RANDOMIZED STUDY OF RADICAL SURGERY VERSUS RADIOTHERAPY FOR STAGE IB-IIA CERVICAL-CANCER

Background Stage tb and Ila cervical carcinoma can be cured by radical surgery or radiotherapy. These two procedures are equally effective, but differ in associated morbidity and type of complications. In this prospective randomised trial of radiotherapy versus surgery, our aim w as to assess the 5-year survival and the rate and pattern of complicat ions and recurrences associated with each treatment. Methods Between S eptember, 1986, and December, 1991, 469 women with newly diagnosed sta ge Ib and Ila cervical carcinoma were referred to our institute. 343 e ligible patients were randomised: 172 to surgery and 171 to radical ra diotherapy. Adjuvant radiotherapy was delivered after surgery for wome n with surgical stage pT2b or greater, less than 3 mm of safe cervical stroma, cut-through, or positive nodes. The primary outcome measures were 5-year survival and the rate of complications. The analysis of su rvival and recurrence was by intention to treat and analysis of compli cations was by treatment delivered. Findings 170 patients in the surge ry group and 167 in the radiotherapy group were included in the intent ion-to-treat analysis; scheduled treatment was delivered to 169 and 15 8 women, respectively. 62 of 114 women with cervical diameters of 4 cm or smaller and 46 of 55 with diameters larger than 4 cm received adju vant therapy. After a median follow-up of 87 (range 57-120) months, 5- year overall and disease-free survival were identical in the surgery a nd radiotherapy groups (83% and 74%, respectively, for both groups). 8 6 women developed recurrent disease: 42 (25%) in the surgery group and 44 (26%) in the radiotherapy group. Significant factors for survival in univariate and multivariate analyses were: cervical diameter, posit ive lymphanglography, and adeno-carcinomatous histotype. 48 (28%) surg ery-group patients had severe morbidity compared with 19 (12%) radioth erapy-group patients (p=0.0004). Interpretation There is no treatment of choice for early-stage cervical carcinoma in terms of overall or di sease-free survival. The combination of surgery and radiotherapy has t he worst morbidity, especially urological complications. The optimum t herapy for each patient should take account of clinical factors such a s menopausal status, age, medical illness, histological type, and cerv ical diameter to yield the best cure with minimum complications.