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PurposeMultiple treatment options exist for patients with metastatic breast cancer (MBC). However, limited information is available on the impact of prior treatment duration and class on survival outcome for novel therapies, such as cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) for patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+ HER2−) MBC.MethodsThis study used a nationwide, de-identified electronic health record-derived database to identify women with HR+ HER2− MBC who received at least one CDK 4/6i between 2011 and 2020. Hazard ratios (HR) and 95% confidence intervals (CI) were estimated for the association between prior duration and class of cancer treatment (both early-stage and metastatic) and prior CDK 4/6i survival as well as for those with multiple CDK 4/6i.ResultsOf 5363 patients, the median survival from first CDK 4/6 inhibitor administration was 3.3 years. When compared to patients with no prior treatments, patients with < 1 year of prior treatment duration had a 30% increased hazard of death (HR, 1.30; 95% CI 1.15–1.46), those with 1 to < 3 years a 68% increased hazard of death (HR 1.68; 95% CI 1.49–1.88), and those with 3 or more years a 55% increased hazard of death (HR 1.55; 95% CI 1.36, 1.76). Patients who received prior therapy (endocrine or chemotherapy) before their CDK 4/6i had worse outcomes than those who received no prior therapy. Similar results were seen when comparing patients in the metastatic setting alone. Finally, patients who received a different CDK 4/6i after their first saw a lower hazard of death compared to patients who received subsequent endocrine or chemotherapy after their first CDK 4/6i.ConclusionPrior treatment duration and class are associated with a decreased overall survival after CDK 4/6 inhibitor administration. This highlights the importance for clinicians to consider prior treatment and duration in treatment decision-making and for trialists to stratify by these factors when randomizing patients or reporting results of future studies.

Uninsured or underinsured individuals with cancer are likely to experience financial hardship, including forgoing healthcare or non-healthcare needs such as food, housing, or utilities. This study evaluates the association between health insurance coverage and financial hardship among cancer survivors during the COVID-19 pandemic. This cross-sectional analysis used Patient Advocate Foundation (PAF) survey data from May to July 2020. Cancer survivors who previously received case management or financial aid from PAF self-reported challenges paying for healthcare and non-healthcare needs during the COVID-19 pandemic. Associations between insurance coverage and payment challenges were estimated using Poisson regression with robust standard errors, which allowed for estimation of adjusted relative risks (aRR). Of 1,437 respondents, 74% had annual household incomes <$48,000. Most respondents were enrolled in Medicare (48%), 22% in employer-sponsored insurance, 13% in Medicaid, 6% in an Affordable Care Act (ACA) plan, and 3% were uninsured. Approximately 31% of respondents reported trouble paying for healthcare during the COVID-19 pandemic. Respondents who were uninsured (aRR 2.58, 95% confidence interval [CI] 1.83–3.64), enrolled in an ACA plan (aRR 1.86, 95% CI 1.28–2.72), employer-sponsored insurance (aRR 1.70, 95% CI 1.23–2.34), or Medicare (aRR 1.49, 95% CI 1.09–2.03) had higher risk of trouble paying for healthcare compared to Medicaid enrollees. Challenges paying for non-healthcare needs were reported by 57% of respondents, with 40% reporting trouble paying for food, 31% housing, 28% transportation, and 20% internet. In adjusted models, Medicare and employer-sponsored insurance enrollees were less likely to have difficulties paying for non-healthcare needs compared to Medicaid beneficiaries. Despite 97% of our cancer survivor sample being insured, 31% and 57% reported trouble paying for healthcare and non-healthcare needs during the COVID-19 pandemic, respectively. Greater attention to both medical and non-medical financial burden is needed given the economic pressures of the COVID-19 pandemic.

Numerous healthcare decisions are faced by persons with advanced cancer from diagnosis to end-of-life. The family caregiver role in these decisions has focused on being a surrogate decision-maker, however, little is known about the caregiver's role in supporting upstream patient decision-making. We aimed to describe the roles of family caregivers in assisting community-dwelling advanced cancer patients with healthcare decision-making across settings and contexts. Qualitative study using one-on-one, semi-structured interviews with community-dwelling persons with metastatic cancer (n = 18) and their family caregivers (n = 20) recruited from outpatient oncology clinics of a large tertiary care academic medical center, between October 2016 and October 2017. Transcribed interviews were analyzed using a thematic analysis approach. Caregivers averaged 56 years and were mostly female (95%), white (85%), and the patient's partner/spouse (70%). Patients averaged 58 years and were mostly male (67%) in self-reported \"fair\" or \"poor\" health (50%) with genitourinary (33%), lung (17%), and hematologic (17%) cancers. Themes describing family member roles in supporting patients' upstream healthcare decision-making were: 1) seeking information about the cancer, its trajectory, and treatments options; 2) ensuring family and healthcare clinicians have a common understanding of the patient's treatment plan and condition; 3) facilitating discussions with patients about their values and the framing of their illness; 5) posing \"what if\" scenarios about current and potential future health states and treatments; 6) addressing collateral decisions (e.g., work arrangements) resulting from medical treatment choices; 6) originating healthcare-related decision points, including decisions about seeking emergency care; and 7) making healthcare decisions for patients who preferred to delegate healthcare decisions to their family caregivers. These findings highlight a previously unreported and understudied set of critical decision partnering roles that cancer family caregivers play in patient healthcare decision-making. Optimizing these roles may represent novel targets for early decision support interventions for family caregivers.

A recent study not only confirms mounting evidence that technology-facilitated symptom monitoring improves care and should be considered for all patients with cancer, but also suggests that patient navigators can help to deliver such interventions. Herein we discuss how such an approach can minimize disparities and maximize access to culturally appropriate patient-centred care.

Background In qualitative work, patients report that seemingly short trips to clinic (eg, a supposed 10-minute blood draw) often turn into “all-day affairs.” We sought to quantify the time patients with cancer spend attending ambulatory appointments. Methods We conducted a retrospective study of patients scheduled for oncology-related ambulatory care (eg, labs, imaging, procedures, infusions, and clinician visits) at an academic cancer center over 1 week. The primary exposure was the ambulatory service type(s) (eg, clinician visit only, labs and infusion, etc.). We used Real-Time Location System badge data to calculate clinic times and estimated round-trip travel times and parking times. We calculated and summarized clinic and total (clinic + travel + parking) times for ambulatory service types. Results We included 435 patients. Across all service day type(s), the median (IQR) clinic time was 119 (78-202) minutes. The estimated median (IQR) round-trip driving distance and travel time was 34 (17-49) miles and 50 (36-68) minutes. The median (IQR) parking time was 14 (12-15) minutes. Overall, the median (IQR) total time was 197 (143-287) minutes. The median total times for specific service type(s) included: 99 minutes for lab-only, 144 minutes for clinician visit only, and 278 minutes for labs, clinician visit, and infusion. Conclusion Patients often spent several hours pursuing ambulatory cancer care on a given day. Accounting for opportunity time costs and the coordination of activities around ambulatory care, these results highlight the substantial time burdens of cancer care, and support the notion that many days with ambulatory health care contact may represent “lost days.” This study used real-time location system and geolocation data to assess how much time (in minutes) patients spent on attending clinic appointments. Even seemingly short appointments can take up hours of patients' days, supporting the notion that that day may indeed represent a ''lost day''.

Abstract Background Strict eligibility criteria for participation in randomized clinical trials (RCTs) often limit the generalizability of data when applied to a more heterogeneous real-world population. Thus, evidence generated directly from real-world populations, including subgroups underrepresented in RCTs, can help inform routine clinical practice. POLARIS (NCT03280303), a prospective, observational, multicenter, cohort study, evaluated patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2−) advanced breast cancer (ABC) receiving palbociclib + endocrine therapy (ET) in routine care. Methods Demographics, baseline characteristics, and treatment patterns were summarized descriptively. Real-world response and clinical benefit rates, real-world progression-free survival (rwPFS), and overall survival (OS) were summarized descriptively by line of therapy and endocrine partner in the overall cohort and various subgroups. Results Between January 2017 and October 2019, 1250 patients (median age of 64.0 years) initiated treatment with palbociclib-based therapy, including 901 in the first-line (1L) setting and 349 in the second-line or later (≥2L) settings. Real-world response and clinical benefit rates with palbociclib + ET were 34.0% and 69.4%, respectively, in 1L, and 21.8% and 57.9% in ≥2L. Median rwPFS was 20.9 (95% CI, 18.7-24.7) and 13.5 (10.6-17.1) months, and median OS was 48.5 (42.0-not estimable) and 37.2 (31.2-40.8) months, with 1L and ≥2L palbociclib + ET, respectively. Conclusions Outcomes in this large, heterogeneous, real-world population are generally consistent with previously reported results from clinical trials and other real-world studies, further supporting the use of palbociclib + ET in patients with HR+/HER2− ABC. Trial registration NCT03280303 (ClinicalTrials.gov).

Breast cancer is the most commonly diagnosed cancer worldwide and is one of the leading causes of cancer death. The incidence, pathological features, and clinical outcomes in breast cancer differ by geographical distribution and across racial and ethnic populations. Importantly, racial and ethnic diversity in breast cancer clinical trials is lacking, with both Blacks and Hispanics underrepresented. In this forum article, breast cancer researchers from across the globe discuss the factors contributing to racial and ethnic breast cancer disparities and highlight specific implications of precision oncology approaches for equitable provision of breast cancer care to improve outcomes and address disparities.

Background Poly (ADP-ribose)-polymerase inhibitors (PARPi) have been approved for cancer patients with germline BRCA1/2 (g BRCA1/2 ) mutations, and efforts to expand the utility of PARPi beyond BRCA1/2 are ongoing. In preclinical models of triple-negative breast cancer (TNBC) with intact DNA repair, we have previously shown an induced synthetic lethality with combined EGFR inhibition and PARPi. Here, we report the safety and clinical activity of lapatinib and veliparib in patients with metastatic TNBC. Methods A first-in-human, pilot study of lapatinib and veliparib was conducted in metastatic TNBC (NCT02158507). The primary endpoint was safety and tolerability. Secondary endpoints were objective response rates and pharmacokinetic evaluation. Gene expression analysis of pre-treatment tumor biopsies was performed. Key eligibility included TNBC patients with measurable disease and prior anthracycline-based and taxane chemotherapy. Patients with g BRCA1/2 mutations were excluded. Results Twenty patients were enrolled, of which 17 were evaluable for response. The median number of prior therapies in the metastatic setting was 1 (range 0–2). Fifty percent of patients were Caucasian, 45% African–American, and 5% Hispanic. Of evaluable patients, 4 demonstrated a partial response and 2 had stable disease. There were no dose-limiting toxicities. Most AEs were limited to grade 1 or 2 and no drug–drug interactions noted. Exploratory gene expression analysis suggested baseline DNA repair pathway score was lower and baseline immunogenicity was higher in the responders compared to non-responders. Conclusions Lapatinib plus veliparib therapy has a manageable safety profile and promising antitumor activity in advanced TNBC. Further investigation of dual therapy with EGFR inhibition and PARP inhibition is needed. Trial registration ClinicalTrials.gov , NCT02158507 . Registered on 12 September 2014