The oncologist · 2026
FOLFOXIRI plus panitumumab for left-sided RAS-wild-type metastatic colorectal cancer.
Клиническое исследование II фазыСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Hochster Howard S, Blatchford Patrick J, Stein Stacey, Lacy Jill, Kasi Anup, Boland Patrick M, Gold Philp, Scott Aaron J, Oberstein Paul, Cusnir Michael, Rouse Kate, Mallalieu Karen, Saeed Anwaar, AGICC Group
Аннотация
BACKGROUND: Colorectal cancer (CRC) can be effectively treated with fluoropyrimidine chemotherapy doublets. The triplet chemotherapy program, FOLFOXIRI, is more effective than a doublet in randomized trials. We combined this triplet with the anti-epidermal growth factor receptor (EGFR) antibody, panitumumab, as first-line therapy in the appropriately targeted population: left-sided, RAS wild-type metastatic CRC.
METHODS: A multicenter trial was conducted with the AGICC (Academic GI Cancer Consortium) group. Patients with stage IV or unresectable, left-sided, Rat Sarcoma Virus oncogene (RAS) wild-type CRC were eligible if they had measurable disease, adequate organ function, and Perfromance Status (PS) 0-1. Consented patients were treated with modified FOLFOXIRI and panitumumab every 2 weeks until progression or toxicity. CT scans were performed every 8 weeks. The primary endpoint was response rate by Response Evaluation Criteria in Solid Tumors (RECiST) v1.1, with an expectation of an RR ≥85%.
RESULTS: Twenty-nine patients were enrolled and 27 were treated. A total of 430 cycles were given, including 7 patients with the maximum of 24 cycles (median 18, range 3-24). Best response included 2 CR, 18 PR, and 6 SD (RR 74%). One patient progressed at the time of first assessment. Grade 3+ toxicity included neutropenia, diarrhea, rash, hypomagnesemia, and hypokalemia, similar to prior reports. No patient had grade 5 toxicity. Median progression-free survival (PFS) was 17.0 months, and overall survival was not reached but exceeded 36 months.
CONCLUSION: In this small US multicenter study, utilizing FOLFOXIRI with an anti-EGFR antibody for appropriately selected patients, we note that the response rates and PFS values are among the highest reported in stage IV colon cancer.
CLINICALTRIALS.GOV IDENTIFIER: NCT04169347.
METHODS: A multicenter trial was conducted with the AGICC (Academic GI Cancer Consortium) group. Patients with stage IV or unresectable, left-sided, Rat Sarcoma Virus oncogene (RAS) wild-type CRC were eligible if they had measurable disease, adequate organ function, and Perfromance Status (PS) 0-1. Consented patients were treated with modified FOLFOXIRI and panitumumab every 2 weeks until progression or toxicity. CT scans were performed every 8 weeks. The primary endpoint was response rate by Response Evaluation Criteria in Solid Tumors (RECiST) v1.1, with an expectation of an RR ≥85%.
RESULTS: Twenty-nine patients were enrolled and 27 were treated. A total of 430 cycles were given, including 7 patients with the maximum of 24 cycles (median 18, range 3-24). Best response included 2 CR, 18 PR, and 6 SD (RR 74%). One patient progressed at the time of first assessment. Grade 3+ toxicity included neutropenia, diarrhea, rash, hypomagnesemia, and hypokalemia, similar to prior reports. No patient had grade 5 toxicity. Median progression-free survival (PFS) was 17.0 months, and overall survival was not reached but exceeded 36 months.
CONCLUSION: In this small US multicenter study, utilizing FOLFOXIRI with an anti-EGFR antibody for appropriately selected patients, we note that the response rates and PFS values are among the highest reported in stage IV colon cancer.
CLINICALTRIALS.GOV IDENTIFIER: NCT04169347.