Lancet Oncol: Phase 3 test | Prognostication of endoscopic surgery vs intensive radiotherapy treatment for patients with relapsed nasopharyngeal cancer

The role of surgery and re-radiation therapy is a controversial issue for patients with resuscisional nasopharyngeal cancer (NPC) who have previously received radiation therapy.
study compared the efficacy and safety of resuscisive, partially relapsed nasopharyngeal cancer patients with endoscopic surgery or intensive radiotherapy (IMRT).
This is a multi-center, open-label, randomized phase 3 trial conducted in three hospitals in China, recruiting locally relapsed NPC patients aged 18-70 years to have endoscopic nasopharyngeal cancer excision (ENPG group) or IMRT (IMRT group).
end point is total survival.
September 30, 2011 - January 16, 2017, 200 patients (100 each) were recruited.
56.0 months of median follow-up and 74 patients died (29 in the ENPG group and 45 in the IMRT group).
3-year total survival rate for enPG and IMRT groups was 85.8% (95% CI 78.9-92.7) and 68.0% (58.6-77.4, respectively; risk ratio 0.47,95% CI 0.29-0.76, p=0.0015).
the most common level 3 and above radiotherapy-related adverse reactions were pharyngitis (5 out of 99 patients treated with ENPG and 26 out of 101 patients treated with IMRT).
5 out of 99 patients treated with ENPG and 20 out of 101 patients treated with IMRT died from radiotherapy-specific late toxicity;
for patients with local relapsed nasopharyngeal cancer who could be removed, endoscopic excision and conditioning radiotherapy can significantly improve the overall survival rate.
results suggest that ENPG can be used as a standard treatment option for this group of patients, although long-term follow-up is needed to further clarify the efficacy and toxicity of the treatment.