title: nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine in Patients with Metastatic Pancreatic Adenocarcinoma: Canadian Subgroup Analysis of the Phase 3 MPACT Trial.
abstract: 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.
authors.affiliation: Centre hospitalier de l'université de Montréal (CHUM), Montreal, QC, Canada. mustapha.tehfe.chum@ssss.gouv.qc.ca.
authors.forename: Mustapha
authors.initials: M
authors.lastname: Tehfe
authors.affiliation: Tom Baker Cancer Centre, Calgary, AB, Canada.
authors.forename: Scot
authors.initials: S
authors.lastname: Dowden
authors.affiliation: British Columbia Cancer Agency, Vancouver, BC, Canada.
authors.forename: Hagen
authors.initials: H
authors.lastname: Kennecke
authors.affiliation: Royal Victoria Regional Health Centre, Barrie, ON, Canada.
authors.forename: Robert
authors.initials: R
authors.lastname: El-Maraghi
authors.affiliation: Hôpital du Sacré-Coeur de Montreal, Montreal, QC, Canada.
authors.forename: Bernard
authors.initials: B
authors.lastname: Lesperance
authors.affiliation: Centre hospitalier universitaire de Québec (CHUQ), Hôtel-Dieu de Quebec, CHUM, Montreal, QC, Canada.
authors.forename: Felix
authors.initials: F
authors.lastname: Couture
authors.affiliation: Centre hospitalier de l'université de Montréal (CHUM), Montreal, QC, Canada.
authors.forename: Richard
authors.initials: R
authors.lastname: Letourneau
authors.affiliation: Celgene Corporation, Summit, NJ, USA.
authors.forename: Helen
authors.initials: H
authors.lastname: Liu
authors.affiliation: Celgene Corporation, Summit, NJ, USA.
authors.forename: Alfredo
authors.initials: A
authors.lastname: Romano
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000473:pathology; D000328:Adult; D000368:Aged; D000418:Albumins / Q000008:administration & dosage / Q000009:adverse effects; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols; D002170:Canada; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D016903:Drug Monitoring; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced / Q000517:prevention & control; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D010190:Pancreatic Neoplasms / Q000188:drug therapy / Q000473:pathology; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: C520255:130-nm albumin-bound paclitaxel; D000418:Albumins; D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D017239:Paclitaxel; D000093542:Gemcitabine
keywords: Canada; Gemcitabine; MPACT; Metastatic pancreatic cancer; Oncology; Subgroup analysis; nab-Paclitaxel