Gemcitabine Plus Platinum versus Docetaxel Plus Platinum as First-Line Therapy for Metastatic Nasopharyngeal Carcinoma: A Randomized Clinical Study

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(2)/d intravenously (IV) for >30 min (days 1 and 8) or docetaxel 75 mg/m(2)/d IV for 1 h (day 1) were administered to the respective group participants. Nedaplatin 75 mg/m(2)/d, IV (day 1), cisplatin 75 mg/m(2)/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%, P < 0.05); mPFS (9.7 vs. 7.8 months, P < 0.05), and mOS (20.6 vs. 16.8 months, P < 0.01). The significance was not associated with increased adverse reactions, as both groups showed similar Grades 3 and 4 adverse reactions (P > 0.05). DCR was non-significantly higher in the gemcitabine group (85.7% vs. 75.4%, P > 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 P < 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.