Phase II clinical trial of h-R3 combined with radiotherapy in locally advanced nasopharyngeal carcinoma

J BUON. 2014 Oct-Dec;19(4):930-6.

Abstract

Purpose: The purpose of this study was to evaluate the short- and long-term efficacy and toxicity of the humanized anti-epidermal growth factor receptor (EGFR) monoclonal antibody h-R3 when combined with radiotherapy for the treatment of locally advanced nasopharyngeal carcinoma (NPC).

Methods: 35 patients with stage III-IVb NPC with moderate- or strong-intensity EGFR expression were randomly divided into either a radiotherapy alone group or a group receiving radiotherapy combined with h-R3.

Results: The complete remission (CR) rates of the combination group at three time points were significantly higher (p<0.05) than those of the radiotherapy alone group. Overall survival, 3-year local control rate, and no distant metastasis rate did not differ between the two groups. No severe toxicity was noticed.

Conclusion: h-R3 is an agent with good safety profile which could help enhance the radiation antitumor effect in locally advanced NPC, but it did not seem to exhibit significant long-term efficacy.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Antibodies, Monoclonal
  • Antineoplastic Combined Chemotherapy Protocols
  • Cisplatin
  • Combined Modality Therapy*
  • ErbB Receptors / immunology
  • ErbB Receptors / therapeutic use*
  • Humans
  • Nasopharyngeal Neoplasms / drug therapy*
  • Nasopharyngeal Neoplasms / radiotherapy*
  • Neoplasm Staging
  • Remission Induction

Substances

  • Antibodies, Monoclonal
  • ErbB Receptors
  • Cisplatin