Randomized Phase III Trial Comparing Surgery Alone to UFT+PSK for Stage II Rectal Cancer (JFMC38 Trial)

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

Journal: Cancer Chemotherapy and Pharmacology

Study Design: Randomized, open-label, multicenter, phase III trial

Participants: 111 patients with curatively resected stage II rectal cancer

Trial Length: The study was conducted from October 2011 to February 2013. The median duration of follow-up was 5.3 years.

Intervention:

• UFT+PSK group (n = 53): UFT (tegafur/uracil) 400 mg/m^2/day orally thrice daily for 5 days followed by 2 days’ rest for 1 year, plus PSK (protein-bound polysaccharide K) 3 g/day orally thrice daily for 1 year
• Surgery-alone group (n = 53)

Primary Outcomes: Disease-free survival (DFS)

Secondary Outcomes: Overall survival (OS)Summary: The study investigated the addition of UFT+PSK to surgery in patients with stage II rectal cancer. The trial was prematurely closed due to poor accrual. The results showed that UFT+PSK did not improve DFS compared to surgery alone. The 5-year DFS rate was 65.1% in the UFT+PSK group and 77.2% in the surgery-alone group. The OS rates were similar between the two groups. The study concludes that UFT+PSK is not an attractive option for adjuvant treatment in stage II rectal cancer.