Phase I/II Study of Erlotinib Combined With Cisplatin and Radiotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck
| Autor: | Miriam Hatsue Honda Federico, Renato G. Martins, Renata E. Knust, Celia Maria Pais Viégas, Carlos Gil Ferreira, Daniel Herchenhorn, Fernando Luiz Dias, Marcos A. Bezerra, I. A. Small, Carlos M.M. Araújo, K. Fontão |
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| Rok vydání: | 2010 |
| Předmět: |
Adult
Male Oncology Cancer Research medicine.medical_specialty medicine.medical_treatment Drug Administration Schedule Erlotinib Hydrochloride Internal medicine Antineoplastic Combined Chemotherapy Protocols Confidence Intervals Carcinoma Humans Medicine Radiology Nuclear Medicine and imaging Basal cell carcinoma Laryngeal Neoplasms Survival rate Aged Salvage Therapy Chemotherapy Hypopharyngeal Neoplasms Radiation business.industry Radiotherapy Dosage Middle Aged medicine.disease Combined Modality Therapy Surgery Survival Rate Radiation therapy Oropharyngeal Neoplasms Epidermoid carcinoma Head and Neck Neoplasms Carcinoma Squamous Cell Quinazolines Female Drug Eruptions Erlotinib Cisplatin business Brazil medicine.drug |
| Zdroj: | International Journal of Radiation Oncology*Biology*Physics. 78:696-702 |
| ISSN: | 0360-3016 |
| Popis: | 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/m 2 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-limiting toxicity 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 progression-free and overall survival rates were 61% and 72%, respectively. Conclusions This combination appears safe, has encouraging activity, and deserves further studies in locally advanced HNSCC. |
| Databáze: | OpenAIRE |
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