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Randomized, Phase III Trial of Panitumumab With Infusional Fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX4) Versus FOLFOX4 Alone As First-Line Treatment in Patients With Previously Untreated Metastatic Colorectal Cancer: The PRIME Study
Abstract
Purpose: Panitumumab, a fully human anti–epidermal growth factor receptor (EGFR) monoclonal antibody that improves progression-free survival (PFS), is approved as monotherapy for patients with chemotherapy-refractory metastatic colorectal cancer (mCRC). The Panitumumab Randomized Trial in Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy (PRIME) was designed to evaluate the efficacy and safety of panitumumab plus infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4) versus FOLFOX4 alone as initial treatment for mCRC. Patients and Methods: In this multicenter, phase III trial, patients with no prior chemotherapy for mCRC, Eastern Cooperative Oncology Group performance status of 0 to 2, and available tissue for biomarker testing were randomly assigned 1:1 to receive panitumumab-FOLFOX4 versus FOLFOX4. The primary end point was PFS; overall survival (OS) was a secondary end point. Results were prospectively analyzed on an intent-to-treat basis by tumor KRAS status. Results: KRAS results were available for 93% of the 1,183 patients randomly assigned. In the wild-type (WT) KRAS stratum, panitumumab-FOLFOX4 significantly improved PFS compared with FOLFOX4 (median PFS, 9.6 v 8.0 months, respectively; hazard ratio [HR], 0.80; 95% CI, 0.66 to 0.97; P = .02). A nonsignificant increase in OS was also observed for panitumumab-FOLFOX4 versus FOLFOX4 (median OS, 23.9 v 19.7 months, respectively; HR, 0.83; 95% CI, 0.67 to 1.02; P = .072). In the mutant KRAS stratum, PFS was significantly reduced in the panitumumab-FOLFOX4 arm versus the FOLFOX4 arm (HR, 1.29; 95% CI, 1.04 to 1.62; P = .02), and median OS was 15.5 months versus 19.3 months, respectively (HR, 1.24; 95% CI, 0.98 to 1.57; P = .068). Adverse event rates were generally comparable across arms with the exception of toxicities known to be associated with anti-EGFR therapy. Conclusion: This study demonstrated that panitumumab-FOLFOX4 was well tolerated and significantly improved PFS in patients with WT KRAS tumors and underscores the importance of KRAS testing for patients with mCRC.
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New Guidelines to Evaluate the Response to Treatment in Solid Tumors
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Self-citationCetuximab and Chemotherapy as Initial Treatment for Metastatic Colorectal Cancer
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Self-citationWild-Type KRAS Is Required for Panitumumab Efficacy in Patients With Metastatic Colorectal Cancer
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Self-citationCetuximab for the Treatment of Colorectal Cancer
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ESMO consensus guidelines for the management of patients with metastatic colorectal cancer
Van Cutsem, E., Cervantes, A., Adam, R., Sobrero, A., Van Krieken, J. H., Aderka, D., Aranda Aguilar, E., Bardelli, A., Benson, A., Bodoky, G., et al. (2016) · Annals of Oncology · doi:10.1093/annonc/mdw235 · Cited by 3,421
Self-citationJapanese Society for Cancer of the Colon and Rectum, Watanabe, T., Muro, K., Ajioka, Y., Hashiguchi, Y., Ito, Y., Saito, Y., Hamaguchi, T., Ishida, H., Ishiguro, M., et al. (2018) · International Journal of Clinical Oncology · doi:10.1007/s10147-017-1101-6 · Cited by 2,467
“(1) Patients appropriate for intensive therapy (a) When the patient has become refractory or intolerant to the first-line therapy, including OX • FOLFIRI [62] + Bmab [85] ▪ FOLFIRI + Rmab [86] • IRIS (note 6) [87] + Bmab • IRI [88] + Bmab • FOLFIRI (or IRI) + Cmab/Pmab [88, 89] (b) When the patient has become refracto…”
InfluentialPanitumumab–FOLFOX4 Treatment and RAS Mutations in Colorectal Cancer
Douillard, J.-Y., Oliner, K. S., Siena, S., Tabernero, J., Burkes, R., Barugel, M., Humblet, Y., Bodoky, G., Cunningham, D., Jassem, J., et al. (2013) · New England Journal of Medicine · doi:10.1056/nejmoa1305275 · Cited by 2,263
Self-citationHashiguchi, Y., Muro, K., Saito, Y., Ito, Y., Ajioka, Y., Hamaguchi, T., Hasegawa, K., Hotta, K., Ishida, H., Ishiguro, M., et al. (2020) · International Journal of Clinical Oncology · doi:10.1007/s10147-019-01485-z · Cited by 1,922
Metadata
- Authors
- Douillard, J.-Y., Siena, S., Cassidy, J., Tabernero, J., Burkes, R., Barugel, M., Humblet, Y., Bodoky, G., Cunningham, D., Jassem, J., Rivera, F., Kocákova, I., Ruff, P., Błasińska-Morawiec, M., Šmakal, M., Canon, J.-L., Rother, M., Oliner, K. S., Wolf, M., & Gansert, J.
- Venue
- Journal of Clinical Oncology
- Published
- 2010-11-01
- Volume
- 28
- Issue
- 31
- Pages
- 4697-4705
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2098354753
- Cited by
- 1,809
- References
- 10
- FWCI
- 69.52
- Type
- journal article
- Language
- en
- Open access
- closed
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- Douillard, J.-Y., Siena, S., Cassidy, J., Tabernero, J., Burkes, R., Barugel, M., Humblet, Y., Bodoky, G., Cunningham, D., Jassem, J., Rivera, F., Kocákova, I., Ruff, P., Błasińska-Morawiec, M., Šmakal, M., Canon, J.-L., Rother, M., Oliner, K. S., Wolf, M., & Gansert, J. (2010). Randomized, Phase III Trial of Panitumumab With Infusional Fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX4) Versus FOLFOX4 Alone As First-Line Treatment in Patients With Previously Untreated Metastatic Colorectal Cancer: The PRIME Study. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2009.27.4860
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