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 difficult to treat successfully by radiation and/or surgery, compared with smaller lesions. This study was designed to evaluate the efficacy of neoadjuvant pelvic intraarterial chemotherapy (IAC) and to determine the optimal dosage of cisplatin for reducing tumor volume in these patients.

METHODS

Twenty-one previously untreated patients with primary cervical carcinoma of more than 4 cm in greatest dimension and parametrial invasion were included in this study. Pelvic IAC was administered using a combination of mitomycin-C, 10 mg/m2; vincristine, 1 mg/m2; and cisplatin, 50 mg/m2 (MVC; group 1, 8 patients) or 75 mg/m2 (group 2, 13 patients). Tumor volumes were measured three-dimensionally by magnetic resonance imaging (MRI) before and after three courses of IAC. Clinical responses were evaluated with gynecologic examination and MRI; pathologic responses were evaluated with histologic examinations of surgical specimens.

RESULTS

The mean volume reduction rate (74.2% vs. 97.2% in groups 1 and 2, respectively, P = 0.0022), the clinical complete response rate (0% vs. 69.2%, P = 0.0033), and the pathologic complete response rate (0% vs. 46.2%, P = 0.0445) were significantly higher in group 2. Type III radical hysterectomy was possible in 19 patients (90.5%). Toxicities of grades 2-3 (World Health Organization criteria) were nausea and/or vomiting (38.1%), leukopenia (33.3%), and fever (14.2%).

CONCLUSIONS

These preliminary results suggest that neoadjuvant pelvic IAC with MVC (especially with cisplatin at a dose of 75 mg/m2) is effective in reducing tumor volume, increasing the clinical and pathologic complete response rate, and improving the operability in most patients with Stage IIb bulky cervical carcinoma, generally considered inoperable.