A PHASE-II TRIAL OF NEOADJUVANT CHEMOTHERAPY PRIOR TO RADICAL HYSTERECTOMY AND OR RADIATION-THERAPY IN THE MANAGEMENT OF ADVANCED-CARCINOMAOF THE UTERINE CERVIX/

Objective: This prospective trial was designed to access tile efficacy and safety of neoadjuvant chemotherapy followed by radical hysterecto my and/or radiation therapy in women with advanced carcinoma of the ut erine cenix. Methods: Thirty women, clinical stages IIb-IVa, were enro lled in this clinical trial. Initial treatment consisted of three cycl es of bleomycin, cisplatin, and vincristine administered every 10 days . Depending on the extent of disease after chemotherapy, patients then either underwent radical hysterectomy with bilateral pelvic and peria ortic lymphadenectomy or surgical staging. Following review of the sur gical findings, tailored radiotherapy was administered, Results: Only 10 women (34%) had tumor regression from neoadjuvant chemotherapy suff icient to allow radical hysterectomy prior to tailored adjuvant radiot herapy; the remainder received primary radiotherapy after surgical sta ging, Two-year disease-free survival was 68, 43, and 0% for women with clinical stages II, III, and IV, respectively. Four women experienced acute toxicity from chemotherapy requiring medical intervention and e ight women suffered chronic toxicities requiring hospitalization and/o r surgery. Conclusion: The neoadjuvant chemotherapy utilized in this t rial was generally ineffective in converting patients from inoperable to operable, had no apparent effect on survival, and was associated wi th significant toxicity. (C) 1995 Academic Press, Inc.