COMBINED RADIOCHEMOTHERAPY IN ADVANCED CERVICAL-CANCER - A PHASE-II TRIAL WITH WEEKLY APPLIED CARBOPLATIN, 5-FLUOROURACIL AND FOLINIC ACID

The 5-year survival of patients with advanced cervical cancer is poor. Major problems are the high frequency of pelvic recurrences and dista nt metastases. To prevent both, various efforts have been made to comb ine local radiotherapy with systemic chemotherapy. In this prospective study, 28 previously untreated patients with advanced cervical cancer (FIGO IIB-lVB) were treated with a newly designed therapy consisting of fractionated external beam irradiation (54 Gy) followed by two intr acavitary cesium (Cs) applications (2x15 Gy), combined with carboplati n (70 mg m(-2)), 5-fluorouracil (5-FU) (400 mg m(-2)) and folinic acid (400 mg m(-2)). Cytotoxic agents were given intravenously on days 1, 8, 15, 22 and 29 as 1-day courses during external irradiation followed by three 3-day courses with carboplatin (100 mg m(-2) i.v. daily), 5- FU (400 mg m(-2) i.v. daily) and folinic acid (400 mg m(-2) i.v. daily ) after 8, 12 and 16 weeks of treatment. Acute toxicities (greater tha n or equal to WHO grade 2) were leucopenia (27 of 28 patients), diarrh ea (23/28), abdominal pain (19/28), nausea (14/28) and skin desquamati on (12/28). Clinically diagnosed pelvic response was achieved in 88.5% (23/26) with a complete response of 34.5% (9/26). As yet 19 of 26 pat ients (73.1%) are alive and well (persistent complete/partial remissio n), two patients (7.7%) are alive with local progression, four (15.4%) have died from pelvic and/or distal recurrence and one (3.8%) died so me weeks after the start of therapy. The combined modality treatment c oncept has to be considered for the therapy of advanced cervical cance r and a prospective and randomized trial with a greater number of pati ents is warranted.