PubMed · 10290643
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D V Axene. 1988. Multi-option plans create risk-sharing problems.. https://pubmed.ncbi.nlm.nih.gov/10290643/
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PURPOSE: The aim of the study was to determine the predictive factors of complications, to evaluate the impact of customized treatment planning on late normal tissue effects per stage, and to report disease-free survival (DFS) and local control (LC) rates. METHODS AND MATERIALS: From 1970 to 1994, 642 patients were treated with radiotherapy alone for carcinoma of the intact uterine cervix. According to the International Federation of Gynecology and Obstetrics (FIGO) substaging, 34% were Stage I, 39% Stage II, and 27% Stage III. The analysis was divided into three periods: 1970-1978 (use of standard prescriptions),1979-1984 (implementation of individual adjustments), 1985-1994 (systematic individual adjustments). Five-year DFS, LC, and complications rates were calculated using the Kaplan-Meier method. Predictive factors of complications were determined by univariate analysis using frequency tables and nonparametric t-tests. Multivariate analysis consisted of a polychotomous stepwise regression. RESULTS: The comparison of the three time periods showed a significant reduction of the external radiation dose (dose above 40 Gy in 47% of patients before 1979 vs. 36% after 1984), of the use of parametrial boost (55% vs. 39%), of the use of vaginal cylinder (28% vs. 11.5%), and of the HWT volume (combined intracavitary and external irradiation) (842 cc vs. 503 cc on average). The total sequelae/complications rate, all toxicity grades, all stages, all organs was 51%. Five-year actuarial rate per toxicity grade was: G1, 42%; G2, 23.5%; G3, 10%; G4, 3%. The three main predictive factors for rectal and bladder sequelae/complications (all toxicity grades) taking into account time period were: the increase of external radiation dose, the high dose rate at reference points, and the whole vagina brachytherapy. No G4 occurred in the third period. The rate of G3 complications dropped from 16% to 6% over time: from 5% during the first period to 0% during the third period in Stage I, from 8% to 6% in Stage II, and from 23% to 12% in Stage III. G3 currently describes a variety of clinical situations with a different impact on quality of life which justifies further refinements of definitions of late effects. In our experience the severity of G3 markedly decreased: less than one-third of G3 had a real impact on quality of life in the last period compared to more than two-thirds in the first period. Meanwhile, 5-year LC rates remained stable in Stages I and II, 91% and 85% respectively. Conversely they fell from 75% to 55% in Stage III, thus raising the problem of underdosage and/or more accurate staging with time. CONCLUSIONS: Customized treatment planning eradicated lethal complications and provided a significant decrease of G3 in all stages while maintaining high cure rates in early stages. Dose reduction should be considered with caution in Stage III.
Percutaneous intervention for the first episode of in-stent restenosis was performed in 177 patients 5.4 +/- 0.3 months after native coronary stent implantation. Medical records were reviewed and patients contacted 13.3 +/- 1.2 months after in-stent intervention to ascertain the subsequent clinical course. The effects of demographic, procedural, and angiographic variables on clinical outcomes were determined. At 2 years, Kaplan-Meier estimated survival was 93 +/- 3% and freedom from death, myocardial infarction, and a third target artery revascularization (TAR) was 67 +/- 4%. The actuarial frequency of a third TAR was 26 +/- 4% at 1 year. Stratification of outcomes according to timing of in-stent intervention revealed an approximate twofold higher frequency of adverse events among patients with early (</=3 months) in-stent restenosis. Advanced age (p = 0.019), prior coronary bypass (p = 0. 017), and early in-stent intervention (p = 0.006) independently predicted increased mortality at follow-up. Systemic hypertension (p = 0.004), diabetes mellitus (p = 0.044), and early in-stent intervention (p <0.0001) independently predicted a third TAR. These variables (p = 0.007, p = 0.027, and p <0.0001, respectively) also independently predicted a composite end point consisting of death, myocardial infarction, and a third TAR. No angiographic variable predicted outcome after in-stent intervention. Thus, long-term outcome following in-stent intervention was favorable. Early in-stent intervention, advanced age, hypertension, and diabetes predicted adverse outcomes.
Patients with Ph+ chronic myelogenous leukemia who relapse after a first allogeneic stem cell transplant still have a possibility of long-term survival. To assess the value of the individual therapeutic options, the factors predicting outcome should be identified. We investigated data from 500 patients who relapsed before July 1996; follow-up was updated during 1998. The actuarial survival from relapse was 34.2% (95% confidence interval [CI]: 29. 9%-38.5%) at 5 years and 23.4% (95% CI: 18.9%-27.9%) at 10 years. Survival after relapse was significantly related to 5 factors: time from diagnosis to transplant (< 2 years vs >/= 2 years), disease phase at transplant (first chronic phase vs other), disease stage at relapse (cytogenetic or chronic phase vs advanced phase), time from transplant to relapse (< 1 year vs >/= 1 year), and donor type (HLA-identical sibling vs volunteer unrelated donor). The effects of individual adverse risk factors were cumulative: The probability of survival at 10 years decreased stepwise from 42% (0 factors), 32% (1 factor), 14% (2 factors), 3% (3 factors), to 0% (4 or 5 factors). Novel strategies for high-risk patients are warranted. We conclude that these 5 factors should be taken into account when comparing results of salvage therapies in patients with Ph+ chronic myeloid leukemia relapsing after allogeneic stem cell transplant.