[en] Purpose: Because of the often expressed concern with the potential for an increase of late toxicity in patients treated with HDR regimens, a detailed analysis was undertaken to determine the incidence, severity, and factors associated with late sequelae in a series of patients whose treatment included high-dose rate intracavitary placements (HDR-ICP). Materials and Methods: Between 1985 and March 1991, 144 consecutive patients with inoperable cancer of the cervix (FIGO stage I: 25 patients, II: 46 patients, III: 58 patients, IV: 15 patients) underwent external beam radiation therapy (EBRT) to the pelvis followed by Ir-192 HDR-ICP. EBRT was delivered with 23 MeV photons through shaped portals using AP/PA or 4-field technique. Maximum doses to the pelvis ranged from 33.3-60 Gy (median 48.4 Gy), minimum doses from 30-54 Gy (median 46 Gy) for AP/PA fields, with maximum doses from 25.3-56 Gy (median 52.6), and minimum doses from 24-50.4 Gy (median 50) for the 4-field technique. HDR-ICP were performed after completion of EBRT in 1-6 fractions (mean 2.6) with total doses ranging from 8.5-38.7 Gy (median 19 Gy). In all cases doses to the bladder base, bladder neck, and anterior wall of the rectum were calculated at the time of HDR-ICP, and the dose of each fraction was adjusted in an attempt to optimize the tumor to normal tissue ratios. Results: The mean follow-up time and percentage of patients remaining free of disease were 51.2 mo, 92%; 41.7 mo, 67.4%; 41.3 mo, 44.8%; 14.5 mo, 6.7% for stages I, II, III, and IV, respectively. Overall 3 year survival rates were 87.6%, 67%, 55.3% and 10% for stages I, II, III, and IV, respectively. Four patients developed five serious radiation induced late sequelae. These included one recto-vaginal fistula (0.7%), two vesico-vaginal fistulas (1.4%), one small bowel obstruction requiring surgery (0.7%), and one patient with necrosis of both ureters and bilateral hydronephrosis. In addition, 14 patients (9.7%) had a total of 19 less severe complications not requiring hospitalization or surgery. These included three partial bowel obstructions, one sigmoidal stenosis, three patients with colitis, three patients with proctitis, three asymtomatic rectal ulcers, two asymtomatic vaginal ulcers, three patients with cystitis and one case of low abdominal subcutaneous induration. Analysis of pretreatment and dosimetric parameters failed to reveal any statistically significant correlations with the development of late sequelae. Conclusion: The stage for stage survival and tumor control rates obtained in this series are comparable with these reported following either low-dose-rate treatment regimens or HDR regimens employing a higher (>5) number of treatment fractions. The relatively low treatment related morbidity and the patient convenience of treatment using EBRT with 2-4 fractions of HDR suggest that further study of this approach is indicated. Careful monitoring of doses to bladder base, bladder neck, and anterior wall of the rectum is necessary to assure optimal tumor control and low normal tissue toxicity