PMID- 35380726 OWN - NLM STAT- MEDLINE DCOM- 20220407 LR - 20220629 IS - 1549-490X (Electronic) IS - 1083-7159 (Print) IS - 1083-7159 (Linking) VI - 27 IP - 4 DP - 2022 Apr 5 TI - Rh-Endostatin Plus Irinotecan/Cisplatin as Second-Line Therapy for Advanced Esophageal Squamous Cell Carcinoma: An Open-Label, Phase II Study. PG - 253-e312 LID - 10.1093/oncolo/oyab078 [doi] AB - BACKGROUND: This open-label, phase II study aimed to investigate the efficacy and safety of recombinant human endostatin (Rh-endostatin) plus irinotecan/cisplatin as second-line treatment in patients with advanced esophageal squamous cell carcinoma (ESCC). METHODS: Eligible patients received 15mg/m2 Rh-endostatin as a continuous intravenous pump infusion (7 continuous days), 60mg/m2 irinotecan (days 1 and 8), and 60mg/m2 cisplatin (day 1) every 3 weeks. The primary endpoint was progression-free survival (PFS). RESULTS: A total of 50 patients were assessable for efficacy and safety analysis. The median follow-up was 10.97 months (95%CI: 7.03-19.42) as the data cutoff. Median PFS was 4.01 months (95% CI: 3.19-5.49), and median overall survival (OS) was 12.32 months (95% CI: 8.21-17.45); 13 (26%; 95% CI: 15.87-39.55) of 50 patients had an objective response, and 31 (62%; 95% CI: 48.15-74.14) had disease control. Grade 3 or greater treatment-related adverse events (AEs) occurred in 12 (24.0%) patients, and no deaths were reported. The common grade 3 or greater AEs were leucopenia (18.0%) and neutropenia (16.0%). Five (10%) patients discontinued treatment because of AEs. CONCLUSION: Rh-endostatin plus irinotecan/cisplatin showed promising anti-tumor activity in advanced ESCC patients with a good safety profile in the second-line setting, which warrants further study in this population. (ClinicalTrials.gov identifier: NCT03797625). CI - (c) The Author(s) 2022. Published by Oxford University Press. The data published online to support this summary are the property of the authors. Please contact the authors about reuse rights of the original data. FAU - Hu, Zhihuang AU - Hu Z AD - Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China. AD - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China. AD - Institute of Thoracic Oncology, Fudan University, Shanghai, People's Republic of China. FAU - Sun, Si AU - Sun S AD - Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China. AD - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China. AD - Institute of Thoracic Oncology, Fudan University, Shanghai, People's Republic of China. FAU - Zhao, Xinmin AU - Zhao X AD - Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China. AD - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China. AD - Institute of Thoracic Oncology, Fudan University, Shanghai, People's Republic of China. FAU - Yu, Hui AU - Yu H AD - Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China. AD - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China. AD - Institute of Thoracic Oncology, Fudan University, Shanghai, People's Republic of China. FAU - Wu, Xianghua AU - Wu X AD - Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China. AD - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China. AD - Institute of Thoracic Oncology, Fudan University, Shanghai, People's Republic of China. FAU - Wang, Jialei AU - Wang J AD - Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China. AD - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China. AD - Institute of Thoracic Oncology, Fudan University, Shanghai, People's Republic of China. FAU - Chang, Jianhua AU - Chang J AD - Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China. AD - Department of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences, Shenzhen Center, Shenzhen, People's Republic of China. FAU - Wang, Huijie AU - Wang H AD - Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China. AD - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China. AD - Institute of Thoracic Oncology, Fudan University, Shanghai, People's Republic of China. LA - eng SI - ClinicalTrials.gov/NCT03797625 PT - Clinical Trial, Phase II PT - Journal Article PL - England TA - Oncologist JT - The oncologist JID - 9607837 RN - 0 (Endostatins) RN - 7673326042 (Irinotecan) RN - Q20Q21Q62J (Cisplatin) SB - IM MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects MH - Cisplatin MH - Endostatins MH - *Esophageal Neoplasms/drug therapy/pathology MH - *Esophageal Squamous Cell Carcinoma/drug therapy/pathology MH - Humans MH - Irinotecan/therapeutic use PMC - PMC8982371 OTO - NOTNLM OT - cisplatin OT - esophageal squamous cell carcinoma OT - irinotecan OT - phase II study OT - recombinant human endostatin (Rh-endostatin) EDAT- 2022/04/06 06:00 MHDA- 2022/04/08 06:00 PMCR- 2022/04/05 CRDT- 2022/04/05 12:12 PHST- 2021/10/19 00:00 [received] PHST- 2021/12/06 00:00 [accepted] PHST- 2022/04/05 12:12 [entrez] PHST- 2022/04/06 06:00 [pubmed] PHST- 2022/04/08 06:00 [medline] PHST- 2022/04/05 00:00 [pmc-release] AID - 6563658 [pii] AID - oyab078 [pii] AID - 10.1093/oncolo/oyab078 [doi] PST - ppublish SO - Oncologist. 2022 Apr 5;27(4):253-e312. doi: 10.1093/oncolo/oyab078.