PMID- 34976813 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220104 IS - 2234-943X (Print) IS - 2234-943X (Electronic) IS - 2234-943X (Linking) VI - 11 DP - 2021 TI - Efficacy and Safety of Docetaxel and Sodium Cantharidinate Combination vs. Either Agent Alone as Second-Line Treatment for Advanced/Metastatic NSCLC With Wild-Type or Unknown EGFR Status: An Open-Label, Randomized Controlled, Prospective, Multi-Center Phase III Trial (Cando-L1). PG - 769037 LID - 10.3389/fonc.2021.769037 [doi] LID - 769037 AB - Second-line treatment options for advanced/metastatic non-small cell lung cancer (NSCLC) patients are limited. We aimed to evaluate the efficacy and safety of docetaxel/sodium cantharidinate combination vs. either agent alone as second-line treatment for advanced/metastatic NSCLC patients with wild-type or unknown EGFR status. A randomized, open-label, phase III study was performed at 12 institutions. Patients with failure of first-line platinum regimens were randomized to receive either single-agent sodium cantharivsdinate (SCA) or single-agent docetaxel (DOX) or docetaxel/sodium cantharidinate combination (CON). The primary endpoints were centrally confirmed progression-free survival (PFS) and overall survival (OS). The secondary endpoints were objective response rate (ORR), disease control rate (DCR), quality of life (QoL) and toxicity. A total of 148 patients were enrolled in our study between October 2016 and March 2020. After a median follow-up time of 8.02 months, no significant difference was observed among the three groups in ORR (SCA vs. DOX vs. CON: 6.00% vs. 8.33% vs. 10.00%, respectively; p=0.814) and DCR (74.00% vs. 52.00% vs. 62.50%, respectively; p=0.080). In additional, the mOS was significantly higher in the CON group, compared with the single-agent groups (7.27 vs. 5.03 vs. 9.83 months, respectively; p=0.035), while no significant differences were observed in terms of PFS (2.7 vs. 2.9 vs. 3.1 months, respectively; p=0.740). There was no significant difference in the baseline QoL scores between the three groups (p>0.05); after treatment, life quality in SCA and CON group was significantly better than that in the DOX group (p<0.05). Furthermore, the incidence of adverse events (AEs) in the SCA group was significantly lower (46.00 vs. 79.17 vs. 25.00%, respectively; p=0.038) and the incidence of grade >/=3 AEs was also significantly lower in the SCA group compared with the DOX and CON groups (10.00 vs. 82.00 vs. 30.00%, respectively; p=0.042). Single-agent SCA and single-agent DOX has similar therapeutic efficacy in the second-line treatment of advanced/metastatic NSCLC with wild-type or unknown EGFR status, but single-agent SCA has fewer AEs and better QoL. Also, SCA plus DOX can significantly improve OS and exerted a significant synergistic effect, with good safety and tolerance profile. CI - Copyright (c) 2021 Wu, Deng, Zhang, Weng, Wu, Zeng, Tang, Cao, Qiu, Zhang, Duan, Zhang, Zhang, Zhang and Hu. FAU - Wu, Lin AU - Wu L AD - Department of Thoracic Medicine, Hunan Cancer Hospital, Changsha, China. FAU - Deng, Chao AU - Deng C AD - Department of Oncology, The Second Xiangya Hospital of Central South University, Changsha, China. FAU - Zhang, Hui AU - Zhang H AD - Department of Oncology, The Central Hospital of Shaoyang, Shaoyang, China. FAU - Weng, Jie AU - Weng J AD - Department of Oncology, The First People's Hospital of Yueyang, Yueyang, China. FAU - Wu, Youhua AU - Wu Y AD - Department of Oncology, The First Affiliated Hospital of South China University, Hengyang, China. FAU - Zeng, Shan AU - Zeng S AD - Department of Oncology, The Xiangya Hospital of Central South University, Changsha, China. FAU - Tang, Tiegang AU - Tang T AD - Department of Oncology, The Central Hospital of Xiangtan, Xiangtan, China. FAU - Cao, Peiguo AU - Cao P AD - Department of Oncology, The Third Xiangya Hospital of Central South University, Changsha, China. FAU - Qiu, Bo AU - Qiu B AD - Department of Oncology, The Central Hospital of Zhuzhou, Zhuzhou, China. FAU - Zhang, Li AU - Zhang L AD - Department of Oncology, Peking Union Medical College Hospital, Beijing, China. FAU - Duan, Huaxin AU - Duan H AD - Department of Oncology, Hunan Provincial People's Hospital and The First Affiliated Hospital of Hunan Normal University, Changsha, China. FAU - Zhang, Bing AU - Zhang B AD - Department of Oncology, The Central Hospital of Yiyang, Yiyang, China. FAU - Zhang, Dong AU - Zhang D AD - Department of Oncology, Chinese PLA General Hospital, Beijing, China. FAU - Zhang, Taotao AU - Zhang T AD - Guizhou Jinqiao Pharmaceutical Co., Ltd., Guiyang, China. FAU - Hu, Chunhong AU - Hu C AD - Department of Oncology, The Second Xiangya Hospital of Central South University, Changsha, China. LA - eng PT - Journal Article DEP - 20211214 PL - Switzerland TA - Front Oncol JT - Frontiers in oncology JID - 101568867 PMC - PMC8715707 OTO - NOTNLM OT - combination OT - docetaxel (DOC) OT - efficacy and safety OT - non-small cell lung cancer OT - sodium cantharidinate COIS- Author TZ was employed by company Guizhou Jinqiao Pharmaceutical Co., Ltd. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. EDAT- 2022/01/04 06:00 MHDA- 2022/01/04 06:01 PMCR- 2021/01/01 CRDT- 2022/01/03 05:46 PHST- 2021/09/01 00:00 [received] PHST- 2021/10/28 00:00 [accepted] PHST- 2022/01/03 05:46 [entrez] PHST- 2022/01/04 06:00 [pubmed] PHST- 2022/01/04 06:01 [medline] PHST- 2021/01/01 00:00 [pmc-release] AID - 10.3389/fonc.2021.769037 [doi] PST - epublish SO - Front Oncol. 2021 Dec 14;11:769037. doi: 10.3389/fonc.2021.769037. eCollection 2021.