Prospective, open-label, and observational study of cetuximab for metastatic colorectal carcinoma: The OPTIM1SE study

Yang TS 1 , Chen HH 2 , Bo-Wen L 3 , Kim TW 4 , Kim JG 5 , Ahn JB 6 Show all authors , Lee MA 7 , Lin J 8 , Ho GF 9 , Anh LT 10 , Temraz S 11 , Burge M 12 , Chua C 13 , Huang J 14 , Park YS 15

Affiliations 

  • 1 Division of Hematology/Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital, Taipei, Taiwan
  • 2 Department of Colorectal Surgery, Chang Gung Memorial Hospital, Kaohsiung City, Taiwan
  • 3 Department of Surgery, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan
  • 4 Department of Oncology, Asan Medical Center, University of Ulsan, Seoul, South Korea
  • 5 Kyungpook National University Medical Center, Daegu, South Korea
  • 6 Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea
  • 7 The Catholic University of Korea, Seoul St Mary's Hospital, Seoul, South Korea
  • 8 Division of Hematology and Oncology, Mackay Memorial Hospital, Taipei, Taiwan
  • 9 Department of Oncology, Faculty of Medicine, University of Malaya Medical Centre, Kuala Lumpur, Malaysia
  • 10 Department of Medical and Radiation Oncology, Cho Ray Hospital, Ho Chi Minh City, Vietnam
  • 11 Division of Hematology and Oncology, American University of Beirut Medical Center, Beirut, Lebanon
  • 12 Department of Medical Oncology, Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia
  • 13 Division of Medical Oncology, National Cancer Centre, Singapore
  • 14 Merck Pte. Ltd., Singapore, an affiliate of Merck KGaA, Darmstadt, Germany
  • 15 Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea
Asia Pac J Clin Oncol, 2023 Dec;19(6):672-680.
PMID: 36855017 DOI: 10.1111/ajco.13920

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.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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