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

作者：Chang, Jianhua; Wu, Yi-Long; Lu, Shun; Wang, Jie; Mok, Tony; Zhang, Li; Feng, Jifeng; Wu, Lin; Tu, Hai-Yan; Zhang, Yiping; Luft, Alexander; Zhou, Jian-ying; Ma, Zhiyong; Lu, You; Hu, Chengping; Shi, Yuankai; Poddubskaya, Elena; Soo, Ross A.; Chia, Yee Hong; Penrod, John R.; Taylor, Fiona; Lawrance, Rachael; Blum, Steven, I; Sun, Xiaowu; Juarez-Garcia, Ariadna; Moreno-Koehler, Alejandro; Li, Ang; Li, Amy; Cheng, Ying^*

来源：Lung Cancer, 2022, 165: 71-81.

DOI：10.1016/j.lungcan.2021.12.009

• Advanced non-small cell lung cancer
• PD-1 checkpoint inhibitor
• Nivolumab
• Patient-reported outcomes
• Asian
• Second-line treatment

Objectives: 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. @@@ Materials and methods: 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/m(2) 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. @@@ Results: 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. @@@ Conclusions: 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.

• 单位
  郑州大学; 1; 中国医学科学院; 四川大学; 广东省人民医院; y; 中国医学科学院北京协和医院; 复旦大学; 中山大学