Results showed that adding erlotinib to cisplatin and docetaxel was superior to chemotherapy alone for both overall survival and progression-free survival in head and neck squamous cell carcinoma.
Adding erlotinib (Tarceva) to platinum-based chemotherapy resulted in a 3.3-month advantage in overall survival (OS) and a 1.7-month advantage in progression-free survival (PFS) for patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).
In results presented in a poster at the 2017 ASCO Annual Meeting, researchers from the University of Texas MD Anderson Cancer Center found that adding erlotinib to cisplatin and docetaxel was superior to chemotherapy alone for both OS (17.0 vs 13.7 months; hazard ratio [HR], 0.67; 95% CI, 0.43-1.04; P = .07) and PFS (6.1 vs 4.4 months; HR, 0.63; 95% CI, 0.42-0.95; P = .026). Two-year outcomes favored the erlotinib group for both PFS (11% vs 4%) and OS (39% vs 21%).
From May 2010 to July 2015, researchers recruited 120 patients with recurrent/metastatic HNSCC and a performance status of 0 to 2 into this phase II study. Patients were randomly assigned to a maximum of 6 cycles of first-line chemotherapy with 75 mg/m2 of cisplatin or AUC 6 carboplatin and 75 mg/m2 of docetaxel every 21 days, plus placebo (n = 60) or 150 mg/daily of erlotinib (n = 60). Patients were then given maintenance placebo or erlotinib until disease progression.
All but 1 patient initiated treatment and were eligible for evaluation of the primary endpoint of PFS. Patient characteristics were generally balanced between the 2 arms. The overall population included 92 men (76.7%) and the median age was 62 years. Most patients (97% in the placebo group and 93% in the experimental group) had a performance status of 0 or 1. Fifty-two patients had cancer of the oropharynx, 40 had cancer of the oral cavity, 19 had cancer of the larynx, and 8 had cancer of the hypopharynx. Eighty-six patients were current or former smokers.
Twenty-one patients (36%) in the placebo group and 22 (37%) in the erlotinib group experienced recurrence within 6 months of completing local treatment. Thirty-eight patients (64%) in both groups experienced late recurrence.
Twenty-seven patients across both arms had prior exposure to EGFR inhibitors, 82 had undergone prior chemotherapy, and 99 had received previous radiation therapy.
Secondary endpoints included OS, response rates, safety, quality of life, and biomarkers, including rash.
Response rate favored the erlotinib group (56% vs 44%; P = .213), but duration of response was longer in the placebo arm (5.5 vs 4.8 months; P = .355). Researchers also found that first-cycle grade 2 to 4 rash was associated with longer OS (HR, 0.40; 95% CI, 0.19-0.87; P = .021) in the erlotinib arm.
Researchers also found that the OS and PFS benefit from erlotinib were greater in patients with oropharyngeal tumors (P ≤.05 for interaction).
The incidence of grade 2 to 5 adverse events (AEs) was greater in the erlotinib arm. The most common grade 2 to 5 AEs in the erlotinib group versus the chemotherapy-alone arm were rash (48% vs 7%), fatigue (47% vs 31%), nausea (40% vs 24%), and diarrhea (33% vs 17%). Only fatigue (31%) and nausea (24%) crossed the ≥20% threshold for grade 2 to 5 AEs in the placebo group.
William NW, Feng L, Kies MS, et al. Randomized, double-blind, placebo-controlled, phase II trial of first-line platinum/docetaxel with or without erlotinib (E) in patients (pts) with recurrent and/or metastatic (R/M) head and neck squamous cell carcinomas (HNSCCs). J Clin Oncol. 35, 2017 (suppl; abstr 6017).