Weekly Cisplatin Plus Radiation for Postoperative Head and Neck Cancer (JCOG1008): A Multicenter, Noninferiority, Phase II/III Randomized Controlled Trial

Author:

Kiyota Naomi1ORCID,Tahara Makoto2ORCID,Mizusawa Junki3,Kodaira Takeshi4,Fujii Hirofumi5,Yamazaki Tomoko6ORCID,Mitani Hiroki7,Iwae Shigemichi8,Fujimoto Yasushi9ORCID,Onozawa Yusuke10,Hanai Nobuhiro4ORCID,Ogawa Takenori11ORCID,Hara Hiroki12ORCID,Monden Nobuya13,Shimura Eiji14,Minami Shujiro15,Fujii Takashi16,Tanaka Kaoru17ORCID,Homma Akihiro18,Yoshimoto Seiichi19ORCID,Oridate Nobuhiko20ORCID,Omori Koichi21ORCID,Ueda Tsutomu22,Okami Kenji23,Ota Ichiro24ORCID,Shiga Kiyoto25ORCID,Sugasawa Masashi26,Asakage Takahiro27,Saito Yuki28ORCID,Murono Shigeyuki29ORCID,Nishimura Yasumasa17,Nakamura Kenichi3,Hayashi Ryuichi2,

Affiliation:

1. Kobe University Hospital, Cancer Center, Kobe, Japan

2. National Cancer Center Hospital East, Kashiwa, Japan

3. Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo

4. Aichi Cancer Center Hospital, Nagoya, Japan

5. Jichi Medical University Hospital, Shimotsuke, Japan

6. Miyagi Cancer Center, Natori, Japan

7. Cancer Institute Hospital, Tokyo, Japan

8. Hyogo Cancer Center, Akashi, Japan

9. Nagoya University Hospital, Nagoya, Japan

10. Shizuoka Cancer Center, Shizuoka, Japan

11. Tohoku University Hospital, Sendai, Japan

12. Saitama Cancer Center, Ina, Japan

13. Shikoku Cancer Center, Matsuyama, Japan

14. Jikei University Hospital, Tokyo, Japan

15. National Hospital Organization Tokyo Medical Center, Tokyo, Japan

16. Osaka International Cancer Institute, Osaka, Japan

17. Kindai University Hospital, Osakasayama, Japan

18. Hokkaido University Hospital, Sapporo, Japan

19. National Cancer Center Hospital, Tokyo, Japan

20. Yokohama City University Hospital, Yokohama, Japan

21. Kyoto University Hospital Kyoto, Japan

22. Hiroshima University Hospital, Hiroshima, Japan

23. Tokai University School of Medicine, Isehara, Japan

24. Nara Medical University, Kashihara, Japan

25. Iwate Medical University, Shiwa, Japan

26. Saitama Medical University International Medical Center, Hidaka, Japan

27. Tokyo Medical and Dental University Hospital, Tokyo, Japan

28. The University of Tokyo Hospital, Tokyo, Japan

29. Fukushima Medical University Hospital, Fukushima, Japan

Abstract

PURPOSE The standard treatment for postoperative high-risk locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN) is chemoradiotherapy with 3-weekly cisplatin (100 mg/m2). However, whether chemoradiotherapy with weekly cisplatin (40 mg/m2) yields comparable efficacy with 3-weekly cisplatin in postoperative high-risk LA-SCCHN is unknown. PATIENTS AND METHODS In this multi-institutional open-label phase II/III trial, patients with postoperative high-risk LA-SCCHN were randomly assigned to receive either chemoradiotherapy with 3-weekly cisplatin (100 mg/m2) or with weekly cisplatin (40 mg/m2) to confirm the noninferiority of weekly cisplatin. The primary end point of phase II was the proportion of treatment completion, and that of phase III was overall survival. A noninferiority margin of hazard ratio was set at 1.32. RESULTS Between October 2012 and December 2018, a total of 261 patients were enrolled (3-weekly cisplatin, 132 patients; weekly cisplatin, 129 patients). At the planned third interim analysis in the phase III part, after a median follow-up of 2.2 (interquartile range 1.19-3.56) years, chemoradiotherapy with weekly cisplatin was noninferior to 3-weekly cisplatin in terms of overall survival, with a hazard ratio of 0.69 (99.1% CI, 0.374 to 1.273 [< 1.32], one-sided P for noninferiority = .0027 < .0043). Grade 3 or more neutropenia and infection were less frequent in the weekly arm (3-weekly v weekly, 49% v 35% and 12% v 7%, respectively), as were renal impairment and hearing impairment. No treatment-related death was reported in the 3-weekly arm, and two (1.6%) in the weekly arm. CONCLUSION Chemoradiotherapy with weekly cisplatin is noninferior to 3-weekly cisplatin for patients with postoperative high-risk LA-SCCHN. These findings suggest that chemoradiotherapy with weekly cisplatin can be a possible treatment option for these patients.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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