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Clinical Trial
. 2016 Dec;27(12):2257-2262.
doi: 10.1093/annonc/mdw428. Epub 2016 Oct 11.

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  1   2   3 , J L Geiger  4 , S Trivedi  2 , N C Schmitt  5   6 , D E Heron  7   2   8 , J T Johnson  2 , S Kim  2 , U Duvvuri  2 , D A Clump  7   5 , J E Bauman  7   4 , J P Ohr  7   4 , W E Gooding  7 , A Argiris  9   10
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Clinical Trial

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 et al. Ann Oncol. 2016 Dec.

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.

Keywords: cisplatin chemoradiotherapy; clinical trial; head and neck squamous cell carcinoma; panitumumab.

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Figures

Figure 1.
Figure 1.
Kaplan–Meier curves showing (A) progression-free survival and (B) overall survival in months.
See this image and copyright information in PMC

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