Metronomic capecitabine as adjuvant therapy in locoregionally advanced nasopharyngeal carcinoma: a multicentre, open-label, parallel-group, randomised, controlled, phase 3 trial

RCT (n=406, China) found addition of metronomic adjuvant capecitabine to chemoradiotherapy improved failure-free survival in patients with high-risk disease (85·3% vs. 75·7% at 3 years; HR 0.50; 95% CI 0.32–0.79; p=0.0023), with a manageable safety profile.

SPS commentary:

Metronomic chemotherapy refers to the frequent and regular administration of chemotherapeutic drugs at substantially lower doses than typically prescribed over long periods without extended drug-free break periods, which has the advantage of low toxicity and good compliance. Biologically, it is thought that metronomic chemotherapy exerts antitumour activity primarily through targeting angiogenesis.

According to a commentary, this and other successful trials of metronomic chemotherapy has the potential to change clinical practice, and if so, would be of particular benefit to patients receiving intensive definitive chemoradiotherapy and in those living in low and middle income countries. It adds, however, that this has to be balanced with some limitations of the trial, which are shared with other similar trials; this was an open-label, non-placebo-controlled trial, the optimal dose and duration of adjuvant metronomic chemotherapy are unknown, and there is no known molecular target that can be exploited as a potential biomarker for metronomic chemotherapy. It notes that despite these problems, and the practicality of the metronomic chemotherapy concept, there have been encouraging phase 2 and 3 trials that can be used as foundations for future trials.

Source:

The Lancet

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Commentary