PMID- 35388976 OWN - NLM STAT- MEDLINE DCOM- 20220517 LR - 20230916 IS - 1759-7714 (Electronic) IS - 1759-7706 (Print) IS - 1759-7706 (Linking) VI - 13 IP - 10 DP - 2022 May TI - A phase II study of anlotinib combined with etoposide and platinum-based regimens in the first-line treatment of extensive-stage small cell lung cancer. PG - 1463-1470 LID - 10.1111/1759-7714.14414 [doi] AB - BACKGROUND: The aim of this prospective, pilot, single-arm phase II trial was to evaluate the safety and efficacy of anlotinib combined with etoposide and platinum-based regimens in the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). METHODS: This phase II study was conducted at Fudan University Shanghai Cancer Center between December 2018 and December 2020. All patients received standard chemotherapy (etoposide plus cisplatin/carboplatin) consisting of four courses and anlotinib at 12 mg once per day for 2 weeks followed by a one-week rest. Anlotinib administration was continued until disease progression, intolerable adverse events (AEs) or patient withdrawal from the study. The primary outcome measure was progression-free survival (PFS). The secondary outcome measures were overall survival (OS), objective control rate (ORR), disease control rate (DCR) and AEs. RESULTS: Thirty-seven patients were included in this study, and 30 patients were eligible for efficacy analysis. ORR and DCR were 90.0% and 96.7%, respectively. The estimated PFS and OS were 6.0 months (95% CI: 1.1-11.9 months) and 14.0 months (95% CI: 8.6-19.4 months), respectively. No unexpected adverse effects were reported. Hypertension (20/37, 54.1%), anemia (16/37, 43.2%), alopecia (15/37, 40.5%), elevated transaminases (9/37, 24.3%) and alkaline phosphatase (9/37, 24.3%) were the most commonly reported AEs. Thirteen patients (35.1%) reported grade 3-5 AEs. No treatment-related deaths occurred during this study. CONCLUSION: The addition of anlotinib to standard etoposide/platinum chemotherapy achieved encouraging PFS and OS in previously untreated ES-SCLC patients, with an acceptable tolerability profile and no new safety signals observed. CI - (c) 2022 The Authors. Thoracic Cancer published by China Lung Oncology Group and John Wiley & Sons Australia, Ltd. FAU - Liu, Chang AU - Liu C AD - Department of Thoracic Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. AD - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. AD - Institute of Thoracic Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. FAU - Liao, Jiatao AU - Liao J AD - Department of Thoracic Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. AD - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. AD - Institute of Thoracic Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. FAU - Wu, Xianghua AU - Wu X AD - Department of Thoracic Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. AD - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. AD - Institute of Thoracic Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. FAU - Zhao, Xinmin AU - Zhao X AD - Department of Thoracic Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. AD - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. AD - Institute of Thoracic Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. FAU - Sun, Si AU - Sun S AD - Department of Thoracic Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. AD - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. AD - Institute of Thoracic Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. FAU - Wang, Huijie AU - Wang H AD - Department of Thoracic Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. AD - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. AD - Institute of Thoracic Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. FAU - Hu, Zhihuang AU - Hu Z AD - Department of Thoracic Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. AD - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. AD - Institute of Thoracic Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. FAU - Zhang, Yao AU - Zhang Y AD - Department of Thoracic Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. AD - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. AD - Institute of Thoracic Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. FAU - Yu, Hui AU - Yu H AD - Department of Thoracic Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. AD - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. AD - Institute of Thoracic Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. FAU - Wang, Jialei AU - Wang J AUID- ORCID: 0000-0001-9977-2219 AD - Department of Thoracic Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. AD - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. AD - Institute of Thoracic Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. LA - eng PT - Clinical Trial, Phase II PT - Journal Article DEP - 20220407 PL - Singapore TA - Thorac Cancer JT - Thoracic cancer JID - 101531441 RN - 0 (Indoles) RN - 0 (Quinolines) RN - 0 (anlotinib) RN - 49DFR088MY (Platinum) RN - 6PLQ3CP4P3 (Etoposide) RN - BG3F62OND5 (Carboplatin) SB - IM MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects MH - Carboplatin MH - China MH - Etoposide MH - Humans MH - Indoles MH - *Lung Neoplasms MH - Platinum/pharmacology/therapeutic use MH - Prospective Studies MH - Quinolines MH - *Small Cell Lung Carcinoma PMC - PMC9108065 OTO - NOTNLM OT - anlotinib OT - antiangiogenic therapy OT - first-line therapy OT - small cell lung cancer COIS- The author reports no conflicts of interest in this work. EDAT- 2022/04/08 06:00 MHDA- 2022/05/18 06:00 PMCR- 2022/05/01 CRDT- 2022/04/07 08:51 PHST- 2022/03/21 00:00 [revised] PHST- 2022/01/24 00:00 [received] PHST- 2022/03/23 00:00 [accepted] PHST- 2022/04/08 06:00 [pubmed] PHST- 2022/05/18 06:00 [medline] PHST- 2022/04/07 08:51 [entrez] PHST- 2022/05/01 00:00 [pmc-release] AID - TCA14414 [pii] AID - 10.1111/1759-7714.14414 [doi] PST - ppublish SO - Thorac Cancer. 2022 May;13(10):1463-1470. doi: 10.1111/1759-7714.14414. Epub 2022 Apr 7.