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Multicenter randomized phase II study comparing alternate-day oral therapy using S-1 with the standard regimen as a first-line treatment for patients with locally advanced and metastatic pancreatic cancer: PAN-01 study.

Abstract Poster

Authors

null

Masayuki Sho

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

Organizations

Department of Surgery, Nara Medical University, Kashihara, Japan, Second Department of Surgery, Wakayama Medical University, Wakayama, Japan, Department of Surgery, Kansai Medical University, Hirakata, Japan, Department of Hepatobiliary and Pancreatic Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan, Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan, Department of Gastroenterology and Hepatology, Kinki University School of Medicine, Osaka-Sayama, Japan, Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan, Center for Gastroenterology, Teine Keijinkai Hospital, Sapporo, Japan, Division of Hepatobiliary and Pancreatic Oncology, Kanagawa Cancer Center, Yokohama, Japan, Department of Gastroenterology, Aichi Cancer Center Hospital, Nagoya, Japan, Department of Gastroenterological Surgery, Kumamoto University Graduate School of Medical Sciences, Kumamoto, Japan, Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan, Department of Gastroenterology, Osaka City General Hospital, Osaka, Japan, Second Department of Gastroenterology, Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital, Hokkaido, Japan, Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan, Department of Biostatistics, School of Public Health, The University of Tokyo, Tokyo, Japan, Department of Integrated Science and Engineering for Sustainable Society, Chuo University, Tokyo, Japan, Kitasato Institute for Life Science, Kitasato University, Tokyo, Japan

Research Funding

Other

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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Abstract Details

Meeting

2016 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gastrointestinal (Noncolorectal) Cancer

Track

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Sub Track

Pancreatic Cancer

Clinical Trial Registration Number

UMIN000008604

Citation

J Clin Oncol 34, 2016 (suppl; abstr 4107)

DOI

10.1200/JCO.2016.34.15_suppl.4107

Abstract #

4107

Poster Bd #

99

Abstract Disclosures

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