Purpose: To compare the efficacy, toxicity and survival of cisplatin monotherapy with concurrent radiotherapy ver-sus combination of cisplatin and 5-fluorouracil (5-FU) with concurrent external beam radiotherapy (EBRT) in patients with locoregionally advanced cervical carcinoma FIGO stages IIB-IV.
Methods: 134 patients with locoregionally advanced, histologically confirmed carcinoma of the uterine cervix were analysed. The first group of patients (n=70; 52.24%) started concomitant chemotherapy on the second day of radiotherapy with single-agent cisplatin 40 mg/m(2) given 2 h before radiotherapy, once a week for 6 courses. The second group of patients (n=64; 47.76%) started concomitant chemotherapy on the second day of radiotherapy with cisplatin 75 mg/m(2). Treatment was continued with 96-h infusion of 5-FU 4 g/m(2) (1 g/ m(2) per day for 5 consecutive days). The patients were irradiated by EBRT followed by intracavitary brachytherapy (ICB).
Results: 24- and 42-month survival in the first group were 71.9 and 57.81% and 52.5 and 35.4% in the second group, respectively (p=0.012). Mean time to progression in the first group was 24 months and in second group it was 15.9 months (p=0.012). After 2 years progression was noted in 38.3% of the first and in 62.9% of second group patients (p=0.003). After 40 months 60 patients were without relapse, 35 (57.81%) patients in the first group and 25 (37.147percnt;) patients in the second group (p=0.018).
Conclusion: Treatment with combined cisplatin and 5-FU with concurrent EBRT was more efficient in comparison to cisplatin monotherapy with concurrent radiotherapy in patients with locoregionally advanced cervical carcinoma, in terms of 12- and 24-month overall survival and disease relapse after 2 years.