PHASE I II STUDY OF NEOADJUVANT INTRAARTERIAL CHEMOTHERAPY WITH MITOMYCIN-C, VINCRISTINE, AND CISPLATIN IN PATIENTS WITH STAGE IIB BULKY CERVICAL-CARCINOMA/

Background. Stage IIb bulky cervical carcinomas have been considered d ifficult to treat successfully by radiation and/or surgery, compared w ith smaller lesions. This study was designed to evaluate the efficacy of neoadjuvant pelvic intraarterial chemotherapy (IAC) and to determin e the optimal dosage of cisplatin for reducing tumor volume in these p atients. Methods. Twenty-one previously untreated patients with primar y cervical carcinoma of more than 4 cm in greatest dimension and param etrial invasion were included in this study. Pelvic IAC was administer ed using a combination of mitomycin-C, 10 mg/m(2); vincristine, 1 mg/m (2); and cisplatin, 50 mg/m(2) (MVC; group 1, 8 patients) or 75 mg/m(2 ) (group 2, 13 patients). Tumor volumes were measured three-dimensiona lly by magnetic resonance imaging (MRI) before and after three courses of IAC. Clinical responses were evaluated with gynecologic examinatio n and MRI; pathologic responses were evaluated with histologic examina tions of surgical specimens. Results. The mean volume reduction rate ( 74.2% vs. 97.2% in groups 1 and 2, respectively, P = 0.0022), the clin ical complete response rate (0% vs. 69.2%, P = 0.0033), and the pathol ogic complete response rate (0% vs. 46.2%, P = 0.0445) were significan tly higher in group 2. Type III radical hysterectomy was possible in 1 9 patients (90.5%). Toxicities of grades 2-3 (World Health Organizatio n criteria) were nausea and/or vomiting (38.1%), leukopenia (33.3%), a nd fever (14.2%). Conclusions. These preliminary results suggest that neoadjuvant pelvic IAC with MVC (especially with cisplatin at a dose o f 75 mg/m(2)) is effective in reducing tumor volume, increasing the cl inical and pathologic complete response rate, and improving the operab ility in most patients with Stage IIb bulky cervical carcinoma, genera lly considered inoperable.