Two-year follow-up of a randomized phaseIIIclinical trial of nivolumab vs. the investigator's choice of therapy in the Asian population for recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate141)

被引：26

作者：

Yen, Chia-Jui ^{[1
]}

Kiyota, Naomi ^{[2
,3
]}

Hanai, Nobuhiro ^{[4
]}

Takahashi, Shunji ^{[5
]}

Yokota, Tomoya ^{[6
]}

Iwae, Shigemichi ^{[7
]}

Shimizu, Yasushi ^{[8
]}

Hong, Ruey-Long ^{[9
]}

Goto, Masahiro ^{[10
]}

Kang, Jin-Hyoung ^{[11
]}

Li, Wing Sum Kenneth ^{[12
]}

Ferris, Robert L. ^{[13
]}

Gillison, Maura ^{[14
]}

Endo, Toshimitsu ^{[15
]}

Jayaprakash, Vijayvel ^{[16
]}

Tahara, Makoto ^{[17
]}

机构：

[1] Natl Cheng Kung Univ, Natl Cheng Kung Univ Hosp, Coll Med, Div Hematol & Oncol,Dept Internal Med, Tainan, Taiwan

[2] Kobe Univ Hosp, Dept Med Oncol & Hematol, Kobe, Hyogo, Japan

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

[4] Aichi Canc Ctr Hosp, Dept Head & Neck Surg, Nagoya, Aichi, Japan

[5] Japanese Fdn Canc Res, Canc Inst Hosp, Dept Med Oncol, Tokyo, Japan

[6] Shizuoka Canc Ctr, Div Gastrointestinal Oncol, Shizuoka, Japan

[7] Hyogo Canc Ctr, Dept Head & Neck Surg, Akashi, Hyogo, Japan

[8] Hokkaido Univ Hosp, Dept Med Oncol, Sapporo, Hokkaido, Japan

[9] Natl Taiwan Univ Hosp, Dept Oncol, Taipei, Taiwan

[10] Osaka Med Coll Hosp, Canc Chemotherapy Ctr, Takatsuki, Osaka, Japan

[11] Catholic Univ Korea, Seoul St Marys Hosp, Dept Internal Med, Div Med Oncol, Seoul, South Korea

[12] Queen Elizabeth Hosp, Dept Clin Oncol, Hong Kong, Peoples R China

[13] Univ Pittsburgh, Med Ctr, Canc Ctr, UPMC Hillman Canc Ctr, Pittsburgh, PA USA

[14] Univ Texas MD Anderson Canc Ctr, Div Canc Med, Dept Thorac Head & Neck Med Oncol, Houston, TX 77030 USA

[15] ONO Pharmaceut Co Ltd, Oncol Med Affairs, Sect 1, Osaka, Japan

[16] Bristol Myers Squibb, BMS, Oncol Clin Dev, Princeton, NJ USA

[17] Natl Canc Ctr Hosp East, Dept Head & Neck Med Oncol, Kashiwa, Chiba, Japan

来源：

HEAD AND NECK-JOURNAL FOR THE SCIENCES AND SPECIALTIES OF THE HEAD AND NECK | 2020年 / 42卷 / 10期

关键词：

Asian population; clinical trial; immunotherapy; nivolumab; squamous cell carcinoma of the head and neck; IMMUNE CHECKPOINT INHIBITORS; PHASE-II TRIAL; ADVERSE EVENTS; SALVAGE CHEMOTHERAPY; RESPONSE RATES; OPEN-LABEL; CANCER; ASSOCIATION; EFFICACY; TRENDS;

D O I：

10.1002/hed.26331

中图分类号：

R76 [耳鼻咽喉科学];

学科分类号：

100213 ;

摘要：

Background The present study evaluated the 2-year survival of the Asian population in the CheckMate 141 trial. Methods The CheckMate 141 trial included patients with recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN). In the present study, 34 Asian patients (nivolumab group: 23 patients; investigator's choice of therapy [IC] group: 11 patients) were analyzed. Results The median overall survival (OS) was 12.1 and 6.2 months for the nivolumab and IC groups, respectively. The estimated 2-year OS rates were 22.7% and 0% for the nivolumab and IC groups, respectively. In the nivolumab group, the patients with any treatment-related adverse events (TRAEs), including skin-related disorders, showed better OS than the patients without any TRAEs. Conclusions Nivolumab demonstrated prolonged OS benefits in the Asian population with platinum-refractory R/M SCCHN and a favorable safety profile. TRAEs, including skin-related disorders, may be favorable prognostic factors for nivolumab efficacy. Clinical trial registration NCT02105636.

引用

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页码：2852 / 2862

页数：11

共 37 条

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