Pooled clinical trial analyses evaluating outcomes of HER2-low vs HER2-0 expression in patients with metastatic breast cancer following chemotherapy.

The therapeutic importance of subsetting patients with HER2-negative breast cancer according to their tumors' cellular HER2 expression (e.g., HER2-low vs.

Association Between State Medicaid Policies and Accrual of Black or Hispanic Patients to Cancer Clinical Trials.

Purpose: It is unknown whether Medicaid expansion under the Affordable Care Act (ACA) or state-level policies mandating Medicaid coverage of the routine costs of clinical trial participation have ameliorated longstanding racial and ethnic disparities in cancer clinical trial enrollment.

Methods: We conducted a retrospective, cross-sectional difference-in-differences analysis examining the effect of Medicaid expansion on rates of enrollment for Black or Hispanic nonelderly adults in nonobservational, US cancer clinical trials using data from Medidata's Rave platform for 2012-2019. We examined heterogeneity in this effect on the basis of whether states had pre-existing mandates requiring Medicaid coverage of the routine costs of clinical trial participation.

Historic Clinical Trial External Control Arm Provides Actionable GEN-1 Efficacy Estimate Before a Randomized Trial.

Purpose: To inform continued development of the novel immune agent GEN-1, we compared ovarian cancer patients' end points from a neoadjuvant single-arm phase IB study with those of similar historic clinical trial (HCT) patients who received standard neoadjuvant chemotherapy.

Methods: Applying OVATION-1 trial (ClinicalTrials.gov identifier: NCT02480374) inclusion and exclusion criteria to Medidata HCT data, we identified historical trial patients for comparison.

Trends in Oncology Clinical Trials Launched Before and During the COVID-19 Pandemic.

This cohort study evaluates the association of the coronavirus disease 2019 (COVID-19) pandemic with clinical research and development for cancer by studying the initiation of oncology clinical trials over time.

Associations Between Amplification (1q) and Prior Cancer in a Real-World De Novo Myeloma Cohort.

Genomic biomarkers inform treatment in multiple myeloma (MM), making patient clinical data a potential window into MM biology. We evaluated de novo MM patients for associations between specific MM cytogenetic patterns and prior cancer history. Analyzing a MM real-world dataset, we identified a cohort of 1769 patients with fluorescent in situ hybridization cytogenetic testing at diagnosis.

Medicare Beneficiaries With Advanced Lung Cancer Experience Diverse Patterns Of Care From Diagnosis To Death.

Characterizations of average end-of-life care for people with cancer can obscure important differences in patients' experiences. Using Medicare claims data for 14,257 patients diagnosed with extensive-stage small-cell lung cancer in the period 1995-2009, we used latent class analysis to identify classes of people with different care patterns. We characterized care trajectories from diagnosis to death using time spent in five care settings-home, hospital inpatient unit (acute), hospital intensive care unit (ICU), postacute skilled nursing facility, and hospice-and transitions across these settings.

Survival and Toxicity After Cisplatin Plus Etoposide Versus Carboplatin Plus Etoposide for Extensive-Stage Small-Cell Lung Cancer in Elderly Patients.

Purpose: Elderly patients with cancer are under-represented in clinical trials and risk greater toxicity from chemotherapy. These patients and their physicians need better evidence to decide among guideline-recommended regimens. We test whether patients with extensive-stage small-cell lung cancer (ES SCLC) have noninferior survival and less hospital-based health care after carboplatin/etoposide compared with cisplatin/etoposide.

Trends in the Treatment of Metastatic Colon and Rectal Cancer in Elderly Patients.

Background: Little is known about the use and costs of antineoplastic regimens for elderly patients with metastatic colorectal cancer (mCRC). We report population-based trends over a 10-year period in the treatment, survival, and costs in mCRC patients, stratified by ages 65-74 and 75+.

Methods: We used Surveillance, Epidemiology, and End Results-Medicare data for persons diagnosed with metastatic colon (N=16117) or rectal cancer (N=4008) between 2000 and 2009.

Comparing a medical records-based and a claims-based index for measuring comorbidity in patients with lung or colon cancer.

Objective: Ascertaining comorbid conditions in cancer patients is important for research and clinical quality measurement, and is particularly important for understanding care and outcomes for older patients and those with multi-morbidity. We compared the medical records-based ACE-27 index and the claims-based Charlson index in predicting receipt of therapy and survival for lung and colon cancer patients.

Materials And Methods: We calculated the Charlson index using administrative data and the ACE-27 score using medical records for Veterans Affairs patients diagnosed with stage I/II non-small cell lung or stage III colon cancer from January 2003 to December 2004.

Generalizability of trial results to elderly Medicare patients with advanced solid tumors (Alliance 70802).

Background: In the United States, patients who enroll in chemotherapy trials seldom reflect the attributes of the general population with cancer, as they are often younger, more functional, and have less comorbidity. We compared survival following three chemotherapy regimens according to the setting in which care was delivered (ie, clinical trial vs usual care) to determine the generalizability of clinical trial results to unselected elderly Medicare patients.

Methods: Using SEER-Medicare data, we estimated survival for elderly patients (ie, age 65 years or older, n = 14097) with advanced pancreatic or lung cancer following receipt of one of three guideline-recommended first-line chemotherapy regimens.

Elderly breast and colorectal cancer patients' clinical course: patient and contextual influences.

Background: The social and medical environments that surround people are each independently associated with their cancer course. The extent to which these characteristics may together mediate patients' cancer care and outcomes is not known.

Methods: Using multilevel methods and data, we studied elderly breast and colorectal cancer patients (level I) within urban social (level II: ZIP code tabulation area) and health care (level III: hospital service area) contexts.

Hospital-based health care use correlates with incidence of adverse events among elderly Medicare patients treated in adjuvant chemotherapy trials (Alliance 70802).

Objective: Medicare claims can be useful in chemotherapy-related comparative effectiveness research (CER) estimating survival, but methods for estimating patients' treatment morbidity are currently lacking. We sought to determine if patients' health care use in the claims is a marker of treatment morbidity.

Materials And Methods: For 249 elderly Medicare patients with breast or colon cancer who were treated in two adjuvant clinical trials, we merged patients' National Cancer Institute Common Toxicity Criteria for Adverse Events (CTC AEs) trial data with their contemporaneous Medicare claims.

Rural residence and cancer outcomes in the United States: issues and challenges.

"Neighborhoods and health" research has shown that area social factors are associated with the health outcomes that patients with cancer experience across the cancer control continuum. To date, most of this research has been focused on the attributes of urban areas that are associated with residents' poor cancer outcomes with less focused on attributes of rural areas that may be associated with the same. Perhaps because there is not yet a consensus in the United States regarding how to define "rural," there is not yet an accepted analytic convention for studying issues of how patients' cancer outcomes may vary according to "rural" as a contextual attribute.

Tumor boards and the quality of cancer care.

Background: Despite the widespread use of tumor boards, few data on their effects on cancer care exist. We assessed whether the presence of a tumor board, either general or cancer specific, was associated with recommended cancer care, outcomes, or use in the Veterans Affairs (VA) health system.

Methods: We surveyed 138 VA medical centers about the presence of tumor boards and linked cancer registry and administrative data to assess receipt of stage-specific recommended care, survival, or use for patients with colorectal, lung, prostate, hematologic, and breast cancers diagnosed in the period from 2001 to 2004 and followed through 2005.

Predictors of newly diagnosed cancer patients' understanding of the goals of their care at initiation of chemotherapy.

Background: The American Society of Clinical Oncology Quality Oncology Practice Initiative endorses in their core measures that providers should discuss the goals of care (GOC) at the time of chemotherapy consent. GOC refers to chemotherapy treatment intent: cure versus noncure. In this study, the authors sought to determine whether attributes of patients and initial patient-physician encounters were associated with patients' understanding of their GOC.

Do socially deprived urban areas have lesser supplies of cancer care services?

Purpose: Area social deprivation is associated with unfavorable health outcomes of residents across the full clinical course of cancer from the stage at diagnosis through survival. We sought to determine whether area social factors are associated with the area health care supply.

Patients And Methods: We studied the area supply of health services required for the provision of guideline-recommended care for patients with breast cancer and colorectal cancer (CRC) in each of the following three distinct clinical domains: screening, treatment, and post-treatment surveillance.

Most colorectal cancer survivors live a large proportion of their remaining life in good health.

Purpose: Colorectal cancer (CRC) diagnosis reduces life expectancy and decreases patients' well-being. We sought to assess the determinants of health and functional status and estimate the proportion of remaining life that CRC survivors would spend in good health.

Methods: Using Sullivan method, healthy life expectancy was calculated based on survival data of 14,849 CRC survivors within a population-based cancer registry in southern Netherlands and quality of life information among a random sample of these survivors (n = 1,291).

Area-level variations in cancer care and outcomes.

Background: : Substantial regional variations in health-care spending exist across the United States; yet, care and outcomes are not better in higher-spending areas. Most studies have focused on care in fee-for-service Medicare; whether spillover effects exist in settings without financial incentives for more care is unknown.

Objective: : We studied care for cancer patients in fee-for-service Medicare and the Veterans Health Administration (VA) to understand whether processes and outcomes of care vary with area-level Medicare spending.

Sensitivity of Medicare claims data for measuring use of standard multiagent chemotherapy regimens.

Purpose: We sought to determine the accuracy with which Medicare billing data documents elderly Medicare cancer patients' receipt of common multiagent chemotherapy regimens.

Methods: We merged gold-standard clinical trial data from 406 elderly cancer patients known to be treated on 1 of 6 Cancer and Leukemia Group B (CALGB) breast, colorectal, and lung cancer trials (trial numbers; 9344, 9730, 9235,9732, 80203, 89803) with their Medicare claims data from Centers for Medicare and Medicaid Services (CMS). Comparing CMS chemotherapy codes to gold-standard CALGB treatment data, we estimated Medicare data's sensitivity at measuring the correct drugs and schedule for each of the multiagent chemotherapy regimens.

Survival of older patients with cancer in the Veterans Health Administration versus fee-for-service Medicare.

Purpose: The Veterans Health Administration (VHA) provides high-quality preventive chronic care and cancer care, but few studies have documented improved patient outcomes that result from this high-quality care. We compared the survival rates of older patients with cancer in the VHA and fee-for-service (FFS) Medicare and examined whether differences in the stage at diagnosis, receipt of guideline-recommended therapies, and unmeasured characteristics explain survival differences.

Patients And Methods: We used propensity-score methods to compare all-cause and cancer-specific survival rates for men older than age 65 years who were diagnosed or received their first course of treatment for colorectal, lung, lymphoma, or multiple myeloma in VHA hospitals from 2001 to 2004 to similar FFS-Medicare enrollees diagnosed in Surveillance, Epidemiology, and End Results (SEER) areas in the same time frame.

Understanding variation in primary prostate cancer treatment within the Veterans Health Administration.

Objective: To examine the variation in prostate cancer treatment in the Veterans Health Administration (VHA)--a national, integrated delivery system. We also compared the care for older men in the VHA with that in fee-for-service Medicare.

Methods: We used data from the Veterans Affairs Central Cancer Registry linked with administrative data and Surveillance, Epidemiology, and End Results-Medicare data to identify men with local or regional prostate cancer diagnosed during 2001 to 2004.

Location of cancer surgery for older veterans with cancer.

Objective: Many veterans undergo cancer surgery outside of the Veterans Health Administration (VHA). We assessed to what extent these patients obtained care in the VHA before surgery.

Data Sources: VHA-Medicare data, VHA administrative data, and Veterans Affairs Central Cancer Registry data.

Reasons for underuse of recommended therapies for colorectal and lung cancer in the Veterans Health Administration.

Background: Many studies have documented low rates of effective cancer therapies, particularly in older or minority populations. However, little is known about why effective therapies are underused in these populations.

Methods: The authors examined medical records of 584 patients with cancer diagnosed or treated in Department of Veterans Affairs facilities to assess reasons for lack of 1) surgery for stage I/II nonsmall cell lung cancer, 2) surgery for stage I/II/III rectal cancer, 3) adjuvant radiation therapy for stage II/III rectal cancer, and 4) adjuvant chemotherapy for stage III colon cancer.