Phase III randomized trial of neoadjuvant chemotherapy (NAC) followed by radical hysterectomy (RH) versus RH for bulky stage I/II cervical cancer: Update of Japan Clinical Oncology Group (JCOG) Protocol 0102.

5047 Background: In 2006, we reported the results of interim analysis of JCOG 0102 (JCO Sup, 24:18S, 2006: 5013) that NAC followed by RH did not demonstrate clinical benefit compared with RH for bulky stage I/II cervical cancer and enrollment was discontinued according to recommendation of the Data and Safety Monitoring Committee. This report provides update data from JCOG 0102. Methods: Patients (pts) with stage IB2, IIA (> 4 cm), or IIB squamous cell carcinoma of the uterine cervix were randomly assigned to receive either BOMP (bleomycin 7 mg day 1-5, vincristine 0.7 mg/m2 day 5, mitomycin 7 mg/m2 day 5 and cisplatin 14 mg/m2 day 1-5, q 21 days for 2 to 4 cycles) followed by radical hysterectomy (NAC arm) or RH (RH arm). Pts with positive surgical margins, metastatic nodes, infiltration to parametrium, and/or deep myometrial invasion received postoperative irradiation. Eligibility included preserved organ function, aged 20-70, and Performance Status 0 or 1. Primary endpoint was overall survival (OS) to ...