Phase II trial of post-operative radiotherapy with concurrent cisplatin plus panitumumab in patients with high-risk, resected head and neck cancer

R. L. Ferris, J. L. Geiger, S. Trivedi, N. C. Schmitt, D. E. Heron, J. T. Johnson, S. Kim, U. Duvvuri, D. A. Clump, J. E. Bauman, J. P. Ohr, W. E. Gooding, A. Argiris

Research output: Contribution to journalArticlepeer-review

10 Scopus citations

Abstract

BACKGROUND: Treatment intensification for resected, high-risk, head and neck squamous cell carcinoma (HNSCC) is an area of active investigation with novel adjuvant regimens under study. In this trial, the epidermal growth-factor receptor (EGFR) pathway was targeted using the IgG2 monoclonal antibody panitumumab in combination with cisplatin chemoradiotherapy (CRT) in high-risk, resected HNSCC.

PATIENTS AND METHODS: Eligible patients included resected pathologic stage III or IVA squamous cell carcinoma of the oral cavity, larynx, hypopharynx, or human-papillomavirus (HPV)-negative oropharynx, without gross residual tumor, featuring high-risk factors (margins <1 mm, extracapsular extension, perineural or angiolymphatic invasion, or ≥2 positive lymph nodes). Postoperative treatment consisted of standard RT (60-66 Gy over 6-7 weeks) concurrent with weekly cisplatin 30 mg/m2 and weekly panitumumab 2.5 mg/kg. The primary endpoint was progression-free survival (PFS).

RESULTS: Forty-six patients were accrued; 44 were evaluable and were analyzed. The median follow-up for patients without recurrence was 49 months (range 12-90 months). The probability of 2-year PFS was 70% (95% CI = 58%-85%), and the probability of 2-year OS was 72% (95% CI = 60%-87%). Fourteen patients developed recurrent disease, and 13 (30%) of them died. An additional five patients died from causes other than HNSCC. Severe (grade 3 or higher) toxicities occurred in 14 patients (32%).

CONCLUSIONS: Intensification of adjuvant treatment adding panitumumab to cisplatin CRT is tolerable and demonstrates improved clinical outcome for high-risk, resected, HPV-negative HNSCC patients. Further targeted monoclonal antibody combinations are warranted.

REGISTERED CLINICAL TRIAL NUMBER: NCT00798655.

Original languageEnglish (US)
Pages (from-to)2257-2262
Number of pages6
JournalAnnals of oncology : official journal of the European Society for Medical Oncology
Volume27
Issue number12
DOIs
StatePublished - Dec 1 2016

Keywords

  • cisplatin chemoradiotherapy
  • clinical trial
  • head and neck squamous cell carcinoma
  • panitumumab

ASJC Scopus subject areas

  • Hematology
  • Oncology

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