TY - JOUR
T1 - Comparison of FOLFIRI with or without cetuximab in patients with resected stage III colon cancer; NCCTG (Alliance) intergroup trial N0147
AU - Huang, Jocelin
AU - Nair, Suresh G.
AU - Mahoney, Michelle R.
AU - Nelson, Garth D.
AU - Shields, Anthony F.
AU - Chan, Emily
AU - Goldberg, Richard M.
AU - Gill, Sharlene
AU - Kahlenberg, Morton S.
AU - Quesenberry, James T.
AU - Thibodeau, Stephen N.
AU - Smyrk, Thomas C.
AU - Grothey, Axel
AU - Sinicrope, Frank A.
AU - Webb, Thomas A.
AU - Farr, Gist H.
AU - Pockaj, Barbara A.
AU - Berenberg, Jeffrey L.
AU - Mooney, Margaret
AU - Sargent, Daniel J.
AU - Alberts, Steven R.
N1 - Funding Information:
This study was conducted as a collaborative trial of the NCCTG, Mayo Clinic, and was supported in part by Public Health Service grants CA-25224 , CA-37404 , CA-35103 , CA-35113 , CA-35272 , CA-114740 , CA-32102 , CA-14028 , CA49957 , CA21115 , CA31946 , CA12027 , CA37377 from the NCI, Department of Health and Human Services. National Cancer Institute of Canada Clinical Trials Group participation in this trial was supported by funding received from the Canadian Cancer Society Research Institute (Grant # 021039 and # 015469 ) and the US NCI (Grant # CA077202 ). The content is solely the responsibility of the authors and does not necessarily represent the views of the NCI or the National Institutes of Health.
PY - 2014/6
Y1 - 2014/6
N2 - Background Two arms with FOLFIRI, with or without cetuximab, were initially included in the randomized phase III intergroup clinical trial NCCTG (North Central Cancer Treatment Group) N0147. When other contemporary trials demonstrated no benefit to using irinotecan as adjuvant therapy, the FOLFIRI-containing arms were discontinued. We report the clinical outcomes for patients randomized to FOLFIRI with or without cetuximab. Patients and Methods After resection, patients were randomized to 12 biweekly cycles of FOLFIRI, with or without cetuximab. KRAS (Kirsten rat sarcoma viral oncogene homolog) mutation status was retrospectively determined in a central lab. The primary end point was disease-free survival (DFS). Secondary end points included overall survival (OS) and toxicity. Results One hundred and six patients received FOLFIRI and 40 received FOLFIRI plus cetuximab. Median follow-up was 5.95 years (range, 0.1-7.0 years). The addition of cetuximab showed a trend toward improved DFS (hazard ratio [HR], 0.53; 95% CI, 0.26-1.1; P =.09) and OS (HR, 0.45; 95% CI, 0.17-1.16; P =.10) in the overall group, regardless of KRAS status, and in patients with wild type KRAS. Grade ≥ 3 nonhematologic adverse effects were significantly increased in the cetuximab versus FOLFIRI-alone arm (68% vs. 46%; P =.02). Adjuvant FOLFIRI resulted in a 3-year DFS less than that expected for FOLFOX. Conclusion In this small randomized subset of patients with resected stage III colon cancer, the addition of cetuximab to FOLFIRI was associated with a nonsignificant trend toward improved DFS and OS. Nevertheless, considering the limitations of this analysis, FOLFOX without the addition of a biologic agent remains the standard of care for adjuvant therapy in resected stage III colon cancer.
AB - Background Two arms with FOLFIRI, with or without cetuximab, were initially included in the randomized phase III intergroup clinical trial NCCTG (North Central Cancer Treatment Group) N0147. When other contemporary trials demonstrated no benefit to using irinotecan as adjuvant therapy, the FOLFIRI-containing arms were discontinued. We report the clinical outcomes for patients randomized to FOLFIRI with or without cetuximab. Patients and Methods After resection, patients were randomized to 12 biweekly cycles of FOLFIRI, with or without cetuximab. KRAS (Kirsten rat sarcoma viral oncogene homolog) mutation status was retrospectively determined in a central lab. The primary end point was disease-free survival (DFS). Secondary end points included overall survival (OS) and toxicity. Results One hundred and six patients received FOLFIRI and 40 received FOLFIRI plus cetuximab. Median follow-up was 5.95 years (range, 0.1-7.0 years). The addition of cetuximab showed a trend toward improved DFS (hazard ratio [HR], 0.53; 95% CI, 0.26-1.1; P =.09) and OS (HR, 0.45; 95% CI, 0.17-1.16; P =.10) in the overall group, regardless of KRAS status, and in patients with wild type KRAS. Grade ≥ 3 nonhematologic adverse effects were significantly increased in the cetuximab versus FOLFIRI-alone arm (68% vs. 46%; P =.02). Adjuvant FOLFIRI resulted in a 3-year DFS less than that expected for FOLFOX. Conclusion In this small randomized subset of patients with resected stage III colon cancer, the addition of cetuximab to FOLFIRI was associated with a nonsignificant trend toward improved DFS and OS. Nevertheless, considering the limitations of this analysis, FOLFOX without the addition of a biologic agent remains the standard of care for adjuvant therapy in resected stage III colon cancer.
KW - Adjuvant therapy
KW - Disease free survival
KW - Overall survival
KW - Response rate
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U2 - 10.1016/j.clcc.2013.12.002
DO - 10.1016/j.clcc.2013.12.002
M3 - Article
C2 - 24512953
AN - SCOPUS:84900482959
SN - 1533-0028
VL - 13
SP - 100
EP - 109
JO - Clinical colorectal cancer
JF - Clinical colorectal cancer
IS - 2
ER -