Faculty Bibliography

PURPOSE: In 2015, both ASCO and the European Society for Medical Oncology (ESMO) proposed frameworks to quantify the benefit of antineoplastic drugs in the face of rising costs. We applied these frameworks to drugs approved by the US Food and Drug Administration over the past 12 years and examined relationships between costs and benefits. METHODS: We searched FDA.gov for drugs that received initial approval for solid tumors from 2004 to 2015 and calculated the ASCO Net Health Benefit version 2016 (NHB16) and 2015 (NHB15) and the ESMO Magnitude of Clinical Benefit Scale scores for each drug. We calculated descriptive statistics and explored correlations and associations among benefit scores, cost, and independent variables. RESULTS: We identified 55 drug approvals supported by phase II (18.2%) and III (81.8%) trials, with primary outcomes of overall survival (36.4%), progression-free survival (43.6%), or response rate (20.0%). No significant association was found between NHB16 and year of approval ( P = .81), organ system ( P = .20), or trial comparator arm ( P = .17), but trials with progression-free survival outcomes were associated with higher scores ( P = .007). Both NHB15 and Magnitude of Clinical Benefit Scale scores were approximately normally distributed, but only a moderate correlation existed between them ( r = 0.40, P = .006). No correlation between benefit score and cost (NHB16, r = 0.19; ESMO, r = -0.07) was found. Before 2010, two (15.3%) of 13 approved drugs exceeded $500/NHB point x month compared with 10 (25.0%) of 40 drugs subsequently approved. CONCLUSION: Our analysis of the ASCO and ESMO value frameworks illuminates the heterogeneous benefit of new medications and highlights challenges in constructing a unified concept of drug value. Drug benefit does not correlate with cost, and the number of high cost/benefit outliers has increased.

OBJECTIVE: A discoid meniscus is more prone to tears than a normal meniscus. Patients with a torn discoid lateral meniscus are at increased risk for early onset osteoarthritis requiring total knee arthroplasty (TKA). Optimal management for this condition is controversial given the up-front cost difference between the two treatment options: the more expensive meniscal allograft transplantation compared with standard partial meniscectomy. We hypothesize that meniscal allograft transplantation following excision of a torn discoid lateral meniscus is more cost-effective compared with partial meniscectomy alone because allografts will extend the time to TKA. METHODS: A decision analytic Markov model was created to compare the cost effectiveness of two treatments for symptomatic, torn discoid lateral meniscus: meniscal allograft and partial meniscectomy. Probability estimates and event rates were derived from the scientific literature, and costs and benefits were discounted by 3%. One-way sensitivity analyses were performed to test model robustness. RESULTS: Over 25 years, the partial meniscectomy strategy cost $10,430, whereas meniscal allograft cost on average $4040 more, at $14,470. Partial meniscectomy postponed TKA an average of 12.5 years, compared with 17.30 years for meniscal allograft, an increase of 4.8 years. Allograft cost $842 per-year-gained in time to TKA. CONCLUSION: Meniscal allografts have been shown to reduce pain and improve function in patients with discoid lateral meniscus tears. Though more costly, meniscal allografts may be more effective than partial meniscectomy in delaying TKA in this model. Additional future long term clinical studies will provide more insight into optimal surgical options.

PURPOSE: While major prostate cancer active surveillance (AS) programs recommend repeat testing such as PSA and prostate biopsy, compliance with such testing is unknown. Our objective was to determine whether men in the community receive the same intensity of AS testing as in prospective AS protocols. MATERIALS AND METHODS: We performed a retrospective cohort study of men aged >/=66 in the SEER-Medicare database diagnosed with prostate cancer from 2001-2009 who did not receive curative therapy in the year after diagnosis with >/=1 post-diagnosis prostate biopsy. We used multivariable-adjusted Poisson regression to determine the association between frequency of AS testing with patient demographics and clinical features. Among 1349 men with /=14 PSA and >/=2 biopsy), and at Johns Hopkins (>/=10 PSA and >/=4 biopsy). RESULTS: Among 5192 patients undergoing AS, >80% had >/=1 PSA test per year but <13% received biopsy beyond the first 2 years. MRI was rarely used during the study period. On multivariable analysis, recent diagnosis and higher income were associated with higher frequency of surveillance biopsy, while older age and greater comorbidity were associated with fewer biopsies. African American men underwent fewer PSAs but similar numbers of biopsies. During 5 years of AS, only 11.1% and 5.0% met the testing standards of the Sunnybrook/PRIAS and Johns Hopkins programs. CONCLUSIONS: In the community, very few elderly men receive the intensity of AS testing recommended by major prospective AS programs.; Key of Definition for Abbreviations: AS=active surveillance, PCa=prostate cancer, PSA=prostate specific antigen, MRI=magnetic resonance imaging, NCCN=National Comprehensive Cancer Network, PRIAS=Prostate Cancer Research International Active Surveillance, WW=watchful waiting.

OBJECTIVE: To determine the frequency of appropriate and inappropriate prostate cancer imaging in an integrated health care system. DATA SOURCES/STUDY SETTING: Veterans Health Administration Central Cancer Registry linked to VA electronic medical records and Medicare claims (2004-2008). STUDY DESIGN: We performed a retrospective cohort study of VA patients diagnosed with prostate cancer (N = 45,084). Imaging (CT, MRI, bone scan, PET) use was assessed among patients with low-risk disease, for whom guidelines recommend against advanced imaging, and among high-risk patients for whom guidelines recommend it. PRINCIPAL FINDINGS: We found high rates of inappropriate imaging among men with low-risk prostate cancer (41 percent) and suboptimal rates of appropriate imaging among men with high-risk disease (70 percent). Veterans utilizing Medicare-reimbursed care had higher rates of inappropriate imaging [OR: 1.09 (1.03-1.16)] but not higher rates of appropriate imaging. Veterans treated in middle [OR: 0.51 (0.47-0.56)] and higher [OR: 0.50 (0.46-0.55)] volume medical centers were less likely to undergo inappropriate imaging without compromising appropriate imaging. CONCLUSIONS: Our results highlight the overutilization of imaging, even in an integrated health care system without financial incentives encouraging provision of health care services. Paradoxically, imaging remains underutilized among high-risk patients who could potentially benefit from it most.

BACKGROUND: Ethnic/racial minorities encounter disparities in healthcare, which may carry into end-of-life (EOL) care. Advanced cancer, highly prevalent and morbid, presents with worsening symptoms, heightening the need for supportive and EOL care. PURPOSE: To conduct a systematic review examining ethnic/racial disparities in EOL care for cancer patients. DESIGN: We searched four electronic databases for all original research examining EOL care use, preferences, and beliefs for cancer patients from ethnic/racial minority groups. RESULTS: Twenty-five studies were included: 20 quantitative and five qualitative. All had a full-text English language article and focused on the ethnic/racial minority groups of African Americans, Hispanics Americans, or Asian Americans. Key themes included EOL decision making processes, family involvement, provider communication, religion and spirituality, and patient preferences. Hospice was the most studied EOL care, and was most used among Whites, followed by use among Hispanics, and least used by African and Asian Americans. African Americans perceived a greater need for hospice, yet more frequently had inadequate knowledge. African Americans preferred aggressive treatment, yet EOL care provided was often inconsistent with preferences. Hispanics and African Americans less often documented advance care plans, citing religious coping and spirituality as factors. CONCLUSION: EOL care differences among ethnic/racial minority cancer patients were found in the processes, preferences, and beliefs regarding their care. Further steps are needed to explore the exact causes of differences, yet possible explanations include religious or cultural differences, caregiver respect for patient autonomy, access barriers, and knowledge of EOL care options.

OBJECTIVE: To compare clinical and treatment characteristics and outcomes in locally advanced anal cancer, a potentially curable disease, in patients referred from a public or private hospital. METHODS: We retrospectively reviewed 112 anal cancer patients from a public and a private hospital who received definitive chemoradiotherapy at the same cancer center between 2004 and 2013. Tumor stage, radiotherapy delay, radiotherapy duration, and unplanned treatment breaks >/=10 days were compared using t-test and chi(2) test. Overall survival (OS), disease free survival (DFS), and colostomy free survival (CFS) were examined using the Kaplan-Meier method and compared with the log-rank test. Cox proportional hazard models for OS and DFS were developed. RESULTS: The follow-up was 14.9 months (range, 0.7-94.8 months). Public hospital patients presented with significantly higher clinical T stage (P<0.05) and clinical stage group (P<0.05), had significantly longer radiotherapy delays (P<0.05) and radiotherapy duration (P<0.05), and had more frequent radiation therapy (RT) breaks >/=10 days (P<0.05). Three-year OS showed a marked trend in favor of private hospital patients for 3-year OS (72.8% vs. 48.9%; P=0.171), 3-year DFS (66.3% vs. 42.7%, P=0.352), and 3-year CFS (86.4% vs. 68.9%, P=0.299). Referral hospital was not predictive of OS or DFS on multivariate analysis. CONCLUSIONS: Public hospital patients presented at later stage and experienced more delays in initiating and completing radiotherapy, which may contribute to the trend in poorer DFS and OS. These findings emphasize the need for identifying clinical and treatment factors that contribute to decreased survival in low socioeconomic status (SES) populations.

OBJECTIVE: To examine public and media response to the United States Preventive Services Task Force's (USPSTF) draft (October 2011) and finalized (May 2012) recommendations against prostate-specific antigen (PSA) testing using Twitter, a popular social network with over 200 million active users. MATERIALS AND METHODS: We used a mixed methods design to analyze posts on Twitter, called "tweets." Using the search term "prostate cancer," we archived tweets in the 24 hour periods following the release of the USPSTF draft and finalized recommendations. We recorded tweet rate per hour and developed a coding system to assess type of user and sentiment expressed in tweets and linked articles. RESULTS: After the draft and finalized recommendations, 2042 and 5357 tweets focused on the USPSTF report, respectively. Tweet rate nearly doubled within two hours of both announcements. Fewer than 10% of tweets expressed an opinion about screening, and the majority of these were pro-screening during both periods. In contrast, anti-screening articles were tweeted more frequently in both draft and finalized study periods. From the draft to the finalized recommendations, the proportion of anti-screening tweets and anti-screening article links increased (p= 0.03 and p<0.01, respectively). CONCLUSIONS: There was increased Twitter activity surrounding the USPSTF draft and finalized recommendations. The percentage of anti-screening tweets and articles appeared to increase, perhaps due to the interval public comment period. Despite this, most tweets did not express an opinion, suggesting a missed opportunity in this important arena for advocacy.

IMPORTANCE: The association between regional norms of clinical practice and appropriateness of care is incompletely understood. Understanding regional patterns of care across diseases might optimize implementation of programs like Choosing Wisely, an ongoing campaign to decrease wasteful medical expenditures. OBJECTIVE: To determine whether regional rates of inappropriate prostate and breast cancer imaging were associated. DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study using the the Surveillance, Epidemiology, and End Results-Medicare linked database. We identified patients diagnosed from 2004 to 2007 with low-risk prostate (clinical stage T1c/T2a; Gleason score,