Gemcitabine in combination with cisplatin is associated with a significant improvement in progression-free survival compared with fluorouracil and cisplatin in patients with recurrent or metastatic nasopharyngeal carcinoma, a study published in the journal The Lancet has shown.1

There is no well-established first-line chemotherapy available for patients with recurrent or metastatic nasopharyngeal carcinoma, and outcomes are poor. Therefore, researchers sought to compare the efficacy and safety of gemcitabine plus cisplatin vs fluorouracil plus cisplatin in this population.

For the multicenter, open-label trial, investigators enrolled 362 patients receiving care at 22 hospitals in China. Participants were randomly assigned 1:1 to receive either gemcitabine 1000 mg/m2 IV on days 1 and 8 and cisplatin 80 mg/m2 IV on day 1, or fluorouracil 4000 mg/m2 via continuous IV infusion over 96 hours and cisplatin 80 mg/m2 on day 1 IV once every 21 days for up to 6 cycles.

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After a median follow-up of 19.4 months, median progression-free survival was 7.0 months (95% CI, 4.4-10.9) in the gemcitabine arm compared with 5.6 months (95% CI, 3.0-7.0) in the fluorouracil arm (hazard ratio [HR], 0.55; 95% CI, 0.44-0.68; P <.0001).

In terms of safety, treatment-related grade 3 or 4 leukopenia (P <.0001) , neutropenia (P =.0251), and thrombocytopenia (P =.0007) were significantly more common in the gemcitabine group, while mucosal inflammation occurred more frequently in the fluorouracil group (P <.0001).

Four percent of patients who received gemcitabine reported serious treatment-related adverse events vs 6% in the fluorouracil arm; 3% and 8%, respectively, discontinued treatment due to drug-related adverse events.

The findings ultimately suggest that gemcitabine plus cisplatin should be the standard first-line treatment option for patients with recurrent or metastatic nasopharyngeal carcinoma.


1. Zhang L, Huang Y, Hong S, et al. Gemcitabine plus cisplatin versus fluorouracil plus cisplatin in recurrent or metastatic nasopharyngeal carcinoma: a multicentre, randomised, open-label, phase 3 trial. Lancet. 2016 Aug 23. doi: 10.1016/S0140-6736(16)31388-5. [Epub ahead of print]