CHICAGO — Patients with locally advanced nasopharyngeal cancer concurrently treated with nimotuzumab, a novel humanized anti-EGFR monoclonal antibody, and radiotherapy had similar rates of progression-free and overall survival to those treated with cisplatin and radiotherapy, but with significantly fewer gastrointestinal and hematologic toxicities, according to phase 3 trial results presented at the American Society of Clinical Oncology (ASCO) 2016 Annual Meeting.1
Given these significant differences in toxicity, the trial was stopped early, said Lin Kong, MD, Fudan University Shanghai Cancer Center, Shanghai, China.
Both regimens are recommended by the Chinese NCCN for treating locally advanced nasopharyngeal cancer; however, they have never been compared. The cisplatin/radiotherapy regimen, in particular “is often associated with severe acute toxicities,” she added.
Between July 2012 and November 2015, the study randomly assigned 160 patients with stage III-IVB nasopharyngeal cancer to receive concurrent radiotherapy 70 Gy/35 fractions plus cisplatin 40 mg/m2/week (n = 83) or nimotuzumab 200 mg/week x 8 week (n = 77) after induction chemotherapy with docetaxel, cisplatin, and 5-fluorouracil.
All patients completed the planned radiotherapy; however, significantly fewer completed the planned 5 cycles of cisplatin, 40.2%, compared with the 8 planned cycles of nimotuzumab, 97.3% (P < .001).
Acute grade 3/4 mucositis and/or dermatitis occurred in 28.8% of patients in the nimotuzumab arm and 40.2% of the cisplatin arm (P = .191). In addition, acute severe GI and hematologic toxicities were significantly less in the patients who received nimotuzumab, she said.
At 3 years, rates of progression-free survival were 79.6% in the nimotuzumab arm and 83.0% in the cisplatin arm (P = .691), and rates of overall survival were 91.1% and 93.3%, respectively (P = .793). The 3-year locoregional control rate was 93.6% in the nimotuzumab arm and 92.3% in the cisplatin arm (P = .831); distant metastasis-free survival was 86.2% and 90.3%, respectively (P = .609).
1. Kong L, Lin Q, Hu C, et al. Radiation plus concurrent nimotuzumab versus CDDP in locally advanced nasopharyngeal cancer: results of a phase III randomised trial. Oral presentation at: ASCO 2016 Annual Meeting; June 3-7, 2016; Chicago, IL.