Gemcitabine plus cisplatin versus docetaxel plus cisplatin and fluorouracil induction chemotherapy combined with locoregional radiotherapy in de novo metastatic nasopharyngeal carcinoma: A single center prospective phase II clinical trial

Purpose

This prospective clinical trial aims to compare the efficacy and safety of gemcitabine plus cisplatin (GP) versus docetaxel plus cisplatin and fluorouracil (TPF) as induction chemotherapy combined with locoregional radiotherapy in de novo metastatic nasopharyngeal carcinoma (dmNPC).

Methods

146 dmNPC patients were randomly assigned in a 1:1 ratio to receive 4–6 cycles of GP (GP group) or TPF induction chemotherapy (TPF group) followed by locoregional radiotherapy (LRRT). The primary endpoint was overall survival (OS). Secondary endpoints consisted of progression-free survival（PFS）, objective response rate (ORR), disease control rate (DCR), and treatment-related adverse events (AEs).

Results

As of data cutoff (May 31, 2024), the median follow-up time was 60.0 months (IQR 40.3–68.1). There is no significant difference in median OS (35.4 vs. 34.8 months, p = 0.2609) and PFS (15.8 vs. 14.3 months, p = 0.2318) between the GP and TPF groups. No significant differences in ORR (65.8 % vs. 71.2 %, p = 0.476) and DCR (79.5 % vs. 82.2 %, p = 0.674) were observed between GP and TPF group too. Furthermore, the 5-year OS was 40.1 % (95 % CI, 29.6 %-54.2 %) in the GP group, compared with 27.2 % (95 % CI, 17.9 %−41.3 %) in the TPF group（HR = 0.79, 95 % CI, 0.53–1.20). However, the TPF group had higher incidences of grade 3–4 AEs such as neutropenia, leukopenia, nausea, and diarrhea.

Conclusion

The study indicates that 4–6 cycles of TPF induction chemotherapy combined with LRRT achieves a therapeutic effect comparable to the GP regimen with controllable safety.