Details

Autor(en) / Beteiligte

• Herchenhorn, D.
• Dias, F. L.
• Pineda, R. M.
• Fonseca, A. J.
• Bezerra, M.
• Ferreira, C. G.
• Knust, R. E.
• Fontão, K.
• Martins, R. G.

Titel

Phase II study of erlotinib combined with cisplatin and radiotherapy for locally advanced squamous cell carcinoma of the head and neck (SCCHN)

Ist Teil von

• Journal of clinical oncology, 2007-06, Vol.25 (18_suppl), p.6033-6033

Erscheinungsjahr

2007

Quelle

EZB Electronic Journals Library

Beschreibungen/Notizen

• Abstract only 6033 Background: Preclinical data indicates synergy of erlotinib with both cisplatin and radiotherapy (RT). We previously reported the phase I results with the dose of erlotinib defined as 150 mg/day. Methods: Patients (pts) with stages III and IV SCCHN were included. Treatment consisted of RT (70.2 Gy in 8 weeks), and cisplatin (C) (100mg/m 2 , q 21 days for 3 doses), both starting on Day 8. Erlotinib (E) was started on Day 1 and continued until the end of RT. Patients with N2/N3 disease were evaluated for elective neck dissection post RT. Results: Thirty one pts have been accrued to the study. Median age was 55 years (35–73), 13 pts had larynx carcinoma (stage III 9pts, IVA 3pts, IVB 1pts), 13pts oropharynx (stage III 2pts, IVA 8pts, IVB 3pts) and 5pts hypopharynx (stage III 1pt, IVA 4pts). Twenty five pts completed treatment and are evaluable for response and toxicity. Grade III or IV toxicity included: in-field dermatitis (14pts), nausea (13pts), mucositis (9pts), emesis (8pts), cutaneous infection (3pts), acneiform rash (7pts), fatigue (7pts), dysphagia (6pts), respiratory infection (4pts), neutropenia (1pt), diarrhea (1pt) and 1pt died due to sepsis. The dose of C was reduced in 4pts and withheld in 3pts; RT was delayed in 6 pts (median of 8 days). Twenty one pts (84%) required enteral feeding. Response was accessed by endoscopy with biopsy and CT/MRI scans. Twenty one pts (84%) had complete pathological response, 2 had residual disease and were submitted to salvage surgery, and 1 had disease progression. The median follow-up is 10.8 months. Five pts (23%) had a local relapse. Nineteen pts are disease-free (16 with organ preserved), 2 alive with disease, and 3 pts died due to disease progression. Conclusions: The combination of RT+C+E showed a high complete pathological response and acceptable toxicity, despite the high incidence of grade III/IV in-field dermatitis. These results encourage the design of a phase III trial. Final results will be presented at the meeting. No significant financial relationships to disclose.