Translational oncology · 2026
Induction chemotherapy with nedaplatin, docetaxel and 5-fluorouracil followed by concurrent nedaplatin and radiotherapy in locoregionally advanced nasopharyngeal carcinoma: A single arm, open label, phase II clinical trial.
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Chen Fang-Zheng, Deng Ying, Yin Wen-Jing, Wang Meng-Yao, Yang Fang, Yang Zhi-Huan, Zhou Li-Ping, Chen Si-Da, Chen Jie-Ling, Jiang Xi-Zhen, Zhou Ao-Xiong, Ou Yu-Meng, Liu Jin-Quan, Chen Dong-Ping, Qi Bin
Аннотация
PURPOSE: To evaluate the efficacy of nedaplatin in induction chemotherapy and concurrent chemoradiotherapy for locoregionally advanced nasopharyngeal carcinoma.
METHODS: In this prospective, single-arm, open-label phase II trial, patients with newly diagnosed stage III-IVa (except T3-4N0) nasopharyngeal carcinoma were enrolled. Participants received three cycles of induction chemotherapy with docetaxel (60 mg/m² IV on days 1, 22, and 43), nedaplatin (60 mg/m² IV on days 1, 22, and 43), and fluorouracil (600 mg/m²/day as a continuous 120 h infusion on days 1-5, 22-26, and 43-47). This was followed by intensity-modulated radiotherapy with concurrent nedaplatin (100 mg/m² IV on days 1, 22, and/or 43) for two or three cycles. The primary endpoint was the objective response rate (ORR). Secondary endpoints included overall survival (OS), progression-free survival (PFS), and toxicity profile.
RESULTS: From March 2020 to November 2021, 32 patients were enrolled. With a median follow-up of 42.4 months (IQR, 35.4-45.2), 32 patients (100 %) achieved ORR at 12 weeks post-treatment. The 36-month PFS was 87.5 % (95 % CI, 76.1 %-98.8 %), and the 36-month OS was 100 %. The most common grade 3 or 4 adverse events during induction chemotherapy were neutropenia (9.4 %), diarrhea (9.4 %), leukopenia (6.2 %), fatigue (3.1 %) and hepatotoxicity (3.1 %). Mucositis (9.4 %) was the most common adverse events during concurrent chemoradiotherapy, followed by leukopenia (3.1 %), neutropenia (3.1 %), and thrombocytopenia (3.1 %). All adverse events were manageable.
CONCLUSION: Induction chemotherapy with nedaplatin, docetaxel, and 5-fluorouracil, followed by concurrent nedaplatin with intensity-modulated radiotherapy, demonstrated promising antitumor activity and manageable toxicities in locoregionally advanced nasopharyngeal carcinoma patients.
TRIAL REGISTRATION: This trial was registered with ClinicalTrials.gov identifier: NCT04834206.
METHODS: In this prospective, single-arm, open-label phase II trial, patients with newly diagnosed stage III-IVa (except T3-4N0) nasopharyngeal carcinoma were enrolled. Participants received three cycles of induction chemotherapy with docetaxel (60 mg/m² IV on days 1, 22, and 43), nedaplatin (60 mg/m² IV on days 1, 22, and 43), and fluorouracil (600 mg/m²/day as a continuous 120 h infusion on days 1-5, 22-26, and 43-47). This was followed by intensity-modulated radiotherapy with concurrent nedaplatin (100 mg/m² IV on days 1, 22, and/or 43) for two or three cycles. The primary endpoint was the objective response rate (ORR). Secondary endpoints included overall survival (OS), progression-free survival (PFS), and toxicity profile.
RESULTS: From March 2020 to November 2021, 32 patients were enrolled. With a median follow-up of 42.4 months (IQR, 35.4-45.2), 32 patients (100 %) achieved ORR at 12 weeks post-treatment. The 36-month PFS was 87.5 % (95 % CI, 76.1 %-98.8 %), and the 36-month OS was 100 %. The most common grade 3 or 4 adverse events during induction chemotherapy were neutropenia (9.4 %), diarrhea (9.4 %), leukopenia (6.2 %), fatigue (3.1 %) and hepatotoxicity (3.1 %). Mucositis (9.4 %) was the most common adverse events during concurrent chemoradiotherapy, followed by leukopenia (3.1 %), neutropenia (3.1 %), and thrombocytopenia (3.1 %). All adverse events were manageable.
CONCLUSION: Induction chemotherapy with nedaplatin, docetaxel, and 5-fluorouracil, followed by concurrent nedaplatin with intensity-modulated radiotherapy, demonstrated promising antitumor activity and manageable toxicities in locoregionally advanced nasopharyngeal carcinoma patients.
TRIAL REGISTRATION: This trial was registered with ClinicalTrials.gov identifier: NCT04834206.