M Dank1, J Zaluski2, C Barone3, V Valvere4, S Yalcin5, C Peschel6, M Wenczl7, E Goker8, L Cisar9, K Wang9, R Bugat10. 1. Semmelweis University, Budapest, Hungary. 2. Wielkopolskie Centrum Onkologii Poznan, Poznan, Poland. 3. Catholic University of Sacred Heart, Rome, Italy. 4. Estonian Oncology Center, Tallinn, Estonia. 5. Hacettepe University Medical Faculty Institute of Oncology, Sihhiye, Ankara, Turkey. 6. III Med. Klinik, Munich, Germany. 7. Markusovszky County Hospital, Szombathely, Markusovszky, Hungary. 8. Ege University Medical School, Izmir, Turkey. 9. Pfizer, New York, NY, USA. 10. Institut Claudius Regaud, Toulouse, France. Electronic address: bugat@icr.fnclcc.fr.
Abstract
BACKGROUND: We aimed to establish the superiority (or noninferiority if superiority was not achieved) in terms of time to progression (TTP) of irinotecan/5-fluorouracil (IF) over cisplatin/5-fluorouracil (CF) in chemonaive patients with adenocarcinoma of the stomach/esophagogastric junction. PATIENTS AND METHODS: Patients received either IF: i.v. irinotecan 80 mg/m(2) 30 min, folinic acid 500 mg/m(2) 2 h, 5-fluorouracil (5-FU) 2000 mg/m(2) 22 h, for 6/7 weeks or CF: cisplatin 100 mg/m(2) 1-3 h, with 5-FU 1000 mg/m(2)/day 24 h, days 1-5, every 4 weeks. RESULTS: In all, 333 patients were randomized and treated (IF 170, CF 163). Patient characteristics were balanced except more IF patients had Karnofsky performance status 100%. TTP for IF was 5.0 months [95% confidence interval (CI) 3.8-5.8] and 4.2 months (95% CI 3.7-5.5) for CF (P = 0.088). Overall survival (OS) was 9.0 versus 8.7 months, response rate 31.8% versus 25.8%, time to treatment failure (TTF) 4.0 versus 3.4 months for IF and CF, respectively. The difference in TTF was statistically significant (P = 0.018). IF was better in terms of toxic deaths (0.6% versus 3%), discontinuation for toxicity (10.0% versus 21.5%), severe neutropenia, thrombocytopenia and stomatitis, but not diarrhea. CONCLUSION: IF did not yield a significant TTP or OS superiority over CF, and the results of noninferiority of IF were borderline. However, IF may provide a viable, platinum-free front-line treatment alternative for metastatic gastric cancer.
RCT Entities:
BACKGROUND: We aimed to establish the superiority (or noninferiority if superiority was not achieved) in terms of time to progression (TTP) of irinotecan/5-fluorouracil (IF) over cisplatin/5-fluorouracil (CF) in chemonaive patients with adenocarcinoma of the stomach/esophagogastric junction. PATIENTS AND METHODS: Patients received either IF: i.v. irinotecan 80 mg/m(2) 30 min, folinic acid 500 mg/m(2) 2 h, 5-fluorouracil (5-FU) 2000 mg/m(2) 22 h, for 6/7 weeks or CF: cisplatin 100 mg/m(2) 1-3 h, with 5-FU 1000 mg/m(2)/day 24 h, days 1-5, every 4 weeks. RESULTS: In all, 333 patients were randomized and treated (IF 170, CF 163). Patient characteristics were balanced except more IF patients had Karnofsky performance status 100%. TTP for IF was 5.0 months [95% confidence interval (CI) 3.8-5.8] and 4.2 months (95% CI 3.7-5.5) for CF (P = 0.088). Overall survival (OS) was 9.0 versus 8.7 months, response rate 31.8% versus 25.8%, time to treatment failure (TTF) 4.0 versus 3.4 months for IF and CF, respectively. The difference in TTF was statistically significant (P = 0.018). IF was better in terms of toxic deaths (0.6% versus 3%), discontinuation for toxicity (10.0% versus 21.5%), severe neutropenia, thrombocytopenia and stomatitis, but not diarrhea. CONCLUSION: IF did not yield a significant TTP or OS superiority over CF, and the results of noninferiority of IF were borderline. However, IF may provide a viable, platinum-free front-line treatment alternative for metastatic gastric cancer.
Authors: Haeseong Park; Ramon U Jin; Andrea Wang-Gillam; Rama Suresh; Caron Rigden; Manik Amin; Benjamin R Tan; Katrina S Pedersen; Kian-Huat Lim; Nikolaos A Trikalinos; Abhilasha Acharya; Megan L Copsey; Katherine A Navo; Ashley E Morton; Feng Gao; A Craig Lockhart Journal: JAMA Oncol Date: 2020-08-01 Impact factor: 31.777
Authors: Thomas Thomaidis; Arndt Weinmann; Martin Sprinzl; Stephan Kanzler; Jochen Raedle; Matthias Ebert; Carl Cristoph Schimanski; Peter Robert Galle; Thomas Hoehler; Markus Moehler Journal: Int J Clin Oncol Date: 2013-03-27 Impact factor: 3.402