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.
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).
There is no evidence from this trial that NACT offered any additional objective benefit to patients undergoing RHPPL for suboptimal Stage IB cervical cancer.