101. Prospective, open-label, and observational study of cetuximab for metastatic colorectal carcinoma: The OPTIM1SE study.
- Author
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Yang TS, Chen HH, Bo-Wen L, Kim TW, Kim JG, Ahn JB, Lee MA, Lin J, Ho GF, Anh LT, Temraz S, Burge M, Chua C, Huang J, and Park YS
- Subjects
- Humans, Male, Middle Aged, Female, Cetuximab therapeutic use, Leucovorin adverse effects, Prospective Studies, Fluorouracil adverse effects, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols adverse effects, Proto-Oncogene Proteins p21(ras) therapeutic use, Camptothecin therapeutic use, Colorectal Neoplasms pathology, Colonic Neoplasms, Rectal Neoplasms, Liver Neoplasms drug therapy
- Abstract
Aim: The OPTIM1SE study observed long-term real-world outcomes of cetuximab-based infusional 5-fluorouracil (5-FU) regimens for first-line treatment of metastatic colorectal cancer (mCRC) across Asia-Pacific and Middle East regions, aiming to characterize their use, effectiveness, and safety in routine practice., Methods: OPTIM1SE was a prospective, open-label, observational study. Patients with untreated KRAS wild-type mCRC and distant metastases were treated per locally approved labels and monitored for 3 years via electronic medical records. The primary endpoint was the overall response rate (ORR). Secondary endpoints included safety, progression-free survival (PFS), and overall survival (OS)., Results: From November 19, 2013, to June 30, 2016, 520 patients were enrolled in 51 sites. Patients were mostly male (61.2%), with a mean age of 58.5 (±12.0) years; 420 patients received leucovorin, 5-FU, and irinotecan-based regimens and 94 received leucovorin, 5-FU, and oxaliplatin. The most common primary tumor site was the rectum (38.8%), with liver metastases (65.0%). ORR was 45.4% (95% CI, 41.1%-49.7%), including 26 patients (5.0%) with a complete response. Median PFS was 9.9 months (95% CI, 8.2-11.0); median OS (mOS) was 30.8 months (95% CI, 27.9-33.6). Higher mOS was associated with tumors of left compared with right-sided origin (hazard ratio, 0.69 [95% CI, 0.49-0.99]); higher ORR was also associated with liver metastases compared with all other metastases (55.4% vs. 40.2%). Adverse events were consistent with the known safety profile of cetuximab., Conclusion: Cetuximab-based 5-FU regimens were effective first-line treatments for mCRC in routine practice, particularly in patients with left-sided disease and liver metastases only., (© 2023 The Authors. Asia-Pacific Journal of Clinical Oncology published by John Wiley & Sons Australia, Ltd.)
- Published
- 2023
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