Sunitinib in Urothelial Cancer: Clinical, Pharmacokinetic, and Immunohistochemical Study of Predictors of Response
David GallagherHikmat Al‐AhmadieIrina OstrovnayaScott R. GerstAshley Marie RegazziIlana Garcia-GrossmanJamie C. RichesSivaraman GounderAnne-Marie FlahertyA. TroutMatthew I. MilowskyDean F. Bajorin
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Cancer-related pain is a problem for many cancer survivors. Treatment summaries (TS) and follow-up care instructions (FCI) provided after cancer treatment could reduce pain for cancer survivors.This study sought to determine how TS and FCI received by cancer survivors relate to cancer survivors' cancer-related pain after treatment completion.Data were from 2010, Behavioral Risk Factor Surveillance System, Cancer Survivorship module, completed by 10 U.S. states and entities.Pain was reported by 9% of survivors. TS (P = 0.02) and FCI (P < 0.001) were associated with pain. Compared with cancer survivors who had not received TS or FCI, those who received TS had greater odds of pain (odds ratio, 1.57; 95% confidence interval, 1.08-2.28) and those who received FCI had more than twice the odds of pain (odds ratio, 2.36; 95% confidence interval, 1.52-3.67).FCI and TS were related to pain but in the opposite direction than predicted. Those who received TS and FCI were more likely to report pain than those who did not receive FCI and TS. This may be explained by the severity of cancer treatment. It is possible that those who undergo more severe cancer treatments are more likely to receive FCI and TS. Testing this relationship is a logical next step.
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Operative procedural training is a key component of orthopaedic surgery residency. The influence of intraoperative resident participation on the outcomes of surgery has not been studied extensively using large, population-based databases.We identified 30,628 patients who underwent orthopaedic procedures from the 2011 American College of Surgeons National Surgical Quality Improvement Program. Outcomes as measured by perioperative complications, readmission rates, and mortality within thirty days were compared for cases with and without intraoperative resident involvement.Logistic regression with propensity score analysis revealed that intraoperative resident participation was associated with decreased rates of overall complications (odds ratio, 0.717 [95% confidence interval, 0.657 to 0.782]), medical complications (odds ratio, 0.723 [95% confidence interval, 0.661 to 0.790]), and mortality (odds ratio, 0.638 [95% confidence interval, 0.427 to 0.951]). Resident presence in the operating room was not predictive of wound complications (odds ratio, 0.831 [95% confidence interval, 0.656 to 1.053]), readmission (odds ratio, 0.962 [95% confidence interval, 0.830 to 1.116]), or reoperation (odds ratio, 0.938 [95% confidence interval, 0.758 to 1.161]). A second analysis by propensity score stratification into quintiles grouped by similar probability of intraoperative resident presence showed resident involvement to correlate with decreased rates of overall and medical complications in three quintiles, but increased rates of overall and medical complications in one quintile. All other outcomes were equivalent across quintiles.Orthopaedic resident involvement during surgical procedures is associated with lower risk of perioperative complications and mortality in the National Surgical Quality Improvement Program database. The results support resident participation in the operative care of orthopaedic patients.Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
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To determine whether high patient inflow volumes to an intensive care unit are associated with unplanned readmissions to the unit.Retrospective comparative analysis.The setting is a large urban tertiary care academic medical center.Patients (n = 3233) discharged from an adult neurosciences critical care unit to a lower level of care from January 1, 2006 through November 30, 2007.None.The main outcome variable is unplanned patient readmission to the neurosciences critical care unit within 72 hrs of discharge to a lower level of care. The odds of one or more discharges becoming an unplanned readmission within 72 hrs were nearly two and a half times higher on days when > or =9 patients were admitted to the neurosciences critical care unit (odds ratio, 2.43; 95% confidence interval, 1.39-4.26) compared with days with < or =8 admissions. The odds of readmission were nearly five times higher on days when > or =10 patients were admitted (odds ratio, 4.99; 95% confidence interval, 2.45-10.17) compared with days with < or =9 admissions. Adjusting for patient complexity, the odds of an unplanned readmission were 2.34 times higher for patients discharged to a lower level of care on days with > or =10 admissions to the neurosciences critical care unit (odds ratio, 2.34; 95% confidence interval, 1.27-4.34) compared with similar patients discharged on days of < or =9 admissions.Days of high patient inflow volumes to the unit were associated significantly with subsequent unplanned readmissions to the unit. Furthermore, the data indicate a possible dose-response relationship between intensive care unit inflow and patient outcomes. Further research is needed to understand how to defend against this risk for readmission.
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15517 Background: Sorafenib, a multi kinase targeted agent with raf and VEGF receptor (VEGF-R) inhibitory properties, has been recently approved for the treatment of metastatic renal cell carcinoma (mRCC). Two other VEGF pathway targeted agents, sunitinib and bevacizumab, have documented efficacy in mRCC. It is not known whether these agents will exhibit biological or clinical activity after prior VEGF directed treatment. Methods: Eligibility applied to patients with mRCC treated with sorafenib within an expanded access program (EAP) at our institution that were later switched to either bevacizumab or sunitinib due to tumor progression or sorafenib intolerance. All patients had measurable disease. Patients were evaluated for response rates (RECIST), treatment duration and progression free survival (PFS). Results: 35 patients that participated in the EAP were identified. 10 patients fulfilled the entry criteria and all of them had clear cell histology. Median age was 66; sex distribution was 70% male-30% female. 6 (60%) received sunitinib and 4 (40%) received bevacizumab. Median treatment duration was 5.5 months (range: 1–15). Of the patients evaluable for response: 5 have SD (50%), 1(10%) had a PR and 1(10%) progressed. 3 are too early to be evaluated. Median PFS was 7 months. Conclusions: Despite the limitations of a small patient sample, the VEGF targeted therapies sunitinib and bevacizumab exhibited a median PFS and reponse rate similar to those reported by other authors as a first line anti-VEGF therapy. Second line anti-angiogenic activity appears to retain efficacy in clear cell mRCC priorly treated with the multi- kinase targeted agent sorafenib. This may provide hypothetical justification for sustained anti-angiogenic therapy after progression. Prospective evaluation of serial and combination approaches is ongoing. No significant financial relationships to disclose.
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Background: Studies about the influence of patient characteristics on mechanical failure of cups in total hip replacement have applied different methodologies and revealed inconclusive results. The fixation mode has rarely been investigated. Therefore, we conducted a detailed analysis of the influence of patient characteristics and fixation mode on cup failure risks. Methods: We conducted a case-control study of total hip arthroplasties in 4420 patients to test our hypothesis that patient characteristics of sex, age, weight, body mass index, and diagnosis have different influences on risks for early mechanical failure in cemented and uncemented cups. Results: Women had significantly reduced odds for failure of cups with cemented fixation (odds ratio = 0.59; 95% confidence interval, 0.43 to 0.83; p = 0.002) and uncemented fixation (odds ratio = 0.63; 95% confidence interval, 0.5 to 0.81; p = 0.0003) compared with that for men (odds ratio = 1). Each additional year of patient age at the time of surgery reduced the failure odds by a factor of 0.98 for both cemented cups (odds ratio = 0.98; 95% confidence interval, 0.96 to 0.99; p = 0.016) and uncemented cups (odds ratio = 0.98; 95% confidence interval, 0.97 to 0.99; p = 0.0002). In patients with cemented cups, the weight group of 73 to 82 kg had significantly lower failure odds (odds ratio = 0.63; 95% confidence interval, 0.4 to 0.98) than the lightest (<64 kg) weight group or the heaviest (>82 kg) weight group (odds ratios = 1.00 and 1.07, respectively). No significant effects of weight were noted in the uncemented group. In contrast, obese patients (a body mass index of >30 kg/m2) with uncemented cups had significantly elevated odds relative to patients with a body mass of <25 kg/m2 (odds ratio = 1.41; 95% confidence interval, 1.03 to 1.91) for early failure of the cups compared with an insignificant effect in the cemented arm of the study. Compared with osteoarthritis as the reference diagnosis (odds ratio = 1), developmental dysplasia (odds ratio = 0.52; 95% confidence interval, 0.28 to 0.97) and hip fracture (odds ratio = 0.38; 95% confidence interval, 0.16 to 0.92) were significantly protective in cemented cups. Conclusions: Female sex and older age have similarly protective effects on the odds for early failure of cemented and uncemented cups. Although a certain body-weight range has a significant protective effect in cemented cups, the more important finding was the significantly increased risk for failure of uncemented cups in obese patients. Patients with developmental dysplasia and hip fracture were the only diagnostic groups with a significantly decreased risk for cup failure, but only with cemented fixation. Level of Evidence: Therapeutic Level III. See Instructions to Authors for a complete description of levels of evidence.
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