Platinum-based Chemotherapy Plus Cetuximab for the First-line Treatment of Japanese Patients with Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck: Results of a Phase II Trial

Abstract

ObjectiveTo assess the efficacy and safety of cetuximab in combination with cisplatin and 5-fluorouracil for first-line treatment of Japanese patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.MethodsIn this open-label, single-arm, multicenter, Phase II study conducted in Japan, patients with confirmed recurrent and/or metastatic squamous cell carcinoma of the head and neck received weekly cetuximab (week 1, 400 mg/m2; subsequent weeks, 250 mg/m2) plus a maximum of six three-weekly cycles of cisplatin (100 mg/m2, day 1) and 5-fluorouracil (1000 mg/m2/day, 24-h infusion, days 1–4). The primary endpoint was the best overall response assessed by an independent review committee according to the modified World Health Organization criteria.ResultsIn total, 33 patients received treatment. The most frequent primary tumor site was the hypopharynx (42%), and most patients had metastatic disease (85%). The best overall response rate as assessed by the independent review committee was 36% (95% confidence interval: 20, 55) and was significantly greater (P = 0.002) than the protocol-specified threshold of 15% at the one-sided 5% level. The disease control rate was 88%. The median progression-free survival and overall survival were 4.1 and 14.1 months, respectively. There were no unexpected safety concerns. Grade 3 or 4 adverse events were experienced by nearly all patients (32, 97%). No adverse events were fatal.ConclusionsThe demonstrated efficacy and safety of cetuximab in combination with cisplatin and 5-fluorouracil for the first-line treatment of Japanese patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck justify the further use of this combination treatment in this patient population (ClinicalTrials.gov number, NCT00971932).

Advanced Squamous Cell Carcinoma of the Head and Neck: The Current Role of Cetuximab

“…Yoshino et al [33] evaluated CTX, cisplatin at 100 mg/m 2 on day 1, and 5-FU at 1,000 mg/m 2 /day on days 1-4 for 6 cycles as first-line treatment in metastatic SCC. ORR was 36%, disease control rate 88%, and PFS and OS were 4.1 and 14.1 months, respectively.…”

Consenso multidisciplinario y multiinstitucional de la utilidad del cetuximab en el tratamiento de los pacientes con carcinoma epidermoide de cabeza y cuello

“…Yoshino, et al 26 evaluaron la combinación de CTX con CDDP y 5-FU en primera línea en cáncer escamoso metastásico recurrente empleando CTX a dosis semanales convencionales, CDDP a dosis de 100 mg/m 2 el día 1 y 5-FU a dosis de 1000 mg/m 2 al día los días 1 a 4, por un máximo de seis ciclos. La tasa de respuesta global fue del 36%, la tasa de control de la enfermedad fue del 88%, la SVLP de 4.1 meses y la SG de 14.1 meses.…”

Collagen gel droplet-embedded culture drug sensitivity testing in hard palate cancer-predicted antitumor efficacy of cetuximab: A case report

“…However, there are no established predictors of OSCC therapeutic responses, and this inability to predict tumor response has resulted in drugs being administered to patients irrespective of tumor sensitivity. C-mab reportedly causes infusion reactions and other serious adverse events (1,10). Therefore, identifying a predictor of OSCC patient therapeutic response is essential to eliminating ineffective drug administration and associated patient risks.…”