Cost of disease progression among US patients with human epidermal growth factor receptor 2-positive metastatic breast cancer.

Aim: The objectives were to investigate the differences in per patient per month (PPPM) healthcare resource utilization (HCRU) and costs among commercially insured and Medicare Advantage patients with human epidermal growth factor receptor 2 positive (HER2+) metastatic breast cancer (mBC) who experience disease progression in 12 months compared with those who don't investigate the impact of progression timing on cumulative healthcare costs. Patients & methods: This claims-based study included patients diagnosed with mBC between 1 January 2013 and 30 April 2020 and received HER2-targeted therapy. Patients were categorized as progressed or nonprogressed. For objective one, monthly HCRU and costs were assessed for up to two lines of therapy (LOTs). Data were summarized descriptively and compared using a generalized linear model (GLM). For objective two, patients with at least 6 months of follow-up were assessed and cumulative healthcare costs were estimated in the 3 years following the start of LOT1 or LOT2 using a GLM and Kaplan-Meier weighting. Results: Among the 4113 patients in the study sample, 3406 had at least 12 months of follow-up (or less if due to death). Compared with nonprogressed patients, progressed patients had higher mean PPPM healthcare costs (LOT1: $22,014 vs $18,372, p < 0.001; LOT2: $19,643 vs $16,863, p = 0.001), and HCRU, including number of emergency room visits and inpatient stays (both p < 0.001) in the 12 months following LOT start. Progressed patients had higher 3-year mean cumulative healthcare costs than nonprogressed patients following LOT1 and LOT2 and this difference was greater for patients who progressed earlier. Conclusion: Disease progression was associated with significant increases in HCRU and costs. Delays in progression were associated with lower cumulative healthcare costs. Earlier use of more clinically effective treatments to delay progression may reduce the economic burden among these patients.

HER2-Mutant Advanced and/or Metastatic Non-Small-Cell Lung Cancer: A US Electronic Health Records Database Analysis of Clinical Characteristics, Treatment Practice Patterns, and Outcomes.

BACKGROUND: Real-world data for advanced/metastatic non-small-cell lung cancer (NSCLC) with mutations in human epidermal growth factor 2 (HER2) are scarce. We aimed to assess treatment patterns and outcomes among patients with HER2-mutant advanced/metastatic NSCLC. PATIENTS AND METHODS: This retrospective nationwide electronic health record study evaluated patient characteristics, treatment patterns, treatment duration, and overall survival for adults with HER2-mutant advanced/metastatic NSCLC without epidermal growth factor receptor mutation. RESULTS: Of 55 included patients, median (quartile 1 [Q1]-quartile 3 [Q3]) age was 63.0 (58.0-72.0) years, 42 (76%) were women, and 39 (71%) were current/former smokers. In first-line therapy, 14 regimens were used for median (Q1-Q3) duration of 3.1 (2.4-6.2) months, with most patients (n = 39, 71%) receiving platinum-based chemotherapy alone or in combination with other agents. Median (95% CI) overall survival from first-line treatment initiation was 19.0 (12.2-not estimable) months, with no significant association with age, sex, or smoking status. Thirty-five (64%) patients received second-line therapy for median (Q1-Q3) duration of 3.3 (2.0-5.2) months. Fourteen second-line regimens were used; most commonly immunotherapy alone or in combination with other agents (n = 16, 46%). Sixteen (46%) patients received third-line therapy for median (Q1-Q3) duration of 1.9 (1.3-2.7) months. Nine third-line regimens were used, with 7 (44%) patients receiving HER2-directed agents. CONCLUSION: First- and second-line treatments for HER2-mutant NSCLC varied widely and treatment duration was short. The approval of trastuzumab deruxtecan for NSCLC supports wider HER2 testing to identify eligible patients for HER2-directed therapy.

Characteristics, healthcare utilization, and outcomes of patients with HER2-low breast cancer.

PURPOSE: Treatment for HER2-low [defined as ImmunoHistoChemistry (IHC) 1 + or 2 + and negative/normal in Situ Hybridization (ISH)] breast cancer patients is rapidly evolving, yet we lack critical information about the HER2-low population. METHODS: We conducted a retrospective cohort study of women aged 18 years or older diagnosed with breast cancer between 2010 and 2016 in North Carolina. Analyses were conducted for the overall cohort and a stage IV sub-cohort. We examined demographic and clinical characteristics, and characterized prevalence of HER2-low disease and healthcare utilization. We estimated adjusted rate ratios for the association between HER2 classifications and utilization outcomes, and hazard ratios for 3-year all cause mortality (stage IV only). RESULTS: The overall and stage IV cohorts included 12,965 and 635 patients, respectively. HER2-low patients represented more than half of both cohorts (59% overall, 53% stage IV). HER2-low patients were more likely than IHC 0 patients to have hormone receptor (HR)-positive disease. In the stage IV cohort, HER2-low patients were more likely to be Black (26% vs. 16% IHC 0, p = 0.0159). In both cohorts, rates of hospitalizations were slightly higher among HER2-low patients. There were no survival differences between HER2-low and IHC 0 among stage IV patients. CONCLUSION: New treatment options for HER2-low breast cancer may have potential for significant impact at the population level particularly for patients with stage IV disease. In light of racial differences between HER2-low and IHC 0 patients observed in our cohort, research- and practice-based efforts to ensure equitable adoption of new treatment guidelines for patients with HER2-low metastatic breast cancer will be essential.

Real-World Treatment Patterns and Economic Burden Following First-Line Trastuzumab in Patients with Metastatic Gastric Cancer in the USA.

BACKGROUND: Trastuzumab in combination with chemotherapy is the standard first-line (1L) treatment for HER2+ metastatic gastric cancer (mGC) in the USA. OBJECTIVE: This study characterizes the real-world treatment patterns, healthcare resource use (HRU), and costs in patients with HER2+ mGC post-1L trastuzumab before approval of fam-trastuzumab deruxtecan-nxki. PATIENTS AND METHODS: This retrospective study used the IQVIA PharMetrics® Plus Database (October 2014-September 2019) to identify adults with HER2+ mGC who discontinued trastuzumab-based regimens in 1L. Patient characteristics, second-line (2L) treatment patterns, and treatment duration were summarized. HRU and costs before and after discontinuation of 1L trastuzumab-based regimens as well as during 2L treatment were described. RESULTS: Of the 190 HER2+mGC patients who discontinued 1L trastuzumab-based regimens, 136 (71.58%) initiated 2L treatments. Trastuzumab-based regimens were the most common in 2L (50.74%), followed by ramucirumab + paclitaxel (19.85%). The median time to 2L discontinuation was 2.37 months. During a mean follow-up of 9.8 months, mean per-patient-per-month (PPPM) healthcare costs post-1L trastuzumab-based regimens were higher in patients receiving 2L treatment than those without subsequent treatment (US$25,178 vs. US$14,812). The mean PPPM cost during 2L treatment was US$30,838, primarily driven by outpatient infusion costs (US$22,262). CONCLUSIONS: The short duration of 2L treatment observed in this study is consistent with a lack of effective treatments post-1L trastuzumab prior to 2020. Re-use of trastuzumab treatment was common despite its limited efficacy and high treatment cost. The findings highlight the unmet medical needs and substantial burden faced by patients with HER2 +mGC previously treated with trastuzumab.

Machine Learning Methods to Identify Missed Cases of Bladder Cancer in Population-Based Registries.

PURPOSE: Population-based cancer incidence rates of bladder cancer may be underestimated. Accurate estimates are needed for understanding the burden of bladder cancer in the United States. We developed and evaluated the feasibility of a machine learning-based classifier to identify bladder cancer cases missed by cancer registries, and estimated the rate of bladder cancer cases potentially missed. METHODS: Data were from population-based cohort of 37,940 bladder cancer cases 65 years of age and older in the SEER cancer registries linked with Medicare claims (2007-2013). Cases with other urologic cancers, abdominal cancers, and unrelated cancers were included as control groups. A cohort of cancer-free controls was also selected using the Medicare 5% random sample. We used five supervised machine learning methods: classification and regression trees, random forest, logic regression, support vector machines, and logistic regression, for predicting bladder cancer. RESULTS: Registry linkages yielded 37,940 bladder cancer cases and 766,303 cancer-free controls. Using health insurance claims, classification and regression trees distinguished bladder cancer cases from noncancer controls with very high accuracy (95%). Bacille Calmette-Guerin, cystectomy, and mitomycin were the most important predictors for identifying bladder cancer. From 2007 to 2013, we estimated that up to 3,300 bladder cancer cases in the United States may have been missed by the SEER registries. This would result in an average of 3.5% increase in the reported incidence rate. CONCLUSION: SEER cancer registries may potentially miss bladder cancer cases during routine reporting. These missed cases can be identified leveraging Medicare claims and data analytics, leading to more accurate estimates of bladder cancer incidence.

Melanoma Tumor Depth Quality Audit: A Nonmatch Analysis.

Background: The National Cancer Institute's Surveillance Research Program (SRP) received reports from cancer registries in the Surveillance, Epidemiology, and End Results (SEER) Program concerning the coding of melanoma tumor depth. To address these concerns, SRP developed an algorithm to identify melanoma depth measurement values and conducted a nonmatch analysis. Methods: A nonmatch analysis was conducted on 1,117 cases diagnosed between 2010 and 2017. With the help of Information Management Services, a natural language processing algorithm was developed to identify melanoma tumor depth values along with a gold standard for comparison. A randomly sampled data set was created to compare the algorithm-generated and gold standard values to the originally reported values; these were analyzed using SAS software version 9.4. Analyses were conducted to determine the distribution of nonmatches by demographics and estimate the distribution of nonmatches by the derived T variable according to the 7th edition of the American Joint Committee on Cancer (AJCC)'s AJCC Cancer Staging Manual. Results: Of the 1,117 cases, 849 cases (76%) were a match between the originally reported values and the gold standard. The majority of cases were found to be in male patients (60%) and non-Hispanic White patients (93%). When comparing derived AJCC-7 T based on the originally reported value to the gold standard, 16% of the original derived AJCC-7 T values were incorrect, with most of the nonmatches resulting in incorrectly coding a case as TX instead of T1. Conclusion: In total, 24% of cases were found to have a discrepancy in the originally recorded values. Decimal errors made up 3% of all cases in this nonmatch analysis. This algorithm may prove to be an essential tool in optimizing registry resources by flagging inconsistencies via automated text review to be adjudicated by registrars, improving their quality of data as needed.

Population-based utilization and costs associated with tyrosine kinase inhibitors for first-line treatment of chronic myelogenous leukemia among elderly patients.

BACKGROUND: Following approval of imatinib, a breakthrough tyrosine kinase inhibitor (TKI), survival significantly improved by more than 20% since 2001 among treated chronic myelogenous leukemia (CML) patients. Subsequently, more expensive second-generation TKIs with varying selectivity profiles have been approved. Population-based studies are needed to evaluate the real-world utilization of TKI therapies, particularly given their escalating costs and recommendations for maintenance therapy. OBJECTIVE: To assess the utilization patterns of first-line TKIs, overall and by specific agent, among elderly CML patients in the United States, and the cost implications. METHODS: CML patients aged 65 years and older at diagnosis between 2007 and 2015 were identified from population-based cancer registries in the linked Surveillance, Epidemiology, and End Results (SEER)-Medicare database. The percentage of CML patients receiving imatinib, dasatinib, or nilotinib within the first year of diagnosis was calculated along with time to first-line treatment initiation. Bivariate comparisons and Cox proportional hazards models were used to identify factors associated with TKI initiation. Average monthly patient responsibility, including patient out-of-pocket (OOP) costs, stratified by Part D low-income subsidy (LIS) status were also calculated. RESULTS: Among the 1,589 CML patients included, receipt of any TKI within 1 year of diagnosis increased from 66.2% to 78.9%. In 2015, the distribution of first-line TKI therapies was 41.3% imatinib, 28.3% dasatinib, and 9.3% nilotinib. Almost 60% of patients initiated TKI treatment within 3 months of diagnosis. Multivariable analysis indicated that TKI use in the first year was lower among the very elderly (aged > 75 years vs. 65-69 years: HR = 0.72; 95% CI = 0.63-0.83), patients with more comorbidities (Hierarchical Condition Category risk score > 2 vs. HR = 0.74, 95% CI = 0.62-0.88), and patients ineligible for LIS (HR = 0.75; 95% CI = 0.65-0.87). Average monthly patient OOP cost was significantly lower for LIS-eligible versus LIS-ineligible patients: imatinib (2016: $12 vs. $487), dasatinib (2016: $34 vs. $557), and nilotinib (2016: $1 vs. $526). CONCLUSIONS: TKI use has increased significantly since 2007. While imatinib remained the most frequently prescribed first-line agent, by 2015 newer TKIs represented one third of the market share. Utilization patterns indicated persistent age, comorbidity, and financial barriers. TKI use is indicated for long-term therapy, and increased adoption of newer, more expensive agents raises concerns about the sustained affordability of CML treatment, particularly among unsubsidized patients. DISCLOSURES: No outside funding supported this study. There are no reported conflicts of interest.

Estimating Chemotherapy Use Among Patients With a Prior Primary Cancer Diagnosis Using SEER-Medicare Data.

Cancer treatment studies commonly exclude patients with prior primary cancers due to difficulties in ascertaining for which site treatment is intended. Surveillance, Epidemiology, and End Results-Medicare patients 65 years and older diagnosed with an index colon or rectal cancer (CRC) or female breast cancer (BC) between 2004 and 2013 were included. Chemotherapy, defined as "any chemotherapy" and more restrictively as "chemotherapy with confirmatory diagnoses," was ascertained based on claims data within 6 months of index cancer diagnosis by prior cancer history. Any chemotherapy use was slightly lower among patients with a prior cancer (CRC: no prior = 17.4%, prior = 16.1%; BC: no prior = 12.9%, prior = 12.0%). With confirmatory diagnoses required, estimates were lower, especially among patients with a prior cancer (CRC: no prior = 16.8%, prior = 13.6%; BC: no prior = 12.6%, prior = 11.0%). These findings suggest that patients with prior cancers can be included in studies of chemotherapy use; requiring confirmatory diagnoses can increase treatment assignment confidence.

Development and Utility of the Observational Research in Oncology Toolbox: Cancer Medications Enquiry Database-Healthcare Common Procedure Coding System (HCPCS).

PURPOSE: Health-care claims are of increasing utility as a rich, real-world data resource for conducting treatment-related cancer research. However, multiple dynamic coding nomenclatures exist, leading to study variability. To promote increased standardization and reproducibility, the National Cancer Institute (NCI) developed the Cancer Medications Enquiry Database (CanMED)-Healthcare Common Procedure Coding System (HCPCS) within the Observational Research in Oncology Toolbox. METHODS: The CanMED-HCPCS includes codes for oncology medications that a) have a US Food and Drug Administration-approved indication for cancer treatment or treatment-related symptom management; b) are present in National Comprehensive Cancer Network guidelines; or c) carry an orphan drug designation for treatment or management of cancer. Included medications and their HCPCS codes were primarily identified based on Center for Medicare and Medicaid Services annual HCPCS Indices (2012-2018). To demonstrate the utility of the CanMED-HCPCS, use of systemic treatment for stage II-IV colorectal cancer patients included in the Surveillance, Epidemiology, and End Results-Medicare data (2007-2013) was assessed. RESULTS: The CanMED-HCPCS (v2018) includes 332 HCPCS codes for cancer-related medications: chemotherapy (156), immunotherapy (74), hormonal therapy (54), and ancillary therapy (48). Observed treatment trends within the NCI Surveillance, Epidemiology, and End Results-Medicare data were as expected; utilization of each treatment type increased with stage, and immunotherapy was largely confined to use among stage IV patients. CONCLUSION: The CanMED-HCPCS provides a comprehensive resource that can be used by the research community to facilitate systematic identification of medications within claims or electronic health data using the HCPCS nomenclature and greater reproducibility of cancer surveillance and health services research.

Using the SEER-Medicare Data to Assess Incident Chronic Myeloid Leukemia and Bladder Cancer Cases Missed by Cancer Registries.

The growing use of oral systemic therapies and transition of some cancer treatments to the outpatient setting makes capturing all cancer case patients more difficult. We aim to develop algorithms to identify potentially missed incident case patients and estimate impact on incidence rates. We reviewed claims from SEER-Medicare 5% noncancer control patient sample to identify potentially missed chronic myeloid leukemia (CML) and bladder case patients based on diagnosis codes, cancer-related treatments, and oncology consultations. Observed rates of definite missed CML and definite and probable missed bladder case patients were calculated and the impact of missed case patients of these two cancers on SEER 65+ incidence rates were estimated. From 2008 to 2015, the algorithm estimated 781 definite CML case patients missed, increasing the number by 10.7%. From 2007 to 2015, the algorithm estimated 4629 definite and 5772 probable bladder case patients missed, increasing the number by 3.8% to 8.1%. Our algorithms offer potential methods for identifying missed case patients and validating the completeness of cancer registries.

Utilization of the Cancer Medications Enquiry Database (CanMED)-National Drug Codes (NDC): Assessment of Systemic Breast Cancer Treatment Patterns.

Cancer Medications Enquiry Database (CanMED) is comprised of two interactive, nomenclature-specific databases within the Observational Research in Oncology Toolbox: CanMED-Healthcare Common Procedure Coding System (HCPCS) and CanMED-National Drug Code (NDC), described through this study. CanMED includes medications with a) a US Food and Drug Administration-approved cancer treatment or treatment-related symptom management indication, b) inclusion in treatment guidelines, or c) an orphan drug designation. To demonstrate the joint utility of CanMED, medication codes associated with female breast cancer treatment were identified and utilization patterns were assessed within Surveillance Epidemiology and End Results-Medicare (SEER) data. CanMED-NDC (11_2018 v.1.2.4) includes 6860 NDC codes: chemotherapy (1870), immunotherapy (164), hormone therapy (3074), and ancillary therapy (1752). Treatment patterns among stage I-IIIA (20 701) and stage IIIB-IV (2381) breast cancer patients were accordant with guideline-recommended treatment by stage and molecular subtype. CanMED facilitates identification of medications from observational data (eg, claims and electronic health records), promoting more standardized and efficient treatment-related cancer research.

Patterns of Care and Costs for Older Patients With Colorectal Cancer at the End of Life: Descriptive Study of the United States and Canada.

PURPOSE: End-of-life (EOL) cancer care is costly, with challenges regarding intensity and place of care. We described EOL care and costs for patients with colorectal cancer (CRC) in the United States and the province of Ontario, Canada, to inform better care delivery. METHODS: Patients diagnosed with CRC from 2007 to 2013, who died of any cancer from 2007 to 2013 at age ≥ 66 years, were selected from the US SEER cancer registries linked to Medicare claims (n = 16,565) and the Ontario Cancer Registry linked to administrative health data (n = 6,587). We estimated total and resource-specific costs (2015 US dollars) from public payer perspectives over the last 360 days of life by 30-day periods, by stage at diagnosis (0-II, III, IV). RESULTS: In all months, especially 30 days before death, higher percentages of SEER-Medicare than Ontario patients received chemotherapy (15.7% v 8.0%), and imaging tests (39.4% v 31.1%). A higher percentage of Ontario patients were hospitalized (62.5% v 51.0%), but 43.2% of hospitalized SEER-Medicare patients had intensive care unit (ICU) admissions versus 17.9% of hospitalized Ontario patients. Cost differences between cohorts were greater for patients with stage IV disease. In the last 30 days, mean total costs for patients with stage IV disease were $15,881 (SEER-Medicare) and $12,034 (Ontario) versus $19,354 and $17,312 for stage 0-II. Hospitalization costs were higher for SEER-Medicare patients ($11,180 v $9,434), with lower daily hospital costs in Ontario ($1,067 v $2,004). CONCLUSION: These findings suggest opportunities for reducing chemotherapy and ICU use in the United States and hospitalizations in Ontario.

Trends in pediatric thyroid cancer incidence in the United States, 1998-2013.

BACKGROUND: Pediatric differentiated thyroid cancer (DTC) rates have increased over time in the United States and worldwide. Improvements in imaging for the diagnosis of DTC have been hypothesized as a potential driver of these increases. This study stratifies temporal trends in pediatric DTC by stage and tumor size to assess whether rates of large, late-stage cancers, which are likely to be clinically meaningful, are increasing over time. METHODS: Age-standardized incidence rates (ASRs) of DTC and annual percent changes (APCs) in primary DTC rates were estimated for 0- to 19-year-olds with data from 39 US cancer registries during 1998-2013. RESULTS: During 1998-2013, 7296 cases of DTC were diagnosed (6652 papillary cases and 644 follicular cases). APCs of pediatric DTCs significantly increased by 4.43%/y [95% CI, 3.74%/y-5.13%/y], primarily because of increases in papillary histologies. Increasing trends were observed for children aged 10 to 19 years for both sexes and for non-Hispanic whites, non-Hispanic blacks, and Hispanics. Rates increased significantly over the time period for all tumor stages (APClocalized , +4.06%/y [95% CI, 2.84%/y-5.29%/y]; APCregional , +5.68%/y [95% CI, 4.64%/y-6.73%/y]; APCdistant , +8.55%/y [95% CI, 5.03%/y-12.19%/y]) and across tumor sizes (APC<1 cm , +9.46%/y [95% CI, 6.13%/y-12.90%/y]; APC1-2 cm , +6.92%/y [95% CI, 4.31%/y-9.60%/y]; APC>2 cm , +4.69%/y [95% CI, 2.75%/y-6.67%/y]). CONCLUSIONS: Significantly increasing rates of DTC over time among 10- to 19-year-olds in the United States are unlikely to be entirely explained by increases in medical surveillance during childhood because rates of large and late-stage DTC are increasing over time. Future studies should examine environmental and other factors that may be contributing to rising DTC rates.

Trends in Pediatric Central Nervous System Tumor Incidence in the United States, 1998-2013.

BACKGROUND: Brain and other central nervous system (CNS) cancers are the leading cause of U.S. pediatric cancer mortality. Incidence trends can provide etiologic insight. We report trends in incidence rates of pediatric malignant CNS cancers and pilocytic astrocytoma (nonmalignant but historically registered) in the United States. METHODS: Age-standardized incidence rates and annual percent changes (APC) in rates during 1998 to 2013 were calculated for children aged 0 to 19, stratified by subtype, age, sex, and for gliomas, histology and location. We estimated the absolute change in number of cases diagnosed U.S.-wide during 2013 compared with the expected number of cases had 1998 rates remained stable. RESULTS: Rates of all pediatric malignant CNS cancer combined (n = 18,612) did not change [APC: 0.16; 95% confidence interval (CI): -0.21-0.53]. There were statistically significant changes in several subtypes; however, glioma incidence (n = 10,664) increased by 0.77% per year (95% CI: 0.29-1.26), embryonal cancer rates (n = 5,423) decreased by 0.88% per year (95% CI: -1.33 to -0.43), and pilocytic astrocytoma rates (n = 6,858) increased by 0.89% per year (95% CI: 0.21-1.58). Of the 1,171 malignant tumors and 450 pilocytic astrocytomas diagnosed in U.S. children in 2013, we estimated 120 excess gliomas, 94 excess pilocytic astrocytomas, and 72 fewer embryonal CNS tumors than would be expected had 1998 rates remained stable. CONCLUSIONS: The gradual changes in incidence we observed for specific types of pediatric CNS cancers are likely due to a combination of changes in classification and diagnosis and true changes in CNS cancer. IMPACT: Continued surveillance of pediatric CNS tumors should remain a priority, given their significant contribution to pediatric cancer-related deaths.

Association of Chemotherapy for Solid Tumors With Development of Therapy-Related Myelodysplastic Syndrome or Acute Myeloid Leukemia in the Modern Era.

Importance: Therapy-related myelodysplastic syndrome or acute myeloid leukemia (tMDS/AML) is a rare, usually fatal complication of chemotherapy, including certain alkylating agents, topoisomerase II inhibitors, and platinum compounds. With the introduction of new chemotherapeutic agents, expanded indications for established agents, and increased neoadjuvant and adjuvant chemotherapy, tMDS/AML risks in the modern age are poorly understood. Objectives: To quantify tMDS/AML risk after chemotherapy for solid cancer among United States adults since 2000 and correlate tMDS/AML risk patterns with chemotherapy treatment practices. Design, Setting, and Participants: A population-based cohort study was conducted using cancer registries from the Surveillance, Epidemiology, and End Results (SEER) Program and Medicare claims. Risk analyses included 1619 tMDS/AML cases among 700 612 adults (age, 20-84 years) who were diagnosed with first primary solid cancer during 2000 to 2013 (followed up through 2014), received initial chemotherapy, and survived 1 year or longer, as reported to SEER. Descriptive analyses were conducted of SEER records linked with Medicare claims for chemotherapy in 165 820 older adults (age, 66-84 years) receiving initial chemotherapy for a first primary solid cancer in 2000-2013. Data analysis was conducted from October 2017 to April 2018. Exposures: Receipt of initial chemotherapy for solid cancer. Main Outcomes and Measures: Second primary tMDS/AML. Results: Based on 1619 tMDS/AML cases in the SEER database (mean [SD] age, 64.3 [12.2] years; 1148 [70.9%] female), tMDS/AML risks were statistically significantly elevated after chemotherapy for 22 of 23 solid cancers (all except colon). Relative risks ranged from 1.5 to greater than 10 and excess absolute risks from 1.4 to greater than 15 cases per 10 000 person-years compared with the general population. Overall survival following tMDS/AML diagnosis was poor (1270 of 1619 patients [78.4%] died; median overall survival, 7 months). For patients treated with chemotherapy at the present time, approximately three-quarters of tMDS/AML cases expected to occur within the next 5 years will be attributable to chemotherapy. In the SEER-Medicare database, use of known leukemogenic agents, particularly platinum compounds, in initial chemotherapy increased substantially since 2000, most notably for gastrointestinal tract cancers (esophagus, stomach, colon, and rectum; 10% in 2000-2001 to 81% during 2012-2013). Conclusions and Relevance: Large-scale, United States population-based data demonstrate excess tMDS/AML risks following chemotherapy for nearly all solid tumor types, consistent with expanded use of known leukemogenic agents in the 21st century. Continued efforts to reduce treatment-related adverse events, particularly for solid cancer patients with favorable prognosis, are needed.

Differences in cancer survival among white and black cancer patients by presence of diabetes mellitus: Estimations based on SEER-Medicare-linked data resource.

Diabetes prevalence and racial health disparities in the diabetic population are increasing in the US. Population-based cancer-specific survival estimates for cancer patients with diabetes have not been assessed. The Surveillance, Epidemiology, and End Results (SEER)-Medicare linkage provided data on cancer-specific deaths and diabetes prevalence among 14 separate cohorts representing 1 068 098 cancer patients ages 66 +  years diagnosed between 2000 and 2011 in 17 SEER areas. Cancer-specific survival estimates were calculated by diabetes status adjusted by age, stage, comorbidities, and cancer treatment, and stratified by cancer site and sex with whites without diabetes as the reference group. Black patients had the highest diabetes prevalence particularly among women. Risks of cancer deaths were increased across most cancer sites for patients with diabetes regardless of race. Among men the largest effect of having diabetes on cancer-specific deaths were observed for black men diagnosed with Non-Hodgkin lymphoma (NHL) (HR = 1.53, 95%CI = 1.33-1.76) and prostate cancer (HR = 1.37, 95%CI = 1.32-1.42). Diabetes prevalence was higher for black females compared to white females across all 14 cancer sites and higher for most sites when compared to white and black males. Among women the largest effect of having diabetes on cancer-specific deaths were observed for black women diagnosed with corpus/uterus cancer (HR = 1.66, 95%CI = 1.54-1.79), Hodgkin lymphoma (HR = 1.62, 95%CI = 1.02-2.56) and breast ER+ (HR = 1.39, 95%CI = 1.32-1.47). The co-occurrence of diabetes and cancer significantly increases the risk of cancer death. Our study suggests that these risks may vary by cancer site, and indicates the need for future research to address racial and sex disparities and enhance understanding how prevalent diabetes may affect cancer deaths.

Quality Assessment of Tumor Size Data Collection for Pancreatic and Breast Cancer in SEER.

BACKGROUND AND OBJECTIVES: In 2017, the Surveillance, Epidemiology, and End Results (SEER) program piloted a reactive quality audit plan (r-QAP) to analyze Collaborative Stage (CS) tumor size in breast and pancreatic cancer. Preevaluation objectives were to establish procedures and analytic scope for SEER quality audits, cutoffs for data completeness/accuracy, and key decision checkpoints. METHODS: Tumor size data between 2004-2014 were selected from SEER registries for pancreatic and breast cancers, and initially assessed by site and registry for completeness. Further exploration was undertaken via cross tabulation in SEER with the American Joint Committee on Cancer (AJCC) 6th edition derived T data item to evaluate discrepancies between these closely related variables. RESULTS: For both cancer sites, completeness improved between 2004 and 2014, with the proportion of known tumor size values increasing from 60.6% to 79.2% in pancreatic cancer and from 94.0% to 95.9% in breast cancer. Tumor size plausibility categories were established wherein any tumor over 100 mm for pancreatic cancer or over 200 mm for breast cancer were considered highly unlikely. Only 2% of pancreas tumors and 0.1% of breast tumors were implausibly large per site-specific cutoffs. Less than 2% of all tumor size values were potentially discrepant in cross-tabulation with AJCC 6th edition derived T for each site. CONCLUSIONS: Most tumor size values appear to fall within acceptable ranges based on r-QAP activities, and implausibly large tumor size values are rare. Different natural histories and clinical presentation for pancreatic and breast cancer illustrate the need for site-specific cutoffs. Our results indicate that there are no major quality issues in the SEER research database for the CS tumor size data item in either pancreatic or breast cancer.

Validation of prostate-specific antigen laboratory values recorded in Surveillance, Epidemiology, and End Results registries.

BACKGROUND: Researchers have used prostate-specific antigen (PSA) values collected by central cancer registries to evaluate tumors for potential aggressive clinical disease. An independent study collecting PSA values suggested a high error rate (18%) related to implied decimal points. To evaluate the error rate in the Surveillance, Epidemiology, and End Results (SEER) program, a comprehensive review of PSA values recorded across all SEER registries was performed. METHODS: Consolidated PSA values for eligible prostate cancer cases in SEER registries were reviewed and compared with text documentation from abstracted records. Four types of classification errors were identified: implied decimal point errors, abstraction or coding implementation errors, nonsignificant errors, and changes related to "unknown" values. RESULTS: A total of 50,277 prostate cancer cases diagnosed in 2012 were reviewed. Approximately 94.15% of cases did not have meaningful changes (85.85% correct, 5.58% with a nonsignificant change of <1 ng/mL, and 2.80% with no clinical change). Approximately 5.70% of cases had meaningful changes (1.93% due to implied decimal point errors, 1.54% due to abstract or coding errors, and 2.23% due to errors related to unknown categories). Only 419 of the original 50,277 cases (0.83%) resulted in a change in disease stage due to a corrected PSA value. CONCLUSIONS: The implied decimal error rate was only 1.93% of all cases in the current validation study, with a meaningful error rate of 5.81%. The reasons for the lower error rate in SEER are likely due to ongoing and rigorous quality control and visual editing processes by the central registries. The SEER program currently is reviewing and correcting PSA values back to 2004 and will re-release these data in the public use research file. Cancer 2017;123:697-703. © 2016 American Cancer Society.