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PORTEC 3

Adjuvant chemoradiotherapy versus radiotherapy alone for women with high-risk endometrial cancer (PORTEC-3): final results of an international, open-label, multicentre, randomized, phase 3 trial

Date of Publication:

March 1, 2018

Pubmed Link:
https://www.ncbi.nlm.nih.gov/pubmed/29449189
Hypothesis:

Does adjuvant chemotherapy during and after radiotherapy versus pelvic radiotherapy alone improve survival for women with high-risk endometrial cancer?

Control Arm(s):

EBRT (4860 cGy)

Experimental Arm(s):

EBRT (4860 cGy) + Cisplatin 50 mg/m2 in wks 1 and 4

Carboplatin AUC 5 and Paclitaxel 175 mg/m2 q3wks x4 cycles

Primary End Point:

Co-primary: PFS and OS

Inclusion Criteria:

Endometrioid histology: Stage IA Grade 3 with +LVSI
, Stage IB Grade 3
, Stage II or III

Serous or Clear Cell: Stage IA (with invasion), Stage IB, II, III

Exclusion Criteria:

Carcinosarcoma

bulky cervical involvement with radical hysterectomy

residual macroscopic disease

Results:

ChemoRT vs. RT:

median f/u: 60.2 mos

5yr OS: 81.8% vs.76.6% (NS)

5yr PFS: 75.5% vs. 68.6% (SS)

Stage III patients:

5 yr PFS: 69.3% vs 58.0% (SS)

5 yr OS: 78.7% vs. 69.8% (NS)

grade 3/4 Hematologic: 45% vs. 5% (SS)

grade 3/4 GI: 14% vs. 5% (SS)

grade 3/4 Neuropathy: 7% vs. 0% (SS)

At 12 months no significant difference in any grade 3 toxicity

Conclusions:

Addition of chemotherapy to EBRT improves PFS, yet OS is unchanged, in women with high risk endometrial cancer. Effect most pronounced in stage III disease and women 70+.

Reviewer:
Kevin McCool, OTF