Chihiro Kosugi1, Keiji Koda2, Keiichiro Ishibashi3, Kazuhiko Yoshimatsu4, Soichi Tanaka5, Ryouji Kato6, Hiroyuki Kato7, Masatoshi Oya8, Kazuo Narushima2, Mikito Mori2, Kiyohiko Shuto2, Hideyuki Ishida3. 1. Department of Surgery, Teikyo University Chiba Medical Center, 3426-3 Anesaki, Ichihara, Chiba, 299-0111, Japan. ckosugi0126@yahoo.co.jp. 2. Department of Surgery, Teikyo University Chiba Medical Center, 3426-3 Anesaki, Ichihara, Chiba, 299-0111, Japan. 3. Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Saitama, Japan. 4. Department of Surgery, Medical Center East, Tokyo Women's Medical University, Tokyo, Japan. 5. Department of Surgery, Matsuda Hospital, Sendai, Japan. 6. Department of Surgery, Sakura Medical Center, School of Medicine, Faculty of Medicine, Toho University, Tokyo, Japan. 7. First Department of Surgery, Dokkyo Medical University, Mibu, Japan. 8. Department of Surgery, Koshigaya Hospital, Dokkyo Medical University, Mibu, Japan.
Abstract
PURPOSE: Adjuvant chemotherapy with oxaliplatin combined with a fluoropyrimidine derivative is widely accepted as standard therapy for patients with stage III colon cancer, since few clinical data are available for Japanese patients. The FACOS trial investigated the tolerability of modified FOLFOX6 (mFOLFOX6) and XELOX regimens in Japanese colon cancer patients. METHODS: Twelve cycles of mFOLFOX6 or 8 cycles of XELOX were given to patients with eligibility: stage III curatively resected colon cancer, performance status of 0-1, age from 20 to 75 years, and adequate organ function. The primary endpoint was 3-year disease-free survival. Secondary endpoints were the incidence of adverse events (AEs) and the completion rate of study therapy. RESULTS: From April 2010 to April 2014, a total of 132 patients were enrolled. Safety was analyzed in 130 patients, with finalized data from 73 patients receiving mFOLFOX6 and 57 patients receiving XELOX. A total of 130 patients (100%) experienced AEs (any grade), and 52 patients (40.0%) experienced AEs of grade ≥ 3. No significant difference in the frequency of grade ≥ 3 AEs was observed between mFOLFOX6 and XELOX groups. Continuation of the planned cycle rate of protocol treatment was 69.9% in the mFOLFOX6 group and 68.4% in the XELOX group. Treatment was discontinued because of AEs in 14 patients (19.2%) in the mFOLFOX6 group and 8 (14.0%) in the XELOX group. Mean relative dose intensity for oxaliplatin was 78.0% in the mFOLFOX6 group and 82.8% in the XELOX group. CONCLUSION: As adjuvant chemotherapy for stage III colon cancer, mFOLFOX6/XELOX regimens are acceptable.
PURPOSE: Adjuvant chemotherapy with oxaliplatin combined with a fluoropyrimidine derivative is widely accepted as standard therapy for patients with stage III colon cancer, since few clinical data are available for Japanese patients. The FACOS trial investigated the tolerability of modified FOLFOX6 (mFOLFOX6) and XELOX regimens in Japanese colon cancerpatients. METHODS: Twelve cycles of mFOLFOX6 or 8 cycles of XELOX were given to patients with eligibility: stage III curatively resected colon cancer, performance status of 0-1, age from 20 to 75 years, and adequate organ function. The primary endpoint was 3-year disease-free survival. Secondary endpoints were the incidence of adverse events (AEs) and the completion rate of study therapy. RESULTS: From April 2010 to April 2014, a total of 132 patients were enrolled. Safety was analyzed in 130 patients, with finalized data from 73 patients receiving mFOLFOX6 and 57 patients receiving XELOX. A total of 130 patients (100%) experienced AEs (any grade), and 52 patients (40.0%) experienced AEs of grade ≥ 3. No significant difference in the frequency of grade ≥ 3 AEs was observed between mFOLFOX6 and XELOX groups. Continuation of the planned cycle rate of protocol treatment was 69.9% in the mFOLFOX6 group and 68.4% in the XELOX group. Treatment was discontinued because of AEs in 14 patients (19.2%) in the mFOLFOX6 group and 8 (14.0%) in the XELOX group. Mean relative dose intensity for oxaliplatin was 78.0% in the mFOLFOX6 group and 82.8% in the XELOX group. CONCLUSION: As adjuvant chemotherapy for stage III colon cancer, mFOLFOX6/XELOX regimens are acceptable.
Authors: Barry C Lembersky; H Samuel Wieand; Nicholas J Petrelli; Michael J O'Connell; Linda H Colangelo; Roy E Smith; Thomas E Seay; Jeffrey K Giguere; M Ernest Marshall; Andrew D Jacobs; Lauren K Colman; Atilla Soran; Greg Yothers; Norman Wolmark Journal: J Clin Oncol Date: 2006-05-01 Impact factor: 44.544
Authors: Hans-Joachim Schmoll; Thomas Cartwright; Josep Tabernero; Marek P Nowacki; Arie Figer; Jean Maroun; Timothy Price; Robert Lim; Eric Van Cutsem; Young-Suk Park; Joseph McKendrick; Claire Topham; Gemma Soler-Gonzalez; Filipo de Braud; Mark Hill; Florin Sirzén; Daniel G Haller Journal: J Clin Oncol Date: 2007-01-01 Impact factor: 44.544
Authors: Chris Twelves; Alfred Wong; Marek P Nowacki; Markus Abt; Howard Burris; Alfredo Carrato; Jim Cassidy; Andrés Cervantes; Jan Fagerberg; Vassilis Georgoulias; Fares Husseini; Duncan Jodrell; Piotr Koralewski; Hendrik Kröning; Jean Maroun; Norbert Marschner; Joseph McKendrick; Marek Pawlicki; Riccardo Rosso; Johannes Schüller; Jean-François Seitz; Borut Stabuc; Jerzy Tujakowski; Guy Van Hazel; Jerzy Zaluski; Werner Scheithauer Journal: N Engl J Med Date: 2005-06-30 Impact factor: 91.245
Authors: Al B Benson; Alan P Venook; Tanios Bekaii-Saab; Emily Chan; Yi-Jen Chen; Harry S Cooper; Paul F Engstrom; Peter C Enzinger; Moon J Fenton; Charles S Fuchs; Jean L Grem; Steven Hunt; Ahmed Kamel; Lucille A Leong; Edward Lin; Wells Messersmith; Mary F Mulcahy; James D Murphy; Steven Nurkin; Eric Rohren; David P Ryan; Leonard Saltz; Sunil Sharma; David Shibata; John M Skibber; Constantinos T Sofocleous; Elena M Stoffel; Eden Stotsky-Himelfarb; Christopher G Willett; Kristina M Gregory; Deborah A Freedman-Cass Journal: J Natl Compr Canc Netw Date: 2014-07 Impact factor: 11.908
Authors: F Levi; B Perpoint; C Garufi; C Focan; P Chollet; P Depres-Brummer; R Zidani; S Brienza; M Itzhaki; S Iacobelli Journal: Eur J Cancer Date: 1993 Impact factor: 9.162
Authors: G Francini; R Petrioli; L Lorenzini; S Mancini; S Armenio; G Tanzini; S Marsili; A Aquino; G Marzocca; S Civitelli Journal: Gastroenterology Date: 1994-04 Impact factor: 22.682
Authors: C G Moertel; T R Fleming; J S Macdonald; D G Haller; J A Laurie; P J Goodman; J S Ungerleider; W A Emerson; D C Tormey; J H Glick Journal: N Engl J Med Date: 1990-02-08 Impact factor: 91.245