AbstractsA prospective randomized study in selected patients with stage IB and IIA carcinoma of the uterine cervix was carried out at Washington University between January 1966 and December 1979. Patients were randomized to be treated with 1) irradiation alone consisting of 1000 cGy to the parametria with a stepwedge midline block, and two intracavitary insertions for 7500 mgh; or 2) irradiation and surgery, consisting of 2000 cGy whole pelvis irradiation, one intracavitary insertion for 5000 to 6000 mgh followed 2 to 6 weeks later by a radical hysterectomy with pelvic lymphadenectomy. A total of 40 patients with stage IB and 16 with stage IIA were randomized to be treated with irradiation alone. A similar group of 48 patients with stage IB and 14 with IIA were randomized to the preoperative radiation and surgery group.The 5-year, tumor-free actuarial survival for stage IB patients was 89 per cent with irradiation alone and 80 per cent in the preoperative radiation and surgery groups. In stage IIA, the 5-year survival was 56 per cent for the irradiation and hysterectomy alone group and 79 per cent for the preoperative irradiation and hysterectomy patients. The difference in these results is not statistically significant.In the stage IB group only one parametrial failure was noted in the 40 patients treated with irradiation alone. Four patients developed distant metastases, one combined with periaortic lymph node involvement. In the preoperative radiation group, there were six parametrial failures, all combined with distant metastases. Two of these patients developed concomitant suburethral recurrences.In stage IIA, of the 16 patients treated with radiation alone, one patient developed a central recurrence and three a parametrial failure (three of them combined with distant metastases). In the preoperative group, there were two pelvic failures combined with distant dissemination.An analysis of the chronological distribution of recurrences showed that 85 per cent of the failures occurred with 3 years from therapy, at about the same rate in the radiation alone or irradiation and surgery groups.The pathological status of the hysterectomy specimens were reviewed in all patients. In 48 patients with stage IB nine showed residual microscopic tumor in the cervix and three (7.3 per cent) in the pelvic lymph nodes. Of these patients, three developed pelvic recurrences. In contrast, of 33 patients with no residual tumor in the cervix or pelvic lymph nodes, only one (3.3 per cent) showed evidence of pelvic recurrence.No residual carcinoma was observed in the cervix or the lymph nodes in the 14 patients with stage IIA disease. Only two of these patients developed a pelvic recurrence.In the irradiation alone groups, one patient suffered a rectosigmoid fistula; another patient developed a pelvic inflammation and an abscess with subsequent formation of a rectovaginal and vesicovaginal fistula 3 months after the completion of radiotherapy. One patient had severe proctitis, and one a sigmoid stricture. An additional patient had a vesicovaginal fistula, and another patient was found to have an ureteral stricture. The total incidence of complications was 8.9 per cent (5/56). One patient developed thrombophlebitis and nonfatal pulmonary embolus. Two patients in the preoperative group developed rectal fibrosis and stricture, one a small bowel stricture, and three ureteral fibrosis in the pelvis. The overall incidence of major complications was 9.7 per cent (6/62).Minor complications consisted mainly of vaginal fibrosis, which was more common in the patients treated with irradiation alone; eight patients developed this complication. In the patients treated with combined therapy, there were two instances of pelvic thrombophlebitis, one pelvic cellulitis, one wound infection, and one vaginal vault necrosis. Only one patient developed a lymphocyst.