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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

Moore, Malcolm J., Goldstein, David, Hamm, John, Figer, Arie, Hecht, Joel R., Gallinger, Steven, Au, Heather J., Murawa, Pawel, Walde, David, Wolff, Robert A., Campos, Daniel, Lim, Robert, Ding, Keyue, Clark, Gary, Voskoglou-Nomikos, Theodora, Ptasynski, Mieke, Parulekar, Wendy·2007·Journal of Clinical Oncology

DOI 10.1200/jco.2006.07.9525

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Abstract

Purpose: Patients 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 Methods: Patients 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. Results: A 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. Conclusion: To 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.

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Authors: Moore, M. J., Goldstein, D., Hamm, J., Figer, A., Hecht, J. R., Gallinger, S., Au, H. J., Murawa, P., Walde, D., Wolff, R. A., Campos, D., Lim, R., Ding, K., Clark, G., Voskoglou-Nomikos, T., Ptasynski, M., & Parulekar, W.
Affiliations: Norton Healthcare (US)
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...
ORCID: Moore, Malcolm J.
Goldstein, David
Hamm, John
Hecht, Joel R.
Au, Heather J.
Wolff, Robert A.
Ding, Keyue
Clark, Gary
Parulekar, Wendy
Venue: Journal of Clinical Oncology
Publisher: American Society of Clinical Oncology (ASCO)
Published: 2007-05-20
Volume: 25
Issue: 15
Pages: 1960-1966
ISSN: 0732-183X (ISSN-L)
1527-7755
DOI: 10.1200/jco.2006.07.9525
OpenAlex: W2158134441
Cited by: 3,848
References: 49
Citations by year: 2026: 45 · 2025: 62 · 2024: 123 · 2023: 113 · 2022: 129 · 2021: 178 · 2020: 159 · 2019: 170 · 2018: 204 · 2017: 217 · 2016: 242 · 2015: 275 · 2014: 274 · 2013: 251 · 2012: 268
FWCI: 133.78
Type: journal article
Language: en
Update notices: new_edition (2023-10-17)
Open access: closed
Locations: Journal of Clinical Oncology (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Oncology › Pancreatic and Hepatic Oncology Research
Health Sciences › Medicine › Surgery › Pancreatitis Pathology and Treatment
Health Sciences › Medicine › Oncology › Cancer Treatment and Pharmacology
Keywords: erlotinib, gemcitabine, advanced pancreatic cancer, targeted therapy, overall survival, progression-free survival, metastatic pancreatic cancer, combination chemotherapy, adverse events
MeSH terms: Erlotinib Hydrochloride, Gemcitabine, Adenocarcinoma, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Deoxycytidine, Double-Blind Method, Female, Humans, International Agencies, Male, Middle Aged, Pancreatic Neoplasms, Placebos, Prognosis, Quinazolines, Survival Rate, Treatment Outcome

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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

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