Cisplatin and radiotherapy with or without erlotinib in locally advanced squamous cell carcinoma of the head and neck: A randomized phase ii trial

Renato G. Martins, Upendra Parvathaneni, Julie E. Bauman, Anand K. Sharma, Luis E. Raez, Michael A. Papagikos, Furhan Yunus, Brenda F. Kurland, Keith D. Eaton, Jay J. Liao, Eduardo Mendez, Neal Futran, David X. Wang, Xiaoyu Chai, Sarah G. Wallace, Melissa Austin, Rodney Schmidt, D. Neil Hayes

Research output: Contribution to journalArticlepeer-review

141 Scopus citations

Abstract

Purpose: The combination of cisplatin and radiotherapy is a standard treatment for patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN). Cetuximab-radiotherapy is superior to radiotherapy alone in this population, validating epidermal growth factor receptor (EGFR) as a target. Erlotinib is a small-molecule inhibitor of EGFR. Adding EGFR inhibition to standard cisplatin-radiotherapy may improve efficacy. Patients and Methods: Patients with locally advanced SCCHN were randomly assigned to receive cisplatin 100 mg/m2 on days 1, 22, and 43 combined with 70 Gy of radiotherapy (arm A) or the same chemoradiotherapy with erlotinib 150 mg per day, starting 1 week before radiotherapy and continued to its completion (arm B). The primary end point was complete response rate (CRR), evaluated by central review. The secondary end point was progression-free survival (PFS). Available tumors were tested for p16 and EGFR by fluorescent in situ hybridization. Results: Between December 2006 and October 2011, 204 patients were randomly assigned. Arms were well balanced for all patient characteristics including p16, with the exception of more women on arm A. Patients on arm B had more rash, but treatment arms did not differ regarding rates of other grade 3 or 4 toxicities. Arm A had a CRR of 40% and arm B had a CRR of 52% (P = .08) when evaluated by central review. With a median follow-up time of 26 months and 54 progression events, there was no difference in PFS (hazard ratio, 0.9; P = .71). Conclusion: Erlotinib did not increase the toxicity of cisplatin and radiotherapy in patients with locally advanced HNSCC but failed to significantly increase CRR or PFS.

Original languageEnglish (US)
Pages (from-to)1415-1421
Number of pages7
JournalJournal of Clinical Oncology
Volume31
Issue number11
DOIs
StatePublished - Apr 10 2013
Externally publishedYes

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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