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Purpose: The purpose of this study was to identify patient-related factors that influence the risk of serious late complications of pelvic radiation therapy., Patients and Methods: The records of 3,489 patients treated with radiation therapy for International Federation of Gynecology and Obstetrics stage I or II carcinoma of the cervix were reviewed for information about patient characteristics, treatment details, and outcomes. Any complication occurring or persisting more than 3 months after treatment that required hospitalization, transfusion, or an operation or caused severe symptoms or the patient's death was considered a major late complication. Complication rates were calculated actuarially. The median duration of follow-up was 85 months, and 99% of patients were followed for at least 3 years or until they died., Results: Heavy smoking was the strongest independent predictor of overall complications (multivariate hazard ratio, 2.30; 95% confidence interval [CI], 1.84 to 2.87). The most striking influence of smoking was on the incidence of small bowel complications (hazard ratio for smokers of one or more packs per day, 3.25; 95% CI, 2.21 to 4.78). Hispanics had a significantly lower rate of small bowel complications than whites, and blacks had higher rates of bladder and rectal complications than whites. Thin women had an increased risk of gastrointestinal complications, and obese women were more likely to have serious bladder complications., Conclusion: Complications of pelvic radiation therapy are strongly correlated with smoking, race, and other patient characteristics. These factors should be considered before the results of clinical studies are generalized to different cultural and racial groups.

Objective: To evaluate the effectiveness of an outcomes-management program designed to provide high-quality patient care, generate data for outcomes research, and decrease costs in a managed-care environment., Methods: An outcomes-management program was launched in June 1994, based on the elimination of wasteful or ineffective therapies through the systematic development of practice guidelines and collaborative care paths, with concomitant definition of desired outcomes. Over 3 months, care paths were developed for our most common surgical procedures. A matched control outcomes study was undertaken for the most commonly performed gynecologic oncology procedure: total abdominal hysterectomy and oophorectomy with pelvic and para-aortic node sampling for endometrial cancer. Thirty consecutive women treated on the care path were compared with 29 matched controls accrued during the period of care-path planning and with 73 controls from the period preceding care-path planning. Patient satisfaction with care-path treatment was assessed by a survey sent 2 weeks after discharge., Results: Median length of hospital stay decreased significantly, from 6 days before care-path planning to 4 days after care-path implementation (P < .001). Median laboratory costs decreased by 74% (P < .001), medication costs by 35% (P < .001), room costs by 29% (P < .001), and total hospital costs by 20% (P < .002). Incremental improvements were observed during care-path planning. There were no readmissions for complications in the care-path group. According to the survey results, patient satisfaction with care was very high among care-path patients., Conclusions: A physician-driven outcomes-management program in an academic setting permits the delivery of high-quality care and supports outcomes research while decreasing costs.

Purpose: To determine the time course and incidence of late complications from radiation therapy in patients treated with radiation for FIGO Stage IB carcinoma of the uterine cervix, and to evaluate patient and tumor factors associated with an increased probability of treatment complications., Methods and Materials: The medical records of 1784 patients with FIGO Stage IB cervical carcinoma who were treated with initial radiation therapy between 1960 and 1989 were retrospectively reviewed. Follow-up was obtained from clinic visits and correspondence with patients and their physicians. Treatment complications were graded retrospectively. Complication rates were calculated actuarially; patients who died of disease or intercurrent illness without experiencing a major complication were censored at the time of death. There were 1241, 924, 548, and 274 patients followed for more than 5, 10, 15, and 20 years, respectively., Results: Of patients treated for Stage IB cervical carcinoma, 7.7% and 9.3% had experienced major (> or = Grade 3) complications at 3 and 5 years, respectively. After 5 years, there was a small but continuous risk of approximately 0.34% per year, resulting in an overall actuarial risk of having had major complications of 14.4% at 20 years. The risk of developing major urinary tract complications was approximately 0.7% per year for the first 3 years of follow-up, decreasing to about 0.25% per year for at least 25 years. In contrast, the risk of developing rectal complications was about 1% per year during the first 2 years, with a subsequent sharp decline to about 0.06% per year between Years 2 and 25. The risk of fistula formation was approximately doubled in the 234 patients who underwent adjuvant extrafascial hysterectomy (5.3 vs. 2.6% at 20 years; p = 0.04) and in the 111 patients who had pretreatment laparotomy (5.2 vs. 2.9%; p = 0.007). The risk of developing small bowel obstruction was increased in patients who underwent pretreatment laparotomy (14.5 vs. 3.7% at 10 years; p < 0.0001) and in patients who weighed < 120 pounds (8.2 vs. 3.6%; p = 0.004), but was not increased in patients who underwent adjuvant hysterectomy. A significantly greater risk of gastrointestinal complications was observed in black and non-Hispanic white patients than in Hispanic women (p = 0.01), even though there was no difference in the rate of developing urinary tract complications (p = 1.0). There was no correlation between the actuarial risk of developing major complications and the patients' age at the time of treatment, but the cumulative risk was greater for patients who were treated at a young age because these patients were more likely to survive to be exposed to a very long period of risk., Conclusions: Using techniques described by Fletcher and Delclos, the risk of major complications from aggressive irradiation for Stage IB carcinoma of the cervix is low and does not warrant compromises in the intensity of treatment that might decrease the high cure rates achieved in such patients. The long time course of some late complications also suggests that continued surveillance of survivors, by physicians experienced in the diagnosis and management of the sequelae of the curative radiation treatment of cervical cancer, is important.