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
Rok vydání: 2014
Předmět:
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