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

Jpn J Clin Oncol. 2013 May;43(5):524-31. doi: 10.1093/jjco/hyt034. Epub 2013 Mar 10.

Abstract

Objective: To 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.

Methods: In 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/m(2); subsequent weeks, 250 mg/m(2)) plus a maximum of six three-weekly cycles of cisplatin (100 mg/m(2), day 1) and 5-fluorouracil (1000 mg/m(2)/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.

Results: In 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.

Conclusions: The 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 .

Trial registration: ClinicalTrials.gov NCT00971932.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antibodies, Monoclonal, Humanized / administration & dosage
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Asian Continental Ancestry Group
  • Carcinoma, Squamous Cell / drug therapy*
  • Carcinoma, Squamous Cell / pathology*
  • Carcinoma, Squamous Cell / secondary
  • Cetuximab
  • Cisplatin / administration & dosage
  • Disease-Free Survival
  • Drug Administration Schedule
  • Female
  • Fluorouracil / administration & dosage
  • Head and Neck Neoplasms / drug therapy*
  • Head and Neck Neoplasms / pathology
  • Humans
  • Japan
  • Male
  • Middle Aged
  • Neoplasm Recurrence, Local / drug therapy*
  • Treatment Outcome

Substances

  • Antibodies, Monoclonal, Humanized
  • Cetuximab
  • Cisplatin
  • Fluorouracil

Associated data

  • ClinicalTrials.gov/NCT00971932