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Three-year follow-up and patient-reported outcomes from CheckMate 078: Nivolumab versus docetaxel in a predominantly Chinese patient population with previously treated advanced non-small cell lung cancer.

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机构： [a]Fudan University Shanghai Cancer Center, 270 Dongan Road, Shanghai 200032, China [b]Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University ofTechnology, 106 Zhongshan Second Road, Guangzhou 510080, China [c]Shanghai Chest Hospital, 241 Huaihai West Road, Shanghai 200030, China [d]National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, No. 17Panjiayuan Nanli, Chaoyang District, Beijing 100021, China [e]State Laboratory of Translational Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital, 30-32 Ngan Shing Street, Hong Kong, China [f]Sun Yat-Sen University Cancer Center, 651 Dong Feng East Road, Guangzhou 510060, China [g]Jiangsu Cancer Hospital, 42 Bai Zi Ting, Nanjing 210000, China [h]Hunan Cancer Hospital, 283 Tongzipo Road, Changsha 410013, China [i]Zhejiang Cancer Hospital, 1 Banshan East Road, Hangzhou 310022, China [j]Leningrad Regional Clinical Hospital, 45-49 Lunacharskogo Avenue, St. Petersburg 194291, Russian Federation [k]The First Affiliated Hospital of College of Medicine, 79 Qingchun Road, Hangzhou 310003, China [l]The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, 127 Dongming Road, Zhengzhou 450008, China [m]West China Hospital, Sichuan University, 37 Guoxue Lane, Chengdu 610041, China [n]Xiangya Hospital of Central South University, 87 Xiangya Road, Changsha 410008, China [o]Clinical Center VitaMed, 10 Seslavinskaya Street, Moscow, Russian Federation [p]National University Hospital, 1E Kent Ridge Road, 119228 Singapore, Singapore [q]Johns Hopkins Singapore Pte Ltd, 11 Jalan Tan Tock Seng, 308433 Singapore, Singapore [r]Bristol Myers Squibb, Princeton, NJ 08540, USA [s]Adelphi Values, Boston, MA, USA [t]Jilin Cancer Hospital, 1018 Huguang Road, Changchun 130012, China

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In the phase 3 CheckMate 078 study, nivolumab prolonged overall survival (OS) and showed a favorable safety profile versus docetaxel in a predominantly Chinese patient population with previously treated advanced non-small cell lung cancer (aNSCLC). However, long-term efficacy, safety, and health-related quality of life findings with second-line nivolumab are very limited in Asian patients with previously treated aNSCLC. Here, we report updated clinical data and patient-reported outcomes (PROs) from the phase 3 CheckMate 078 trial with a 3-year minimum follow-up.Patients with aNSCLC and disease progression after platinum-doublet chemotherapy were randomized 2:1 to nivolumab (3 mg/kg every 2 weeks) or docetaxel (75 mg/m2 every 3 weeks) until progression or unacceptable toxicity. The primary endpoint was OS; secondary endpoints included objective response rate, progression-free survival, safety, and disease-related symptom deterioration assessed using the Lung Cancer Symptom Scale (LCSS) by Week 12. Additional PRO assessments were exploratory endpoints.At ≥ 37.3 months follow-up, 3-year OS rates were 19% with nivolumab and 12% with docetaxel; 30% and 0% of responders remained in response for ≥ 3 years, respectively. Incidence of treatment-related adverse events occurring after 2 years was lower than during the first 2 years. No new treatment-related deaths were reported. By Week 12 of treatment, rates of disease-related symptom deterioration were 32% with nivolumab and 47% with docetaxel. Completion rates for PRO questionnaires were ≥ 80% in both arms. Clinically meaningful and sustained improvements in LCSS Average Symptom Burden Index scores and delayed time to first symptom deterioration were observed with nivolumab against docetaxel.At 3 years, nivolumab continued to demonstrate survival benefit versus docetaxel, exhibiting improvements in disease-related symptoms and overall health status in a predominantly Chinese patient population with previously treated aNSCLC. No new safety signals were observed. These findings are similar to the global population.Copyright © 2021. Published by Elsevier B.V.

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出版当年[2022]版：

大类 | 2 区医学

小类 | 2 区呼吸系统 2 区肿瘤学

最新[2023]版：

大类 | 2 区医学

小类 | 3 区肿瘤学 3 区呼吸系统

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出版当年[2022]版：

Q2 ONCOLOGY Q2 RESPIRATORY SYSTEM

最新[2023]版：

Q1 ONCOLOGY Q1 RESPIRATORY SYSTEM

影响因子： 4.5 最新[2023版] 4.7 最新五年平均 5.3 出版当年[2022版] 5.6 出版当年五年平均 6.081 出版前一年[2021版] 4.5 出版后一年[2023版]

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第一作者机构： [a]Fudan University Shanghai Cancer Center, 270 Dongan Road, Shanghai 200032, China

通讯作者：

通讯机构： [t]Jilin Cancer Hospital, 1018 Huguang Road, Changchun 130012, China [*1]Jilin Cancer Hospital, 1018 Huguang Road, Changchun, Jilin 130012, China.

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