Platinum-based chemotherapy plus cetuximab first-line for Asian patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck: Results of an open-label, single-arm, multicenter trial

Head Neck. 2015 Aug;37(8):1081-7. doi: 10.1002/hed.23707. Epub 2014 Sep 17.

Abstract

Background: The purpose of this study was to assess the efficacy, safety, and pharmacokinetics of cisplatin-based chemotherapy plus cetuximab as first-line treatment in Chinese and Korean patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).

Methods: Patients (n = 68) received cetuximab weekly plus 3-week cycles of cisplatin/5-fluorouracil (5-FU) chemotherapy for up to 6 cycles. The primary endpoint was overall response rate.

Results: The overall response rate was 55.9%, including 2 complete responses (CRs). Median overall survival (OS) was 12.6 months and median progression-free survival (PFS) was 6.6 months. Grade 3/4 adverse events (AEs) were reported in 41 (60.3%) patients. The safety profile was in line with previous clinical experience. The pharmacokinetic profile was in line with that observed with cetuximab in white and Japanese patients.

Conclusion: The efficacy, safety, and pharmacokinetic findings from this study support the use of first-line platinum-based chemotherapy plus cetuximab in Chinese and Korean patients with recurrent and/or metastatic SCCHN (ClinicalTrials.gov NCT01177956).

Keywords: Chinese; EXTREME trial; cetuximab; head and neck cancer; recurrent and metastatic squamous cell carcinoma.

Publication types

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

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Asian People
  • Carcinoma, Squamous Cell / mortality
  • Carcinoma, Squamous Cell / secondary*
  • Carcinoma, Squamous Cell / therapy*
  • Cetuximab / administration & dosage
  • China / epidemiology
  • Cisplatin / administration & dosage
  • Female
  • Fluorouracil / administration & dosage
  • Head and Neck Neoplasms / mortality
  • Head and Neck Neoplasms / pathology*
  • Head and Neck Neoplasms / therapy*
  • Humans
  • Infusions, Intravenous / methods
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Neoplasm Recurrence, Local / mortality
  • Neoplasm Recurrence, Local / pathology
  • Neoplasm Recurrence, Local / therapy*
  • Radiotherapy, Adjuvant
  • Republic of Korea / epidemiology
  • Treatment Outcome

Substances

  • Cetuximab
  • Cisplatin
  • Fluorouracil

Associated data

  • ClinicalTrials.gov/NCT01177956