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GOG 85

Randomized Comparison of Fluorouracil Plus Cisplatin Versus Hydroxyurea as an Adjunct to Radiation Therapy in Stage IIB-IVA Carcinoma of the Cervix With Negative Para-Aortic Lymph Nodes: A Gynecologic Oncology Group and Southwest Oncology Group Study

Date of Publication:

May 1, 1999

Pubmed Link:
https://pubmed.ncbi.nlm.nih.gov/10334517/
Hypothesis:

Is survival different in women with locally advanced cervical cancer treated with RT with either concurrent hydroxyurea vs cis/5FU?

Control Arm(s):

para-aortic lymphadenectomy, peritoneal inspection, washings, +/- pelvic lymphadenectomyEBRT + brachyhydroxyurea 80mg/kg, twice a week

Experimental Arm(s):

para-aortic lymphadenectomy, peritoneal inspection, washings, +/- pelvic lymphadenectomyEBRT + brachycisplatin 50mg/m2 day 1 and 295FU day 2-5 and 30-33, 1000mg/m2/d

Primary End Point:

OS

Inclusion Criteria:

squamous, adenosquamous, adenostage IIB, III or IVA

Exclusion Criteria:

metastases to para-aortic LNintra-abdominal metastasespositive cytology

Results:

hydroxyurea (n=191) vs cis/5FU (N=177):more non-squamous in cis/5FU arm (6% vs 12%)grade 3/4 leukopenia: 24% vs 4% (SS)median f/u: 8.7 yrs6yr PFS: 47% vs 57% (SS)6yr OS: 43% vs 55% (SS)

Conclusions:

RT with concurrent cis/5FU improves outcomes over RT with concurrent hydroxyurea in women with locally advanced cervical cancer and has a more favorable side effect profile

Reviewer:
Olga T Filippova