The effect of adding adjuvant chemotherapy to concurrent chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma is unclear. This intervention was therefore evaluated in an open-label phase III RCT at seven institutions in China involving. patients with non-metastatic stage III or IV (except T3—4N0) nasopharyngeal carcinoma assigned to receive either concurrent chemoradiotherapy plus adjuvant chemotherapy (n= 251) or concurrent chemoradiotherapy alone (n= 257). The trial is ongoing but 2 year survival results and acute toxicity have been reported in the Lancet.

In the study, both groups received 40mg/m2 cisplatin weekly up to 7 weeks, concurrently with radiotherapy. The concurrent chemoradiotherapy plus adjuvant chemotherapy group subsequently received 80 mg/m2 adjuvant cisplatin and 800 mg/m2 per day fluorouracil for 120 hours every 4 weeks for three cycles. The primary endpoint was failure-free survival.  The efficacy analysis was conducted in the intention-to-treat population.

The following findings were reported:

• After a median follow-up of 37.8 months (range 1.3 to 61.0), the estimated 2 year failure-free survival rate was 86% in the concurrent chemoradiotherapy plus adjuvant chemotherapy group and 84% in concurrent chemoradiotherapy only group (hazard ratio 0.74, 95% CI 0.49 to 1.10; p=0.13).

• Stomatitis was the most commonly reported grade 3 or 4 adverse event during both radiotherapy (76 of 249 patients in concurrent chemoradiotherapy plus adjuvant chemotherapy group and 82 of 254 in the concurrent chemoradiotherapy alone group) and adjuvant chemotherapy (43 [21%] of 205 patients treated with adjuvant chemotherapy).

The researchers conclude from these findings that adjuvant cisplatin and fluorouracil chemotherapy did not significantly improve failure-free survival after concurrent chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma, longer follow-up is needed to fully assess survival and late toxic effects. They add that such regimens should not, at present, be used outside well-designed clinical trials.