Phase III Trial: Adjuvant Pelvic Radiation Therapy Versus Vaginal Brachytherapy Plus Paclitaxel/Carboplatin in High-Intermediate and High-Risk Early Stage Endometrial Cancer
April 17, 2019
Does vaginal cuff brachytherapy + chemo improve PFS compared to EBRT in women with early stage endometrial cancer?
RT (4500-5040cGy over 5 weeks)
paclitaxel 175 mg/m2 (3 hours) +carboplatin AUC 6
q21 days x3 cycles
Stage I/II endometrioid histology
Age 70+ with 1 risk factor, age 50-69 with 2 risk factors, or age 18-49 with 3 risk factors.
Risk factors: grade 2/3, outer half invasion, LVSI.
All stage II endometrioid
Serous or clear cell tumors with stage I/II disease, negative peritoneal cytology
VCB/C vs RT:
median f/u: 53 mos
5yr PFS: 76% vs 76% (NS)
5yr OS: 85% vs 87% (NS)
5yr PALN/PLN recurrences: 9 vs 4% (SS)
No difference in vaginal or distant recurrences
Acute toxicities higher in VCB/C arm.
Vaginal brachytherapy followed by 3 cycles of paclitaxel/carboplatin was not superior to EBRT, and was associated with more frequent and severe acute toxicity.