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GOG 109

Concurrent chemotherapy and pelvic radiation therapy compared with pelvic radiation therapy alone as adjuvant therapy after radical surgery in high-risk early-stage cancer of the cervix

Date of Publication:

April 1, 2000

Pubmed Link:
https://pubmed.ncbi.nlm.nih.gov/10764420/
Hypothesis:

Does the addition of chemotherapy to RT after radical hysterectomy improve OS in women with early stage cervical cancer with high risk features (positive LN, margins or parametria)?

Control Arm(s):

type 3 radical hysterectomypelvic lymphadenectomyEBRT 4930cGy

Experimental Arm(s):

type 3 radical hysterectomypelvic lymphadenectomyEBRT 4930cGy1 cycle = cispaltin 70mg/m2 2hr infusion on day 1 of RT and 5FU 1000mg/m2 96hr continuous infusionthen cycles on day 22, 43, 64 (last 2 after RT complete)

Primary End Point:

OS

Inclusion Criteria:

type 3 radical hysterectomypelvic lymphadenectomystage IA2, IB or IIA cervical cancersquamous, adenocarcinoma, adenosquamouspositive LN, margin or parametria

Exclusion Criteria:
Results:

RT only (n=116) vs chemo/RT (n=127): median f/u: 42 mosgrade 4 toxicity: n=4 vs n=274yr PFS: 63% vs 80% (SS)same pattern of recurrences4yr OS: 71% VS 81% (SS)worse prognosis of adeno and adenosquamous, mitigated by addition of chemotherapy

Conclusions:

The addition of chemotherapy to RT after radical hysterectomy improves OS in women with early stage cervical cancer with high risk features (positive LN, margins or parametria)

Reviewer:
Olga T Filippova