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A Randomized Phase IIIB Trial of Chemotherapy, Bevacizumab, and Panitumumab Compared With Chemotherapy and Bevacizumab Alone for Metastatic Colorectal Cancer
Open accessAbstract
Purpose: Panitumumab, a fully human antibody targeting the epidermal growth factor receptor, is active in patients with metastatic colorectal cancer (mCRC). This trial evaluated panitumumab added to bevacizumab and chemotherapy (oxaliplatin- and irinotecan-based) as first-line treatment for mCRC. Patients and Methods: Patients were randomly assigned within each chemotherapy cohort to bevacizumab and chemotherapy with or without panitumumab 6 mg/kg every 2 weeks. The primary end point was progression-free survival (PFS) within the oxaliplatin cohort. Tumor assessments were performed every 12 weeks and reviewed centrally. Results: A total of 823 and 230 patients were randomly assigned to the oxaliplatin and irinotecan cohorts, respectively. Panitumumab was discontinued after a planned interim analysis of 812 oxaliplatin patients showed worse efficacy in the panitumumab arm. In the final analysis, median PFS was 10.0 and 11.4 months for the panitumumab and control arms, respectively (HR, 1.27; 95% CI, 1.06 to 1.52); median survival was 19.4 months and 24.5 months for the panitumumab and control arms, respectively. Grade 3/4 adverse events in the oxaliplatin cohort (panitumumab v control) included skin toxicity (36% v 1%), diarrhea (24% v 13%), infections (19% v 10%), and pulmonary embolism (6% v 4%). Increased toxicity without evidence of improved efficacy was observed in the panitumumab arm of the irinotecan cohort. KRAS analyses showed adverse outcomes for the panitumumab arm in both wild-type and mutant groups. Conclusion: The addition of panitumumab to bevacizumab and oxaliplatin- or irinotecan-based chemotherapy results in increased toxicity and decreased PFS. These combinations are not recommended for the treatment of mCRC in clinical practice.
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“The PACCE study evaluated the addition of panitumumab to chemotherapy and bevacizumab, showing that the combined use of two biological agents may result in adverse outcomes irrespective of RAS mutation status [19].”
From RAS Mutations in Advanced Colorectal Cancer: Mechanisms, Clinical Implications, and Novel Therapeutic Approaches (2025) · cites this paper as [19]
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Metadata
- Authors
- Hecht, J. R., Mitchell, E., Chidiac, T., Scroggin, C., Hagenstad, C., Spigel, D., Marshall, J., Cohn, A., McCollum, D., Stella, P., Deeter, R., Shahin, S., & Amado, R. G.
- Affiliations
- Amgen (United States) (US)
- Venue
- Journal of Clinical Oncology
- Published
- 2009-02-10
- Volume
- 27
- Issue
- 5
- Pages
- 672-680
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2002226820
- Cited by
- 850
- References
- 30
- Citations by year
- 2026: 5 · 2025: 8 · 2024: 19 · 2023: 10 · 2022: 21 · 2021: 15 · 2020: 29 · 2019: 29 · 2018: 26 · 2017: 38 · 2016: 44 · 2015: 57 · 2014: 56 · 2013: 88 · 2012: 101
- FWCI
- 53.42
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of Clinical Oncology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Amgen
- Topics
- Health Sciences › Medicine › Oncology › Colorectal Cancer Treatments and Studies
- Health Sciences › Medicine › Oncology › Colorectal Cancer Surgical Treatments
- Health Sciences › Medicine › Oncology › Pancreatic and Hepatic Oncology Research
- Keywords
- metastatic colorectal cancer, panitumumab, bevacizumab, oxaliplatin, irinotecan, EGFR inhibition, first-line chemotherapy, progression-free survival, treatment toxicity, KRAS mutation, anti-EGFR monoclonal antibody
- MeSH terms
- Bevacizumab, Irinotecan, Oxaliplatin, Panitumumab, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Camptothecin, Female, Humans, Male, Middle Aged, Neoplasm Metastasis, Organoplatinum Compounds, Colorectal Neoplasms, Antibodies, Monoclonal, Humanized
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