BACKGROUND: In anorectal cancer patients, an acute side effect of chemoradiotherapy is gastrointestinal toxicity, which often impedes treatment delivery. Based on previous trials, octreotide acetate is widely recommended for the control of chemotherapy-induced diarrhea. However, the effectiveness of octreotide in preventing or controlling radiation- and chemoradiation-induced diarrhea is not known. METHODS: A randomized, double-blinded, placebo-controlled trial was designed to determine the efficacy of long-acting octreotide acetate (LAO) in preventing the onset of acute diarrhea in patients undergoing chemoradiation therapy for rectal or anal cancer. Between 4 and 7 days before the start of radiation therapy, patients received a 30-mg dose of LAO (109 patients) or placebo (106 patients) via intramuscular injection. A second dose was given on day 22 (+/-3 days) of radiation treatment. A total of 215 patients were included in the final analysis. The primary endpoint was the incidence of grade 2-4 acute diarrhea; secondary endpoints included treatment compliance, medical resource utilization, patient-reported bowel function, and quality of life (QoL). Statistical tests were one- or two-sided, as specified. RESULTS: After a median follow-up time of 9.64 months, incidence rates of grades 2-4 acute diarrhea were similar in both groups (49% placebo vs 44% LAO; P = .21). No statistically significant treatment differences in chemotherapy or radiation delivery, medical resource utilization, patient-reported bowel function, or QoL were observed. CONCLUSION: In this study, the prophylactic use of LAO did not prevent the incidence or reduce the severity of diarrhea and had no notable impact on patient-reported bowel function or QoL.
RCT Entities:
BACKGROUND: In anorectal cancerpatients, an acute side effect of chemoradiotherapy is gastrointestinal toxicity, which often impedes treatment delivery. Based on previous trials, octreotide acetate is widely recommended for the control of chemotherapy-induced diarrhea. However, the effectiveness of octreotide in preventing or controlling radiation- and chemoradiation-induced diarrhea is not known. METHODS: A randomized, double-blinded, placebo-controlled trial was designed to determine the efficacy of long-acting octreotide acetate (LAO) in preventing the onset of acute diarrhea in patients undergoing chemoradiation therapy for rectal or anal cancer. Between 4 and 7 days before the start of radiation therapy, patients received a 30-mg dose of LAO (109 patients) or placebo (106 patients) via intramuscular injection. A second dose was given on day 22 (+/-3 days) of radiation treatment. A total of 215 patients were included in the final analysis. The primary endpoint was the incidence of grade 2-4 acute diarrhea; secondary endpoints included treatment compliance, medical resource utilization, patient-reported bowel function, and quality of life (QoL). Statistical tests were one- or two-sided, as specified. RESULTS: After a median follow-up time of 9.64 months, incidence rates of grades 2-4 acute diarrhea were similar in both groups (49% placebo vs 44% LAO; P = .21). No statistically significant treatment differences in chemotherapy or radiation delivery, medical resource utilization, patient-reported bowel function, or QoL were observed. CONCLUSION: In this study, the prophylactic use of LAO did not prevent the incidence or reduce the severity of diarrhea and had no notable impact on patient-reported bowel function or QoL.
Authors: A Trotti; D J Johnson; C Gwede; L Casey; B Sauder; A Cantor; J Pearlman Journal: Int J Radiat Oncol Biol Phys Date: 1998-09-01 Impact factor: 7.038
Authors: S Wadler; A B Benson; C Engelking; R Catalano; M Field; S M Kornblau; E Mitchell; J Rubin; P Trotta; E Vokes Journal: J Clin Oncol Date: 1998-09 Impact factor: 44.544
Authors: N Wolmark; H S Wieand; D M Hyams; L Colangelo; N V Dimitrov; E H Romond; M Wexler; D Prager; A B Cruz; P H Gordon; N J Petrelli; M Deutsch; E Mamounas; D L Wickerham; E R Fisher; H Rockette; B Fisher Journal: J Natl Cancer Inst Date: 2000-03-01 Impact factor: 13.506
Authors: Jaffer A Ajani; Kathryn A Winter; Leonard L Gunderson; John Pedersen; Al B Benson; Charles R Thomas; Robert J Mayer; Michael G Haddock; Tyvin A Rich; Christopher Willett Journal: JAMA Date: 2008-04-23 Impact factor: 56.272
Authors: Deborah W Bruner; Daniel Hunt; Jeff M Michalski; Walter R Bosch; James M Galvin; Mahul Amin; Canhua Xiao; Jean-Paul Bahary; Malti Patel; Susan Chafe; George Rodrigues; Harold Lau; Marie Duclos; Madhava Baikadi; Snehal Deshmukh; Howard M Sandler Journal: Cancer Date: 2015-04-02 Impact factor: 6.860
Authors: Joanne M Bowen; Rachel J Gibson; Janet K Coller; Nicole Blijlevens; Paolo Bossi; Noor Al-Dasooqi; Emma H Bateman; Karen Chiang; Charlotte de Mooij; Bronwen Mayo; Andrea M Stringer; Wim Tissing; Hannah R Wardill; Ysabella Z A van Sebille; Vinisha Ranna; Anusha Vaddi; Dorothy Mk Keefe; Rajesh V Lalla; Karis Kin Fong Cheng; Sharon Elad Journal: Support Care Cancer Date: 2019-07-08 Impact factor: 3.603
Authors: Bryan K Kee; Jeffrey S Morris; Rebecca S Slack; Todd Crocenzi; Lucas Wong; Ben Esparaz; Michael Overman; Katrina Glover; Desiree Jones; Sijin Wen; Michael J Fisch Journal: Support Care Cancer Date: 2014-08-27 Impact factor: 3.603
Authors: Theresa A Lawrie; John T Green; Mark Beresford; Linda Wedlake; Sorrel Burden; Susan E Davidson; Simon Lal; Caroline C Henson; H Jervoise N Andreyev Journal: Cochrane Database Syst Rev Date: 2018-01-23
Authors: V M Coyle; D Lungulescu; C Toganel; A Niculescu; S Pop; T Ciuleanu; C Cebotaru; J Devane; M Martin; R H Wilson Journal: Br J Cancer Date: 2013-03-05 Impact factor: 7.640