Long-Term Follow-Up of JCOG1008, a Randomized Phase II/III Trial of Chemoradiotherapy Comparing 3-Weekly Cisplatin With Weekly Cisplatin in Postoperative Head and Neck Cancer
Makoto Tahara, Naomi Kiyota, Takeshi Kodaira, Hiroshi Nishino, Yukinori Asada, Hiroki Mitani, Yuji Hirayama, Yusuke Onozawa, Naoki Nishio, Nobuhiro Hanai, Akira Ohkoshi, Hiroki Hara, Nobuya Monden, Masato Nagaoka, Shujiro Minami, Kaoru Tanaka, Takashi Fujii, Seiichi Yoshimoto, Tsutomu Ueda, Yo Kishimoto, Akihiro Homma, Nobuhiko Oridate, Kenji Okami, Hirokazu Uemura, Katsunori Katagiri, Tomoko Yamazaki, Takahiro Asakage, Yuki Saito, Shigeyuki Murono, Junki Mizusawa, Kenichi Nakamura, Ryuichi Hayashi, , Akihiro Homma, Kiyoto Shiga, Takenori Ogawa, Tomoko Yamazaki, Shigeyuki Murono, Hiroshi Nishino, Hiroki Hara, Masashi Sugasawa, Makoto Tahara, Seiichi Yoshimoto, Shujiro Minami, Takahiro Asakage, Eiji Shimura, Hiroki Mitani, Mizuo Ando, Nobuhiko Oridate, Kenji Okami, Yusuke Onozawa, Nobuhiro Hanai, Yasushi Fujimoto, Koichi Omori, Kazuhiko Nakagawa, Takashi Fujii, Naomi Kiyota, Shigemichi Iwae, Ichiro Ota, Tsutomu Ueda, Nobuya MondenThe interim analysis of JCOG1008 demonstrated that chemoradiotherapy with cisplatin 40 mg/m 2 once a week for seven cycles (weekly cisplatin) was noninferior in terms of overall survival (OS) compared with chemoradiotherapy with cisplatin 100 mg/m 2 once every 3 weeks for three cycles (3-weekly cisplatin) for postoperative high-risk locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). This report presents the long-term follow-up results of JCOG1008. In this phase II/III trial, patients with postoperative high-risk LA-SCCHN were randomly assigned to receive either chemoradiotherapy with 3-weekly cisplatin or with weekly cisplatin. A total of 261 patients were enrolled. At the final analysis, with a median follow-up of 5.6 years, 5-year OS was 58.7% in the 3-weekly arm and 71.2% in the weekly arm (hazard ratio, 0.76 [95% CI, 0.52 to 1.12 [<1.32]]), confirming the noninferiority of the weekly regimen. Both 5-year relapse-free survival (RFS) and 5-year local RFS were numerically better in the weekly arm. No late adverse event showed more than a 10% difference between the two arms. In conclusion, 5-year follow-up confirmed that chemoradiotherapy with weekly cisplatin is noninferior in OS to chemoradiotherapy with 3-weekly cisplatin in patients with postoperative high-risk LA-SCCHN. These results further support the use of weekly cisplatin plus radiotherapy as a reasonable alternative for this patient population.