A randomized phase 3 trial comparing nimotuzumab plus cisplatin chemoradiotherapy vs cisplatin chemoradiotherapy alone in locally advanced head and neck cancer
Cancer Jul 09, 2019
Patil VM, et al. - Since improved outcomes in locally advanced head and neck cancer have been reported in relation to the addition of nimotuzumab to chemoradiation in a phase 2 study, researchers intended to corroborate these findings in this open-label, investigator-initiated, phase 3, randomized trial. Either radical radiotherapy (66-70 grays) with concurrent weekly cisplatin (30 mg/m2) (CRT) or the same schedule of CRT with weekly nimotuzumab (200 mg) (NCRT) was randomly 1:1 administered to adult patients with locally advanced head and neck cancer who were suitable for radical chemoradiation. The equal allocation of 536 patients to both treatment arms was done. A median follow-up of 39.13 months revealed improvements in progression-free survival, locoregional control, and disease-free survival in relation to the addition of nimotuzumab to concurrent weekly CRT. In patients treated with radical-intent CRT for locally advanced head and neck cancer, the addition of nimotuzumab to concurrent weekly CRT affords a new alternative therapeutic choice to a 3-weekly schedule of 100 mg/m2 cisplatin.
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