Conclusion: In Medicare beneficiaries, repair of isolated, intact abdominal aortic aneurysms (AAA) by endovascular means is associated with a lower risk of all-cause mortality and AAA-related mortality than repair using open techniques. Summary: Randomized clinical trials (RCTs) have failed to demonstrate a long-term survival advantage of endovascular repair vs open repair of AAA. Furthermore, a previous study of Medicare beneficiaries undergoing AAA repair between 2001 and 2004 also failed to demonstrate a survival advantage of endovascular repair over open repair beyond 3 years of follow-up (Schemerhorn ML et al, N Engl J Med 2008;358:464-74). It is possible current endovascular devices may provide improved overall results of endovascular repair than those available for analysis of endovascular vs open AAA repair in the previous study of Medicare beneficiaries. The authors, therefore, decided to compare overall and AAA-specific mortality, readmission, and reintervention after endovascular vs open repair of nonruptured AAAs in Medicare beneficiary patients using a database from 2003 to 2007. This was a retrospective analysis of patients aged Ն65 years in the Medicare standard analytic file, 2003 to 2007, who underwent isolated repair of an intact AAA. The national death index was used to determine cause of death. Primary outcome was all-cause mortality. Secondary outcomes were AAA-related mortality, hospital length of stay, 1-year readmission, repeat AAA repair, incisional hernia repair, and lower extremity amputation. The Medicare standard analytic files contained data from a 5% example of Medicare inpatient discharges. The study included 4029 patients; of these, 703 underwent open repair and 3826 underwent endovascular repair. Mean and median follow-up times were 2.6 (SD, 1.5) and 2.5 (interquartile range, 2.4) years, respectively. After adjusting for emergency admission, age, calendar year, sex, race, and comorbidities, there was a higher risk of both all-cause mortality (hazard ratio, 1.24; 95% confidence interval [CI], 1.05-1.47; P ϭ .01) and AAA-related mortality after open vs endovascular repair (hazard ratio, 4.37l; 95% CI, 2.51-7.66; P Ͻ .001). Adjusted hospital length of stay averaged 6.5 days (95% CI, 6.0-7.0 days; P Ͻ .001) longer after open repair (mean, 10.4 days) compared with endovascular repair (mean, 3.6 days). Need for incisional hernia repair was higher after open AAA (P Ͻ .001). The 1-year readmission rates, repeat AAA repair, and lower extremity amputation did not differ by repair type. Comment: The data presented here do not demonstrate inferiority of endovascular vs open AAA repair. However, there are really too many deficiencies in the data to justify a conclusion that the data demonstrate superiority of endovascular vs open repair of AAAs. First, follow-up is relatively short and the number of patients analyzed quite small compared with the number potentially available for analysis. In addition, the Medicare database does not contain information about aneurysm configuration and other an...
Trastuzumab improves outcomes among patients with HER2-positive breast cancer but is associated with a risk of treatment-induced cardiotoxicity (TIC). It is unclear how frequently TIC leads to trastuzumab interruption outside of prospective trials, and how TIC is managed in clinical practice. Patients with HER2-postive breast cancer receiving adjuvant trastuzumab from 2005 to 2010 were identified (n = 608). We evaluated the incidence, risk factors, and management of trastuzumab interruption due to TIC. In total, 488 (80 %) patients were treated with anthracycline prior to trastuzumab. Trastuzumab was interrupted in 108 (18 %) patients. Cumulative trastuzumab dose was lower in the interrupted group (median 86 vs. 108 mg/kg, p<0.0001). The most common reason for interruption was TIC (66 of 108 patients): 20 had symptomatic heart failure and 46 had asymptomatic left ventricular ejection fraction (LVEF) decline. Patients with trastuzumab interruption for TIC were older (54 vs. 50 years, p = 0.014) with lower LVEF before anthracycline (63 vs. 67 %, p<0.0001) and trastuzumab (62 vs. 67 %, p<0.0001) therapy. Mean LVEF at baseline, TIC diagnosis, and follow-up after trastuzumab interruption was 63, 45, and 55 %, respectively. Thirty-three of 66 patients with TIC were re-challenged with trastuzumab, and five patients had recurrent LVEF decline. In clinical practice, trastuzumab interruption is common and most often due to TIC, with most patients receiving anthracycline prior to trastuzumab. Cardiac dysfunction improves after trastuzumab interruption but may not fully recover to baseline. Strategies to minimize cardiotoxicity and treatment interruption should be investigated to prevent persistent left ventricular dysfunction in affected patients.
This is the first objective report of single-agent mitotane using modern objective criteria. Although the vast majority of patients did not respond (and toxicity was high), we identified a remarkable 8% complete response rate (i.e. cure) in biopsy proven stage IV adrenocortical cancer patients. Biomarkers are desperately needed for this rare disease.
Background. Adjuvant trastuzumab is a highly effective targeted treatment that improves survival for patients with HER2-positive breast cancer. However, trastuzumab interruption is recommended for patients who develop treatmentinduced cardiotoxicity (i.e., decline in left ventricular ejection fraction [LVEF], with or without symptoms) and can lead to an incomplete course of treatment.We studied the cardiac safety of continuous trastuzumab therapy among patients with asymptomatic declines in LVEF. Methods. We retrospectively evaluated patients with HER2-positive breast cancer treated with adjuvant trastuzumab at our institution between 2005 and 2010. Treatment-induced cardiotoxicity was defined by an absolute decrease in LVEF of $10% to below 55% or an absolute decrease of $16%. Logistic regression was used to determine the association
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