Randomized trial of neoadjuvant cisplatin, vincristine, bleomycin, and radical hysterectomy versus radiation therapy for bulky stage IB and IIA cervical cancer

Purpose: To compare the efficacy of neoadjuvant chemotherapy (NAC) followed by radical hysterectomy with that of radiotherapy (R/T) for bulky early-st age cervical cancer, Patients and Methods: Women with previously untreated bulky (primary tumor greater than or equal to 4 cm) stage IB or IIA non-small-cell carcinoma of the uterine cervix were randomly assigned to receive either cisplatin 50 mg /m(2) and vincristine 1 mg/m(2) for 1 day and bleomycin 25 mg/m(2) for 3 da ys for three cycles followed by radical hysterectomy (NAC arm) or receive p rimary pelvic radiotherapy only (R/T arm). The ratio of patient allocation was 6:4 for the NAC and R/T arms. Women with enlarged para-aortic lymph nod es on image study were ineligible unless results of cytologic or histologic studies were negative. Results: Of the 124 eligible patients, 68 in the NAC arm and 52 in the R/T arm could be evaluated. The median duration of follow-up was 39 months. Thi rty-one percent of patients in the NAC arm and 27% in the R/T arm had relap se or persistent diseases after treatment, and 21% in each group died of di sease. Estimated cumulative survival rates at 2 years were 81% for the NAC arm and 84% for the R/T arm; the 5-year rates were 70% and 61%, respectivel y. There were no significant differences in disease-free survival and overa ll survival, Conclusion: NAC followed by radical hysterectomy and primary R/T showed sim ilar efficacy for bulky stage IB or IIA cervical cancer. Further study to i dentify patient subgroups better suited for either treatment modality and t o evaluate the concurrent use of cisplatin and radiation without routine hy sterectomy is necessary. J Clin Oncol 18:1740-1747. (C), 2000 by American Society of Clinical Oncolo gy.