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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
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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“The first approved, EGFR inhibitor erlotinib in combination with gemcitabine, gave a modest survival benefit compared to gemcitabine alone and was effectively abandoned by the community after negative data for EGFR-directed therapy in KRAS-mutant colorectal cancer emerged (6).”
From KRAS mutation in pancreatic cancer (2021) · cites this paper as [6]
In the citing paper
“Gemcitabine ± erlotinib | | First line advanced | OS | | | | 5.9 months 0.3 months 0.82 (0.69-0.99) | | 1 | [130]”
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New Guidelines to Evaluate the Response to Treatment in Solid Tumors
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Self-citationErlotinib in Previously Treated Non–Small-Cell Lung Cancer
Shepherd, F. A., Rodrigues Pereira, J., Ciuleanu, T., Tan, E. H., Hirsh, V., Thongprasert, S., Campos, D., Maoleekoonpiroj, S., Smylie, M., Martins, R., et al. (2005) · New England Journal of Medicine · doi:10.1056/nejmoa050753 · Cited by 5,419
Self-citationCunningham, D., Humblet, Y., Siena, S., Khayat, D., Bleiberg, H., Santoro, A., Bets, D., Mueser, M., Harstrick, A., Verslype, C., et al. (2004) · New England Journal of Medicine · doi:10.1056/nejmoa033025 · Cited by 5,035
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A Randomized Trial of Chemoradiotherapy and Chemotherapy after Resection of Pancreatic Cancer
Neoptolemos, J. P., Stocken, D. D., Friess, H., Bassi, C., Dunn, J., Hickey, H., Beger, H. G., Fernández‐Cruz, L., Dervenis, C., LACAINE, F., et al. (2004) · New England Journal of Medicine · doi:10.1056/nejmoa032295 · Cited by 2,709
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Erlotinib in Lung Cancer — Molecular and Clinical Predictors of Outcome
Tsao, M., Sakurada, A., Cutz, J.-C., Zhu, C., Kamel‐Reid, S., Squire, J. A., Lorimer, I. A. J., Zhang, T., Liu, G., Daneshmand, M., et al. (2005) · New England Journal of Medicine · doi:10.1056/nejmoa050736 · Cited by 1,815
Self-citationHidalgo, M., Siu, L. L., Nemunaitis, J., Rizzo, J., Hammond, L. A., Takimoto, C., Eckhardt, S. G., Tolcher, A., Britten, C. D., Denis, L., et al. (2001) · Journal of Clinical Oncology · doi:10.1200/jco.2001.19.13.3267 · Cited by 1,001
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Conroy, T., Desseigne, F., Ychou, M., Bouché, O., Guimbaud, R., Bécouarn, Y., Adenis, A., Raoul, J.-L., Gourgou-Bourgade, S., de la Fouchardière, C., et al. (2011) · New England Journal of Medicine · doi:10.1056/nejmoa1011923 · Cited by 7,810
Increased Survival in Pancreatic Cancer with nab-Paclitaxel plus Gemcitabine
Von Hoff, D. D., Ervin, T., Arena, F. P., Chiorean, E. G., Infante, J., Moore, M., Seay, T., Tjulandin, S. A., Ma, W. W., Saleh, M. N., et al. (2013) · New England Journal of Medicine · doi:10.1056/nejmoa1304369 · Cited by 6,712
Self-citationWild-Type KRAS Is Required for Panitumumab Efficacy in Patients With Metastatic Colorectal Cancer
Amado, R. G., Wolf, M., Peeters, M., Van Cutsem, E., Siena, S., Freeman, D. J., Juan, T., Sikorski, R., Suggs, S., Radinsky, R., et al. (2008) · Journal of Clinical Oncology · doi:10.1200/jco.2007.14.7116 · Cited by 3,207
Targeting the Raf-MEK-ERK mitogen-activated protein kinase cascade for the treatment of cancer
Roberts, P. J., & Der, C. J. (2007) · Oncogene · doi:10.1038/sj.onc.1210422 · Cited by 2,788
Vincent, A., Herman, J. M., Schulick, R., Hruban, R. H., & Goggins, M. (2011) · The Lancet · doi:10.1016/s0140-6736(10)62307-0 · Cited by 2,678
Metadata
- 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
- Venue
- Journal of Clinical Oncology
- Published
- 2007-05-20
- Volume
- 25
- Issue
- 15
- Pages
- 1960-1966
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- 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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