Tehfe Mustapha, Dowden Scot, Kennecke Hagen, El-Maraghi Robert, Lesperance Bernard, Couture Felix, Letourneau Richard, Liu Helen, Romano Alfredo
Centre hospitalier de l'université de Montréal (CHUM), Montreal, QC, Canada.
Tom Baker Cancer Centre, Calgary, AB, Canada.
Adv Ther. 2016 May;33(5):747-59. doi: 10.1007/s12325-016-0327-4. Epub 2016 Apr 16.
The phase III MPACT trial in patients with metastatic pancreatic cancer (MPC) demonstrated superior efficacy of nab-paclitaxel (nab-P) plus gemcitabine (Gem) compared with Gem monotherapy, including the primary endpoint of overall survival (OS; median 8.7 vs. 6.6 months; hazard ratio [HR] 0.72; P < 0.001). A significant treatment difference favoring nab-P + Gem over Gem was observed for OS in patients treated in North America. The majority of patients were from the US (88%) with only 12% from Canada. Healthcare systems and treatment patterns are different between the 2 countries, and there is limited published information on outcomes of Canadian patients treated with first-line nab-P + Gem. This analysis evaluated efficacy and safety outcomes in Canadian patients in the MPACT trial.
Treatment-naive patients with MPC (N = 861) received either nab-P 125 mg/m(2) + Gem 1000 mg/m(2) on days 1, 8, and 15 every 4 weeks or Gem 1000 mg/m(2) weekly for the first 7 of 8 weeks (cycle 1) and then on days 1, 8, and 15 every 4 weeks (cycle ≥2).
The MPACT trial enrolled 63 patients in Canada. Baseline characteristics were well balanced and comparable with those of the intent-to-treat population. Both OS (median 11.9 vs. 7.1 months; HR 0.76; P = 0.373) and progression-free survival (median 7.2 vs. 5.2 months; HR 0.65; P = 0.224) were numerically longer and overall response rate (27% vs. 17%; P = 0.312) was numerically higher with nab-P + Gem vs. Gem. The most common grade ≥3 adverse events with nab-P + Gem vs. Gem were neutropenia (22% vs. 10%), fatigue (34% vs. 33%), and neuropathy (25% vs. 0%).
This subanalysis confirmed that nab-P + Gem is an efficacious treatment option and has a manageable safety profile in patients with MPC treated in Canada.
ClinicalTrials.gov identifier, NCT00844649.
Celgene Corporation, Summit, NJ, USA.
转移性胰腺癌（MPC）患者的III期MPACT试验表明，与吉西他滨（Gem）单药治疗相比，白蛋白结合型紫杉醇（nab-P）联合Gem具有更高的疗效，包括总生存期（OS）这一主要终点（中位生存期8.7个月对6.6个月；风险比[HR] 0.72；P <0.001）。在北美接受治疗的患者中，观察到OS方面nab-P + Gem相对于Gem有显著的治疗差异。大多数患者来自美国（88%），只有12%来自加拿大。两国的医疗保健系统和治疗模式不同，关于一线使用nab-P + Gem治疗的加拿大患者的预后，公开信息有限。本分析评估了MPACT试验中加拿大患者的疗效和安全性结果。
初治的MPC患者（N = 861）接受每4周第1、8和15天给予nab-P 125 mg/m² + Gem 1000 mg/m²，或在第1周期的8周中的前7周每周给予Gem 1000 mg/m²，然后每4周第1、8和15天给药（≥2周期）。
MPACT试验在加拿大纳入了63例患者。基线特征平衡良好，与意向性治疗人群的特征相当。nab-P + Gem组的OS（中位生存期11.9个月对7.1个月；HR 0.76；P = 0.373）和无进展生存期（中位生存期7.2个月对5.2个月；HR 0.65；P = 0.224）在数值上更长，总体缓解率（27%对17%；P = 0.312）在数值上更高。nab-P + Gem组与Gem组最常见的≥3级不良事件分别为中性粒细胞减少（22%对10%）、疲劳（34%对33%）和神经病变（25%对0%）。
该亚组分析证实，nab-P + Gem是一种有效的治疗选择，在加拿大接受治疗的MPC患者中具有可管理的安全性。
ClinicalTrials.gov标识符，NCT00844649。
美国新泽西州萨米特的赛尔基因公司。
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