Nimotuzumab-CRT improves PFS in head, neck cancers
The addition of the EGFR inhibitor nimotuzumab to a chemoradiotherapy (CRT) regimen using cisplatin improved progression-free survival (PFS) and disease-free survival (DFS) in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) compared with CRT alone, according to data from a phase III trial presented at ASCO 2018.
A total of 536 patients with stage III/IV SCCHN (50 percent oropharyngeal cancers) were randomized 1:1 to receive weekly radical radiotherapy (66–70 Gy) and cisplatin 30 mg/m2 (CRT), either with nimotuzumab 200 mg (NCRT) or without. Median follow-up was 33.0 months. [ASCO 2018, abstract 6000]
PFS was significantly longer among NCRT vs CRT recipients (median, 60.3 vs 21.0 months, hazard ratio [HR], 0.74, 95 percent confidence interval [CI], 0.56–0.95; p=0.023), with a 2-year PFS rate of 58.9 percent vs 49.5 percent, respectively.
The addition of nimotuzumab also improved DFS in NCRT vs CRT recipients (HR, 0.75, 95 percent CI, 0.57–0.97; p=0.028), with a 2-year DFS rate of 59.2 percent and 49.0 percent, respectively.
The researchers attributed the improvements in PFS and DFS to the better local regional control that NCRT provided compared with CRT (65.1 percent vs 56.5 percent; p=0.018).
The median OS rate was 43.4 vs 31.3 months (HR, 0.85, 95 percent CI, 0.65–1.10; p=0.22) in the NCRT arm vs the CRT arm, respectively, but the researchers noted that the OS data has yet to mature and suggest a trend towards an improvement with NCRT, noted the researchers.
The rates of grade 3–5 adverse events (AEs) were similar between the NCRT and CRT arms (27.7 percent vs 29.2 percent for radiation dermatitis, 41.3 percent vs 37.7 percent for odynophagia, and 30.3 percent vs 28.8 percent for dysphagia) except for mucositis, which was higher among NCRT recipients (66.7 percent vs 55.8 percent; p=0.010). Hospitalization due to AEs was also higher with NCRT (21.6 percent vs 15.3 percent; p=0.058).
These results suggest that nimotuzumab enhanced the effect of cisplatin when combined with RT, noted the researchers. Therefore, NCRT combination may provide an alternative therapeutic option for the treatment of head and neck cancers, as other alternatives such as neoadjuvant/adjuvant chemotherapy, altered radiation schedules, or other chemotherapeutic agents added to cisplatin failed to improve outcomes, they added.