Phase II trial of vaginal cuff brachytherapy followed by chemotherapy in early stage endometrial cancer patients with high-intermediate risk factors
Autor: | Robert S. Mannel, Kathleen N. Moore, D. Scott McMeekin, Joan L. Walker, Rosemary E. Zuna, Elizabeth Syzek, Lisa M. Landrum, Elizabeth K. Nugent |
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Rok vydání: | 2014 |
Předmět: |
Oncology
medicine.medical_specialty medicine.medical_treatment Brachytherapy Population chemistry.chemical_compound Risk Factors Uterine cancer Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Adjuvant therapy Humans Prospective Studies Progression-free survival education Aged Neoplasm Staging Aged 80 and over education.field_of_study business.industry Endometrial cancer Obstetrics and Gynecology Chemoradiotherapy Middle Aged medicine.disease Carboplatin Endometrial Neoplasms chemistry Female business |
Zdroj: | Gynecologic Oncology. 132:50-54 |
ISSN: | 0090-8258 |
DOI: | 10.1016/j.ygyno.2013.11.005 |
Popis: | 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 (175mg/m 2 ). The primary endpoint was PFS at 2years, 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 3cycles of chemotherapy. Mean time to complete VCB was 14.5days with minimal acute toxicity noted. At 6months, all toxicity related to VCB had resolved. In total 60cycles 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 44.5months, 91% of patients remained progression free at 2years. 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 2year 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. |
Databáze: | OpenAIRE |
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