Nivolumab versus docetaxel in previously treated advanced non-small-cell lung cancer (CheckMate 017 and CheckMate 057): 3-year update and outcomes in patients with liver metastases
| Autor: | Scott N. Gettinger, Neal Ready, Oscar Arrieta, Charles Butts, Marco Angelo Burgio, Diane Healey, David M. Waterhouse, David R. Spigel, Marina Chiara Garassino, Julie R. Brahmer, Ang Li, O. Aren Frontera, George R. Blumenschein, Everett E. Vokes, S.J. Antonia, Enriqueta Felip, Martin Steins, Esther Holgado, Manuel Domine, L. Crinò, Leora Horn, Laura Q.M. Chow, Fabrice Barlesi, Justin F. Gainor, Bruno Coudert, William J. Geese |
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| Rok vydání: | 2018 |
| Předmět: |
Male
0301 basic medicine Oncology medicine.medical_specialty Lung Neoplasms Population Antineoplastic Agents Docetaxel 03 medical and health sciences 0302 clinical medicine Carcinoma Non-Small-Cell Lung Internal medicine medicine Clinical endpoint Carcinoma Humans Lung cancer education Survival analysis Aged Randomized Controlled Trials as Topic education.field_of_study business.industry Liver Neoplasms Hazard ratio Hematology Middle Aged medicine.disease Survival Analysis Nivolumab Treatment Outcome 030104 developmental biology 030220 oncology & carcinogenesis Female business Follow-Up Studies medicine.drug |
| Zdroj: | Annals of Oncology. 29:959-965 |
| ISSN: | 0923-7534 |
| Popis: | Background Long-term data with immune checkpoint inhibitors in non-small-cell lung cancer (NSCLC) are limited. Two phase III trials demonstrated improved overall survival (OS) and a favorable safety profile with the anti-programmed death-1 antibody nivolumab versus docetaxel in patients with previously treated advanced squamous (CheckMate 017) and nonsquamous (CheckMate 057) NSCLC. We report results from ≥3 years’ follow-up, including subgroup analyses of patients with liver metastases, who historically have poorer prognosis among patients with NSCLC. Patients and methods Patients were randomized 1 : 1 to nivolumab (3 mg/kg every 2 weeks) or docetaxel (75 mg/m2 every 3 weeks) until progression or discontinuation. The primary end point of each study was OS. Patients with baseline liver metastases were pooled across studies by treatment for subgroup analyses. Results After 40.3 months’ minimum follow-up in CheckMate 017 and 057, nivolumab continued to show an OS benefit versus docetaxel: estimated 3-year OS rates were 17% [95% confidence interval (CI), 14% to 21%] versus 8% (95% CI, 6% to 11%) in the pooled population with squamous or nonsquamous NSCLC. Nivolumab was generally well tolerated, with no new safety concerns identified. Of 854 randomized patients across both studies, 193 had baseline liver metastases. Nivolumab resulted in improved OS compared with docetaxel in patients with liver metastases (hazard ratio, 0.68; 95% CI, 0.50–0.91), consistent with findings from the overall pooled study population (hazard ratio, 0.70; 95% CI, 0.61–0.81). Rates of treatment-related hepatic adverse events (primarily grade 1–2 liver enzyme elevations) were slightly higher in nivolumab-treated patients with liver metastases (10%) than in the overall pooled population (6%). Conclusions After 3 years’ minimum follow-up, nivolumab continued to demonstrate an OS benefit versus docetaxel in patients with advanced NSCLC. Similarly, nivolumab demonstrated an OS benefit versus docetaxel in patients with liver metastases, and remained well tolerated. Clinical trial registration CheckMate 017: NCT01642004; CheckMate 057: NCT01673867. |
| Databáze: | OpenAIRE |
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