RESUMO
BACKGROUND: Cisplatin plus fluorouracil is widely used for the treatment of head and neck cancer. However, the cisplatin plus fluorouracil regimen necessitates hospitalization. Therefore, we planned to develop a new regimen that can be administered on an outpatient basis and performed a phase I study of S-1 + nedaplatin. METHODS: S-1 was given orally at a fixed dose for 14 days, and nedaplatin was administered intravenously on day 8 of S-1 administration. The dose of nedaplatin was increased in 10-mg/m(2) steps to find the maximum tolerated dose, depending on the appearance of dose-limiting toxicities. RESULTS: A total of 14 patients were registered. The maximum tolerated dose of nedaplatin was determined to be 90 mg/m(2). The main toxicities were neutropenia and thrombocytopenia. The response rate was 57.1%. CONCLUSION: The recommended dose of nedaplatin for a phase II study was determined to be 80 mg/m(2). We concluded that our regimen was well tolerated and that the response rate was acceptable.
Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica , Neoplasias de Cabeça e Pescoço/tratamento farmacológico , Compostos Organoplatínicos/administração & dosagem , Ácido Oxônico/administração & dosagem , Tegafur/administração & dosagem , Idoso , Carcinoma/tratamento farmacológico , Carcinoma de Células Escamosas , Cisplatino/administração & dosagem , Cisplatino/uso terapêutico , Progressão da Doença , Combinação de Medicamentos , Feminino , Fluoruracila/administração & dosagem , Fluoruracila/uso terapêutico , Humanos , Masculino , Dose Máxima Tolerável , Pessoa de Meia-Idade , Recidiva Local de Neoplasia , Neoplasias de Células Escamosas/tratamento farmacológico , Compostos Organoplatínicos/efeitos adversos , Compostos Organoplatínicos/uso terapêutico , Ácido Oxônico/efeitos adversos , Ácido Oxônico/uso terapêutico , Carcinoma de Células Escamosas de Cabeça e Pescoço , Tegafur/efeitos adversos , Tegafur/uso terapêuticoRESUMO
Preservation of the larynx is the most critical factor influencing quality of life in the treatment of head and neck cancer. This clinical study focuses on laryngeal function-preserving chemoradiotherapy for locally advanced hypopharyngeal and laryngeal cancer. Thirty-two resectable cases with histologically proven squamous cell carcinoma undergoing function-preserving therapy were examined. Induction chemotherapy comprised cisplatin and 5-fluorouracil, and another cycle of chemotherapy was performed for responders. Chemoradiotherapy comprised conventional irradiation and weekly chemotherapy (nedaplatin plus docetaxel). Non-responder patients were excluded from further chemotherapy and were changed to other surgical treatment. Three patients were non-responders for induction chemotherapy, and 29 patients were treated with chemoradiotherapy. Thus, 21 out of 29 patients obtained preserved laryngeal function. Initial larynx preservation rate with these treatment strategies was 93.8%. This study provides a new concept for laryngeal function-preserving treatment that should be considered for locally advanced laryngeal and hypopharyngeal cancer.