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.

• DOI: 10.1200/jco.2023.41.16_suppl.6067
• Publication Date: 2023-06-04T15:58:27Z
• Authors: Chen Fangzheng; Ying Deng; Fang Yang; Meng-Yao Wang; wen-Jing Yin; Jin-Quan Liu; Dong-Ping Chen; Bin Qi
• Keywords: Nedaplatin; Induction chemotherapy; Clinical endpoint

6067 Background: To evaluate the efficacy of induction chemotherapy with nedaplatin, docetaxel and 5-fluorouracil followed by concurrent nedaplatin combined radical radiotherapy in locoregionally advanced nasopharyngeal carcinoma (LA-NPC). Methods: This is a prospective, single-arm, open-label, phase II trial. Patients aged 18-65 years, newly diagnosed stage III-IVa (except T3-4N0) were enrolled. Eligible patients received (60 mg/m² intravenously on days (D) 1, 22 43), Nedaplatin D 43) fluorouracil (600 per day as continuous 120 hours (h) infusion 1-5, 22-26 43-47) every three weeks for cycles, thereafter intensity-modulated (IMRT) concurrently (100mg/m 2 (or) two or cycles. The primary end point was objective response rate (ORR). secondary points included overall survival (OS), progression-free (PFS), distant metastasis-free (DMFS) local recurrence-free (LRFS). Results: Between March 2020 June 2021, total 32 LA-NPC With median follow-up duration 14.0 months (IQR 11.7-16.3), (100%) achieved ORR at after treatment. 12-month PFS 95.7% (95% CI 87.3% to 100%) OS 100%. most common grade 3 4 adverse events during neutropenia (3 [9.4%]), diarrhea [9.4%]) hepatoxicity leucopenia (2 [6.3%]) fatigue (1 [3.1%]). mucositis [3.1%]), [3.1%]) thrombocytopenia All these manageable. Conclusions: Induction showed promising antitumor activity manageable toxicities LA-NPC. Further III randomized controlled trials are warranted validate our findings. Clinical trial information: NCT04834206 .