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First-Line Cisplatin Plus Gemcitabine or Fluorouracil for Advanced Nasopharyngeal Carcinoma: Final Overall Survival Analysis


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As reported in the Journal of Clinical Oncology by Hong et al, the final overall survival analysis of the Chinese phase III GEM20110714 trial showed a significant benefit with gemcitabine/cisplatin vs fluorouracil/cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma.

Study Details

In the open-label multicenter trial, 362 patients with newly diagnosed stage IV disease or recurrent disease not suitable for local treatment were randomly assigned between February 2012 and October 2015 to receive gemcitabine at 1 g/m2 once daily on days 1 and 8 (n = 181) or fluorouracil at 4 g/m2 via continuous infusion over 96 hours (n = 181) together with cisplatin at 80 mg/m2 once daily on day 1 in 21-day cycles.

The primary endpoint was progression-free survival; overall survival was a secondary endpoint.

Among patients with previously untreated advanced nasopharyngeal carcinoma, those who receive gemcitabine/cisplatin have longer overall survival than those who receive fluorouracil/cisplatin. Gemcitabine plus cisplatin should be considered a preferred front-line option for these patients.
— Hong et al

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Key Findings

As previously reported, gemcitabine/cisplatin significantly improved progression-free survival vs fluorouracil/cisplatin (hazard ratio [HR] = 0.55, 95% confidence interval [CI] = 0.44–0.68, P < .001).

After median follow-up of approximately 70 months in both groups, death had occurred in 81.8% of patients in the gemcitabine/cisplatin group vs 91.7% of the fluorouracil/cisplatin group, with an estimated hazard ratio of 0.72 (95% CI = 0.58–0.90, P = .004).

Median overall survival was 22.1 months (95% CI = 19.2–25.0 months) vs 18.6 months (95% CI = 15.4–21.7 months); survival probabilities at 1, 3, and 5 years were 79.9% vs 71.8% (P = .093), 31.0% vs 20.4% (P = .021), and 19.2% vs 7.8% (P < .001). Restricted mean survival time was 33.0 months vs 25.4 months (P = .003).

Systemic therapy was initiated after study therapy in 51.9% vs 55.2% of patients; among these, the most common treatment was platinum-based combination therapy (68.1% vs 83.0%). With survival data censored at time of initiation of second-line therapy, median overall survival was 29.3 vs 16.1 months (HR = 0.51, 95% CI = 0.36–0.71, P < .001).

The investigators concluded, “Among patients with previously untreated advanced nasopharyngeal carcinoma, those who receive gemcitabine/cisplatin have longer overall survival than those who receive fluorouracil/cisplatin. Gemcitabine plus cisplatin should be considered a preferred front-line option for these patients.”

Li Zhang, MD, of Sun Yat-sen University Cancer Center, Guangzhou, is the corresponding author for the Journal of Clinical Oncology article.

Disclosure: The study was supported by the 5010 Clinical Research Foundation of Sun Yat-sen University and Eli Lilly and Company. For full disclosures of the study authors, visit ascopubs.org.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
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