Treatment of ("bulky") stage IB cervical cancer with or without neoadjuvant vincristine and cisplatin prior to radical hysterectomy and pelvic/para-aortic lymphadenectomy: A phase III trial of the gynecologic oncology group

Objective. A randomized phase Ill trial was conducted to determine if neoadjuvant chemotherapy (NACT) prior to radical hysterectomy and pelvic/para-aortic lymphadenectomy (RHPPL) could improve progression-free survival (PFS) and overall survival (OS), as well as operability, with acceptable levels of toxicity. Adjuvant radiation therapy was prescribed for specific surgical/pathological risk factors for both regimens. Methods. Eligible patients were required to have bulky FIGO Stage IB cervical cancer, tumor diameter >= 4 cm, adequate bone marrow, renal and hepatic function, and performance status <= 2. Prospective random allocation was to either NACT (vincristine-cisplatin chemotherapy every 10 days for 3 cycles) before exploratory laparotomy and planned RHPPL (NACT+RHPPL), or RHPPL only. Results. The study was closed prematurely, because of slow accrual, after 291 patients were enrolled, three were ineligible; thus 288 were eligible and randomly allocated to RHPPL (N=143) or NACT+RHPPL (N=145). There were no notable differences between regimens with regard to patient age, race, performance status, or tumor size. The median follow-up time is 62 months among living patients. The NACT+ RHPPL group had very similar recurrence rates (relative risk: 0.998) and death rates (relative risk: 1.008) when compared to the RHPPL group. There were 79% that had surgery in the RHPPL group compared to 78% in the NACT RHPPL group. There were 52% who received post op RT in the RHPPL group compared to 45% in the NACT+RHPPL group (not statistically significant). Conclusion. There is no evidence from this trial that NACT offered any additional objective benefit to patients undergoing RHPPL for suboptimal Stage IB cervical cancer. (C) 2007 Elsevier Inc. All rights reserved.