{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,20]],"date-time":"2026-01-20T15:02:07Z","timestamp":1768921327669,"version":"3.49.0"},"reference-count":19,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2023,2,28]],"date-time":"2023-02-28T00:00:00Z","timestamp":1677542400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100009945","name":"Merck KGaA","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009945","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Asia-Pac J Clncl Oncology"],"published-print":{"date-parts":[[2023,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aim<\/jats:title><jats:p>The OPTIM1SE study observed long\u2010term real\u2010world outcomes of cetuximab\u2010based infusional 5\u2010fluorouracil (5\u2010FU) regimens for first\u2010line treatment of metastatic colorectal cancer (mCRC) across Asia\u2010Pacific and Middle East regions, aiming to characterize their use, effectiveness, and safety in routine practice.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>OPTIM1SE was a prospective, open\u2010label, observational study. Patients with untreated <jats:italic>KRAS<\/jats:italic> wild\u2010type 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\u2010free survival (PFS), and overall survival (OS).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>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 (\u00b112.0) years; 420 patients received leucovorin, 5\u2010FU, and irinotecan\u2013based regimens and 94 received leucovorin, 5\u2010FU, 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%\u201349.7%), including 26 patients (5.0%) with a complete response. Median PFS was 9.9 months (95% CI, 8.2\u201311.0); median OS (mOS) was 30.8 months (95% CI, 27.9\u201333.6). Higher mOS was associated with tumors of left compared with right\u2010sided origin (hazard ratio, 0.69 [95% CI, 0.49\u20130.99]); higher ORR was also associated with liver metastases compared with all other metastases (55.4%\u00a0vs. 40.2%). Adverse events were consistent with the known safety profile of cetuximab.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Cetuximab\u2010based 5\u2010FU regimens were effective first\u2010line treatments for mCRC in routine practice, particularly in patients with left\u2010sided disease and liver metastases only.<\/jats:p><\/jats:sec>","DOI":"10.1111\/ajco.13920","type":"journal-article","created":{"date-parts":[[2023,3,1]],"date-time":"2023-03-01T04:04:06Z","timestamp":1677643446000},"page":"672-680","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Prospective, open\u2010label, and observational study of cetuximab for metastatic colorectal carcinoma: The OPTIM1SE study"],"prefix":"10.1111","volume":"19","author":[{"given":"Tsai\u2010Sheng","family":"Yang","sequence":"first","affiliation":[{"name":"Division of Hematology\/Oncology Department of Internal Medicine Chang Gung Memorial Hospital  Taipei Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hong\u2010Hwa","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Colorectal Surgery Chang Gung Memorial Hospital  Kaohsiung City Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lin","family":"Bo\u2010Wen","sequence":"additional","affiliation":[{"name":"Department of Surgery National Cheng Kung University Hospital College of Medicine, National Cheng Kung University  Tainan Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tae Won","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Oncology Asan Medical Center University of Ulsan  Seoul South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jong Gwang","family":"Kim","sequence":"additional","affiliation":[{"name":"Kyungpook National University Medical Center  Daegu South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joong Bae","family":"Ahn","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Severance Hospital, Yonsei University College of Medicine  Seoul South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Myung\u2010Ah","family":"Lee","sequence":"additional","affiliation":[{"name":"The Catholic University of Korea Seoul St Mary's Hospital  Seoul South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Johnson","family":"Lin","sequence":"additional","affiliation":[{"name":"Division of Hematology and Oncology Mackay Memorial Hospital  Taipei Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gwo Fuang","family":"Ho","sequence":"additional","affiliation":[{"name":"Department of Oncology, Faculty of Medicine University of Malaya Medical Centre  Kuala Lumpur Malaysia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Le Tuan","family":"Anh","sequence":"additional","affiliation":[{"name":"Department of Medical and Radiation Oncology Cho Ray Hospital  Ho Chi Minh City Vietnam"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sally","family":"Temraz","sequence":"additional","affiliation":[{"name":"Division of Hematology and Oncology American University of Beirut Medical Center  Beirut Lebanon"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matthew","family":"Burge","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Royal Brisbane and Women's Hospital  Brisbane Queensland Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Clarinda","family":"Chua","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology National Cancer Centre  Singapore"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jason","family":"Huang","sequence":"additional","affiliation":[{"name":"Merck Pte. 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