WEEKLY CISPLATIN PLUS EXTERNAL-BEAM RADIOTHERAPY AND HIGH-DOSE-RATE BRACHYTHERAPY IN PATIENTS WITH LOCALLY ADVANCED-CARCINOMA OF THE CERVIX

Purpose: Prospective, single arm, Phase I/II trial performed to assess the efficacy and toxicity of the concomitant use of weekly cisplatin and pelvic radiotherapy in patients with locally advanced carcinoma of the cervix. Methods and Materials: Between December 1988 and April 19 91, 50 previously untreated patients with bulky, locally advanced, squ amous cell carcinoma entered the study. All patients were evaluated by a gynecologist and a radiation oncologist and were submitted to stand ard pre-treatment staging procedures. The International Federation of Gynecology and Obstetrics stage distribution was as follows: IIA three patients, IIB seventeen, IIIA two, IIIB 25, and IVA three. Radiothera py consisted of 46 Gy external beam irradiation plus three high dose r ate intracavitary treatments given on a weekly basis to a total dose o f 30 Gy to point A. Cisplatin 30 mg/m(2) was also given weekly startin g on day 1 of radiotherapy. Results: With a median follow-up time of 2 7 months, complete response was seen in 88% (44/50) of the patients. T he actuarial survival rate at 44 months was 65%. Total pelvic failure rate was 26% (13/50). Of the 44 patients who achieved a complete remis sion, only seven have failed in the pelvis. Distant disease was observ ed in 24% of the cases. Treatments were well tolerated with no patient requiring an interruption in the radiotherapy. However, the incidence of late gastrointestinal toxicity was high, with 10 patients developi ng a rectal ulcer (four colostomies for severe bleeding), two patients a small bowel obstruction, and two patients a recto-vaginal fistula. Moreover, gastrointestinal complications appeared sooner than expected , at a median follow-up time of 11 months after completion of treatmen t. Conclusion: The combination of weekly cisplatin and radiotherapy ap pears to be a very effective regimen for patients with locally advance d carcinoma of the cervix, but resulted in a relatively high frequency of late gastrointestinal complications.