PMID- 37543550 OWN - NLM STAT- Publisher LR - 20231011 IS - 1534-4681 (Electronic) IS - 1068-9265 (Linking) VI - 30 IP - 12 DP - 2023 Nov TI - The Efficacy and Safety of Surufatinib Combined with Anti PD-1 Antibody Toripalimab in Neoadjuvant Treatment of Locally Advanced Differentiated Thyroid Cancer: A Phase II Study. PG - 7172-7180 LID - 10.1245/s10434-023-14031-z [doi] AB - BACKGROUND: Surgery is the primary treatment for locally advanced differentiated thyroid cancer (DTC). However, some locally advanced patients are not candidates for R0/1 resection. There is limited evidence of neoadjuvant treatment in locally advanced DTC. Surufatinib targets multiple kinases, which is efficient, tolerable, and safe in patients with radioiodine-refractory DTC. In addition, surufatinib plus toripalimab (an anti-PD-1 antibody) showed encouraging antitumor activity in advanced solid tumors. This study was designed to evaluate the efficacy and safety of surufatinib plus toripalimab in locally advanced DTC in the neoadjuvant setting. METHODS: In this single-arm, phase II study, patients with pathologically confirmed unresectable or borderline resectable DTC were eligible and received a combination of 250 mg of surufatinib (orally daily) with 240 mg of toripalimab (intravenous, every 3 weeks). Treatment continued until satisfied for curative surgery, disease progression, withdrawal of consent, unacceptable toxicity, or investigator decision. Primary endpoint was objective response rate (ORR). Secondary endpoints included R0/1 resection rate, adverse events (AEs), etc. RESULTS: Ten patients were enrolled and received at least 4 cycles of treatment. The ORR was 60%. Nine patients received R0/1 resections after neoadjuvant treatment. The median best percentage change in the sum of the target lesion diameter was 32%. Most adverse events (AEs) were grade 1 or 2. CONCLUSIONS: Surufatinib in combination with toripalimab as neoadjuvant therapy for locally advanced DTC was feasible, and the majority of patients achieved R0/1 resection. It represents a new option for locally advanced DTC and needs further investigation. CI - (c) 2023. Society of Surgical Oncology. FAU - Chen, Jia-Ying AU - Chen JY AD - Department of Head and Neck Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China. AD - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. FAU - Huang, Nai-Si AU - Huang NS AD - Department of Head and Neck Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China. AD - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. FAU - Wei, Wen-Jun AU - Wei WJ AD - Department of Head and Neck Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China. AD - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. FAU - Hu, Jia-Qian AU - Hu JQ AD - Department of Head and Neck Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China. AD - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. FAU - Cao, Yi-Ming AU - Cao YM AD - Department of Head and Neck Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China. AD - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. FAU - Shen, Qiang AU - Shen Q AD - Department of Head and Neck Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China. AD - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. FAU - Lu, Zhong-Wu AU - Lu ZW AD - Department of Head and Neck Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China. AD - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. FAU - Wang, Yu-Long AU - Wang YL AD - Department of Head and Neck Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China. yulongwang@fudan.edu.cn. AD - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. yulongwang@fudan.edu.cn. FAU - Wang, Yu AU - Wang Y AD - Department of Head and Neck Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China. neck130@hotmail.com. AD - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. neck130@hotmail.com. FAU - Ji, Qing-Hai AU - Ji QH AD - Department of Head and Neck Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China. jq_hai@126.com. AD - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. jq_hai@126.com. LA - eng GR - SHDC22021201/Shanghai Shenkang Hospital Development Centre/ PT - Journal Article DEP - 20230805 PL - United States TA - Ann Surg Oncol JT - Annals of surgical oncology JID - 9420840 SB - IM EDAT- 2023/08/06 05:42 MHDA- 2023/08/06 05:42 CRDT- 2023/08/05 23:03 PHST- 2023/03/29 00:00 [received] PHST- 2023/07/11 00:00 [accepted] PHST- 2023/08/06 05:42 [pubmed] PHST- 2023/08/06 05:42 [medline] PHST- 2023/08/05 23:03 [entrez] AID - 10.1245/s10434-023-14031-z [pii] AID - 10.1245/s10434-023-14031-z [doi] PST - ppublish SO - Ann Surg Oncol. 2023 Nov;30(12):7172-7180. doi: 10.1245/s10434-023-14031-z. Epub 2023 Aug 5.