# 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

## TL;DR

A new chemotherapy regimen using nedaplatin, docetaxel, and 5-fluorouracil followed by radiotherapy shows promising results for advanced nasopharyngeal cancer.

## Contribution

Demonstrates the effectiveness and safety of a nedaplatin-based regimen for nasopharyngeal carcinoma treatment.

## Key findings

- 100% of patients achieved objective response rate at 12 weeks post-treatment.
- 36-month progression-free survival was 87.5% and overall survival was 100%.
- Adverse events were manageable with predictable side effects.

## Abstract

•Nedaplatin works well for both induction and concurrent chemotherapy treatments.•Nedaplatin, docetaxel, and 5-FU form an effective induction chemotherapy regimen.•Nedaplatin treatment offers reliable objective response rates and survival outcomes.•Nedaplatin is well-tolerated with predictable, manageable side effects.•Nedaplatin is a viable alternative to cisplatin in treating nasopharyngeal carcinoma.

Nedaplatin works well for both induction and concurrent chemotherapy treatments.

Nedaplatin, docetaxel, and 5-FU form an effective induction chemotherapy regimen.

Nedaplatin treatment offers reliable objective response rates and survival outcomes.

Nedaplatin is well-tolerated with predictable, manageable side effects.

Nedaplatin is a viable alternative to cisplatin in treating nasopharyngeal carcinoma.

To evaluate the efficacy of nedaplatin in induction chemotherapy and concurrent chemoradiotherapy for locoregionally advanced nasopharyngeal carcinoma.

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.

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.

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.

This trial was registered with ClinicalTrials.gov identifier: NCT04834206.