Erlotinib Plus Gemcitabine Compared With Gemcitabine Alone in Patients With Advanced Pancreatic Cancer: A Phase III Trial of the National Cancer Institute of Canada Clinical Trials Group

Author:

Moore Malcolm J.1,Goldstein David1,Hamm John1,Figer Arie1,Hecht Joel R.1,Gallinger Steven1,Au Heather J.1,Murawa Pawel1,Walde David1,Wolff Robert A.1,Campos Daniel1,Lim Robert1,Ding Keyue1,Clark Gary1,Voskoglou-Nomikos Theodora1,Ptasynski Mieke1,Parulekar Wendy1

Affiliation:

1. From the Divisions of Medical Oncology, Hematology, and Surgical Oncology, Princess Margaret Hospital, Toronto; National Cancer Institute of Canada Clinical Trials Group, Kingston; Algoma District Cancer Program, Sault Ste Marie, Ontario; Cross Cancer Institute, Edmonton, Alberta, Canada; the Australasian Gastrointestinal Tumor Group, Sydney, Australia; Norton Healthcare Pavilion, Louisville, KY; UCLA Medical Center, Los Angeles, CA; M. D. Anderson Cancer Centre, Houston, TX; OSI Pharmaceuticals, Boulder...

Abstract

PurposePatients with advanced pancreatic cancer have a poor prognosis and there have been no improvements in survival since the introduction of gemcitabine in 1996. Pancreatic tumors often overexpress human epidermal growth factor receptor type 1 (HER1/EGFR) and this is associated with a worse prognosis. We studied the effects of adding the HER1/EGFR-targeted agent erlotinib to gemcitabine in patients with unresectable, locally advanced, or metastatic pancreatic cancer.Patients and MethodsPatients were randomly assigned 1:1 to receive standard gemcitabine plus erlotinib (100 or 150 mg/d orally) or gemcitabine plus placebo in a double-blind, international phase III trial. The primary end point was overall survival.ResultsA total of 569 patients were randomly assigned. Overall survival based on an intent-to-treat analysis was significantly prolonged on the erlotinib/gemcitabine arm with a hazard ratio (HR) of 0.82 (95% CI, 0.69 to 0.99; P = .038, adjusted for stratification factors; median 6.24 months v 5.91 months). One-year survival was also greater with erlotinib plus gemcitabine (23% v 17%; P = .023). Progression-free survival was significantly longer with erlotinib plus gemcitabine with an estimated HR of 0.77 (95% CI, 0.64 to 0.92; P = .004). Objective response rates were not significantly different between the arms, although more patients on erlotinib had disease stabilization. There was a higher incidence of some adverse events with erlotinib plus gemcitabine, but most were grade 1 or 2.ConclusionTo our knowledge, this randomized phase III trial is the first to demonstrate statistically significantly improved survival in advanced pancreatic cancer by adding any agent to gemcitabine. The recommended dose of erlotinib with gemcitabine for this indication is 100 mg/d.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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