Paulo M. Hoff and Daniel F. Saragiotto, Instituto do Câncer do Estado de São Paulo, Hospital Sírio Libanês; Auro del Giglio, Centro de Estudos e Pesquisas em Hematologia e Oncologia da Faculdade de Medicina do ABC; Nora M. Forones, Universidade Federal de São Paulo; Mariangela Correa, Hospital Alemão Oswaldo Cruz; Maria do Socorro O. Portella and Renata N. Chinen, Novartis Biociências; Brigitte van Eyll, Instituto de Câncer Arnaldo Vieira de Carvalho, São Paulo; Carlos H. Barrios, Hospital São Lucas, Porto Alegre; Anelisa K. Coutinho, Clínica Assisténcia Multidisciplinar Oncologia, Salvador; Aline C. Andrade, Biocâncer, Belo Horizonte; Carolina Dutra, Centro de Pesquisas Oncológicas, Florianópolis, Brazil; and Vanessa Q. Passos, Novartis Pharmaceuticals, Florham Park, NJ.
J Clin Oncol. 2014 Apr 1;32(10):1006-11. doi: 10.1200/JCO.2013.50.8077. Epub 2014 Feb 10.
Chemotherapy-induced diarrhea (CID) is a relatively common adverse event in the treatment of patients with colorectal cancer. The LAR for Chemotherapy-Induced Diarrhea (LARCID) trial evaluated the efficacy and safety of long-acting release octreotide (octreotide LAR) for the prevention of CID in this population.
Patients with colorectal cancer starting adjuvant or first-line treatment with a chemotherapy combination containing fluorouracil, capecitabine, and/or irinotecan were randomly assigned to receive octreotide LAR 30 mg intramuscularly every 4 weeks (experimental arm) or the physician's treatment of choice in case of diarrhea (control arm).
A total of 139 patients were randomly assigned, most of whom received fluorouracil- and oxaliplatin-containing chemotherapy regimens. The rate of diarrhea was 76.1% in the experimental group (n = 68) and 78.9% in the control group (n = 71). Treatment with octreotide LAR did not prevent or reduce the severity of CID. Treatment choices for diarrhea management included loperamide in the majority of patients. No benefit from octreotide LAR was identified in terms of need for diarrhea treatment, opioids, or intravenous hydration or in the rate of hospitalization or quality of life.
This study could not prove the efficacy of octreotide LAR in the prevention of CID.
化疗引起的腹泻（CID）是结直肠癌患者治疗中较为常见的不良反应。LAR 用于化疗引起的腹泻（LARCID）试验评估了长效奥曲肽（奥曲肽 LAR）预防该人群 CID 的疗效和安全性。
开始接受含氟尿嘧啶、卡培他滨和/或伊立替康的化疗联合辅助或一线治疗的结直肠癌患者被随机分配接受奥曲肽 LAR 30mg 肌内注射，每 4 周一次（实验组）或医生在发生腹泻时的治疗选择（对照组）。
共随机分配了 139 例患者，他们大多接受了含氟尿嘧啶和奥沙利铂的化疗方案。实验组（n=68）腹泻发生率为 76.1%，对照组（n=71）为 78.9%。奥曲肽 LAR 治疗并未预防或减轻 CID 的严重程度。腹泻管理的治疗选择包括大多数患者使用洛哌丁胺。奥曲肽 LAR 并未在腹泻治疗、阿片类药物、静脉补液或住院率或生活质量方面显示出获益。
本研究未能证明奥曲肽 LAR 预防 CID 的疗效。
