Sakti Chakrabarti 1 , Tyler J Zemla 2 , Daniel H Ahn 3 , Fang-Shu Ou 2 , Briant Fruth 2 , Mitesh J Borad 3 , Mindy L Hartgers 1 , Jaclynn Wessling 1 , Rachel L Walkes 1 , Steven R Alberts 1 , Robert R McWilliams 1 , Minetta C Liu 1 , Lori M Durgin 1 , Tanios S Bekaii-Saab 3 , Amit Mahipal 1 Show Affiliations »
Abstract
LESSONS LEARNED: Trifluridine/tipiracil (FTD/TPI) shows promising antitumor activity in heavily pretreated patients with advanced biliary tract carcinoma, including patients with 5-fluorouracil refractory tumors. FTD/TPI has an acceptable safety profile and should be studied further in patients with advanced biliary tract carcinoma after progression on standard first-line therapy. BACKGROUND: Patients with advanced biliary tract carcinoma (BTC) refractory to first-line therapy lack an established second-line option. Trifluridine/tipiracil (FTD/TPI) has activity in both fluoropyrimidine-sensitive and -resistant tumors, which led us to conduct a single arm phase II trial to evaluate the safety and efficacy of FTD/TPI for patients previously treated for advanced BTC. METHODS: Patients with advanced BTC previously treated with at least one line of chemotherapy were enrolled and treated with FTD/TPI until disease progression or unacceptable toxicity. The primary endpoint target was to have at least 6 patients who were progression free and alive at 16 weeks among 25 evaluable patients. Secondary endpoints included overall survival (OS), overall response rate (ORR), progression-free survival (PFS), and toxicity. RESULTS: Of 27 evaluable patients, 59.3% received at least three prior lines of therapy, and 81.5% had previous exposure to fluoropyrimidine. Eight (32%, 95% confidence interval [CI], 14.9%-53.5%) patients were progression free at 16 weeks in the primary analysis population (n = 25), which met the predefined efficacy criteria. Median PFS and OS were 3.8 (95% CI, 2-5.8 months) and 6.1 (95% CI, 4.4-11.4 months) months, respectively. No objective responses were seen. There were no unexpected safety signals noted. CONCLUSION: FTD/TPI demonstrated promising antitumor activity, with acceptable toxicity, in heavily pretreated patients with advanced BTC. © AlphaMed Press; the data published online to support this summary are the property of the authors.
LESSONS LEARNED: Trifluridine /tipiracil (FTD /TPI ) shows promising antitumor activity in heavily pretreated patients with advanced biliary tract carcinoma , including patients with 5-fluorouracil refractory tumors . FTD /TPI has an acceptable safety profile and should be studied further in patients with advanced biliary tract carcinoma after progression on standard first-line therapy. BACKGROUND: Patients with advanced biliary tract carcinoma (BTC) refractory to first-line therapy lack an established second-line option. Trifluridine /tipiracil (FTD /TPI ) has activity in both fluoropyrimidine -sensitive and -resistant tumors , which led us to conduct a single arm phase II trial to evaluate the safety and efficacy of FTD /TPI for patients previously treated for advanced BTC . METHODS: Patients with advanced BTC previously treated with at least one line of chemotherapy were enrolled and treated with FTD /TPI until disease progression or unacceptable toxicity . The primary endpoint target was to have at least 6 patients who were progression free and alive at 16 weeks among 25 evaluable patients . Secondary endpoints included overall survival (OS), overall response rate (ORR), progression-free survival (PFS), and toxicity . RESULTS: Of 27 evaluable patients , 59.3% received at least three prior lines of therapy, and 81.5% had previous exposure to fluoropyrimidine . Eight (32%, 95% confidence interval [CI], 14.9%-53.5%) patients were progression free at 16 weeks in the primary analysis population (n = 25), which met the predefined efficacy criteria. Median PFS and OS were 3.8 (95% CI, 2-5.8 months) and 6.1 (95% CI, 4.4-11.4 months) months, respectively. No objective responses were seen. There were no unexpected safety signals noted. CONCLUSION: FTD /TPI demonstrated promising antitumor activity, with acceptable toxicity , in heavily pretreated patients with advanced BTC . © AlphaMed Press; the data published online to support this summary are the property of the authors.
Entities: Chemical
Disease
Gene
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Year: 2019
PMID： 31826977 PMCID： PMC7216452 DOI： 10.1634/theoncologist.2019-0874
Source DB: PubMed Journal: Oncologist ISSN： 1083-7159