Background: Randomized studies comparing induction chemotherapy followed by surgical resection with radiation alone found that the neoadjuvant approach produces better results. So far, this latter modality has not been compared with standard concomitant chemoradiation. The objective of this report was to compare the results of two consecutive phase II studies: neoadjuvant chemotherapy followed by surgery or chemoradiation for the unresectable cases versus standard cisplatin-based chemoradiation.
Patients and methods: From February 1999 to July 1999, 41 patients with cervical carcinoma, stages IB2-IIIB, were treated with neoadjuvant chemotherapy. Treatment consisted of three 21-day courses of cisplatin 100 mg/m(2) on day 1 and gemcitabine 1000 mg/m(2) on days 1 and 8, followed by either surgery or concomitant chemoradiation for the non-operable cases. From August 1999 to December 1999, an equal number of patients having comparable clinicopathological characteristics were treated with six weekly courses of cisplatin 40 mg/m(2) during standard pelvic radiation.
Results: A total of 82 patients were analyzed. Both groups were similar with regard to age, histology, International Federation of Gynecology and Obstetrics (FIGO) stage, tumor size, pretreatment hemoglobin levels, parametrial infiltration and performance status. In the neoadjuvant arm the overall response rate to induction chemotherapy was 95% (95% confidence interval 88% to 100%). Twenty-three patients had surgery and 14 underwent chemoradiation. In the definitive chemoradiation study, 38 patients completed treatment, the median number of cisplatin courses was six for a dose intensity of 33 mg/m(2)/week. Doses to points A and B were 85 Gy (range 68-95) and 55 Gy (range 51-65), respectively. Chemoradiation was delivered in 44.6 (range 28-113) days. Complete response rates after all treatment were similar: 97% and 87% in the neoadjuvant and chemoradiation groups, respectively. At a median follow-up of 28 (range 2-33) and 24 (range 3-30) months, respectively, there were no differences in overall survival. To date, 15 and 13 patients in the neoadjuvant and chemoradiation groups, respectively, have died of disease (P = 0.8567).
Conclusions: The results of this non-randomized comparison suggest that induction chemotherapy followed by surgery or chemoradiation is at least as effective in terms of response and survival as standard cisplatin-based chemoradiation. A randomized study is needed to confirm these findings.