Randomized study of preoperative chemotherapy versus primary surgery for stage IB cervical cancer

Abstract Aim: To determine the most effective treatment and long‐term outcome of patients with stage IB carcinoma of the cervix. Methods: From January 1999 to December 2001, 106 women with cervical cancer stage IB received neoadjuvant chemotherapy ( n = 52) or primary surgery ( n = 54). These were randomly assigned. Clinical effects and pathological changes were simultaneously recorded. Results: The overall clinical response rate was 84.6% and included a complete response (CR) in four patients (7.7%), partial response (PR) in 40 patients (76.9%), and stable disease (SD) in the remaining eight patients (15.4%). Surgery revealed positive nodes in 9.6% neoadjuvant chemotherapy group patients and in 29.6% primary surgery group patients ( P = 0.014). Similar results occurred with vascular space involvement: 27.8% in the primary surgery group compared to 9.6% in the neoadjuvant chemotherapy group ( P = 0.024). However, parametrial infiltration was found in 7.4% of the patients in the primary surgery group, while only 3.8% showed it in the neoadjuvant chemotherapy group ( P = 0.679). The overall 5‐year survival rate was significantly higher for all patients who received neoadjuvant chemotherapy (84.6%) than for the control group (75.9%) ( P = 0.0112). The median survival time in patients with complete response and partial response to chemotherapy (83.3 months) was significantly higher than that of patients with stable disease to chemotherapy (55.2 months) ( P = 0.0049). 27.3% of patients developed recurrent disease within 5 years of the primary treatment. The women with recurrence included partial response in six patients (60.0%), and stable disease in four patients (40.0%). For the other patients there was partial response and complete response in 38 patients (90.5%), and stable disease in the remaining four patients (9.5%) ( P = 0.035). Conclusion: Neoadjuvant chemotherapy can effectively eliminate the pathological risk factors and improve long‐term survival in patients with locally advanced cervical cancer.