Gemcitabine plus cisplatin significantly improved overall survival (OS) when compared with fluorouracil plus cisplatin in treatment-naïve patients with advanced nasopharyngeal carcinoma, according to final results of a phase 3 study published in the Journal of Clinical Oncology.1
The GEM20110714 trial (ClinicalTrials.gov Identifier: NCT01528618) enrolled 362 patients who were randomly assigned 1:1 to receive gemcitabine plus cisplatin or fluorouracil plus cisplatin.
The primary analysis showed significantly longer progression-free survival with gemcitabine than with fluorouracil — 7 months and 5.6 months, respectively (hazard ratio [HR], 0.55; P <.0001).2
At the final OS analysis, the median follow-up was 69.5 months for the gemcitabine arm and 69.7 months for the fluorouracil arm. There were 314 deaths overall, with 81.8% of patients in the gemcitabine arm dying and 91.7% of patients in the fluorouracil arm dying.
The median OS was significantly longer with gemcitabine than with fluorouracil — 22.1 months and 18.6 months, respectively (HR, 0.72; 95% CI, 0.58-0.90; P =.004).
The 1-year OS was 79.9% in the gemcitabine arm and 71.8% in the fluorouracil arm (P =.093). The 3-year OS was 31.0% and 20.4%, respectively (P =.021). The 5-year OS was 19.2% and 7.8%, respectively (P <.001).
There were more patients who survived at least 5 years in the gemcitabine arm (13.8%) than in the fluorouracil arm (5.5%).
There were 94 patients (51.9%) in the gemcitabine arm and 100 (55.2%) in the fluorouracil arm who received post-study treatment. The rate of response to first subsequent therapy was 20.2% in the gemcitabine arm and 17.0% in the fluorouracil arm. The rate of stable disease was 44.7% and 52.0%, respectively.
When the OS data were censored at the start of second-line therapy, the median OS was still significantly longer with gemcitabine than with fluorouracil — 29.3 months and 16.1 months, respectively (HR, 0.51; 95% CI, 0.36-0.71; P <.001).
The study authors concluded that this analysis “provides a new benchmark for OS” in patients with advanced nasopharyngeal carcinoma and “highlights the benefit” of first-line treatment with gemcitabine plus cisplatin in this patient population.
Disclosures: This research was supported by Eli Lilly and Company and the 5010 Clinical Research Foundation of Sun Yat-sen University. The study authors reported having no conflicts of interest.
- Hong S, Zhang Y, Yu G, et al. Gemcitabine plus cisplatin versus fluorouracil plus cisplatin as first-line therapy for recurrent or metastatic nasopharyngeal carcinoma: Final overall survival analysis of GEM20110714 phase III study. J Clin Oncol. Published online August 11, 2021. doi: 10.1200/JCO.21.00396
- 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;388(10054):1883-1892. doi:10.1016/S0140-6736(16)31388-5