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A randomized comparison of cisplatin and oral vinorelbine as radiosensitizers in aged or comorbid locally advanced cervical cancer patients.
Coronel, Jaime Alberto; Cetina, Lucely del Carmen; Cantú, David; Cerezo, Oscar; Hernández, Cintia Sánchez; Rivera, Lesbia; Chacón, Adela Poitevin; Duenas-Gonzalez, Alfonso.
Afiliação
  • Coronel JA; Division of Clinical Research, Instituto de Investigaciones Biomédicas, Universidad Nacional Autonoma de Mexico, Instituto Nacional de Cancerologia, México City, Mexico.
Int J Gynecol Cancer ; 23(5): 884-9, 2013 Jun.
Article em En | MEDLINE | ID: mdl-23694982
OBJECTIVE: Chemoradiation with cisplatin is considered the standard of care for patients with locally advanced cervical cancer; however, cisplatin could be difficult to use in aged patients or patients with comorbidities such as diabetes mellitus and blood hypertension; hence, it is important to investigate nonplatinum drugs for radiosensitization. In addition, oral cytotoxics may overcome the drawbacks of intravenous infusions and could be of easier administration. METHODS: In this small randomized trial, we tested cisplatin against oral vinorelbine as radiosensitizers in these patients. A total of 39 patients 65 years or older or diabetic and hypertensive patients of any age were randomized to cisplatin or oral vinorelbine at 40 mg/m² or 60 mg/m², respectively. Both drugs were administered weekly for 6 courses during pelvic external-beam radiotherapy and brachytherapy radiation. Efficacy and safety were assessed. RESULTS: Nineteen patients received oral vinorelbine, and 20 patients received cisplatin. The median cumulative dose to point A was 80.8 Gy for both groups, and the overall treatment time was 48 (42-54) and 50 (43-55) days for vinorelbine and cisplatin groups, respectively. Patients in both arms received a median of 5 applications of chemotherapy. Treatment was well tolerated in both arms. The most frequent toxicity in both arms was lymphopenia grades 2 and 3. At a median follow-up time of 16 months (4-19), there were no differences in either progression-free survival or overall survival between groups. CONCLUSIONS: Our results suggest that these patient populations can safely be treated with either cisplatin or navelbine as radiosensitizers; however, a larger randomized study is needed to demonstrate the noninferiority of oral vinorelbine as an easier and practical alternative for radiosensitization in cervical cancer.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Radiossensibilizantes / Carcinoma de Células Escamosas / Adenocarcinoma / Protocolos de Quimioterapia Combinada Antineoplásica / Neoplasias do Colo do Útero / Recidiva Local de Neoplasia Tipo de estudo: Clinical_trials / Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Aged / Female / Humans / Middle aged Idioma: En Revista: Int J Gynecol Cancer Assunto da revista: GINECOLOGIA / NEOPLASIAS Ano de publicação: 2013 Tipo de documento: Article País de afiliação: México País de publicação: Reino Unido

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Radiossensibilizantes / Carcinoma de Células Escamosas / Adenocarcinoma / Protocolos de Quimioterapia Combinada Antineoplásica / Neoplasias do Colo do Útero / Recidiva Local de Neoplasia Tipo de estudo: Clinical_trials / Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Aged / Female / Humans / Middle aged Idioma: En Revista: Int J Gynecol Cancer Assunto da revista: GINECOLOGIA / NEOPLASIAS Ano de publicação: 2013 Tipo de documento: Article País de afiliação: México País de publicação: Reino Unido