Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings.
Vol 23, No 16S (June 1 Supplement), 2005: 1
© 2005 American Society of Clinical Oncology

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Abstract

Erlotinib plus gemcitabine compared to gemcitabine alone in patients with advanced pancreatic cancer. A phase III trial of the National Cancer Institute of Canada Clinical Trials Group [NCIC-CTG]

Princess Margaret Hosp, Toronto, ON, Canada; AGITG, Melbourne, Australia; NCIC Clin Trials Group, Kingston, ON, Canada; OSI Pharmaceuticals, Boulder, CO

1

Background: Pancreatic cancer is known to frequently over express epidermal growth factor receptor [EGFR]. Erlotinib [Tarceva, OSI-774] is an oral reversible inhibitor of EGFR tyrosine kinase. Methods: Patients had advanced pancreatic adenocarcinoma and no prior systemic chemotherapy other than that given concurrently with radiation therapy. EGFR status was not an entry criterion. Patients were randomized to receive gemcitabine 1000 mg/m² IV weekly X 7 for 8 weeks then weekly x 3 out of 4 weeks plus either erlotinib 100 mg p.o. daily or a placebo in a double blind fashion. Patients were stratified by centre, stage [locally advanced versus metastatic] and performance status [ECOG 0,1 versus 2]. Disease was evaluated by cross sectional imaging every 8 weeks. Dose escalation to 150 mg of erlotinib/placebo was performed in Canadian centres from September 2002- January 2003 (n=48). Results: From November 2001 - January 2003 569 patients were entered on study; 485 had died at the time of analysis. There was a difference in overall survival [p=0.025;log-rank test] that favored the erlotinib arm with a hazard ratio of 0.81 [95% CI 0.67 - 0.97]. The corresponding one-year survival rates were 24% versus 17%. PFS was also significantly improved in the gemcitabine + erlotinib treatment group with a hazard ratio of 0.76, p=0.003. The tumor control rates [CR/PR/SD] were 57% [CR/PR=9%] and 49% [CR/PR=8%] for the erlotinib and placebo groups respectively. An increase in grade 1,2 rash, diarrhea and hematological toxicity was seen with erlotinib. Rates of grade 3, 4 toxicity were comparable in both arms. Tumour retrieval for correlative studies is ongoing- an initial 170 samples have been analyzed for EGFR by immunohistochemistry. Conclusions: The addition of erlotinib to gemcitabine significantly improves survival and progression free survival in advanced pancreatic cancer.

Author Disclosure

Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration OSI OSI

Abstract presentation from the 2005 ASCO Annual Meeting