Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
A Multicentre Phase II Study of Trifluridine/Tipiracil in Recurrent/Metastatic Platinum-Resistant Nasopharyngeal Carcinomas.
СтатьяКлиническое исследование II фазыМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Low Jia Li, Chong Wan Qin, Hui Edwin Pun, Tan Tuan Zea, Lai Winky, Le Thi Bich Uyen, Sooi Kenneth, Walsh Robert John, Li Wen Yun, Kong Li Ren, Lim Yaw Chyn, Chan Anthony T C, Ma Brigette, Goh Boon Cher
Аннотация
PURPOSE: Therapeutic options beyond platinum, gemcitabine, and immunotherapy in recurrent/metastatic (R/M) nasopharyngeal carcinoma (NPC) remain limited. Median overall survival (OS) for R/M disease is 20 months. This study evaluated the efficacy and safety of trifluridine/tipiracil (FTD/TPI) in platinum-resistant R/M NPC.
PATIENTS AND METHODS: In this single-arm, phase II study, patients received oral FTD/TPI at 35 mg/m2 twice daily on days 1 to 5 and 8 to 12 of each 28-day cycle. The primary endpoint was disease control rate (DCR) at 12 weeks. Secondary endpoints included progression-free survival (PFS), overall response rate (ORR), and safety.
RESULTS: Thirty-five patients were enrolled. The median age was 56 years with a median of 2 prior lines of systemic therapy (range, 1-7). Forty five percent patients had prior fluoropyrimidine. The DCR at 12 weeks was 57.1% [95% confidence interval (CI), 39.4%-73.7%], and the ORR was 22.9% (95% CI, 10.4-40.1). The DCR was comparable with and without fluoropyrimidine exposure (55.6% vs. 58.8%). The median PFS was 6.5 months, and the median OS was 13.1 months. Treatment-emergent adverse events were predominantly hematologic, including ≥ grade 3 neutropenia (43%), anemia (26%), and thrombocytopenia (9%), with grade ≥3 events largely hematologic. Dose modifications were required in 60%, most commonly due to neutropenia, manageable with dose reduction. One patient discontinued treatment because of symptomatic anemia. Grades 3 to 4 neutropenia was significantly associated with improved ORR (P < 0.001). Exploratory plasma proteomic analyses suggested potential differences in baseline and on-treatment protein expression between responders and nonresponders, warranting further validation in larger cohorts.
CONCLUSIONS: FTD/TPI demonstrated a manageable safety profile and encouraging antitumor activity. It is a convenient oral alternative to intravenous chemotherapy.
PATIENTS AND METHODS: In this single-arm, phase II study, patients received oral FTD/TPI at 35 mg/m2 twice daily on days 1 to 5 and 8 to 12 of each 28-day cycle. The primary endpoint was disease control rate (DCR) at 12 weeks. Secondary endpoints included progression-free survival (PFS), overall response rate (ORR), and safety.
RESULTS: Thirty-five patients were enrolled. The median age was 56 years with a median of 2 prior lines of systemic therapy (range, 1-7). Forty five percent patients had prior fluoropyrimidine. The DCR at 12 weeks was 57.1% [95% confidence interval (CI), 39.4%-73.7%], and the ORR was 22.9% (95% CI, 10.4-40.1). The DCR was comparable with and without fluoropyrimidine exposure (55.6% vs. 58.8%). The median PFS was 6.5 months, and the median OS was 13.1 months. Treatment-emergent adverse events were predominantly hematologic, including ≥ grade 3 neutropenia (43%), anemia (26%), and thrombocytopenia (9%), with grade ≥3 events largely hematologic. Dose modifications were required in 60%, most commonly due to neutropenia, manageable with dose reduction. One patient discontinued treatment because of symptomatic anemia. Grades 3 to 4 neutropenia was significantly associated with improved ORR (P < 0.001). Exploratory plasma proteomic analyses suggested potential differences in baseline and on-treatment protein expression between responders and nonresponders, warranting further validation in larger cohorts.
CONCLUSIONS: FTD/TPI demonstrated a manageable safety profile and encouraging antitumor activity. It is a convenient oral alternative to intravenous chemotherapy.