In a Chinese phase III trial reported in The Lancet, Zhang et al found that gemcitabine/cisplatin improved progression-free survival vs fluorouracil/cisplatin in patients with recurrent or metastatic nasopharyngeal carcinoma.
In the open-label trial, 362 patients from 22 sites in China were randomized between February 2012 and October 2015 to receive gemcitabine at 1 g/m² on days 1 and 8 and cisplatin at 80 mg/m² on day 1 (n = 181) or fluorouracil (5-FU) at 4 g/m² via continuous infusion over 96 hours and cisplatin on day 1 every 3 weeks, for a maximum of 6 cycles. The primary endpoint was progression-free survival on independent image committee assessment in the intent-to-treat population. The study is ongoing.
Median follow-up for progression-free survival was 19.4 months. Median progression-free survival was 7.0 months (95% confidence interval [CI] = 4.4–10.9 months) in the gemcitabine group vs 5.6 months (95% CI = 3.0–7.0 months) in the 5-FU group (hazard ratio [HR] = 0.55, P < .0001). Estimated progression-free survival was 66% vs 45% at 6 months, 20% vs 6% at 12 months, and 11% vs 2% at 18 months.
Objective response was observed in 64% vs 42 % (P < .0001), with complete response reported in 15 vs 5 patients; disease control rates were 90% vs 86%. Median follow-up for overall survival was 22.0 months. Median overall survival was 29.1 vs 20.9 months (HR = 0.62, P = .0025). After disease progression, 41% of the gemcitabine group and 48% of the 5-FU group received second- or third-line chemotherapy, with paclitaxel-containing salvage treatment being the most common.
Treatment-related grade 3 or 4 adverse events significantly more common in the gemcitabine group were leukopenia (29% vs9%, P < .0001), neutropenia (23% vs 13%, P = .0251), and thrombocytopenia (13% vs 2%, P = .0007), with grade 3 or 4 mucosal inflammation being significantly more common in the 5-FU group (0% vs 14%, P < .0001). Serious treatment-related adverse events occurred in 4% vs 6%. Treatment-related adverse events led to discontinuation of treatment in 3% vs 8%. No treatment-related deaths were observed.
The investigators concluded: “Gemcitabine plus cisplatin prolongs progression-free survival in patients with recurrent or metastatic nasopharyngeal carcinoma. The results establish gemcitabine plus cisplatin as the standard first-line treatment option for this population.”
The study was funded by the 5010 Clinical Research Foundation of Sun Yat-sen University.
Li Zhang, MD, of Sun Yat-sen University Cancer Center, is the corresponding author of The Lancet article.
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