Neoadjuvant nivolumab plus chemotherapy versus chemotherapy for resectable NSCLC: subpopulation analysis of Chinese patients in CheckMate 816

被引：11

作者：

Wang, C. ^{[1
,19
]}

Chen, K. -N. ^{[2
]}

Chen, Q. ^{[3
]}

Wu, L. ^{[1
,4
,5
]}

Wang, Q. ^{[6
,7
]}

Li, X. ^{[8
]}

Ying, K. ^{[4
,5
,9
]}

Wang, W. ^{[1
,4
,5
]}

Zhao, J. ^{[10
]}

Liu, L. ^{[8
,11
]}

Fu, J. ^{[12
]}

Zhang, C. ^{[13
]}

Liu, J. ^{[14
]}

Hu, Y. ^{[15
]}

Ntambwe, I. ^{[16
]}

Cai, J. ^{[16
]}

Bushong, J. ^{[16
]}

Tran, P. ^{[16
]}

Lut, S. ^{[17
,18
,20
,21
]}

机构：

[1] Tianjin Med Univ Canc Inst & Hosp, Tianjin, Peoples R China

[2] Peking Univ Canc Hosp & Inst, Beijing, Peoples R China

[3] Univ Chinese Acad Sci, Zhejiang Canc Hosp, Canc Hosp, Hangzhou, Peoples R China

[4] Cent South Univ, Hunan Canc Hosp, Changsha, Peoples R China

[5] Cent South Univ, Xiangya Sch Med, Affiliated Canc Hosp, Changsha, Peoples R China

[6] Zhongshan Hosp, Shanghai, Peoples R China

[7] Fudan Univ, Shanghai, Peoples R China

[8] Tangdu Hosp, Xian, Peoples R China

[9] Sir Run Run Shaw Hosp, Hangzhou, Peoples R China

[10] Guangzhou Med Univ, Canc Ctr, Guangzhou, Peoples R China

[11] Sichuan Univ, West China Hosp, Chengdu, Peoples R China

[12] Xi An Jiao Tong Univ, Affiliated Hosp 1, Xian, Peoples R China

[13] Cent South Univ, Xiangya Hosp, Changsha, Peoples R China

[14] Nanchang Univ, Affiliated Hosp 2, Nanchang, Peoples R China

[15] Chinese Peoples Liberat Army Gen Hosp, Hosp 301, Beijing, Peoples R China

[16] Bristol Myers Squibb, Princeton, NJ USA

[17] Shanghai Chest Hosp, Shanghai, Peoples R China

[18] Shanghai Jiao Tong Univ, Shanghai, Peoples R China

[19] Tianjin Med Univ Canc Inst & Hosp, Huan Hu Xi Rd, Tianjin 300060, Peoples R China

[20] Shanghai Chest Hosp, 241 West Huaihai Rd, Shanghai 200030, Peoples R China

[21] Shanghai Jiao Tong Univ, 241 West Huaihai Rd, Shanghai 200030, Peoples R China

来源：

ESMO OPEN | 2023年 / 8卷 / 06期

关键词：

Key words: immunotherapy; immune checkpoint inhibitors; China; subgroup analysis; non-small-cell lung cancer; CELL LUNG-CANCER; ADJUVANT CHEMOTHERAPY; RECURRENCE; UPDATE; TRIAL;

D O I：

10.1016/j.esmoop.2023.102040

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background: Neoadjuvant nivolumab plus chemotherapy significantly improved event-free survival (EFS) and pathologic complete response (pCR) versus chemotherapy alone in patients with resectable non-small-cell lung cancer (NSCLC) in the global phase III CheckMate 816 study. Here, we report post hoc exploratory efficacy, safety, and surgical outcomes in the Chinese subpopulation of this study. Methods: Adults with stage IB-IIIA resectable NSCLC were randomized to receive nivolumab 360 mg plus chemotherapy or chemotherapy alone every 3 weeks for three cycles followed by surgery. Primary endpoints included EFS and pCR (both per blinded independent review). EFS and pCR results were from 14 October 2022, and 16 September 2020,Results: The Chinese subpopulation comprised 97 patients (nivolumab plus chemotherapy, 44; chemotherapy, 53). At 38.2 months of minimum follow-up, median EFS was not reached [95% confidence interval (CI) 23.4 months-not reached] in the nivolumab plus chemotherapy arm and 13.9 months (95% CI 8.3-34.3 months) in the chemotherapy arm (hazard ratio 0.47, 95% CI 0.25-0.88). pCR rates were 25.0% (95% CI 13.2% to 40.3%) and 1.9% (95% CI 0.0% to 10.1%), respectively (odds ratio 11.05; 95% CI 1.41-86.49). Of 97 Chinese patients, 36 (82%) in the nivolumab plus chemotherapy arm and 41 (77%) in the chemotherapy arm underwent definitive surgery. Grade 3-4 treatmentrelated adverse events occurred in 18/43 patients (42%) treated with nivolumab plus chemotherapy and 22/53 patients (42%) treated with chemotherapy.Conclusions: Consistent with findings in the global study population of CheckMate 816, neoadjuvant nivolumab plus chemotherapy improved EFS and pCR versus chemotherapy in the Chinese subpopulation without impacting treatment tolerability or the feasibility of surgery. These findings support the use of nivolumab plus chemotherapy as a standard neoadjuvant treatment option for Chinese patients with resectable NSCLC.

引用

页数：9

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