Shanghai Jiaotong University, 160 Pujian Lu, Shanghai 200127, China. [5]Sir Run Run Shaw Hospital, Zhejiang University, 3 East Qingchun Road, Hangzhou City 310016, China. [6]Xijing Hospital, W Rd, Xi’an, Changle 127, China. [7]307 Hospital of the People’s Liberation Army, Beijing 100021, China. [8]Harbin Medical University Cancer Hospital, Haping Road No.150, Harbin, China. [9]Henan Cancer Hospital, Zhengzhou 450003, China. [10]Jiangsu Provincial Tumor Hospital, 300 Guangzhou Road, Nanjing 210029, China. [11]Zhejiang Cancer Hospital, 38 Guangji Road, Banshan Bridge, Hangzhou City 310022, China. [12]Chinese People’s Liberation Army General Hospital No.28, Fuxing Road, Beijing, China. [13]Celgene Corporation, Summit, NJ, USA. [14]Peking University Cancer Hospital and Institute, No. 52 Fucheng Road, Haidian District, Beijing 100142, China. [15]Department of Gastrointestinal Oncology, Peking University Cancer Hospital and Institute, No. 52 Fucheng Road, Haidian District, Beijing 100142, China.
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关键词: Chinese Gemcitabine Metastatic MPACT nab-paclitaxel Pancreatic cancer

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Background: This 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). Methods: This 3-part sequential study evaluated nab-paclitaxel 125 mg/m 2 plus gemcitabine 1000 mg/m 2 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. Results: Eighty-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). Conclusions: The MPACT regimen of nab-paclitaxel/gemcitabine is efficacious in Chinese patients with MPC. No new safety signals were observed. Trial registration:NCT02135822, May 8, 2014. © 2017 The Author(s).

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出版当年[2017]版:
大类 | 3 区 医学
小类 | 3 区 肿瘤学
最新[2023]版:
大类 | 2 区 医学
小类 | 3 区 肿瘤学
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第一作者机构: [1]Sun Yat-sen University Cancer Center, 651 Dongfeng East Road, Guangzhou 510060, China.
通讯作者:
通讯机构: [14]Peking University Cancer Hospital and Institute, No. 52 Fucheng Road, Haidian District, Beijing 100142, China. [15]Department of Gastrointestinal Oncology, Peking University Cancer Hospital and Institute, No. 52 Fucheng Road, Haidian District, Beijing 100142, China.
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