PMID- 36860259 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230303 IS - 2304-3881 (Print) IS - 2304-389X (Electronic) IS - 2304-3881 (Linking) VI - 12 IP - 1 DP - 2023 Feb 28 TI - Nab-paclitaxel plus tegafur gimeracil oteracil potassium capsule (S-1) as first-line treatment for advanced biliary tract adenocarcinoma: a phase 2 clinical trial. PG - 37-44 LID - 10.21037/hbsn-21-172 [doi] AB - BACKGROUND: This study aimed to evaluate the efficacy and safety of a new combination of nab-paclitaxel plus tegafur gimeracil oteracil potassium capsule (S-1) for patients with advanced biliary tract carcinoma (BTC). METHODS: Patients were treated with nab-paclitaxel at a dose of 125 mg/m(2) on day 1 and 8, and S-1, 80 to 120 mg/day on days 1-14 of a 21-day cycle. Treatments were repeated until disease progression or unacceptable toxicity occurred. The primary endpoint was objective response rate (ORR). The secondary endpoints were median progression-free survival (PFS), overall survival (OS), and adverse events (AEs). RESULTS: The number of patients enrolled were 54, and 51 patients were evaluated for efficacy. A total of 14 patients achieved partial response (PR) with an ORR of 27.5%. The ORR varied by sites, with 53.8% (7/13) for gallbladder carcinoma, 18.4% (7/38) for cholangiocarcinoma. The most common grade 3 or 4 toxicities were neutropenia and stomatitis. The median PFS and OS were 6.0 and 13.2 months, respectively. CONCLUSIONS: The combination of nab-paclitaxel with S-1 showed explicit antitumor activities and favorable safety profile in advanced BTC and could serve as a potential non-platinum and -gemcitabine-based regimen. CI - 2023 Hepatobiliary Surgery and Nutrition. All rights reserved. FAU - Zhang, Wen AU - Zhang W AD - Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. FAU - Sun, Yongkun AU - Sun Y AD - Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. FAU - Jiang, Zhichao AU - Jiang Z AD - Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. FAU - Qu, Wang AU - Qu W AD - Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. FAU - Gong, Caifeng AU - Gong C AD - Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. FAU - Zhou, Aiping AU - Zhou A AD - Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. LA - eng PT - Journal Article DEP - 20211018 PL - China (Republic : 1949- ) TA - Hepatobiliary Surg Nutr JT - Hepatobiliary surgery and nutrition JID - 101600750 PMC - PMC9944545 OTO - NOTNLM OT - Biliary tract adenocarcinoma OT - chemotherapy OT - nab-paclitaxel OT - tegafur gimeracil oteracil potassium capsule (S-1) COIS- Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://hbsn.amegroups.com/article/view/10.21037/hbsn-21-172/coif). The authors have no conflicts of interest to declare. EDAT- 2023/03/03 06:00 MHDA- 2023/03/03 06:01 PMCR- 2023/02/28 CRDT- 2023/03/02 02:04 PHST- 2021/04/30 00:00 [received] PHST- 2021/09/10 00:00 [accepted] PHST- 2023/03/02 02:04 [entrez] PHST- 2023/03/03 06:00 [pubmed] PHST- 2023/03/03 06:01 [medline] PHST- 2023/02/28 00:00 [pmc-release] AID - hbsn-12-01-37 [pii] AID - 10.21037/hbsn-21-172 [doi] PST - ppublish SO - Hepatobiliary Surg Nutr. 2023 Feb 28;12(1):37-44. doi: 10.21037/hbsn-21-172. Epub 2021 Oct 18.