Adding nimotuzumab to concomitant chemoradiotherapy (CCRT) may improve long-term survival in patients with locally advanced nasopharyngeal carcinoma (NPC), according to research presented at the 2022 ASCO Annual Meeting.1
In a phase 3 trial, researchers found that nimotuzumab improved overall survival (OS) at 5 years, but this benefit was confined to patients who received 3D radiotherapy (RT).
The trial (ClinicalTrials.gov Identifier: NCT01074021) enrolled patients with stage III/IV NPC. They were randomly assigned to receive CCRT plus nimotuzumab (200 mg weekly for 7-8 weeks) or CCRT plus placebo. CCRT consisted of intensity-modulated RT or conventional RT (days 1-5 of every week for 6-8 weeks) plus cisplatin (100 mg/m2 every 3 weeks for 3 cycles).
A total of 482 patients were treated — 361 in the nimotuzumab arm and 121 in the placebo arm. Patient demographics were well balanced between the arms. The median follow-up was 75.7 months in the nimotuzumab arm and 73.6 months in the placebo arm.
In the entire cohort, the 5-year OS rate was significantly higher in the nimotuzumab arm than in the placebo arm — 76.9% and 64.3%, respectively (hazard ratio [HR], 0.64; 95% CI, 0.55-0.72; P =.042). Nimotuzumab provided a 12.6% absolute benefit in OS at 5 years.
However, among patients treated per protocol (n=444), the difference in 5-year OS was not significant. The 5-year OS rate was 74.7% in the nimotuzumab arm and 64.3% in the placebo arm (HR, 0.76; 95% CI, 0.51-1.14; P =.183).
In a multivariate analysis of the full population, there was a significant OS benefit with nimotuzumab (adjusted HR, 0.64; 95% CI, 0.45-0.93; P =.018). However, the OS benefit was confined to the subset of patients who received 3D RT (P=.002) and was not seen in patients who received intensity-modulated RT (P =.717), according to the study discussant, Sophie Huang, MD, of the University of Toronto.2
In the overall cohort, there was no significant difference in disease-free survival (DFS), locoregional recurrence-free survival (LRRFS), or distant metastasis-free survival (DMFS) between the treatment arms.
At 3 years, the DFS rate was 65.1% in the nimotuzumab arm and 60.3% in the placebo arm (P =.192). The 3-year LRRFS rate was 94% and 94.6%, respectively (P =.804). The 3-year DMFS rate was 81.5% and 84.8%, respectively (P =.500).
The researchers did observe a significant improvement in complete response rate with nimotuzumab vs placebo in both the full cohort — 57.3% vs 45.5% (P =.023) — and in the per-protocol group — 62.4% vs 49.1% (P =.014).
Nimotuzumab plus CCRT was considered well tolerated. The rate of adverse events (AEs) was 35.7% in the nimotuzumab arm and 42.1% in the placebo arm (P =.207). The rate of grade 3-5 AEs was 17.7% and 15.7%, respectively (P =.609).
Although the researchers concluded that nimotuzumab can improve 5-year OS, Dr Huang said the role of nimotuzumab is uncertain in the era of intensity-modulated RT.
- Sun Y, Hu C, Lin Q, et al. Nimotuzumab plus chemoradiotherapy versus placebo plus chemoradiotherapy in patients with locally advanced nasopharyngeal carcinoma (NPC): A prospective, randomized-controlled, double-blinded, multicenter phase III clinical trial. Presented at ASCO 2022; June 3-7, 2022. Abstract 6001.
- Huang S. On the nose: Risk-tailored therapy for nasopharyngeal carcinoma. Presented at ASCO 2022; June 3-7, 2022.