Phase I/II Study of erlotinib combined with cisplatin and radiotherapy in patients with locallyadvanced squamous cell carcinoma of the head and neck
Herchenhorn, Daniel; Dias, Fernando L; Viegas, Cla M. P; Federico, Miriam H; Ara£jo, Carlos Manoel M; Small, Isabelle; Bezerra, Marcos; FontÆo, Karina; Knust, Renata E; Ferreira, Carlos Gil Moreira; Martins, Renato G.
Int J Radiat Oncol Biol Phys
; 78(3): 696-702, 1 nov.2010. graf
Artículo
en Inglés
| TXTC | ID: txt-23698
Purpose:
Erlotinib, an oral tyrosine kinase inhibitor, is active against head-and-neck squamous cell carcinoma (HNSCC) and possibly has a synergistic interaction with chemotherapy and radiotherapy. We investigated the safety and efficacy of erlotinib added to cisplatin and radiotherapy in locally advanced HNSCC. Methods and Materials In this Phase I/II trial 100 mg/m2 of cisplatin was administered on Days 8, 29, and 50, and radiotherapy at 70 Gy was started on Day 8. During Phase I, the erlotinib dose was escalated (50 mg, 100 mg, and 150 mg) in consecutive cohorts of 3 patients, starting on Day 1 and continuing during radiotherapy. Dose-limitingtoxicity was defined as any Grade 4 event requiring radiotherapy interruptions. Phase II was initiated 8 weeks after the last Phase I enrollment.Results:
The study accrued 9 patients in Phase I and 28 in Phase II; all were evaluable for efficacy and safety. No dose-limiting toxicity occurred in Phase I, and the recommended Phase II dose was 150 mg. The most frequent nonhematologic toxicities were nausea/vomiting, dysphagia, stomatitis, xerostomia and in-field dermatitis, acneiform rash, and diarrhea. Of the 31 patients receiving a 150-mg daily dose of erlotinib, 23 (74%; 95% confidence interval, 56.8%86.3%) had a complete response, 3 were disease free after salvage surgery, 4 had inoperable residual disease, and 1 died of sepsis during treatment.With a median 37 months follow-up, the 3-year progressionfree and overall survival rates were 61% and 72%, respectively.Conclusions:
This combination appears safe, has encouraging activity, and deserves further studies in locally advancedHNSCC.(AU)
Biblioteca responsable:
BR440.1
Ubicación: BR440.1
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