221O - Induction chemotherapy regimen of docetaxel plus cisplatin vs docetaxel, cisplatin plus fluorouracil followed by concurrent chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma: Preliminary results of a phase III multicenter randomized controlled trial

Background

Induction chemotherapy regimens of docetaxel and cisplatin plus fluorouracil (TPF) are currently clinically used for patients with locoregionally advanced nasopharyngeal carcinoma (LA-NPC) but have well-known side effects, such as myelosuppression and diarrhea. A docetaxel plus cisplatin (TP) regimen was developed to decrease the toxic effects induced by fluorouracil. In this trial, we assessed whether the TP induction chemotherapy regimen was noninferior to the TPF regimen.

Methods

We performed an open-label, noninferiority, phase 3, multicenter, randomized, controlled trial at six centers in China. Eligible NPC patients were randomly assigned (1:1) to receive either TP or TPF followed by concurrent chemoradiotherapy. The primary endpoint was failure-free survival. Secondary endpoints included overall survival, safety, and treatment compliance. The trial was stopped early because of strong evidence for noninferiority of TP in failure-free survival.

Results

Between June 2018 and October 2021, we randomly assigned 361 patients to the TP (n = 181) or TPF (n = 180) induction chemotherapy group. The 2-year failure-free survival was 91·3% in the TP group and 82·4% in the TPF group (P = 0·029). Patients in the TPF group had a higher frequency of grade 1 or 2 neutropenia (P = 0·001), grade 1 or 2 diarrhea (P = 0·032), and grade 3 or 4 neutropenia (P = 0·014) in the induction chemotherapy period.

Conclusions

The preliminary results revealed that TP induction chemotherapy regimen was found to be clearly non-inferior compared to the TPF regimen in failure-free survival, with a lower frequency of neutropenia, anaemia and diarrhoea. The more convenient and beneficial survival regimen of the TP regimen should be recommended in patients with LA-NPC.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.