BACKGROUND: The aim of this study was to evaluate the efficacy of irinotecan (CPT-11) monotherapy and CPT-11 plus 5-fluorouracil (5-FU)/leucovorin (LV) combination (mFOLFIRI) as second-line treatment in patients with advanced gastric cancer (AGC). METHODS:A total of 59 patients were randomly assigned to either CPT-11 (150 mg/m(2) iv on day 1) or mFOLFIRI (CPT-11 150 mg/m(2) plus LV 20 mg/m(2) on day 1 followed by 5-FU 2,000 mg/m(2) over 48 h), every 2 weeks. The primary end point was objective response rate (ORR). RESULTS: Following random assignment, 29 patients received CPT-11 and 30 patients mFOLFIRI. The ORR was 17.2 % [95 % confidence interval (CI) 3.4-30.9] and 20.0 % (95 % CI 5.6-34.3) for the CPT-11 and mFOLFIRI arms, respectively (P = 0.525). There was no significant difference in median progression-free survival: 2.2 months (95 % CI 0.2-4.3) for CPT-11 versus 3.0 months (95 % CI 2.0-3.7) for mFOLFIRI (P = 0.481) or in median overall survival: 5.8 months (95 % CI 3.0-8.7), compared with 6.7 months (95 % CI 5.3-8.2) (P = 0.514). Grade 3/4 toxicity was observed in 21 and 28 events in the CPT-11 and mFOLFIRI arms, respectively. CONCLUSIONS: Although this study had a small sample size and limited statistical power, CPT-11 monotherapy and mFOLFIRI appear to be equally active and tolerable as second-line chemotherapy for AGC. The addition of 5-FU/LV to CPT-11 did not significantly improve efficacy.
RCT Entities:
BACKGROUND: The aim of this study was to evaluate the efficacy of irinotecan (CPT-11) monotherapy and CPT-11 plus 5-fluorouracil (5-FU)/leucovorin (LV) combination (mFOLFIRI) as second-line treatment in patients with advanced gastric cancer (AGC). METHODS: A total of 59 patients were randomly assigned to either CPT-11 (150 mg/m(2) iv on day 1) or mFOLFIRI (CPT-11 150 mg/m(2) plus LV 20 mg/m(2) on day 1 followed by 5-FU 2,000 mg/m(2) over 48 h), every 2 weeks. The primary end point was objective response rate (ORR). RESULTS: Following random assignment, 29 patients received CPT-11 and 30 patientsmFOLFIRI. The ORR was 17.2 % [95 % confidence interval (CI) 3.4-30.9] and 20.0 % (95 % CI 5.6-34.3) for the CPT-11 and mFOLFIRI arms, respectively (P = 0.525). There was no significant difference in median progression-free survival: 2.2 months (95 % CI 0.2-4.3) for CPT-11 versus 3.0 months (95 % CI 2.0-3.7) for mFOLFIRI (P = 0.481) or in median overall survival: 5.8 months (95 % CI 3.0-8.7), compared with 6.7 months (95 % CI 5.3-8.2) (P = 0.514). Grade 3/4 toxicity was observed in 21 and 28 events in the CPT-11 and mFOLFIRI arms, respectively. CONCLUSIONS: Although this study had a small sample size and limited statistical power, CPT-11 monotherapy and mFOLFIRI appear to be equally active and tolerable as second-line chemotherapy for AGC. The addition of 5-FU/LV to CPT-11 did not significantly improve efficacy.
Authors: Zhe-Ling Chen; Andi Zhao; Pan Li; Mi Zhang; Jiao Yang; Lingxiao Zhang; Xiaoai Zhao; Jin Yang; Le Wang Journal: Oncol Lett Date: 2018-07-25 Impact factor: 2.967
Authors: S F McGee; W AlGhareeb; C H Ahmad; D Armstrong; S Babak; S Berry; J Biagi; C Booth; D Bossé; P Champion; B Colwell; N Finn; R Goel; S Gray; J Green; M Harb; A Hyde; A Jeyakumar; D Jonker; S Kanagaratnam; P Kavan; A MacMillan; A Muinuddin; N Patil; G Porter; E Powell; R Ramjeesingh; M Raza; S Rorke; M Seal; F Servidio-Italiano; J Siddiqui; J Simms; L Smithson; S Snow; E St-Hilaire; T Stuckless; A Tate; M Tehfe; M Thirlwell; E Tsvetkova; M Valdes; M Vickers; K Virik; S Welch; C Marginean; T Asmis Journal: Curr Oncol Date: 2018-08-14 Impact factor: 3.677
Authors: Stefano Cascinu; György Bodoky; Kei Muro; Eric Van Cutsem; Sang Cheul Oh; Gunnar Folprecht; Sumitra Ananda; Gustavo Girotto; Zev A Wainberg; Maria Luisa Limon Miron; Jaffer Ajani; Ran Wei; Astra M Liepa; Roberto Carlesi; Michael Emig; Atsushi Ohtsu Journal: Oncologist Date: 2020-12-23
Authors: Farshid Dayyani; Kit Tam; Edward J Kim; Samuel Ejadi; Jennifer Valerin; Thomas H Taylor; May T Cho Journal: Med Oncol Date: 2022-05-23 Impact factor: 3.738