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GOG 99

A phase III trial of surgery with or without adjunctive external pelvic radiation therapy in intermediate risk endometrial adenocarcinoma

Date of Publication:

March 1, 2004

Pubmed Link:
https://www.ncbi.nlm.nih.gov/pubmed/14984936
Hypothesis:

Does addition of adjuvant RT improve survival in high-intermediate risk endometrial cancer?

Control Arm(s):

Surveillance

Experimental Arm(s):

EBRT 5040 cGy

No brachytherapy

Primary End Point:

PFS

Inclusion Criteria:

High-intermediate risk endometrial cancer

Risk factors - (1) Grade 2/3 tumor, (2) LVSI, (3) outer-third myometrial invasion

Patients were included if: (1) 70+ w/1 RF, (2) 50-70 w/2 RF, (3) <50 w/3 RF

Exclusion Criteria:

Serous and clear cell histology

Unstaged patients

Patients who underwent laparoscopic staging surgery

Results:

RT (n=190) vs observation (n=202):

median f/u: 69 mos

4yr OS: 92% vs 86% (NS)

2yr recurrence: 3% vs 12% (SS)

2yr Local recurrences: 1.6% vs 8.9%

Distant recurrences: 5.3% vs 6.4 %

RT associated with increased risks of GI, Hematologic, GU and cutaneous toxicities

2 deaths in RT arm secondary to radiation GI toxicity

Conclusions:

Adjuvant pelvic EBRT reduces risk of recurrence in HIR endometrial cancer, without apparent impact on overall survival

Reviewer:
Kevin McCool, OTF