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Adv Ther. 2016 May;33(5):747-59. doi: 10.1007/s12325-016-0327-4. Epub 2016 Apr 16.

nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine in Patients with Metastatic Pancreatic Adenocarcinoma: Canadian Subgroup Analysis of the Phase 3 MPACT Trial.

Author information

1
Centre hospitalier de l'université de Montréal (CHUM), Montreal, QC, Canada. mustapha.tehfe.chum@ssss.gouv.qc.ca.
2
Tom Baker Cancer Centre, Calgary, AB, Canada.
3
British Columbia Cancer Agency, Vancouver, BC, Canada.
4
Royal Victoria Regional Health Centre, Barrie, ON, Canada.
5
Hôpital du Sacré-Coeur de Montreal, Montreal, QC, Canada.
6
Centre hospitalier universitaire de Québec (CHUQ), Hôtel-Dieu de Quebec, CHUM, Montreal, QC, Canada.
7
Centre hospitalier de l'université de Montréal (CHUM), Montreal, QC, Canada.
8
Celgene Corporation, Summit, NJ, USA.

Abstract

INTRODUCTION:

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.

METHODS:

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).

RESULTS:

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%).

CONCLUSION:

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.

TRIAL REGISTRATION:

ClinicalTrials.gov identifier, NCT00844649.

FUNDING:

Celgene Corporation, Summit, NJ, USA.

KEYWORDS:

Canada; Gemcitabine; MPACT; Metastatic pancreatic cancer; Oncology; Subgroup analysis; nab-Paclitaxel

PMID:
27085323
PMCID:
PMC4882352
DOI:
10.1007/s12325-016-0327-4
[Indexed for MEDLINE]
Free PMC Article

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