Gemcitabine: a game changer in nasopharyngeal carcinoma

Arguably, an abundance of single-arm phase 2 and 3 studies have been testing novel single or combination systemic drugs (gemcitabine, paclitaxel, docetaxel, vinorelbine, pemetrexed, and molecular-targeted treatments); however, these studies often had small sample sizes, catered to patients with treatment-refractory disease, and showed only slight gains in disease control and survival.2 This and other reasons relating to the paucity of robust preclinical models for high throughput drug screens3 led to a dormancy of the chemotherapeutic landscape and a resistance to replace fluorouracil plus cisplatin as the first-line systemic treatment in metastatic nasopharyngeal carcinoma. The potency of gemcitabine, either as a monotherapy or in combination, in nasopharyngeal carcinoma was subsequently documented in several single-arm phase 2 trials.6-8 However, in 2015, a randomised controlled, phase 3 trial of chemoradiotherapy with or without induction gemcitabine, carboplatin, and paclitaxel in patients with non-metastatic nasopharyngeal carcinoma did not show a benefit with additional gemcitabine-containing chemotherapy.9 With this new evidence from Zhang and colleagues,4 we await the results of two ongoing randomised controlled phase 3 trials of induction or adjuvant gemcitabine plus cisplatin in individuals with high-risk non-metastatic nasopharyngeal carcinoma (ClinicalTrials.gov, numbers NCT01872962 and NCT00370890).