Cumulative Incidence Of Events Research Articles

Eight-Year Update of a Prospective Study of Wide Excision Alone for Ductal Carcinoma In Situ of the Breast

The need for radiation therapy (RT) in conservatively managed DCIS is a source of ongoing debate. This is an updated analysis of a Phase II prospective study of wide excision alone for DCIS. The study was activated in May 1995 and closed in July 2002 following accrual of 158 patients because the number of local recurrences (LR) met the predetermined stopping rules. The objective of the analysis is to update the distribution and cumulative incidence of events (LR, contralateral breast cancer [CBC], second malignancy and death from other causes).

Lung Transplantation With Uncontrolled Non-Heart-Beating Donors. Transplantation. Donor Prognostic Factor and Immediate Evolution Post Transplant

Introduction Uncontrolled donation after cardiac death (DACD) has become an alternative to lung transplantation with encephalic-death donation. The main objective of this study is to describe the incidence of clinically relevant events in the period of 30 days after lung transplant with uncontrolled DACD and the influence of factors depending on the donor and donation process as well. Patients and methods Historical cohort study of 33 lung transplant receivers at Hospital Puerta de Hierro and Hospital Marqués de Valdecilla with 32 DACD from Hospital Clínico San Carlos from 2002 to 2008. We studied surgical and medical complications, primary graft dysfunction, acute rejection, pneumonia, and mortality. We made an evaluation of the donor characteristics and donation procedure times (min). Results Median age of recipients was 50.5 years (interquartile range, 38.5–58). There were 28 males and 5 females. Cumulative incidence of events in the first month was: pneumonia, 10 (31.3%); primary graft dysfunction, 15 (46.9%); rejection, 12 (37.5%); mortality, 4 (12.1%); medical complications, 25 (78.1%); and surgical complications, 18 (56.3%). Median time of cardiac arrest was higher in those who presented pneumonia (15 vs 7.5; P=.027). Median time of cold ischemia was higher in those who presented surgical complications and mortality (436 vs 343.5; P=.04; 505 vs 410; P=.033, respectively), and median of total ischemia times were longer in the recipients who died (828 vs 695; P=.036). Conclusions Uncontrolled DACD is a valid alternative for expanding the donor pool in order to mitigate the current shortage of lungs that are valid for transplantation. The incidence of complications is comparable with published data in the literature.

6 Cardiac morbidity and mortality can be accurately predicted in patients presenting with ACS using multiple biomarkers measured on an admission blood sample

Background Rapid assessment of patients with suspected acute coronary syndrome (ACS) allows the right patients to receive the right treatment at the right time. Discrimination of risk permits clinical triage into pathways of immediate inpatient or deferred outpatient care. It is known that a significant proportion of the ACS patients sent home following an “MI screen”, based on a negative 12-h troponin level, are misdiagnosed as having non-cardiac chest pain when in fact they are at high risk of cardiac events. It has been shown that the novel biomarker H-FABP can detect myocardial ischaemia even in the absence of myocyte necrosis. We hypothesise that a multi biomarker blood test incorporating troponin I, CK-MB and H-FABP, taken on admission, can accurately discriminate those patients with a non-cardiac cause of chest pain who are at low risk of cardiac morbidity or mortality. Methods We studied 519 patients with suspected ACS admitted to a single UK Teaching Hospital. A risk scoring model was constructed based on tertile values for Randox Cardiac-Array measurement of troponin I, H-FABP and CK-MB. These were measured on a blood sample taken at the time of hospital admission. The lowest two lower tertiles were each given a score of 1 and the top tertile a score of 3. The scores were then combined by summation resulting in an overall score of between 3 and 9. Outcome measures up to 12 months were: (i) death from all causes; (ii) repeat acute coronary syndrome (ACS) (iii); readmission for heart failure; (iv) readmission for cerebrovascular event (CVA); (v) coronary revascularisation. Results The distribution of Cardio-Array scores was: 3 (n=164; 31.6%); 5 (n=134; 25.8%); 7 (n=110; 21.2%); 9 (n=111; 21.4%). The cumulative incidence of events according to the Cardiac-Array score is shown in Abstract 6 table 1. Conclusion Patients presenting with possible ACS who have a Cardiac-Array biomarker score of 3 or 5, as measured on their admission blood sample, have a very low rate of cardiovascular events. This tool could be used to safely triage patients towards early discharge and outpatient care, based upon available resources. A score of 7 or 9 would merit admission to hospital, and consideration of early cardiac catheterisation.

Abstract P1-15-03: Eight-Year Update of a Prospective Study of Wide Excision Alone for Ductal Carcinoma In Situ (DCIS) of the Breast

Abstract Background: The need for radiation therapy (RT) in conservatively managed DCIS is a source of ongoing debate. This is an updated analysis of a phase II prospective study of wide excision alone for DCIS. The study was activated in May 1995 and closed in July 2002 following accrual of 158 patients because the number of local recurrences (LR) met the predetermined stopping rules. The objective of the analysis is to update the distribution and cumulative incidence of events (LR, contralateral breast cancer [CBC], second malignancy and death from other causes). Materials and Methods: A total of 158 patients had DCIS with predominant nuclear grade 1 or 2, a mammographic extent of ≥2.5 cm, and excision with final microscopic margins of ≥1 cm or a re-excision without residual DCIS. Tamoxifen was not permitted. The results presented are from the 8-year analysis (8-year minimum potential follow-up time). Twenty-six patients without recurrence who were followed less than 8 years were excluded from the analysis as were 7 first events (4 LR) that occurred beyond 8 years of follow-up; the analysis thus includes 132 patients and 36 first events. Cumulative incidence curves were generated to assess the rates of LR or other events. Median follow up time was 10 years. Results: Overall, 36/132 patients (27%) had a first event as of April 2010. Of these 36 events, 19 were LR, 13 were CBC, 1 was a second malignancy, and 3 were deaths from other causes. Of the 19 LR, 13 (68%) were DCIS only and 6 (32%) were invasive. Fourteen occurred in the same quadrant and 5 were elsewhere in the ipsilateral breast. The 8-year estimated cumulative incidence of LR was 14.4% (95% CI: 8.4-20.4%). For all other events, the 8-year estimated cumulative incidence was 12.9% (95% CI: 3.6-13.1%). The estimated annual percentage rates of LR, CBC, and other events were 2.1%, 1.5% and 0.4%, respectively. Discussion: The results of this prospective study demonstrate a substantial and ongoing risk of LR and CBC in patients with small, nuclear grade 1 or 2 DCIS treated with wide excision with margins of ≥1cm in the absence of RT. Most LRs occurred in the same quadrant, rather than elsewhere in the breast, suggesting that excision alone is inadequate even for this highly selected population. Further study is warranted to determine if there is a subgroup of DCIS patients with nuclear grade 1 or 2 disease who are at low enough risk of LR following wide excision that RT can be omitted safely. Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P1-15-03.

Prediction of Radiation Pneumonitis Following High-dose Thoracic Radiation Therapy by 3 Gy/fraction for Non-small Cell Lung Cancer: Analysis of Clinical and Dosimetric Factors

This study was undertaken to identify the factors predictive of radiation pneumonitis (RP) in 69 non-small cell lung cancer patients treated with thoracic radiation therapy only by 3 Gy fractions. A total of 69 patients who received only RT in daily 3 Gy were included in this study. Grade > or =3 RP was defined as an RP event. The cumulative incidence of RP was estimated and the correlations of the development of RP with the potential predictors were determined. The cumulative incidence of events was 17.1% at 12 months. By univariate analysis, all clinical factors [age, performance status, weight loss, pre-RT forced expiratory volume in 1 s, tumour location, stage, RT dose and clinical target volume] were not associated with the risk of Grade > or =3 RP; however, all dosimetric factors [V5-50 and mean lung dose (MLD)] closely correlated with the development of RP. The receiver-operative characteristics (ROC) analysis revealed that MLD was the best predictors of Grade > or =3 RP (area under curve ROC = 0.937). By multivariate analysis, MLD was the only significant factor to be predictive of RP risk: the probability of Grade > or =3 RP was 3.7% when MLD < or = 16.1 Gy and 78.4% when MLD > 16.1 Gy. Dosimetric parameters were valuable in predicting the development of RP.