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Prospective, open-label, and observational study of cetuximab for metastatic colorectal carcinoma: The OPTIM1SE study.
Yang, Tsai-Sheng; Chen, Hong-Hwa; Bo-Wen, Lin; Kim, Tae Won; Kim, Jong Gwang; Ahn, Joong Bae; Lee, Myung-Ah; Lin, Johnson; Ho, Gwo Fuang; Anh, Le Tuan; Temraz, Sally; Burge, Matthew; Chua, Clarinda; Huang, Jason; Park, Young Suk.
Afiliación
  • Yang TS; Division of Hematology/Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital, Taipei, Taiwan.
  • Chen HH; Department of Colorectal Surgery, Chang Gung Memorial Hospital, Kaohsiung City, Taiwan.
  • Bo-Wen L; Department of Surgery, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
  • Kim TW; Department of Oncology, Asan Medical Center, University of Ulsan, Seoul, South Korea.
  • Kim JG; Kyungpook National University Medical Center, Daegu, South Korea.
  • Ahn JB; Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.
  • Lee MA; The Catholic University of Korea, Seoul St Mary's Hospital, Seoul, South Korea.
  • Lin J; Division of Hematology and Oncology, Mackay Memorial Hospital, Taipei, Taiwan.
  • Ho GF; Department of Oncology, Faculty of Medicine, University of Malaya Medical Centre, Kuala Lumpur, Malaysia.
  • Anh LT; Department of Medical and Radiation Oncology, Cho Ray Hospital, Ho Chi Minh City, Vietnam.
  • Temraz S; Division of Hematology and Oncology, American University of Beirut Medical Center, Beirut, Lebanon.
  • Burge M; Department of Medical Oncology, Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.
  • Chua C; Division of Medical Oncology, National Cancer Centre, Singapore.
  • Huang J; Merck Pte. Ltd., Singapore, an affiliate of Merck KGaA, Darmstadt, Germany.
  • Park YS; Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Asia Pac J Clin Oncol ; 19(6): 672-680, 2023 Dec.
Article en En | MEDLINE | ID: mdl-36855017
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias del Recto / Neoplasias Colorrectales / Neoplasias del Colon / Neoplasias Hepáticas Tipo de estudio: Observational_studies / Risk_factors_studies Límite: Female / Humans / Male / Middle aged Idioma: En Revista: Asia Pac J Clin Oncol Asunto de la revista: NEOPLASIAS Año: 2023 Tipo del documento: Article País de afiliación: Taiwán Pais de publicación: Australia
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias del Recto / Neoplasias Colorrectales / Neoplasias del Colon / Neoplasias Hepáticas Tipo de estudio: Observational_studies / Risk_factors_studies Límite: Female / Humans / Male / Middle aged Idioma: En Revista: Asia Pac J Clin Oncol Asunto de la revista: NEOPLASIAS Año: 2023 Tipo del documento: Article País de afiliación: Taiwán Pais de publicación: Australia