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Phase II study of weekly paclitaxel/carboplatin in combination with prophylactic G-CSF in the treatment of gynecologic cancers: A study in 108 patients by the Belgian Gynaecological Oncology Group.
Vergote, Ignace; Debruyne, Philip; Kridelka, Frédéric; Berteloot, Patrick; Amant, Frédéric; Honhon, Brigitte; Lybaert, Willem; Leunen, Karin; Geldhof, Kurt; Verhoeven, Didier; Forget, Frédéric; Vuylsteke, Peter; D'Hondt, Lionel; Huizing, Manon; Van den Bulck, Heidi; Laenen, Annouschka.
Afiliación
  • Vergote I; Gynecologic Oncology, University Hospital Leuven, Leuven Cancer Institute, Leuven, Belgium. Electronic address: Ignace.vergote@uzleuven.be.
  • Debruyne P; AZ Groeninge, Kortrijk, Belgium.
  • Kridelka F; CHU de Liège, Liège, Belgium.
  • Berteloot P; Gynecologic Oncology, University Hospital Leuven, Leuven Cancer Institute, Leuven, Belgium.
  • Amant F; Gynecologic Oncology, University Hospital Leuven, Leuven Cancer Institute, Leuven, Belgium.
  • Honhon B; Grand Hôpital de Charleroi, Charleroi, Belgium.
  • Lybaert W; AZ Nikolaas, St. Niklaas, Belgium.
  • Leunen K; Gynecologic Oncology, University Hospital Leuven, Leuven Cancer Institute, Leuven, Belgium.
  • Geldhof K; Jan Yperman ziekenhuis, Ieper, Belgium.
  • Verhoeven D; AZ Klina, Brasschaat, Belgium.
  • Forget F; CHA - Centre Hospitalier de l'Ardenne, Libramont, Belgium.
  • Vuylsteke P; Clinique et Maternité Sainte Elisabeth, Namur, Belgium.
  • D'Hondt L; Cliniques universitaires UCL de Mont-Godinne, Yvoir, Belgium.
  • Huizing M; UZ Antwerpen, Edegem, Belgium.
  • Van den Bulck H; Imeldaziekenhuis, Bonheiden, Belgium.
  • Laenen A; Leuvens Biostatistiek en Statistische Bioinformatica Centrum, Leuven, Belgium.
Gynecol Oncol ; 138(2): 278-84, 2015 Aug.
Article en En | MEDLINE | ID: mdl-26049123
OBJECTIVE: To investigate the addition of prophylactic G-CSF to each weekly paclitaxel/carboplatin course in patients with recurrent platinum-resistant ovarian (OC), or recurrent or advanced endometrial (EC) or cervical carcinoma (CC). METHODS: 108 patients were enrolled i.e. 36 in each cohort. Eighteen courses of paclitaxel (60 mg/m(2)) and carboplatin (AUC 2.7) were administered weekly. G-CSF (filgrastim) was given to all patients on day 5 (and if needed on day 6). RESULTS: For patients with OC, 91% had platinum-resistant and 9% platinum-refractory disease. Median number of prior chemotherapy lines was 3 for OC, 1 for EC, and 1 for CC. Grade 3-4 neutropenia was observed in 34% of patients (95% CI: 26%-44%, P<0,0001) (OC 29%, EC 36%, CC 38%). This is lower compared to historical data in all cohorts (84%). Confirmed sepsis was observed in 5%, grade 3-4 thrombocytopenia in 41%, grade 2-3 peripheral neuropathy in 17% of patients. In 71% of patients dose was delayed. Dose reduction was necessary for carboplatin in 47% and paclitaxel in 18% of patients. ORR was 51% (OC 48%, EC 45%, CC 58%). Median (95% CI) PFS and OS was 7.1 (5.1-8.1) and 12.7 (10.2-16.3) months, respectively (OC 7 and 13, EC 6 and 19, CC 6 and 14). CONCLUSION: Weekly paclitaxel/carboplatin with G-CSF is an effective treatment with acceptable toxicity in patients with platinum-resistant or platinum-refractory OC, advanced or recurrent EC and CC. The incidence of grade 3-4 neutropenia is lower with the addition of weekly G-CSF compared with earlier studies without routine use of prophylactic G-CSF.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Protocolos de Quimioterapia Combinada Antineoplásica / Neoplasias de los Genitales Femeninos Tipo de estudio: Clinical_trials / Etiology_studies / Incidence_studies / Observational_studies / Risk_factors_studies Límite: Aged / Female / Humans / Middle aged Idioma: En Revista: Gynecol Oncol Año: 2015 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Protocolos de Quimioterapia Combinada Antineoplásica / Neoplasias de los Genitales Femeninos Tipo de estudio: Clinical_trials / Etiology_studies / Incidence_studies / Observational_studies / Risk_factors_studies Límite: Aged / Female / Humans / Middle aged Idioma: En Revista: Gynecol Oncol Año: 2015 Tipo del documento: Article Pais de publicación: Estados Unidos