Chu Matsuda1, Megumi Ishiguro2, Satoshi Teramukai3, Yoshiki Kajiwara4, Shoichi Fujii5, Yusuke Kinugasa6, Yoshihiko Nakamoto7, Masanori Kotake8, Yoshiyuki Sakamoto9, Kiyotaka Kurachi10, Atsuyuki Maeda11, Koji Komori12, Naohiro Tomita13, Yasuhiro Shimada14, Keiichi Takahashi15, Kenjiro Kotake16, Masahiko Watanabe17, Hidetaka Mochizuki18, Yoko Nakagawa19, Kenichi Sugihara20. 1. Osaka General Medical Center, Department of Surgery, 3-1-56 Bandaihigashi, Sumiyoshi-ku, Osaka 558-8558, Japan. Electronic address: chu0710pinefield@aol.com. 2. Tokyo Medical and Dental University, Graduate School, Department of Translational Oncology, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan. Electronic address: ishiguro.srg2@tmd.ac.jp. 3. Kyoto Prefectural University of Medicine, Department of Biostatistics, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan. Electronic address: steramu@koto.kpu-m.ac.jp. 4. National Defense Medical College, Department of Surgery, 3-2 Namiki, Tokorozawa, Saitama 359-8513, Japan. Electronic address: ykaji@ndmc.ac.jp. 5. Yokohama City University Medical Center, Department of Gastroenterological Surgery, 4-57 Urafune-cho, Minami-ku, Yokohama, Kanagawa 232-0024, Japan. Electronic address: sfujii@kaken-hp.or.jp. 6. Shizuoka Cancer Center Hospital, Division of Colon and Rectal Surgery, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan. Electronic address: y.kinugasa@scchr.jp. 7. Kobe City Medical Center West Hospital, Department of Surgery, 2-4 Ichiban-cho, Nagata-ku, Kobe, Hyogo 653-0013, Japan. Electronic address: myy2000815@gmail.com. 8. Kouseiren Takaoka Hospital, Department of Surgery, 5-10 Eiraku-cho, Takaoka, Toyama 933-8555, Japan. Electronic address: kotake628@gmail.com. 9. Hirosaki University Graduate School of Medicine, Department of Gastroenterological Surgery, 5 Zaifu-cho, Hirosaki, Aomori 036-8562, Japan. Electronic address: sakemoto@hirosaki-u.ac.jp. 10. Hamamatsu University School of Medicine, Second Department of Surgery, 1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka 431-3192, Japan. Electronic address: KKURACHI@me.com. 11. Ogaki Municipal Hospital, Department of Surgery, 4-86 Minaminokawa-cho, Ogaki, Gifu 503-8502, Japan. Electronic address: omhamaeda@yahoo.co.jp. 12. Aichi Cancer Center Hospital, Department of Gastroenterological Surgery, 1-1, Kanokoden, Chikusa, Nagoya, Aichi 464-8681, Japan. Electronic address: kkomori@aichi-cc.jp. 13. Hyogo College of Medicine, Department of Surgery, Division of Lower GI Surgery, 1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501, Japan. Electronic address: ntomita@hyo-med.ac.jp. 14. Kochi Health Sciences Center, Division of Clinical Oncology, 2125-1 Ike, Kochi-city, Kochi 781-8555, Japan. Electronic address: yasuhiro.shimada@gmail.com. 15. Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Department of Surgery, 18-22, Honkomagome 3-chome, Bunkyo-ku, Tokyo 113-8677, Japan. Electronic address: keiichi@cick.jp. 16. Tochigi Cancer Center, Department of Surgery, 4-9-13 Yonan, Utsunomiya, Tochigi 320-0834, Japan. Electronic address: kkotake018@gmail.com. 17. Kitasato University School of Medicine, Department of Surgery, 1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0375, Japan. Electronic address: gekaw@med.kitasato-u.ac.jp. 18. National Defense Medical College, Department of Surgery, 3-2 Namiki, Tokorozawa, Saitama 359-8513, Japan. Electronic address: hide-moon@xc5.so-net.ne.jp. 19. Translational Research Informatics Center, Foundation for Biomedical Research and Innovation, Division of Medical Statistics, 1-5-4 Minatojima-minamimachi, Chuo-ku, Kobe, Hyogo 650-0047, Japan. Electronic address: yoko-nakagawa@tri-kobe.org. 20. Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan. Electronic address: k-sugi.srg2@tmd.ac.jp.
Abstract
BACKGROUND: Efficacy of adjuvant chemotherapy in patients with stage II colon cancer is still controversial. The SACURA trial is a randomised-controlled study evaluating the superiority of 1-year adjuvant treatment with oral tegafur-uracil (UFT) to surgery alone for stage II colon cancer. METHODS: Patients were randomly assigned to the surgery-alone group or UFT group (UFT at 500-600 mg/day for 5 days, followed by 2-day rest, for 1 year). The primary end-point was disease-free survival (DFS). Target sample size was 2000, determined with one-sided alpha of 0.05, power of 0.9 and assumed hazard ratio (HR) 0.729. RESULTS: A total of 1982 patients (997 in the surgery-alone group and 985 in the UFT group) were analysed. Median follow-up was 69.5 months, median age was 66 years and for stage IIA/IIB/IIC, the distribution was 84%/13%/3%. The 5-year DFS rate was 78.4% in the surgery-alone group and 80.2% in the UFT group. The HR for DFS was 0.91 (95% confidence interval [CI], 0.75-1.10; p = 0.31); superiority of UFT was not demonstrated. Approximately 9% of patients experienced second cancers, which consist 40.7% of the DFS events. The 5-year relapse-free and overall survival rates of the surgery-alone and UFT group were 84.6% and 87.2% (HR, 0.82; 95% CI, 0.65-1.04) and 94.3% and 94.5% (HR, 0.93; 95% CI, 0.66-1.31), respectively. Subgroup analysis failed to disclose superiority in prognosis of adding UFT to the patients with risk factors for recurrence. CONCLUSIONS: Superiority of 1-year adjuvant UFT over surgery alone was not demonstrated in stage II colon cancer. Patients with risk factors for recurrence did not benefit from UFT. TRIAL REGISTRATION: ClinicalTrials. Gov. #NCT00392899.
RCT Entities:
BACKGROUND: Efficacy of adjuvant chemotherapy in patients with stage II colon cancer is still controversial. The SACURA trial is a randomised-controlled study evaluating the superiority of 1-year adjuvant treatment with oral tegafur-uracil (UFT) to surgery alone for stage II colon cancer. METHODS:Patients were randomly assigned to the surgery-alone group or UFT group (UFT at 500-600 mg/day for 5 days, followed by 2-day rest, for 1 year). The primary end-point was disease-free survival (DFS). Target sample size was 2000, determined with one-sided alpha of 0.05, power of 0.9 and assumed hazard ratio (HR) 0.729. RESULTS: A total of 1982 patients (997 in the surgery-alone group and 985 in the UFT group) were analysed. Median follow-up was 69.5 months, median age was 66 years and for stage IIA/IIB/IIC, the distribution was 84%/13%/3%. The 5-year DFS rate was 78.4% in the surgery-alone group and 80.2% in the UFT group. The HR for DFS was 0.91 (95% confidence interval [CI], 0.75-1.10; p = 0.31); superiority of UFT was not demonstrated. Approximately 9% of patients experienced second cancers, which consist 40.7% of the DFS events. The 5-year relapse-free and overall survival rates of the surgery-alone and UFT group were 84.6% and 87.2% (HR, 0.82; 95% CI, 0.65-1.04) and 94.3% and 94.5% (HR, 0.93; 95% CI, 0.66-1.31), respectively. Subgroup analysis failed to disclose superiority in prognosis of adding UFT to the patients with risk factors for recurrence. CONCLUSIONS: Superiority of 1-year adjuvant UFT over surgery alone was not demonstrated in stage II colon cancer. Patients with risk factors for recurrence did not benefit from UFT. TRIAL REGISTRATION: ClinicalTrials. Gov. #NCT00392899.
Authors: Romain Cohen; Dewi Vernerey; Carine Bellera; Aurélia Meurisse; Julie Henriques; Xavier Paoletti; Benoît Rousseau; Steven Alberts; Thomas Aparicio; Ioannis Boukovinas; Sharlene Gill; Richard M Goldberg; Axel Grothey; Tetsuya Hamaguchi; Timothy Iveson; Rachel Kerr; Roberto Labianca; Sara Lonardi; Jeffrey Meyerhardt; James Paul; Cornelis J A Punt; Leonard Saltz; Marck P Saunders; Hans-Joachim Schmoll; Manish Shah; Alberto Sobrero; Ioannis Souglakos; Julien Taieb; Atsuo Takashima; Anna Dorothea Wagner; Marc Ychou; Franck Bonnetain; Sophie Gourgou; Takayuki Yoshino; Greg Yothers; Aimery de Gramont; Qian Shi; Thierry André Journal: Eur J Cancer Date: 2020-03-12 Impact factor: 9.162