A Multicentre Phase II Study of Trifluridine/Tipiracil in Recurrent/Metastatic Platinum-Resistant Nasopharyngeal Carcinomas

Rákkutatás · Nasopharyngeal carcinoma

Trifluridine/tipiracil showed an overall response rate of 22.9% in patients with platinum‑resistant, recurrent/metastatic nasopharyngeal carcinoma.

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 received oral FTD/TPI 35 mg/m² twice daily on days 1‑5 and 8‑12 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. Thirty‑five patients were enrolled. Median PFS was 6.5 months and median OS was 13.1 months. The DCR at 12 weeks was 57.1%, and ORR was 22.9%. Hematologic toxicities were the most common adverse events. FTD/TPI demonstrated a manageable safety profile and encouraging antitumor activity as a convenient oral therapy.

Piloting an oral chemotherapeutic in a setting where options after platinum failure are scarce, showing meaningful disease control and manageable toxicity.

Bizonyítékszint: Korai humán adat. Kis vagy feltáró emberi adat.

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