Back

PORTEC 2

Vaginal brachytherapy versus pelvic external beam radiotherapy for patients with endometrial cancer of high-intermediate risk (PORTEC-2): an open label, non-inferiority, randomized trial

Date of Publication:

March 6, 2010

Pubmed Link:
https://pubmed.ncbi.nlm.nih.gov/20206777/
Hypothesis:

Does treatment with EBRT or IVRT lead to similar vaginal recurrence rates in women with high-intermediate risk endometrial cancer?

Control Arm(s):

TAH/BSO, washings, suspicious LN removedEBRT - 4600cGy, 200cGy fractions 5x/wk (23 fractions)

Experimental Arm(s):

TAH/BSO, washings, suspicious LN removedIVRT high dose - 2100 cGy in 3 fractions of 700 cGy, 1 week apartIVRT medium dose - 2800 cGy at 100cGy/hIVRT low dose - 3000 cGy at 50-70cGy/h

Primary End Point:

vaginal recurrence (non-inferiority)

Inclusion Criteria:

19 Dutch RadOnc centresendometrial adenocarcinoma>60 yo AND stage IB grade 3, stage IC grade 1 or 2any age AND stage IIA

Exclusion Criteria:

serous or clear cell histologyprior treatmentCrohn's or ulcerative colitis

Results:

427 total: EBRT (n=214) vs IVRT (n=213):median f/u - 45 monthsvaginal recurrences: 4 (1.9%) vs 3 (1.4%)estimated 5yr vaginal recurrences: 1.6% vs 1.8% (NS)estimated 5yr locoregional: 2.1% vs 5.1% (NS)estimated 5yr distant: 5.7% vs 8.3% (NS)5yr OS: 79.6% vs 84.8% (NS)5yr DFS: 78.1% bs 82.7% (NS)grade 1/2 GI side effects at completion of treatment : 53.8% vs 12.6%, but lost SS at 24 mos f/umore grade 1/2 mucosal atrophy with IVRT

Conclusions:

IVRT should be the adjuvant treatment of choice in high-intermediate patients with endometrioid histology

Reviewer:
Olga T Filippova