Sangaralingham, Lindsey R.

Abstract Background: The clinical utility of routine annual mammogram after curative-intent treatment for male breast cancer is uncertain. There is potentially greater value after lumpectomy (as surveillance for ipsilateral recurrence) than mastectomy (as screening for a new contralateral cancer). The goal of this study was to assess real world use of mammography in men during the first year after lumpectomy or mastectomy to treat breast cancer. Methods: Administrative claims data from OptumLabs Data Warehouse (a large US database that includes privately insured patients and Medicare Advantage-insured enrollees from all 50 states and of all ages and ethnic and racial groups) were used to identify men treated with breast surgery for a new diagnosis of breast cancer between 2007 and 2017. We required continuous coverage starting at least 6 months prior to the non-metastatic breast cancer diagnosis and continuing until at least 13 months after the breast surgery. Our primary endpoint was the proportion of patients who had at least one mammogram during the year (13-month period, to allow for scheduling and other logistical delays) after lumpectomy or mastectomy. Univariate and multivariate testing were performed to identify predictors of mammography (with p<0.05 used as the threshold for statistical significance for both). Our secondary endpoint was the proportion with at least one mammogram within 24 months of surgery, performed in a subset who maintained their insurance coverage for at least that duration. Results: The 13-month analysis included 730 men with a median age at diagnosis of 62 years (Range: 25 to 87 years) and a median follow-up duration of 35 months (Range: 13 to 134 months). 209 (29%) of these men underwent mammography within 13 months after surgery. The characteristics of patients who underwent mammography and those who did not are shown in Table 1. Mammography was more likely after lumpectomy than mastectomy (41% vs. 27%) and after radiation therapy (41% vs. 32% in those who did not receive radiation). In a multivariate logistic regression model, more recent diagnosis (2015+) was associated with lower odds of undergoing mammography, while receipt of radiation was associated with higher odds of undergoing mammography. In the subset of patients with two or more years of post-surgery coverage (n=527), the proportion who had at least one mammogram during that 24-month period was 49% after lumpectomy and 40% after mastectomy. Conclusions: In this insured cohort, 73% of men did not undergo mammography within a year after mastectomy, and 59% did not within a year after lumpectomy. Mammography was less likely in patients diagnosed more recently (perhaps due to acknowledgment of the unique aspects of male breast cancer including a relatively low risk of contralateral second primary tumors), and more likely in those who received radiation. These variations in practice likely result from the paucity of evidence-based guidelines for male breast cancer survivorship care. More research is needed pertaining to whether or not mammograms improve clinical outcomes after curative intent treatment for male breast cancer. Table 1: Patient characteristics associated with receipt of mammogram within first 13 months after male breast cancer surgeryUnivariate AnalysisMultivariate AnalysisNo Mammogram (N=521)Mammogram (N=209)P-value, chi-square testOdds Ratio (OR) and 95% CIP-value for ORAge Group:0.1225-4966 (12.7%)32 (15.3%)Reference50-64216 (41.5%)98 (46.9%)0.99 (0.60, 1.63)0.9665-74112 (21.5%)44 (21.1%)0.87 (0.48, 1.57)0.6575+127 (24.4%)35 (16.7%)0.57 (0.30, 1.07)0.08Census Region:0.52Midwest138 (26.5%)59 (28.2%)ReferenceNortheast97 (18.6%)47 (22.5%)1.10 (0.68, 1.78)0.69South223 (42.8%)79 (37.8%)0.74 (0.49, 1.11)0.15West63 (12.1%)24 (11.5%)0.83 (0.47, 1.47)0.51Year of diagnosis:0.072007-2010126 (24.2%)65 (31.1%)Reference2011-2014199 (38.2%)82 (39.2%)0.80 (0.54, 1.20)0.292015+196 (37.6%)62 (29.7%)0.63 (0.41, 0.96)0.03Elixhauser Category:0.250148 (28.4%)69 (33.0%)Reference1-2218 (41.8%)74 (35.4%)0.85 (0.56, 1.28)0.433+155 (29.8%)66 (31.6%)1.18 (0.75, 1.87)0.47Surgery Type:0.005Lumpectomy55 (10.6%)38 (18.2%)ReferenceMastectomy466 (89.4%)171 (81.8%)1.57 (0.97, 2.55)0.07Chemotherapy:0.79No301 (57.8%)123 (58.9%)ReferenceYes220 (42.2%)86 (41.1%)0.79 (0.54, 1.16)0.23Radiation:0.02No355 (68.1%)124 (59.3%)ReferenceYes166 (31.9%)85 (40.7%)1.51 (1.03, 2.20)0.03 Citation Format: Siddhartha Yadav, Lindsey Sangaralingham, Stephanie R. Payne, Karthik V. Giridhar, Tina J. Hieken, Judy C. Boughey, Robert W. Mutter, John R. Hawse, Rafael E. Jimenez, Rachel A. Freedman, Sadia Choudhery, Fergus J. Couch, Celine M. Vachon, Nilay Shah, Roberto A. Leon-Ferre, Kathryn J. Ruddy. Surveillance mammography after treatment for male breast cancer [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P4-17-08.

Background: The National Comprehensive Cancer Network and American Society of Clinical Oncology recommend consideration of the use of echocardiography 6 to 12 months after completion of anthracycline-based chemotherapy in at-risk populations. Assessment of BNP (B-type natriuretic peptide) has also been suggested by the American College of Cardiology/American Heart Association/Heart Failure Society of America for the identification of Stage A (at risk) heart failure patients. The real-world frequency of the use of these tests in patients after receipt of anthracycline therapy, however, has not been studied previously. Methods and Results: In this retrospective study, using administrative claims data from the OptumLabs Data Warehouse, we identified 31 447 breast cancer and lymphoma patients (age ≥18 years) who were treated with an anthracycline in the United States between January 1, 2008 and January 31, 2018. Continuous medical and pharmacy coverage was required for at least 6 months before the initial anthracycline dose and 12 months after the final dose. Only 36.1% of patients had any type of cardiac surveillance (echocardiography, BNP, or cardiac imaging) in the year following completion of anthracycline therapy (29.7% echocardiography). Surveillance rate increased from 37.5% in 2008 to 42.7% in 2018 (25.6% in 2008 to 40.5% echocardiography in 2018). Lymphoma patients had a lower likelihood of any surveillance compared with patients with breast cancer (odds ratio, 0.79 [95% CI, 0.74–0.85]; P <0.001). Patients with preexisting diagnoses of coronary artery disease and arrhythmia had the highest likelihood of cardiac surveillance (odds ratio, 1.54 [95% CI, 1.39–1.69] and odds ratio, 1.42 [95% CI, 1.3–1.53]; P <0.001 for both), although no single comorbidity was associated with a >50% rate of surveillance. Conclusions: The majority of survivors of breast cancer and lymphoma who have received anthracycline-based chemotherapy do not undergo cardiac surveillance after treatment, including those with a history of cardiovascular comorbidities, such as heart failure.

Background: Adherence to surveillance guidelines in resected colon cancer has significant implications for patient morbidity, cost of care, and healthcare utilization. This study measured the underuse and overuse of imaging for staging and surveillance in stage I–II colon cancer. Methods: The OptumLabs database was queried for administrative claims data on adult patients with stage I–II colon cancer who underwent surgery alone in 2008 through 2016. Use of PET and CT imaging was evaluated during both initial staging (n=6,921) and surveillance for patients with at least 1 year of follow-up (n=5,466). “High use” was defined as >2 CT abdominal/pelvic (CT A/P) or PET scans per year during surveillance. Results: Overall, 27% of patients with stage I–II colon cancer did not have a staging CT A/P or PET scan and 95% did not have a CT chest scan. However, rates of staging CT A/P and CT chest scans increased from 62.0% (2008) to 74.8% (2016) and from 2.3% (2008) to 7.1% (2016), respectively. Staging PET use was overall very low (5.2%). During surveillance, approximately 30% of patients received a CT A/P or PET and 5% received a CT chest scan within the first year after surgery. Of patients who had surveillance CT A/P or PET scans, the proportion receiving >2 scans within the first year (high use) declined from 32.4% (2008) to 9.6% (2016) (P = .01). Conclusions: Although PET use remains appropriately low, many patients with stage I–II colon cancer do not receive appropriate staging and surveillance CT chest scans. Among those who do receive these scans during surveillance, high use has declined significantly over time.

Background: The purpose of the present study was to identify trends in management and to compare the outcomes and complications following nonoperative and operative management (including external fixation, closed reduction and percutaneous pinning, and open reduction and internal fixation) for distal radial fractures in patients ≥65 years of age. Methods: We performed a retrospective analysis, with use of the OptumLabs Data Warehouse database, of patients ≥65 years of age who had been managed for a distal radial fracture between 2009 and 2014 (as indicated by diagnosis codes according to the International Classification of Diseases, Ninth Revision, Clinical Modification). Ninety-day and 1-year complication rates per 1,000 fractures were analyzed overall and by treatment modality. Results: Thirteen thousand, seven hundred and thirteen distal radial fractures were analyzed. The overall 90-day complication rate was 36.5 per 1,000 fractures, and the 1-year upper-extremity-specific complication rate was 236.2 and 307.5 per 1,000 fractures for nonoperative and operative management, respectively. Overall, post-injury stiffness was the most common 1-year upper-extremity-specific complication (incidence, 11.5%). There was no significant difference between operative and nonoperative management in terms of 90-day complication rates. However, operative management had a higher 1-year complication rate than nonoperative management (307.5 versus 236.2 per 1,000 fractures). Overall, the 5 most common upper-extremity-specific complications following operative treatment of distal radial fracture were stiffness (16.0%), chronic regional pain syndrome (9.9%), median neuropathy (8.0%), implant-related complications (3.8%), and tendon-related complications (2.8%). Stiffness was significantly more frequent following operative management (16.0% versus 9.8%; p < 0.01). Conclusions: Operative management of a distal radial fracture should be carefully considered when discussing treatment options with patients ≥65 years of age. Level of Evidence: Therapeutic Level III . See Instructions for Authors for a complete description of levels of evidence.

Abstract Breast cancer survivorship guidelines recommend at least annual follow-up visits, yet the degree to which this occurs in clinical practice is uncertain. Claims data from a US commercial insurance database (OptumLabs) were used to identify women treated with curative intent surgery for newly diagnosed breast cancer between 2006 and 2014. In 25 035 women, median follow-up was 3 years. In the second year after surgery, 9.6% of the patients did not visit a primary care provider, an oncologist, or a surgeon (guideline-nonadherent). The guideline-nonadherent proportion increased from 7.8% in women diagnosed in 2006 to 12.2% in those diagnosed in 2014 (two-sided Wald P &lt; .001). During years 2–6, guideline-nonadherence was also associated with older age, nonwhite race, no radiation, no chemotherapy, no endocrine therapy, and increasing time after surgery. There is a substantial and increasing rate of inadequate follow-up among breast cancer survivors. This has the potential to impair outcomes.

Abstract Background: The optimal follow-up of MGUS patients, including frequency of visits and type of tests to order, is unknown because there are no evidence-based data available for guidance. Nevertheless, there are currently 4 clinical practice guidelines that are based on expert-consensus: UK-Nordic (2009), International Myeloma Working Group (IMWG; 2010), International Expert Consensus (IEC; 2010) and European Myeloma Network (EMN; 2014). Most guidelines recommend annual follow-up with laboratory tests until life expectancy becomes limited. How MGUS patients are followed in the US and whether clinical practice guidelines are being followed remain largely unknown. Methods: We conducted a retrospective analysis of adult (age >18 years) patients from 2006-2012 using theOptum Labs Data Warehouse,a large database including administrative claims information on >150 million privately insured and Medicare Advantage enrollees throughout the US. We identified patients with an incident diagnosis of MGUS (ICD9: 273.1) who had enrollment periods of>1 year pre- and>2 years post-diagnosis in order to exclude patients with a prior history or subsequent diagnosis of lymphoplasmacytic malignancy. We determined the overall outpatient follow-up practice patterns (visits or tests performed for MGUS), their variations over time and by geo-demographic subgroups, and concordance with current clinical practice guidelines Results: There were 10,349 MGUS patients who met the study criteria. The mean interval per MGUS follow-up visit was 13.1 months. The distribution of patients by mean interval between visits was: q<6 months (39.9%), q6-12 months (10.7%), q13-24 months (2.6%) and q>24 months (46.8%). There was a significant trend towards a higher proportion of patients being followed q<6 over time from 36.2% in 2006 to 43.7% in 2013 (P=0.01). Patients ≥70 years were more likely followed q<6 months, while those from the Northeast or ≤50 years were more likely followed q>24 months compared to their counterparts (P<0.01). Over half of patients≥80 years were being followed either q<6 (44.7%) or q6-12 (11.6%) months (Figure 1). Only about half of the patients diagnosed in 2013 were concordant with any of the available guidelines regardless of whether the guidelines were more aggressive (UK-Nordic/IEC) or more conservative (IMWG/EMN) in their follow-up recommendations (54.6% and 56.5%, respectively). The tests ordered during follow-up are shown in Figure 2. The most common tests were complete blood count, calcium, and creatinine as they were ordered in over half of the follow-up visits (56.5% to 68.4%). In 11.6% of the follow-up, a face-to-face visit was not associated with any ancillary test, while in 31.5%, the follow-up was comprised of ancillary tests only without a face-to-face visit. The test combination of complete blood count, calcium, creatinine, and serum protein electrophoresis with or without free light chain was ordered in 25.0% of the visits. Conclusions: In the US, the MGUS follow-up practice patterns varied demographically and geographically. Only half of the patients were followed according to current guideline recommendations. A large proportion of patients with limited life expectancy continued to undergo close follow-ups. Figure 1 Figure 1. Figure 2 Figure 2. Disclosures No relevant conflicts of interest to declare.

Abstract Background: Prior studies on the risk of progression of monoclonal gammopathy of undetermined significance (MGUS) into lymphoplasmacytic malignancies (LPMs) were almost exclusively in the White populations, comprised of limited number of patients residing in relatively small geographic areas, or included patients mostly detected by serologic screening as part of clinical study (as opposed to detected clinically during evaluation of symptoms suspicious for LPMs). Similar epidemiologic studies in a large, racially diverse population are lacking. Methods: We conducted a retrospective analysis of incident MGUS patients diagnosed from 2006-2013 using theOptum Labs Data Warehouse, a large database including administrative claims information on >110 million privately insured and Medicare Advantage enrollees throughout the United States. We identified patients with a diagnosis of MGUS (ICD9: 273.1) with 1-5 years of continuous enrollment. Each enrollment cohort based on the duration of follow-up (1-, 2-, 3-, 4-, or 5-year) was analyzed individually to help estimate the progression to cancer. We excluded patients who were diagnosed with LPMs within three months of MGUS diagnosis. We calculated the rate of progression into LPMs (chronic lymphocytic leukemia [CLL], light chain amyloidosis [AL], multiple myeloma [MM], non-Hodgkin lymphoma [NHL], and Waldenström macroglobulinemia [WM]) expressed as number per 100 person-years. Results: There were 14,728 MGUS patients for a total of 21,288 person-years of follow-up. The distributions of the number of patients and events according to the cohorts classified by duration of follow-up were: 1-year (14,728 patients; 243 events), 2-year (10,644 patients; 307 events), 3-year (7,333 patients; 299 events), 4-year (4,497 patients; 237 events), and 5-year (2,960 patients; 191 events). The rates of progression to LPMs were consistently highest during the first year after MGUS diagnosis (~2.00), generally declined by half during the second year and remained fairly stable thereafter (~1.00; Table 1). The rates of progression into LPMs overall as well as by demographics are shown in Table 2. The risk of progression was significantly higher among men (P < 0.01) and older patients (>50 years; P = 0.03) compared to their counterparts but similar among races (P = 0.15). Of the 243 patients who progressed, the distribution of LPMs was MM (70.0%), NHL (13.2%), WM (12.3%), AL (4.1%), and CLL (0.4%). Conclusions: Among patients withMGUS, the risk of transformation into LPMs is continuous although twice as high during the first year after MGUS diagnosis compared to subsequent years. The risk of transformation was higher among men and those who were older but did not differ among the racial subgroups. Our findings can be used to develop an optimal risk-based MGUS follow-up strategy that incorporates not only serum biomarkers but also demographic factors. Disclosures No relevant conflicts of interest to declare.

Abstract Direct-acting antivirals (DAA) are now the mainstay of treatment for patients with chronic hepatitis C virus (HCV); however, there is some controversy over whether use of DAAs for HCV, as compared with IFN-based regimens, leads to an increased risk for hepatocellular carcinoma (HCC) development. We investigated the association between use of DAAs and subsequent development of HCC in longitudinal data from patients with HCV from diverse backgrounds (various ages, ethnicities, and geographic regions) across the United States. The design was a retrospective study performed using medical and pharmacy claims from OptumLabs. HCV treatment exposure was categorized as DAA-only, DAA + IFN, any-DAA, or IFN-only. To account for confounding by indication, inverse probability of treatment weighting was performed. Cox proportional hazard models were used to calculate hazard ratios (HR) and 95% confidence intervals (CI). We identified 5,781 patients with HCV with no history of HCC at baseline. Compared with IFN-only regimen, no significant increase in HCC risk was found for use of DAA-only (HR, 1.53; 95% CI, 0.73–3.23), DAA + IFN (HR, 1.02; 95% CI, 0.51–2.06), or any-DAA (HR, 1.04; 95% CI, 0.65–1.65). When stratified by sustained virological response (SVR), we noted a higher HCC risk for DAA-only among patients who achieved SVR post-treatment (HR, 7.53; 95% CI, 1.48–38.34), but the CIs were wide, which might be due to the small sample size of the subgroups. Among those who did not achieve SVR, no association was found for use of DAA-only (HR, 0.59; 95% CI, 0.19–1.91). These findings do not provide compelling evidence for the conception that use of DAAs for HCV is associated with increased risk of HCC development.