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

下载

页码：2852 / 2862

页数：11

共 37 条

[21] NEUTRON THERAPY FOR SQUAMOUS-CELL CARCINOMA OF THE HEAD AND NECK - THE 5-YEAR FOLLOW-UP OF THE EDINBURGH RANDOMIZED CLINICAL-TRIAL
MACDOUGALL, RH
ORR, JA
KERR, GR
BRITISH JOURNAL OF CANCER, 1990, 61 (01) : 157 - 157
[22] Nivolumab Versus Investigator'S Choice (IC) for Platinum-Refractory Recurrent or Metastatic (R/M) Squamous Cell Carcinoma of the Head and Neck (SCCHN; CHECKMATE 141): Outcomes in First-Line R/M Patients and Updated Safety and Efficacy
Gillison, Maura L.
Blumenschein, George, Jr.
Fayette, Jerome
Guigay, Joel
Colevas, A. Dimitrios
Licitra, Lisa
Harrington, Kevin J.
Kasper, Stefan
Vokes, Everett E.
Even, Caroline
Worden, Francis
Saba, Nabil F.
Iglesias Docampo, Lara Carmen
Haddad, Robert
Rordorf, Tamara
Kiyota, Naomi
Tahara, Makoto
Lynch, Mark
Kopit, Justin
Ferris, Robert L.
ASIA-PACIFIC JOURNAL OF CLINICAL ONCOLOGY, 2017, 13 : 144 - 144
[23] Real-world Data Study of the Efficacy and Toxicity of Nivolumab vs. Cetuximab and Predictors of Response to Nivolumab in Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck in a European Population
Macia-Rivas, Lola
Fernandez-Laguna, Clara luz
Alvarez-Asteinza, Cristina
Maray, Ivan
Carbajales-Alvarez, Monica
Lozano-Blazquez, Ana
ANTICANCER RESEARCH, 2023, 43 (04) : 1681 - 1688
[24] A QUALITY-ADJUSTED TIME WITHOUT SYMPTOMS OF DISEASE AND TOXICITY (Q-TWIST) ANALYSIS COMPARING NIVOLUMAB AND THERAPY OF INVESTIGATOR'S CHOICE (IC) IN PATIENTS WITH RECURRENT OR METASTATIC (R/M) PLATINUM-REFRACTORY SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK (SCCHN) (CHECKMATE 141)
Simpson, S.
Cocks, K.
Contente, M.
DeRosa, M.
Taylor, F.
Shaw, J. W.
VALUE IN HEALTH, 2017, 20 (09) : A450 - A450
[25] CAMRESBRT: Randomized Phase II Trial of Camrelizumab with Stereotactic Body Radiotherapy vs. Camrelizumab Alone in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Lei, Q.
Wang, Y.
Sui, J.
Luo, Q.
Jin, F.
Long, B.
Shu, X.
Li, S.
Huang, L.
Zhong, M.
Mao, K.
INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS, 2022, 114 (03): : E282 - E282
[26] Nivolumab (Nivo) vs investigator's choice (IC) for platinum-refractory (PR) recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN; Checkmate 141): Outcomes in first-line (1L) R/m patients and updated safety and efficacy.
Gillison, Maura L.
Blumenschein, George R.
Fayette, Jerome
Guigay, Joel
Colevas, A. Dimitrios
Licitra, Lisa
Harrington, Kevin
Kasper, Stefan
Vokes, Everett E.
Even, Caroline
Worden, Francis P.
Saba, Nabil F.
Docampo, Lara Carmen Iglesias
Haddad, Robert I.
Rordorf, Tamara
Kiyota, Naomi
Tahara, Makoto
Lynch, Mark John
Kopit, Justin
Ferris, Robert L.
JOURNAL OF CLINICAL ONCOLOGY, 2017, 35
[27] Nivolumab (Nivo) vs Investigator's Choice (IC) for Platinum-Refractory (PR) Recurrent or Metastatic (R/M) Squamous Cell Carcinoma of the Head and Neck (SCCHN; CheckMate 141): Outcomes in First-line (1L) R/M Patients (Pts) and Updated Safety and Efficacy
Kasper, S.
Gillison, M. L.
Blumenschein, G.
Fayette, J.
Guigay, J.
Colevas, A. D.
Licitra, L.
Harrington, K.
Vokes, E. E.
Even, C.
Worden, F.
Saba, N. F.
Docampo, L. C. I.
Haddad, R.
Rordorf, T.
Kiyota, N.
Makoto, T.
Lynch, M.
Kopit, J.
Ferris, R. L.
ONCOLOGY RESEARCH AND TREATMENT, 2018, 41 : 96 - 96
[28] First-line pembrolizumab with or without chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: 5-year follow-up of the Japanese population of KEYNOTE‑048
Nobuhiko Oridate
Shunji Takahashi
Kaoru Tanaka
Yasushi Shimizu
Yasushi Fujimoto
Koji Matsumoto
Tomoya Yokota
Tomoko Yamazaki
Masanobu Takahashi
Tsutomu Ueda
Nobuhiro Hanai
Hironori Yamaguchi
Hiroki Hara
Tomokazu Yoshizaki
Ryuji Yasumatsu
Masahiro Nakayama
Kiyoto Shiga
Takashi Fujii
Kenji Mitsugi
Kenichi Takahashi
Nijiro Nohata
Burak Gumuscu
Nati Lerman
Makoto Tahara
International Journal of Clinical Oncology, 2024, 29 (12) : 1825 - 1839
[29] Two-year follow-up from the phase 3 KEYNOTE-045 trial of pembrolizumab (pembro) vs investigator's choice (paclitaxel, docetaxel, or vinflunine) in recurrent, advanced urothelial cancer (UC).
Bellmunt, Joaquim
De Wit, Ronald
Vaughn, David J.
Fradet, Yves
Lee, Jae-Lyun
Fong, Lawrence
Vogelzang, Nicholas J.
Climent, Miguel A.
Petrylak, Daniel Peter
Choueiri, Toni K.
Necchi, Andrea
Gerritsen, Winald
Gurney, Howard
Quinn, David I.
Culine, Stephane
Sternberg, Cora N.
Nam, Kijoeng
Frenkl, Tara L.
Perini, Rodolfo F.
Bajorin, Dean F.
JOURNAL OF CLINICAL ONCOLOGY, 2018, 36 (06)
[30] ASSOCIATION OF HEALTH-RELATED QUALITY OF LIFE (HRQOL) AND HEALTHCARE RESOURCE UTILIZATION (HCRU) IN CHECKMATE 141, A PHASE 3 STUDY OF NIVOLUMAB VERSUS INVESTIGATOR'S CHOICE (IC) IN PATIENTS WITH RECURRENT OR METASTATIC (R/M) PLATINUM-REFRACTORY SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK (SCCHN)
DeRosa, M.
Cocks, K.
Korytowsky, B.
Contente, M.
Taylor, F.
Shaw, J. W.
VALUE IN HEALTH, 2017, 20 (09) : A447 - A447

← 1 2 3 4 →