Department of Surgery, Nara Medical University, Kashihara, Japan
Masayuki Sho , Atsushi Shimizu , Hiroaki Yanagimoto , Shoji Nakamori , Takuji Okusaka , Hiroshi Ishii , Masayuki Kitano , Kazuya Sugimori , Hiroyuki Maguchi , Shinichi Ohkawa , Hiroshi Imaoka , Daisuke Hashimoto , Kazuki Ueda , Hiroko Nebiki , Tatsuya Nagakawa , Hiroyuki Isayama , Yasuhiro Hagiwara , Yasuo Ohashi , Tetsuhiko Shirasaka , Hiroki Yamaue
Background: S-1 is an active agent for the treatment of pancreatic cancer. GEST study has previously shown the noninferiority of S-1 to gemcitabine in advanced pancreatic cancer. However, the standard regimen of 4 weeks of administration followed by 2 weeks of rest frequently causes adverse effects. To induce the effect of S-1 while reducing toxicity, alternate-day administration may be a treatment option. The aim of this study was to clarify the efficacy and toxicity of alternate-day administration of S-1 compared to the standard regimen for advanced pancreatic cancer. To this end, we conducted multicenter randomized phase II study, PAN-01. Methods: Patients who met the study criteria, including histological confirmation, age > 20, Performance Status of 0 or 1, no prior chemotherapy/radiotherapy, and adequate organ functions, were randomly assigned at a ratio of 1:2 to standard daily administration (Arm A) or alternate-day administration (Arm B). The primary end point was overall survival (OS). Secondary end points were safety, response rate, progression-free survival (PFS), and time to treatment failure. Results: A total of 190 patients were enrolled and 185 were subject to final analysis (Arm A: 64, Arm B: 121). The median OS for Arms A and B were 10.4 and 9.4 months, respectively (hazard ratio, 1.19; 95% CI, 0.86-1.64). Data did not indicate the noninferiority of alternate-day administration to standard regimen in overall survival. Furthermore, the median PFS were 4.2 and 3.0 months, respectively (hazard ratio, 1.65; 95% CI, 1.20-2.29), indicating that alternate-day administration was significantly worse than standard regimen in tumor progression. Anorexia (all grade: Arm A vs Arm B (%): 58.5 vs 50.0, P = 0.04), fatigue (60.0 vs 42.6, P = 0.02), pigmentation (24.6 vs 7.4, P < 0.001) and pneumonitis (7.7 vs 1.6, P = 0.03) were more common in daily administration than alternate-day administration. Conclusions: This study failed to demonstrate the noninferiority of alternate-day administration of S-1 to standard regimen as a first-line chemotherapy in unresectable pancreatic cancer. Clinical trial information: UMIN000008604.
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