BACKGROUND

A well-established first-line chemotherapy standard for metastatic nasopharyngeal carcinoma is yet lacking.

OBJECTIVES

To compare the efficacy and safety of gemcitabine plus platinum versus docetaxel plus platinum regimen as first-line therapies for distal metastatic nasopharyngeal carcinoma.

STUDY DESIGN AND PARTICIPANTS

A single center, randomized, open-label, parallel-arm study. The study included 120 patients with metastatic nasopharyngeal carcinoma who met the study requirements.

INTERVENTIONS

Participants were randomized in a 1:1 ratio through a sealed envelope selection. Gemcitabine 1000 mg/m/d intravenously (IV) for >30 min (days 1 and 8) or docetaxel 75 mg/m/d IV for 1 h (day 1) were administered to the respective group participants. Nedaplatin 75 mg/m/d, IV (day 1), cisplatin 75 mg/m/d IV (day 1) or carboplatin (area under the curve set as 5) IV (day 1) were used in both groups. One cycle duration was 21 days, with 4-6 cycles for all participants.

OUTCOMES

The primary assessed outcomes were progression-free survival (PFS) and overall survival (OS), and the secondary outcomes were short-term efficacy [i.e., response rate (RR) and disease control rate (DCR)] and safety.

RESULTS

Seven patients withdrew from the study, and efficacy and adverse reactions were obtained for 113 patients (gemcitabine: 56; docetaxel: 57). Compared with the docetaxel plus platinum group, the gemcitabine plus platinum group had significantly higher RR (71.4% vs. 52.6%, < 0.05); mPFS (9.7 vs. 7.8 months, < 0.05), and mOS (20.6 vs. 16.8 months, < 0.01). The significance was not associated with increased adverse reactions, as both groups showed similar Grades 3 and 4 adverse reactions ( > 0.05). DCR was non-significantly higher in the gemcitabine group (85.7% vs. 75.4%, > 0.05). Multivariable analysis revealed that time to disease progression, number of involved organs, liver metastasis, and grouping were associated with mPFS and mOS (all < 0.05).

CONCLUSION

The combination of gemcitabine with platinum is likely superior to that of docetaxel with platinum as first-line treatment for metastatic nasopharyngeal carcinoma.