title: Randomized phase III trial exploring the use of long-acting release octreotide in the prevention of chemotherapy-induced diarrhea in patients with colorectal cancer: the LARCID trial.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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).
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  This study could not prove the efficacy of octreotide LAR in the prevention of CID.
authors: 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.
authors: Paulo M
authors: PM
authors: Hoff
authors: Daniel F
authors: DF
authors: Saragiotto
authors: Carlos H
authors: CH
authors: Barrios
authors: Auro
authors: A
authors: del Giglio
authors: Anelisa K
authors: AK
authors: Coutinho
authors: Aline C
authors: AC
authors: Andrade
authors: Carolina
authors: C
authors: Dutra
authors: Nora M
authors: NM
authors: Forones
authors: Mariangela
authors: M
authors: Correa
authors: Maria do Socorro O
authors: Mdo S
authors: Portella
authors: Vanessa Q
authors: VQ
authors: Passos
authors: Renata N
authors: RN
authors: Chinen
authors: Brigitte
authors: B
authors: van Eyll
mesh_terms: D000328:Adult; D000368:Aged; D000930:Antidiarrheals / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D000069287:Capecitabine; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D003692:Delayed-Action Preparations; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D003967:Diarrhea / Q000139:chemically induced / Q000517:prevention & control*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D000077146:Irinotecan; D008139:Loperamide / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D015282:Octreotide / Q000627:therapeutic use*; D011788:Quality of Life; D012720:Severity of Illness Index; D055815:Young Adult
chemical_list: D000930:Antidiarrheals; D003692:Delayed-Action Preparations; D003841:Deoxycytidine; D000069287:Capecitabine; D008139:Loperamide; D000077146:Irinotecan; D015282:Octreotide; D005472:Fluorouracil; D002166:Camptothecin