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Effect of prior cancer on outcomes in advanced lung cancer: implications for clinical trial eligibility and accrual

Laccetti, Andrew L; Pruitt, Sandi L; Xuan, Lei; Halm, Ethan A; Gerber, David E
BACKGROUND:Prior cancer is a common exclusion criterion in lung cancer trials. This practice reflects concerns that prior cancer may affect trial conduct or outcomes. However, the impact of prior cancer on survival in lung cancer is not known. METHODS:We identified patients older than age 65 years with stage IV lung cancer diagnosed between 1992 and 2009 in the Surveillance, Epidemiology, and End Results-Medicare linked registry. Prior cancer was characterized by type, stage, and timing. All-cause and lung cancer-specific survival were compared between patients with and without prior cancer using propensity score-adjusted Cox regression. RESULTS:Overall, 102 929 patients with stage IV lung cancer were identified, of whom 14.7% had a history of prior cancer. More than two-thirds (76.0%) of prior cancers were localized or regional stage; most were diagnosed five or fewer years prior to the lung cancer diagnosis. In propensity score-adjusted analysis, patients with prior cancer had better all-cause (hazard ratio [HR] = 0.93, 95% confidence interval [CI] = 0.91 to 0.94) and lung cancer-specific (HR = 0.81, 95% CI = 0.79 to 0.82) survival. In a simulated clinical trial-eligible population (age <75 years, no comorbidity, treated with chemotherapy), similar trends were noted. In subset analyses according to stage, type, and timing of prior cancer, no group of patients with prior cancer had inferior survival compared with patients without prior cancer. CONCLUSION/CONCLUSIONS:Among patients with stage IV lung cancer, prior cancer does not convey an adverse effect on clinical outcomes, regardless of prior cancer stage, type, or timing. Broader inclusion in clinical trials of advanced lung cancer patients with a history of prior cancer should be considered.
PMCID:4402360
PMID: 25667420
ISSN: 1460-2105
CID: 5872712

Impact of prior cancer on eligibility for lung cancer clinical trials

Gerber, David E; Laccetti, Andrew L; Xuan, Lei; Halm, Ethan A; Pruitt, Sandi L
BACKGROUND:In oncology clinical trials, the assumption that a prior cancer diagnosis could interfere with study conduct or outcomes results in frequent exclusion of such patients. We determined the prevalence and characteristics of this practice in lung cancer clinical trials and estimated impact on trial accrual. METHODS:We reviewed lung cancer clinical trials sponsored or endorsed by the Eastern Oncology Cooperative Group for exclusion criteria related to a prior cancer diagnosis. We estimated prevalence of prior primary cancer diagnoses among lung cancer patients using Surveillance Epidemiology and End Results (SEER)-Medicare linked data. We assessed the association between trial characteristics and prior cancer exclusion using chi-square analysis. All statistical tests were two-sided. RESULTS:Fifty-one clinical trials (target enrollment 13072 patients) were included. Forty-one (80%) excluded patients with a prior cancer diagnosis as follows: any prior (14%), within five years (43%), within two or three years (7%), or active cancer (16%). In SEER-Medicare data (n = 210509), 56% of prior cancers were diagnosed within five years before the lung cancer diagnosis. Across trials, the estimated number and proportion of patients excluded because of prior cancer ranged from 0-207 and 0%-18%. Prior cancer was excluded in 94% of trials with survival primary endpoints and 73% of trials with nonsurvival primary endpoints (P = .06). CONCLUSIONS:A substantial proportion of patients are reflexively excluded from lung cancer clinical trials because of prior cancer. This inclusion criterion is applied widely across studies, including more than two-thirds of trials with nonsurvival endpoints. More research is needed to understand the basis and ramifications of this exclusion policy.
PMID: 25253615
ISSN: 1460-2105
CID: 5872702

Predictors and intensity of online access to electronic medical records among patients with cancer

Gerber, David E; Laccetti, Andrew L; Chen, Beibei; Yan, Jingsheng; Cai, Jennifer; Gates, Samantha; Xie, Yang; Lee, Simon J Craddock
INTRODUCTION/BACKGROUND:Electronic portals are secure Web-based servers that provide patients with real-time access to their personal health record (PHR). These applications are now widely used at cancer centers nationwide, but their impact has not been well studied. This study set out to determine predictors and patterns of use of a Web-based portal for accessing PHRs and communicating with health providers among patients with cancer. METHODS:Retrospective analysis of enrollment in and use of MyChart, a PHR portal for the Epic electronic medical record system, among patients seen at a National Cancer Institute-designated cancer center. Predictors of MyChart use were analyzed through univariable and multivariable regression models. RESULTS:A total of 6,495 patients enrolled in MyChart from 2007 to 2012. The median number of log-ins over this period was 57 (interquartile range 17-137). The most common portal actions were viewing test results (37%), viewing and responding to clinic messages (29%), and sending medical advice requests (6.4%). Increased portal use was significantly associated with younger age, white race, and an upper aerodigestive malignancy diagnosis. Thirty-seven percent of all log-ins and 31% of all medical advice requests occurred outside clinic hours. Over the study period, the average number of patient log-ins per year more than doubled. CONCLUSIONS:Among patients with cancer, PHR portal use is frequent and increasing. Younger patients, white patients, and patients with upper aerodigestive malignancies exhibit the heaviest portal use. Understanding the implications of this new technology will be central to the delivery of safe and effective care.
PMCID:4161732
PMID: 25006222
ISSN: 1935-469x
CID: 5872692