PMID- 34131807 OWN - NLM STAT- MEDLINE DCOM- 20220207 LR - 20230508 IS - 1432-0851 (Electronic) IS - 0340-7004 (Print) IS - 0340-7004 (Linking) VI - 71 IP - 2 DP - 2022 Feb TI - Evaluation of efficacy and toxicity of nivolumab combined with or without docetaxel in patients with advanced NSCLC. PG - 267-276 LID - 10.1007/s00262-021-02964-x [doi] AB - BACKGROUND: The combination of PD-1/PD-L1 inhibitor and chemotherapy has been clinically confirmed to be beneficial as the first-line treatment of patients with advanced NSCLC. This study aimed to assess the effect of nivolumab + docetaxel versus nivolumab monotherapy in patients with NSCLC after the failure of platinum doublet chemotherapy. MATERIALS AND METHODS: The efficacy and toxicity of nivolumab + docetaxel combination therapy versus nivolumab monotherapy were compared in this retrospective study. Primary endpoint of the study was progression-free survival (PFS), and the secondary endpoints were objective response rate (ORR), overall survival (OS), and toxicity. RESULTS: Between November 2017 and December 2019, 77 patients were included in this study, with 58 patients in the nivolumab group and 19 in the nivolumab + docetaxel group. The median follow-up was 18 months, and the PFS was 8 months for patients receiving nivolumab + docetaxel and 2 months for those receiving nivolumab alone (p = 0.001), respectively. Nivolumab + docetaxel showed superior OS compared with nivolumab, with the median OS unreached versus 7 months (p = 0.011). Among patients without EGFR/ALK variation, compared to nivolumab monotherapy, nivolumab + docetaxel showed better PFS (p = 0.04) and OS (p = 0.05). There was no significant difference in grade 3-4 adverse events (AEs) between the two groups (p = 0.253). CONCLUSIONS: The combination of nivolumab and docetaxel demonstrated a meaningful improvement in progression-free survival and overall survival compared to nivolumab monotherapy, in patients with NSCLC after the failure of platinum doublet chemotherapy, irrespective of EGFR/ALK variation status. CI - (c) 2021. The Author(s). FAU - Wang, Yang AU - Wang Y AD - Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Thoracic Oncology II, Peking University Cancer Hospital & Institute, Haidian District, 52# Fucheng Road, Beijing, 100142, China. FAU - Nie, Jun AU - Nie J AD - Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Thoracic Oncology II, Peking University Cancer Hospital & Institute, Haidian District, 52# Fucheng Road, Beijing, 100142, China. FAU - Dai, Ling AU - Dai L AD - Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Thoracic Oncology II, Peking University Cancer Hospital & Institute, Haidian District, 52# Fucheng Road, Beijing, 100142, China. FAU - Hu, Weiheng AU - Hu W AD - Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Thoracic Oncology II, Peking University Cancer Hospital & Institute, Haidian District, 52# Fucheng Road, Beijing, 100142, China. FAU - Zhang, Jie AU - Zhang J AD - Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Thoracic Oncology II, Peking University Cancer Hospital & Institute, Haidian District, 52# Fucheng Road, Beijing, 100142, China. FAU - Chen, Xiaoling AU - Chen X AD - Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Thoracic Oncology II, Peking University Cancer Hospital & Institute, Haidian District, 52# Fucheng Road, Beijing, 100142, China. FAU - Ma, Xiangjuan AU - Ma X AD - Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Thoracic Oncology II, Peking University Cancer Hospital & Institute, Haidian District, 52# Fucheng Road, Beijing, 100142, China. FAU - Tian, Guangming AU - Tian G AD - Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Thoracic Oncology II, Peking University Cancer Hospital & Institute, Haidian District, 52# Fucheng Road, Beijing, 100142, China. FAU - Han, Jindi AU - Han J AD - Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Thoracic Oncology II, Peking University Cancer Hospital & Institute, Haidian District, 52# Fucheng Road, Beijing, 100142, China. FAU - Han, Sen AU - Han S AD - Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Thoracic Oncology II, Peking University Cancer Hospital & Institute, Haidian District, 52# Fucheng Road, Beijing, 100142, China. FAU - Wu, Di AU - Wu D AD - Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Thoracic Oncology II, Peking University Cancer Hospital & Institute, Haidian District, 52# Fucheng Road, Beijing, 100142, China. FAU - Long, Jieran AU - Long J AD - Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Thoracic Oncology II, Peking University Cancer Hospital & Institute, Haidian District, 52# Fucheng Road, Beijing, 100142, China. FAU - Zhang, Ziran AU - Zhang Z AD - Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Thoracic Oncology II, Peking University Cancer Hospital & Institute, Haidian District, 52# Fucheng Road, Beijing, 100142, China. FAU - Fang, Jian AU - Fang J AUID- ORCID: 0000-0002-3004-9708 AD - Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Thoracic Oncology II, Peking University Cancer Hospital & Institute, Haidian District, 52# Fucheng Road, Beijing, 100142, China. jianfang@bjcancer.org. LA - eng GR - Y-BMS2019-010/Chinese Society of Clinical Oncology - Bristol-Myers Squibb Cancer Immunology Research Fund/ PT - Comparative Study PT - Journal Article DEP - 20210615 PL - Germany TA - Cancer Immunol Immunother JT - Cancer immunology, immunotherapy : CII JID - 8605732 RN - 15H5577CQD (Docetaxel) RN - 31YO63LBSN (Nivolumab) SB - IM MH - Aged MH - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use MH - Carcinoma, Non-Small-Cell Lung/*drug therapy/pathology MH - Docetaxel/administration & dosage MH - Female MH - Follow-Up Studies MH - Humans MH - Lung Neoplasms/*drug therapy/pathology MH - Male MH - Middle Aged MH - Nivolumab/administration & dosage MH - Prognosis MH - Retrospective Studies MH - Survival Rate PMC - PMC8783906 OTO - NOTNLM OT - ALK OT - Combination therapy OT - Docetaxel OT - EGFR OT - Nivolumab OT - Non-small cell Lung cancer COIS- None of the authors have actual or potential conflicts of interest, including any financial, personal or other relation- ships with other people or organizations that could inappropriately influence this article, to declare. EDAT- 2021/06/17 06:00 MHDA- 2022/02/08 06:00 PMCR- 2021/06/15 CRDT- 2021/06/16 06:56 PHST- 2020/12/28 00:00 [received] PHST- 2021/05/09 00:00 [accepted] PHST- 2021/06/17 06:00 [pubmed] PHST- 2022/02/08 06:00 [medline] PHST- 2021/06/16 06:56 [entrez] PHST- 2021/06/15 00:00 [pmc-release] AID - 10.1007/s00262-021-02964-x [pii] AID - 2964 [pii] AID - 10.1007/s00262-021-02964-x [doi] PST - ppublish SO - Cancer Immunol Immunother. 2022 Feb;71(2):267-276. doi: 10.1007/s00262-021-02964-x. Epub 2021 Jun 15.