Nimotuzumab in Combination With Concurrent Radiotherapy and Cisplatin Is Active in Locally Advanced SCCHN
Nimotuzumab in combination with concurrent radiotherapy and cisplatin provides significant clinical benefits in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN).
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Nimotuzumab in combination with concurrent radiotherapy and cisplatin provides significant clinical benefits in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) compared with those not receiving nimotuzumab, according to data presented at the 2018 American Society of Clinical Oncology Annual Meeting in Chicago, Illinois.1
Nimotuzumab in a humanized antibody against the epidermal growth factor receptor (EGFR) and inhibits the binding of the ligand, EGF, to EGFR.
The phase 3 study randomly assigned patients with stage III/IV locally advanced SCCHN to receive nimotuzumab or placebo. All patients received concurrent radiotherapy and cisplatin.
All patients received radical radiotherapy (66-70 Gy) with weekly cisplatin 30 mg/m2. Patients in the nimotuzumab arm of the arm also received weekly nimotuzumab 200 mg.
The study required an enrollment of 536 patients for a superiority margin of 12% assuming a progression-free survival (PFS) of 60% with an 80% power and an alpha of 0.05.
Patients (n = 536) were randomly assigned equally in both arms. At a median follow up of 33 months, median PFS was significantly longer in patients receiving nimotuzumab (58.9% vs 49.5% for placebo; P = .022). With a hazard ratio of 0.74, patients receiving nimotuzumab were at a 26% reduced risk for progression.
Median duration of PFS was also longer for patients receiving nimotuzumab: 60.3 months compared with 21 months for patients receiving placebo.
The report also indicated that locoregional control and disease-free survival were significant with nimotuzumab (hazard ratio: 0.75; P = .030).
Overall survival trended towards significance with nimotuzumab (HR: 0.85; P = .222).
Except for mucositis, grade 3/4 adverse events were similar across the two arms. Incidence of mucositis was higher with nimotuzumab (66.7% vs 55.8% for placebo; P = .010).
According to the report, nimotuzumab given concurrently with radiotherapy and cisplatin was superior to the combination of radiotherapy and cisplatin in the treatment of locally advanced SCCHN.
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- Patil VM, Noronha V, Joshi A, et al. Results of a randomized phase III study of nimotuzumab in combination with concurrent radiotherapy and cisplatin versus radiotherapy and cisplatin alone, in locally advanced squamous cell carcinoma of the head and neck. J Clin Oncol. 2018: 36, (suppl; abstr 6000). Presented at 2018 ASCO Annual Meeting; June 1-5, 2018; Chicago, IL.