Randomized phase III trial comparing surgery alone to UFT\u2009+\u2009PSK for stage II rectal cancer (JFMC38 trial)

Kiyotaka Okuno,Toru Aoyama,Koji Oba,Takaki Yoshikawa,Shigetoyo Saji,Junichi Sakamoto,Takaya Kobatake,Satoshi Morita,Hiroki Akamatsu,Katsuyuki Kunieda,Nobuhisa Matsuhashi,Noboru Yokoyama,Yoji Nishimura

doi:10.1007/s00280-017-3466-7

Abstract

BackgroundWe conducted a randomized phase III trial comparing tegafur/uracil (UFT) and Polysaccharide-K (PSK) to surgery alone in curatively resected stage II rectal cancer patients.MethodsPatients were randomly assigned to receive either UFT and PSK or surgery alone in a 1:1 ratio with a minimization method to balance the treatment allocation. The primary end point of this study was the disease-free survival (DFS). The secondary end point was the overall survival (OS).ResultsFrom October 2011 to February 2013, 111 patients were registered from 62 institutions. The study was prematurely closed due to poor accrual after reaching 20% of its goal. The patients’ characteristics were similar between the UFT and PSK group and the surgery-alone group. The DFS rate was 76.0% at 3 years and 65.1% at 5 years in the UFT and PSK arm and 84.0% at 3 years and 77.2% at 5 years in the surgery-alone arm. The DFS was slightly worse in the UFT + PSK arm than in the surgery-alone arm, but the difference did not reach statistical significance (log rank p = 0.102). The OS rate was 100% at 3 years and 97.9% at 5 years in the UFT + PSK arm, while that was 100% at 3 years and 93.4% at 5 years in the surgery-alone arm. The OS was similar in the UFT + PSK arm and surgery-alone arm (p = 0.533).ConclusionThe present study suggests that UFT and PSK are not attractive candidates to advance to the next phase III study because the DFS was slightly worse in the UFT and PSK arm than in the surgery-alone arm.

Highlights

Colorectal cancer is the third-most commonly diagnosed cancer in males and the second-most commonly diagnosed cancer in females, with an estimated 1.4 million new cases and 693,900 deaths occurring in 2012 [1]
The present study suggests that UFT and PSK are not attractive candidates to advance to the phase III study because the disease-free survival (DFS) was slightly worse in the UFT and PSK arm than in the surgery-alone arm
From October 2011 to February 2013, 200 institutions collaborated with the JFMC-38 study, and 111 patients were registered from 62 institutions

Summary

Introduction

Colorectal cancer is the third-most commonly diagnosed cancer in males and the second-most commonly diagnosed cancer in females, with an estimated 1.4 million new cases and 693,900 deaths occurring in 2012 [1]. We conducted a randomized phase III trial comparing tegafur/uracil (UFT) and Polysaccharide-K (PSK) to surgery alone in curatively resected stage II rectal cancer patients. The DFS rate was 76.0% at 3 years and 65.1% at 5 years in the UFT and PSK arm and 84.0% at 3 years and 77.2% at 5 years in the surgery-alone arm. The DFS was slightly worse in the UFT + PSK arm than in the surgery-alone arm, but the difference did not reach statistical significance (log rank p = 0.102). Conclusion The present study suggests that UFT and PSK are not attractive candidates to advance to the phase III study because the DFS was slightly worse in the UFT and PSK arm than in the surgery-alone arm

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