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

被引：103

作者：

Kiyota, Naomi ^{[1
]}

Tahara, Makoto ^{[2
]}

Mizusawa, Junki ^{[3
]}

Kodaira, Takeshi ^{[4
]}

Fujii, Hirofumi ^{[5
]}

Yamazaki, Tomoko ^{[6
]}

Mitani, Hiroki ^{[7
]}

Iwae, Shigemichi ^{[8
]}

Fujimoto, Yasushi ^{[9
]}

Onozawa, Yusuke ^{[10
]}

Hanai, Nobuhiro ^{[4
]}

Ogawa, Takenori ^{[11
]}

Hara, Hiroki ^{[12
]}

Monden, Nobuya ^{[13
]}

Shimura, Eiji ^{[14
]}

Minami, Shujiro ^{[15
]}

Fujii, Takashi ^{[16
]}

Tanaka, Kaoru ^{[17
]}

Homma, Akihiro ^{[18
]}

Yoshimoto, Seiichi ^{[19
]}

Oridate, Nobuhiko ^{[20
]}

Omori, Koichi ^{[21
]}

Ueda, Tsutomu ^{[22
]}

Okami, Kenji ^{[23
]}

Ota, Ichiro ^{[24
]}

Shiga, Kiyoto ^{[25
]}

Sugasawa, Masashi ^{[26
]}

Asakage, Takahiro ^{[27
]}

Saito, Yuki ^{[28
]}

Murono, Shigeyuki ^{[29
]}

Nishimura, Yasumasa ^{[17
]}

Nakamura, Kenichi ^{[3
]}

Hayashi, Ryuichi ^{[2
]}

机构：

[1] Kobe Univ Hosp, Canc Ctr, Kobe, Hyogo, Japan

[2] Natl Canc Ctr Hosp East, Kashiwa, Chiba, Japan

[3] Natl Canc Ctr, Japan Clin Oncol Grp, Data Ctr, Operat Off, Tokyo, Japan

[4] Aichi Canc Ctr Hosp, Nagoya, Aichi, Japan

[5] Jichi Med Univ Hosp, Shimotsuke, Tochigi, Japan

[6] Miyagi Canc Ctr, Natori, Miyagi, Japan

[7] Canc Inst Hosp, Tokyo, Japan

[8] Hyogo Canc Ctr, Akashi, Hyogo, Japan

[9] Nagoya Univ Hosp, Nagoya, Aichi, Japan

[10] Shizuoka Canc Ctr, Shizuoka, Japan

[11] Tohoku Univ Hosp, Sendai, Miyagi, Japan

[12] Saitama Canc Ctr, Ina, Saitama, Japan

[13] Shikoku Canc Ctr, Matsuyama, Ehime, Japan

[14] Jikei Univ Hosp, Tokyo, Japan

[15] Natl Hosp Org Tokyo Med Ctr, Tokyo, Japan

[16] Osaka Int Canc Inst, Osaka, Japan

[17] Kindai Univ Hosp, Osakasayama, Japan

[18] Hokkaido Univ Hosp, Sapporo, Hokkaido, Japan

[19] Natl Canc Ctr, Tokyo, Japan

[20] Yokohama City Univ Med, Yokohama, Kanagawa, Japan

[21] Kyoto Univ Hosp, Kyoto, Japan

[22] Hiroshima Univ Hosp, Hiroshima, Japan

[23] Tokai Univ, Sch Med, Isehara, Kanagawa, Japan

[24] Nara Med Univ, Kashihara, Nara, Japan

[25] Iwate Med Univ, Shiwa, Japan

[26] Saitama Med Univ, Int Med Ctr, Hidaka, Japan

[27] Tokyo Med & Dent Univ Hosp, Tokyo, Japan

[28] Univ Tokyo Hosp, Tokyo, Japan

[29] Fukushima Med Univ Hosp, Fukushima, Japan

来源：

JOURNAL OF CLINICAL ONCOLOGY | 2022年 / 40卷 / 18期

关键词：

SQUAMOUS-CELL CARCINOMA; LOCALLY ADVANCED HEAD; LOW-DOSE CISPLATIN; HIGH-RISK HEAD; CONCURRENT RADIATION; 3-WEEKLY CISPLATIN; ADJUVANT CHEMORADIOTHERAPY; RADICAL RADIOTHERAPY; JAPANESE PATIENTS; CHEMOTHERAPY;

D O I：

10.1200/JCO.21.01293

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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/m(2)). However, whether chemoradiotherapy with weekly cisplatin (40 mg/m(2)) 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/m(2)) or with weekly cisplatin (40 mg/m(2)) 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.

引用

页码：1980 / +

页数：12

共 31 条

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