PMID- 36090635 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220913 IS - 2218-6751 (Print) IS - 2226-4477 (Electronic) IS - 2218-6751 (Linking) VI - 11 IP - 8 DP - 2022 Aug TI - Efficacy and safety of anlotinib combined with carboplatin and pemetrexed as first-line induction therapy followed by anlotinib plus pemetrexed as maintenance therapy in EGFR/ALK wild-type advanced non-squamous non-small cell lung cancer in China: a multicenter, single-arm trial. PG - 1657-1666 LID - 10.21037/tlcr-22-558 [doi] AB - BACKGROUND: The efficacy and safety of chemotherapy strategies combining the multi-target receptor tyrosine kinase inhibitor in patients with advanced EGFR/ALK wild-type non-squamous non-small-cell lung cancer (nsq-NSCLC) are undetermined. We aimed to investigate the efficacy and safety of anlotinib combined with carboplatin/pemetrexed-based chemotherapy followed by maintenance therapy (anlotinib plus pemetrexed) in advanced EGFR/ALK wild-type nsq-NSCLC. METHODS: Eligible patients with wild-type EGFR/ALK advanced nsq-NSCLC who received first-line therapy in Henan Province from March 2019 to February 2021 were recruited. All patients were treated with anlotinib in combination with carboplatin/pemetrexed-based chemotherapy, followed by maintenance therapy (anlotinib plus pemetrexed). The primary endpoint was progression-free survival (PFS). The secondary endpoints included overall survival (OS), disease control rate (DCR), objective response rate (ORR), and adverse events (AEs). Response and AEs were assessed based on the Response Evaluation Criteria in Solid Tumors (1.1) and National Cancer Institute - Common Terminology Criteria for Adverse Events v.4.0.3, respectively. The follow-up interval for survival was 6 weeks and the safety follow-up was performed until the end of treatment. Kaplan-Meier analysis was used to calculate the median PFS and OS. RESULTS: Thirty-eight participants with median age of 62 (range, 33-75) years were evaluated. Five participants were still on maintenance therapy until the end of the study. The majority were non-smokers (68.4%). The median follow-up was 13.6 (range, 12.3-14.9) months. The median PFS (mPFS) was 10.5 (95% CI: 4.1, 17.0) months, and the median OS was 23.4 [95% CI: not evaluable (NE), NE] months. The DCR and ORR were 94.7% and 60.5%, respectively. Grade 3 and above treatment-related adverse events (TRAEs) happened to 12 participants. The most common TRAEs were hypertension (23.7%), neutropenia (19.4%), and bone marrow toxicity (10.5%). Seven patients discontinued treatment, including two patients during induction and five patients during maintenance treatment. No grade 5 TRAE was reported. In the non-smoker participants, the mPFS was 14.5 (95% CI: 4.0-25.0) months. CONCLUSIONS: Anlotinib in combination with carboplatin/pemetrexed-based chemotherapy followed by anlotinib plus pemetrexed as maintenance therapy might be an effective choice in treating patients with wild-type EGFR/ALK advanced nsq-NSCLC. CI - 2022 Translational Lung Cancer Research. All rights reserved. FAU - He, Zhen AU - He Z AD - Department of Internal Medicine, Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China. FAU - Yang, Xiuli AU - Yang X AD - Department of Oncology, The First Affiliated Hospital of Nanyang Medical College, Nanyang, China. FAU - Ma, Tianjiang AU - Ma T AD - Department of Medical Oncology, Luohe Central Hospital, Luohe, China. FAU - Yang, Qiumin AU - Yang Q AD - Department of Oncology, Shangqiu First People's Hospital, Shangqiu, China. FAU - Zhang, Chenghui AU - Zhang C AD - Department of Oncology, Nanyang Central Hospital, Nanyang, China. FAU - Chen, Yunfang AU - Chen Y AD - Department of Oncology, Zhumadian Central Hospital, Zhumadian, China. FAU - Wang, Pengyuan AU - Wang P AD - Department of Medical Oncology, Xuchang Central Hospital, Xuchang, China. FAU - D'Incecco, Armida AU - D'Incecco A AD - Medical Oncology Unit, "G. Mazzini" Hospital of Teramo, Teramo, Italy. FAU - Metro, Giulio AU - Metro G AD - Medical Oncology, Santa Maria della Misericordia Hospital, Azienda Ospedaliera di Perugia, Perugia, Italy. FAU - Uematsu, Shugo AU - Uematsu S AD - Respiratory Disease Center, Showa University Northern Yokohama Hospital, Kanagawa, Japan. FAU - Wang, Qiming AU - Wang Q AD - Department of Internal Medicine, Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China. LA - eng PT - Journal Article PL - China TA - Transl Lung Cancer Res JT - Translational lung cancer research JID - 101646875 PMC - PMC9459624 OTO - NOTNLM OT - Anlotinib OT - carboplatin OT - non-small-cell lung cancer (NSCLC) OT - non-squamous OT - pemetrexed COIS- Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-22-558/coif). The authors have no conflicts of interest to declare. EDAT- 2022/09/13 06:00 MHDA- 2022/09/13 06:01 PMCR- 2022/08/01 CRDT- 2022/09/12 03:46 PHST- 2022/05/20 00:00 [received] PHST- 2022/08/15 00:00 [accepted] PHST- 2022/09/12 03:46 [entrez] PHST- 2022/09/13 06:00 [pubmed] PHST- 2022/09/13 06:01 [medline] PHST- 2022/08/01 00:00 [pmc-release] AID - tlcr-11-08-1657 [pii] AID - 10.21037/tlcr-22-558 [doi] PST - ppublish SO - Transl Lung Cancer Res. 2022 Aug;11(8):1657-1666. doi: 10.21037/tlcr-22-558.