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Phase II trial of vaginal cuff brachytherapy followed by chemotherapy in early stage endometrial cancer patients with high-intermediate risk factors.
Landrum, Lisa M; Nugent, Elizabeth K; Zuna, Rosemary E; Syzek, Elizabeth; Mannel, Robert S; Moore, Kathleen N; Walker, Joan L; McMeekin, D Scott.
Afiliación
  • Landrum LM; Section of Gynecology Oncology, University of Oklahoma Health Sciences Center, Oklahoma City, OK 73104, USA. Electronic address: Lisa-landrum@ouhsc.edu.
  • Nugent EK; Section of Gynecology Oncology, University of Oklahoma Health Sciences Center, Oklahoma City, OK 73104, USA.
  • Zuna RE; Department of Pathology, University of Oklahoma Health Sciences Center, Oklahoma City, OK 73104, USA.
  • Syzek E; Department of Radiation Oncology, University of Oklahoma Health Sciences Center, Oklahoma City, OK 73104, USA.
  • Mannel RS; Section of Gynecology Oncology, University of Oklahoma Health Sciences Center, Oklahoma City, OK 73104, USA.
  • Moore KN; Section of Gynecology Oncology, University of Oklahoma Health Sciences Center, Oklahoma City, OK 73104, USA.
  • Walker JL; Section of Gynecology Oncology, University of Oklahoma Health Sciences Center, Oklahoma City, OK 73104, USA.
  • McMeekin DS; Section of Gynecology Oncology, University of Oklahoma Health Sciences Center, Oklahoma City, OK 73104, USA.
Gynecol Oncol ; 132(1): 50-4, 2014 Jan.
Article en En | MEDLINE | ID: mdl-24219982
OBJECTIVE: To determine the progression free survival (PFS), toxicity, and patterns of failure for early stage, high-intermediate risk (H-IR) patients in a phase II trial with adjuvant vaginal cuff brachytherapy (VCB) and three cycles of carboplatin and paclitaxel. METHODS: Surgically staged patients with stage I-IIb endometrial cancer with H-IR factors were treated with VCB (2100cGy) followed by three cycles of carboplatin (AUC 6) and paclitaxel (175 mg/m(2)). The primary endpoint was PFS at 2 years, with toxicity and sites of failure as secondary endpoints. Toxicity was assessed by patient report (CTCAE v. 3) as well as by delays or dose modifications in treatment. RESULTS: All patients completed VCB and 19/23 (83%) completed both VCB and 3 cycles of chemotherapy. Mean time to complete VCB was 14.5 days with minimal acute toxicity noted. At 6 months, all toxicity related to VCB had resolved. In total 60 cycles of chemotherapy were given, with one dose reduction (1.6%) for grade 2 neuropathy and seven delays (11.6%) in treatment due to hematologic toxicity. At a median follow-up of 44.5 months, 91% of patients remained progression free at 2 years. Four patients experienced a recurrence; they recurred both locally and distant. CONCLUSIONS: Adjuvant therapy with VCB and chemotherapy is well tolerated in a population of patients with H-IR endometrial carcinoma and provides 2 year PFS of 91%. A randomized trial is currently underway to assess whether combined VCB and chemotherapy reduces the rate of recurrence compared to external beam radiation therapy (EBRT) in this patient population.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Braquiterapia / Protocolos de Quimioterapia Combinada Antineoplásica / Neoplasias Endometriales / Quimioradioterapia Tipo de estudio: Clinical_trials / Etiology_studies / Observational_studies / Risk_factors_studies Límite: Aged / Aged80 / Female / Humans / Middle aged Idioma: En Revista: Gynecol Oncol Año: 2014 Tipo del documento: Article Pais de publicación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Braquiterapia / Protocolos de Quimioterapia Combinada Antineoplásica / Neoplasias Endometriales / Quimioradioterapia Tipo de estudio: Clinical_trials / Etiology_studies / Observational_studies / Risk_factors_studies Límite: Aged / Aged80 / Female / Humans / Middle aged Idioma: En Revista: Gynecol Oncol Año: 2014 Tipo del documento: Article Pais de publicación: Estados Unidos