Gemcitabine plus cisplatin versus fluorouracil plus cisplatin in recurrent or metastatic nasopharyngeal carcinoma
The first phase 3 trial in metastatic nasopharyngeal cancer found gemcitabine with cisplatin held the disease back for longer than the older fluorouracil-cisplatin combination, and it became the chemotherapy backbone to which immunotherapy was later added.
Overview
Chinese multicentre open-label randomised phase 3 trial of 362 patients with recurrent or metastatic nasopharyngeal carcinoma assigned to gemcitabine plus cisplatin or fluorouracil plus cisplatin for up to six cycles.
Median progression-free survival was 7.0 months with gemcitabine-cisplatin against 5.6 months (hazard ratio 0.55), with a higher response rate and a later overall survival advantage; toxicity profiles differed (myelosuppression versus mucositis).
- Median progression-free survival 7.0 months with gemcitabine-cisplatin versus 5.6 months with fluorouracil-cisplatin; hazard ratio 0.55.
- Higher objective response rate with gemcitabine-cisplatin.
Gemcitabine and cisplatin is the first-line chemotherapy for recurrent or metastatic nasopharyngeal carcinoma and the backbone of the toripalimab, camrelizumab and tislelizumab combinations.
- Open-label; conducted entirely in China.
- Median survival remained under two years with chemotherapy alone.
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