RADIOTHERAPY AND NEOADJUVANT CHEMOTHERAPY FOR CERVICAL-CARCINOMA - A RANDOMIZED MULTICENTER STUDY OF SEQUENTIAL CISPLATIN AND 5-FLUOROURACIL AND RADIOTHERAPY IN ADVANCED CERVICAL-CARCINOMA STAGE 3B AND 4A

BACKGROUND. The locoregional failure rate remains high in advanced cer vical carcinoma. Chemotherapy (CT) was added to radiotherapy (RT) in o rder to increase disease control and to improve 5-year survival. METHO DS. CT+RT included cisplatin administered 100 mg/m(2), d.l plus 5-fluo rouracil 1000 mg/m(2) D.1 to 5, ci (120 hrs), q every 3rd week for 3 c ycles, followed by RT. RT included external beam irradiation 64.8 Gy i n 1.8 Gy fractions, five days a week, by 4-field box technique. The me dian follow-up was 46 months. Ninety-four patients were evaluable for survival, 47 in the CT+RT group and 47 in the RT group. Ninety-two pat ients were evaluable for response. Known prognostic factors were equal ly distributed between the two groups. RESULTS. Of the 43 patients eva luable before RT, 31 (72%) achieved a partial or complete response aft er CT alone. After RT, 52 patients attained a complete response, 25 in the CT+RT group and 27 in the RT-group. Sixty-three patients develope d distant metastases or local relapse, 30 in the CT+RT group and 33 in the RT group. In the CT+RT group 6 of the 9 patients with metastases also had local progression at relapse, in the RT group, 7 of 17 patien ts. The survival rates for the two groups are not statistically differ ent. Thirty-seven patients are alive, 29 have no evidence of disease. Fifty-seven have died, 29 in the CT+RT group and 28 in the RT group. F ifty-four deaths were related to cancer, and 3 to therapy. CONCLUSIONS . Sequential CT and RT did not improve the survival, local control, or metastasis rate compared with RT alone. (C) 1996 American Cancer Soci ety.