PHASE I II STUDY OF CONCOMITANT IRRADIATION AND CARBOPLATIN FOR LOCALLY ADVANCED-CARCINOMA OF THE UTERINE CERVIX - AN INTERIM-REPORT/

The outcome of women treated with either definitive irradiation alone or in combination with cisplatin-based chemotherapy for locally advanc ed (>IIb) squamous cell carcinoma of the cervix has been disappointing . To improve upon our reported results with irradiation alone, a trial using irradiation plus carboplatin chemotherapy was designed for thes e patients. Twenty-seven women with unresectable squamous cell carcino ma of the uterine cervix were referred to our institution between July 1991 and September 1994. Seven of these patients were enrolled in a p hase I/II protocol combining concurrent irradiation and carboplatin ch emotherapy. Megavoltage irradiation was used to deliver 45-50.4 Gy to the pelvis (and paraaortic chain when nodes were involved) through a m ultiple-held technique followed by the application of Fletcher-Suit-De lclos tandem and ovoids to boost the point A dose to 85 Gy. Chemothera py consisted of intravenous carboplatin (60 mg/m(2)) administered in c onjunction with irradiation to a total dose of 300 mg/m(2). The enroll ed patients consisted of six women with stage IIIb disease and one wit h stage IIa with concomitant paraaortic adenopathy. All seven patients enrolled in the study completed the planned course of treatment and t olerated the treatment without severe acute morbidities. No dose modif ications were required for the radiation therapy regimen, For one pati ent, a dose of carboplatin was withheld to allow recovery from thrombo cytopenia. The overall response rate was 100% (four complete response, three partial response). The combination of concurrent irradiation (p elvic or pelvic + paraaortic fields) and carboplatin chemotherapy can be safely administered to patients with locally advanced squamous cell carcinoma of the cervix. The treatment is well tolerated and is assoc iated with a high rate of response. Longer follow-up will be necessary to assess the durability of response. In the meantime, we have electe d to escalate the dose of carboplatin (90 mg/m(2)) in the hope of incr easing the rate of complete response without incurring unacceptable to xicity.