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
Abstract
The 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.
Article Details
Journal Info
Journal of Clinical Oncology
Lippincott Williams & Wilkins
Authors (42)
Takeshi Kodaira
Aichi Cancer Center Hospital, Nagoya, Japan
Yukinori Asada
Yuji Hirayama
Hyogo Cancer Center, Akashi, Japan
Naoki Nishio
Department of Otorhinolaryngology, Nagoya University Graduate School of Medicine, Aichi, Japan
Akira Ohkoshi
Department of Otolaryngology—Head and Neck Surgery, Tohoku University Graduate School of Medicine, Miyagi, Japan
Masato Nagaoka
Department of Otorhinolaryngology—Head and Neck Surgery, Jikei University School of Medicine, Tokyo, Japan
Kaoru Tanaka
Kindai University Hospital, Sakai, Japan
Yo Kishimoto
Kyoto University, Kyoto, Japan
Hirokazu Uemura
Nara Medical University, Kashihara, Japan
Katsunori Katagiri
Iwate Medical University, Shiwa, Japan
Yuki Saito
Junki Mizusawa
Kenichi Nakamura
National Cancer Center Hospital, Tokyo, Japan
Ryuichi Hayashi
National Cancer Center Hospital East, Kashiwa, Japan
Akihiro Homma
Hokkaido University Hospital, Sapporo, Japan
Kiyoto Shiga
Takenori Ogawa
Tomoko Yamazaki
Saitama Medical University International Medical Center, Hidaka, Japan
Shigeyuki Murono
Fukushima Medical University Hospital, Fukushima, Japan
Hiroshi Nishino
Hiroki Hara
Saitama Cancer Center, Ina, Japan
Masashi Sugasawa
Makoto Tahara
Seiichi Yoshimoto
National Cancer Center Hospital, Tokyo, Japan
Shujiro Minami
NHO Tokyo Medical Center, Tokyo, Japan
Takahiro Asakage
Institute of Science Tokyo Hospital, Tokyo, Japan
Eiji Shimura
Hiroki Mitani
Mizuo Ando
Nobuhiko Oridate
Kenji Okami
Tokai University School of Medicine, Isehara, Japan
Yusuke Onozawa
Shizuoka Cancer Center, Shizuoka, Japan
Nobuhiro Hanai
Aichi Cancer Center Hospital, Nagoya, Japan
Yasushi Fujimoto
Koichi Omori
Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Kyoto University
Kazuhiko Nakagawa
Takashi Fujii
Department of Electrical and Electronic Engineering, Ritsumeikan University 2 , 1-1-1 Noji-Higashi, Kusatsu, Shiga 525-8577,
Naomi Kiyota
Department of Medical Oncology and Hematology, Cancer Center, Kobe University Hospital, Hyogo, Japan
Shigemichi Iwae
Ichiro Ota
Tsutomu Ueda
Hiroshima University Hospital, Hiroshima, Japan
Nobuya Monden
NHO Shikoku Cancer Center, Matsuyama, Japan