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GOG 249

Phase III Trial: Adjuvant Pelvic Radiation Therapy Versus Vaginal Brachytherapy Plus Paclitaxel/Carboplatin in High-Intermediate and High-Risk Early Stage Endometrial Cancer

Date of Publication:

April 17, 2019

Pubmed Link:
https://www.ncbi.nlm.nih.gov/pubmed/?term=30995174
Hypothesis:

Does vaginal cuff brachytherapy + chemo improve PFS compared to EBRT in women with early stage endometrial cancer?

Control Arm(s):

RT (4500-5040cGy over 5 weeks)

Experimental Arm(s):

vaginal brachytherapy

paclitaxel 175 mg/m2 (3 hours) +carboplatin AUC 6
q21 days x3 cycles

Primary End Point:

PFS

Inclusion Criteria:

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

Exclusion Criteria:
Results:

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.

Conclusions:

Vaginal brachytherapy followed by 3 cycles of paclitaxel/carboplatin was not superior to EBRT, and was associated with more frequent and severe acute toxicity.

Reviewer:
Courtney Griffiths, OTF