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
May 1, 1999
Is survival different in women with locally advanced cervical cancer treated with RT with either concurrent hydroxyurea vs cis/5FU?
para-aortic lymphadenectomy, peritoneal inspection, washings, +/- pelvic lymphadenectomyEBRT + brachyhydroxyurea 80mg/kg, twice a week
para-aortic lymphadenectomy, peritoneal inspection, washings, +/- pelvic lymphadenectomyEBRT + brachycisplatin 50mg/m2 day 1 and 295FU day 2-5 and 30-33, 1000mg/m2/d
OS
squamous, adenosquamous, adenostage IIB, III or IVA
metastases to para-aortic LNintra-abdominal metastasespositive cytology
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)
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