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Combined oral topotecan plus carboplatin in relapsed or advanced cervical cancer: a GINECO phase I-II trial.
Kurtz, J E; Freyer, G; Joly, F; Gladieff, L; Kaminski, M C; Fabbro, M; Floquet, A; Hardy-Bessard, A C; Raban, N; Ray-Coquard, I; Pujade-Lauraine, E.
Afiliação
  • Kurtz JE; Oncology and Haematology Department, Hautepierre Hospital, 1 Av Molière, 67098 Strasbourg, France. j-emmanuel.kurtz@chru-strasbourg.fr
Anticancer Res ; 32(3): 1045-9, 2012 Mar.
Article em En | MEDLINE | ID: mdl-22399630
AIM: Combined cisplatin-topotecan therapy is standard care for advanced cervical cancer, however it is associated with haematotoxicity and nephrotoxicity. This trial was designed to assess the combination of carboplatin which is less nephrotoxic, and oral topotecan. PATIENTS AND METHODS: Patients with advanced/recurrent squamous cervical cancer received carboplatin (AUC5) on day 1, with escalating oral topotecan (3.0 mg/m(2) starting dose) on days 1, 8 and 15, every 4 weeks. Endpoints were the maximal tolerated dose for the phase I part and safety profiles and response rates for the phase II part of the study. RESULTS: Two dose levels were evaluated. A total of 18 patients (6 phase I, 12 phase II) were treated. The maximal tolerated dose was 3.0 mg/m(2) topotecan with carboplatin AUC5. Phase II accrual was interrupted following unacceptable toxicity, with 10 therapy-related related serious events in 9 out of 12 patients: grade 3-4 pancytopenia (7), febrile neutropenia (1), grade 3 haemorrhage (1) and grade 3 vomiting (1). CONCLUSION: Weekly oral topotecan combined with carboplatin is associated with unmanageable toxicity and is not recommended. Future studies are warranted to better understand the toxicity of such a combination and explore alternative combinations for advanced cervical cancer.
Assuntos
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Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Protocolos de Quimioterapia Combinada Antineoplásica / Neoplasias do Colo do Útero Tipo de estudo: Clinical_trials Limite: Female / Humans Idioma: En Revista: Anticancer Res Ano de publicação: 2012 Tipo de documento: Article
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Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Protocolos de Quimioterapia Combinada Antineoplásica / Neoplasias do Colo do Útero Tipo de estudo: Clinical_trials Limite: Female / Humans Idioma: En Revista: Anticancer Res Ano de publicação: 2012 Tipo de documento: Article