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  • 1
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    Online Resource
    Real-world effectiveness of palbociclib in combination with an aromatase inhibitor as first-line therapy in metastatic breast cancer.
    American Society of Clinical Oncology (ASCO) ; 2019
    In:  Journal of Clinical Oncology Vol. 37, No. 15_suppl ( 2019-05-20), p. e12541-e12541
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 37, No. 15_suppl ( 2019-05-20), p. e12541-e12541
    Abstract: e12541 Background: Palbociclib in combination with an aromatase inhibitor (AI) was approved as initial endocrine therapy for patients with HR+/HER2– metastatic/advanced breast cancer (mBC) in February 2015. Evidence of real world outcomes for the combination to date has been limited by small sample size and short follow-up. This study describes patient characteristics and effectiveness of palbociclib + AI as first-line therapy in a large cohort of mBC patients in US clinical practice. Methods: Utilizing Flatiron Health’s longitudinal database, a retrospective cohort study was conducted to evaluate patients with HR+/HER2– mBC who started palbociclib + AI as first-line therapy between February 3, 2015 and August, 31, 2018. Patients were evaluated retrospectively from start of palbociclib + AI therapy on or after February 3, 2015 to November 30, 2018, death, or last visit in the database, whichever came first. Real-world progression free survival (rwPFS) was defined as months from start of palbociclib + AI therapy to death or disease progression based on clinical assessment or evidence by radiographic scan/tissue biopsy. Kaplan-Meier methods were used to estimate survival proportions in overall survival (OS) and rwPFS. Results: Of 878 who met the criteria, 66.9% were white, mean age was 65.2 years, 50.8% had visceral disease (liver and/or lung involvement), and 94% were treated in community practice. Patients were followed up to 46 months. Median rwPFS was 21.9 months (95% CI = 20.1 – 28.2). At 3 years of follow-up, OS rate was 91.9%. For additional outcomes, see Table. Conclusions: These findings from the largest cohort yet evaluated for real world effectiveness confirm the effectiveness of palbociclib + AI in routine clinical practice as a standard of care for first line treatment of HR+/HER2- mBC. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2019.37.15_suppl.e12541
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2019
    detail.hit.zdb_id: 2005181-5
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  • 2
    Online Resource
    Online Resource
    The effect of neutropenia on patient-reported functioning and quality of life (QOL) among palbociclib participants of the MADELINE study.
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. 1064-1064
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. 1064-1064
    Abstract: 1064 Background: MADELINE is an observational, multicenter study of women with HR+/HER2- advanced or metastatic breast cancer who were followed for 6 months to evaluate patient reported QOL after initiating palbociclib combination therapy or other approved treatment in the US. A novel mobile application was developed to capture PROs for QOL at daily, weekly, monthly/cycle-based intervals for up to 6 months. QOL measures were evaluated to determine if palbociclib-treated patients experiencing episodes of neutropenia had associated decreases in QOL compared to patients without episodes of neutropenia. Methods: Patients completed the SF-12 and CES-D-10 at baseline and each cycle. Change from baseline was assessed using mean scores and mixed-effects models. Daily pain and fatigue severity were measured on an 11-point scale (0-10, 10 being worst possible pain/fatigue) and averaged to create weekly scores. Patients indicated weekly how breast cancer or its treatment interfered with family/social life, productivity, physical activity and energy on a 5-point scales (from not at all to a great deal). Demographic and clinical data including adverse events were recorded in an eCRF. Results: 25 sites contributed 139 patients (median [range] age 60 [34, 82] ; white: 83%; ECOG 0-1: 87%). During the 6-month follow up period, 45% of patients experienced ≥1 neutropenia event (grade 1-4: 17%, 27%, 24%, 2%) and 11% had an event resulting in a dose change. Least-square (LS) mean change from baseline to end of study for the SF-12 Physical/Mental Component summaries (PCS/MCS) and the CES-D-10 showed no association between neutropenia and decreased QOL. Daily pain/fatigue was relatively stable for those with neutropenia (cycle 1, week 1: 2.8 [1.95] and 1.8 [0.95] ; cycle 6, week 1: 2.4 [1.95] and 2.3 [1.59] ) and those without (cycle 1, week 1: 2.2 [2.46] and 2.8 [2.39] ; cycle 6, week 1: 1.6 [2.29] and 2.4 [2.22] ). There was no significant change for impact of breast cancer or treatment across cycles. Conclusions: Patients with neutropenia did not experience decreased QOL compared to patients without neutropenia nor did patients as a whole experience numerically or clinically meaningful decrease in QOL throughout the follow up period. Daily PROs collected suggest a low level of pain/fatigue that did not change substantially over time. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.1064
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
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  • 3
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    Comparative effectiveness of first-line palbociclib plus letrozole versus letrozole alone for HR+/HER2− metastatic breast cancer in US real-world clinical practice
    Springer Science and Business Media LLC ; 2021
    In:  Breast Cancer Research Vol. 23, No. 1 ( 2021-12)
    Details
    In: Breast Cancer Research, Springer Science and Business Media LLC, Vol. 23, No. 1 ( 2021-12)
    Abstract: Findings from randomized clinical trials may have limited generalizability to patients treated in routine clinical practice. This study examined the effectiveness of first-line palbociclib plus letrozole versus letrozole alone on survival outcomes in patients with hormone receptor–positive (HR+)/human epidermal growth factor receptor–negative (HER2−) metastatic breast cancer (MBC) treated in routine clinical practice in the USA. Patients and methods This was a retrospective observational analysis of electronic health records within the Flatiron Health Analytic Database. A total of 1430 patients with ≥ 3 months of follow-up received palbociclib plus letrozole or letrozole alone in the first-line setting between February 3, 2015, and February 28, 2019. Stabilized inverse probability treatment weighting (sIPTW) was used to balance baseline demographic and clinical characteristics. Real-world progression-free survival (rwPFS) and overall survival (OS) were analyzed. Results After sIPTW adjustment, median follow-up was 24.2 months (interquartile range [IQR], 14.2–34.9) in the palbociclib group and 23.3 months (IQR, 12.7–34.3) in those taking letrozole alone. Palbociclib combination treatment was associated with significantly longer median rwPFS compared to letrozole alone (20.0 vs 11.9 months; hazard ratio [HR] , 0.58; 95% CI, 0.49–0.69; P   〈  0.0001). Median OS was not reached in the palbociclib group and was 43.1 months with letrozole alone (HR, 0.66; 95% CI, 0.53–0.82; P  = 0.0002). The 2-year OS rate was 78.3% in the palbociclib group and 68.0% with letrozole alone. A propensity score matching analysis showed similar results. Conclusions In this “real-world” population of patients with HR+/HER2− MBC, palbociclib in combination with endocrine therapy was associated with improved survival outcomes compared with patients treated with letrozole alone in the first-line setting. Trial registration Clinicaltrials.gov; NCT04176354
    Type of Medium: Online Resource
    ISSN: 1465-542X
    URL: Article
    DOI: 10.1186/s13058-021-01409-8
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2021
    detail.hit.zdb_id: 2041618-0
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  • 4
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    Online Resource
    Many Faces of Openness in Adoption: Perspectives of Adopted Adolescents and Their Parents
    Informa UK Limited ; 2007
    In:  Adoption Quarterly Vol. 10, No. 3-4 ( 2007-07-01), p. 79-101
    Details
    In: Adoption Quarterly, Informa UK Limited, Vol. 10, No. 3-4 ( 2007-07-01), p. 79-101
    Type of Medium: Online Resource
    ISSN: 1092-6755 , 1544-452X
    URL: Article
    DOI: 10.1080/10926750802163204
    Language: English
    Publisher: Informa UK Limited
    Publication Date: 2007
    detail.hit.zdb_id: 2112803-0
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  • 5
    Online Resource
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    Comorbidities among patients with breast cancer during COVID-19: Agreement between patient-reported data and electronic medical records.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 28_suppl ( 2022-10-01), p. 409-409
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 28_suppl ( 2022-10-01), p. 409-409
    Abstract: 409 Background: Comorbidities are a major cause of complications in cancer patients and can increase the risk of severe illness from coronavirus disease 2019 (COV). Yet, in real-world studies of cancer patients, comorbidities are often not well captured in electronic medical records (EMR); self-reported comorbidities may be limited by recall error. Combining and comparing self-reported and EMR data may help identify key data gaps in comorbidity diagnosis. We aimed to estimate self-reported and EMR-documented comorbidities and examine agreement between these data sources in US patients with early-stage (eBC) or metastatic (mBC) breast cancer. Methods: From March 30 to July 6, 2021, patients (aged ≥18 years) who self-reported a BC diagnosis (no current Stage 0 or ductal carcinoma in situ) and provided consent were recruited via Ciitizen, a patient-mediated health records and real-world evidence platform, and patient advocacy groups to complete a cross-sectional online survey. EMR data from Invitaes Ciitizen platform, covering November 1, 2019-September 28, 2021, were collected. The datasets were then linked; in preliminary assessment, depression (DEP), anxiety (ANX), and COV were the only comorbidities sufficiently populated to enable agreement analysis. DEP, ANX, and COV prevalence rates in EMR and survey data were computed. Agreement between data sources was estimated using Cohens kappa. Results: Overall, 542 patients in the linked sample were included in the analyses. A majority was female (99%), aged ≥50 years (52%), and diagnosed with mBC (53%). Patients were similarly distributed by US geographic region. DEP, ANX, and COV prevalence rates were 40%, 50%, and 6% in EMR and 20%, 16% and 10% in survey, respectively (Table). The kappa values for agreement were.5 (DEP),.3 (ANX), and.8 (COV). Conclusions: Mental health conditions and COV were prevalent in BC patients during the pandemic. It is important for oncologists to consider that DEP and ANX are often underreported among patients with BC. Agreement between data sources was low for mental health conditions. Self-report and EMR data may thus provide complementary information on comorbidities.[Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.28_suppl.409
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
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  • 6
    Online Resource
    Online Resource
    Table_1.docx
    Frontiers Media SA ; 2023
    In:  Frontiers in Oncology Vol. 13 ( 2023-9-28)
    Details
    In: Frontiers in Oncology, Frontiers Media SA, Vol. 13 ( 2023-9-28)
    Abstract: Elderly patients are generally underrepresented in oncology clinical trials; therefore, real-world data are needed to inform clinical management of elderly patients with hormone receptor–positive/human epidermal growth factor receptor 2–negative (HR+/HER2−) metastatic breast cancer (mBC). This subanalysis of the P-REALITY X study (NCT05361655) evaluated palbociclib treatment patterns and comparative effectiveness of palbociclib plus an aromatase inhibitor (AI) versus an AI alone among patients with HR+/HER2− mBC aged ≥ 75 years treated in routine clinical practice in the United States. Methods This retrospective observational cohort study used electronic health records from the Flatiron Health Analytic Database. Palbociclib treatment patterns, overall survival (OS), real-world progression-free survival (rwPFS), and time to chemotherapy (TTC) were evaluated. Three methods were used for comparative analyses: (1) an unadjusted analysis, (2) stabilized inverse probability treatment weighting (sIPTW; primary analysis), and (3) propensity score matching (PSM; sensitivity analysis). Results A total of 961 patients aged ≥ 75 years with HR+/HER2− mBC were identified who started palbociclib plus an AI (n = 313) or an AI alone (n = 648) as first-line (1L) therapy between February 2015 and March 2020 (data cut-off: September 30, 2020). Among patients in the palbociclib plus an AI group with a documented palbociclib starting dose (n = 306), approximately 75% started palbociclib at 125 mg/day, and approximately 40% experienced dose adjustment. After sIPTW, patients treated with palbociclib plus an AI versus an AI alone had significantly improved OS (median of 43.0 vs. 32.4 months; hazard ratio [HR], 0.66 [95% confidence interval (CI), 0.51–0.84] ; P = 0.0007), rwPFS (median of 20.0 vs. 15.0 months; HR, 0.72 (0.59–0.89); P = 0.0021), and TTC (median of 40.2 vs. 27.4 months; HR, 0.69 [0.55–0.87]; P = 0.0014). These significant improvements in OS, rwPFS, and TTC remained consistent in the unadjusted analysis and after PSM. Conclusion This real-world comparative analysis demonstrated that 1L palbociclib plus an AI is associated with improved effectiveness compared with an AI alone among patients with HR+/HER2− mBC aged ≥ 75 years. These findings support palbociclib plus an AI as a standard-of-care 1L treatment for elderly patients with HR+/HER2− mBC.
    Type of Medium: Online Resource
    ISSN: 2234-943X
    URL: Article
    URL: Article
    DOI: 10.3389/fonc.2023.1237751
    DOI: 10.3389/fonc.2023.1237751.s001
    Language: Unknown
    Publisher: Frontiers Media SA
    Publication Date: 2023
    detail.hit.zdb_id: 2649216-7
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  • 7
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    Real-World Effectiveness of Palbociclib Plus Letrozole vs Letrozole Alone for Metastatic Breast Cancer With Lung or Liver Metastases: Flatiron Database Analysis
    Frontiers Media SA ; 2022
    In:  Frontiers in Oncology Vol. 12 ( 2022-7-4)
    Details
    In: Frontiers in Oncology, Frontiers Media SA, Vol. 12 ( 2022-7-4)
    Abstract: Cyclin-dependent kinase 4/6 inhibitors are a standard treatment for patients with hormone receptor−positive (HR+)/human epidermal growth factor receptor 2−negative (HER2−) metastatic breast cancer (MBC). However, real-world data on effectiveness in patients with liver or lung metastatic disease is limited. This study compared outcomes of palbociclib plus letrozole versus letrozole alone in patients with HR+/HER2− MBC with lung or liver metastasis treated in routine clinical practice in the United States. Methods This retrospective analysis used Flatiron Health’s database of electronic health records. Women with HR+/HER2− MBC and liver or lung metastasis received first-line palbociclib plus letrozole or letrozole alone between February 2015 and February 2019. Real-world progression-free survival (rwPFS) was defined as time from start of treatment to death or disease progression. Stabilized inverse probability treatment weighting (sIPTW) was used to balance baseline demographic and clinical characteristics between palbociclib plus letrozole versus letrozole cohorts. Cox proportional-hazards models were used to estimate the effectiveness of palbociclib plus letrozole versus letrozole alone in rwPFS and overall survival (OS). Results The study included 353 patients with lung metastasis, 123 with liver metastasis, and 75 with both. After sIPTW, palbociclib plus letrozole versus letrozole alone was significantlly associated with prolonged rwPFS (hazard ratio (HR), 0.56) and OS (HR, 0.58) (both p & lt;0.001) in all patients. Palbociclib plus letrozole compared with letrozole alone demonstrated a median rwPFS of 16.5 versus 10.5 months, respectively (adjusted HR, 0.52; P & lt;0.001), a median OS of not reached versus 40.3 months (adjusted HR, 0.60; P & lt;0.01) in patients with lung metastasis, and median OS of 30.1 versus 16.8 months (adjusted HR, 0.56; P & lt;0.03 in patients with liver metastasis. In patients with liver metastasis, palbociclib plus letrozole had a median rwPFS of 10.7 months versus 8.0 months in the letrozole alone cohort (adjusted HR, 0.70; P =0.12). Conclusions In this real-world population, palbociclib in combination with letrozole is associated with improved outcomes compared with letrozole alone for patients with HR+/HER2− MBC and liver or lung metastasis in the first-line setting. The findings support first-line palbociclib in combination with an aromatase inhibitor as standard of care for HR+/HER2− MBC regardless of visceral disease. Clinical Trial Registration NCT04176354.
    Type of Medium: Online Resource
    ISSN: 2234-943X
    URL: Article
    DOI: 10.3389/fonc.2022.865292
    Language: Unknown
    Publisher: Frontiers Media SA
    Publication Date: 2022
    detail.hit.zdb_id: 2649216-7
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  • 8
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    A prospective observational study of patient-reported functioning and quality of life in advanced and metastatic breast cancer utilizing a novel mobile application
    Springer Science and Business Media LLC ; 2021
    In:  Breast Cancer Research and Treatment Vol. 187, No. 1 ( 2021-05), p. 113-124
    Details
    In: Breast Cancer Research and Treatment, Springer Science and Business Media LLC, Vol. 187, No. 1 ( 2021-05), p. 113-124
    Abstract: To assess and describe patient-reported outcomes (PROs) in women with locally advanced/unresectable or metastatic breast cancer (aBC/mBC) with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR + /HER2 −) status receiving palbociclib combination therapy in a US real-world setting. Methods A prospective, noninterventional, multicenter longitudinal study was conducted in US patients initiating treatment with palbociclib combination therapy for HR + /HER2 − aBC/mBC. PRO data (SF-12; CES-D-10; mood; pain; fatigue; interference of aBC/mBC or its treatment on family life, social life, physical activity, energy, and productivity; overall health rating; and quality of life [QOL]) were collected via a custom-developed mobile application at daily, weekly, and cycle-based intervals. Patient medical information (demographics, clinical characteristics, treatment information, and adverse events) was collected from medical records at baseline and at the end of the 6-month follow-up period. Results Patients’ general health status (SF-12) remained consistent throughout treatment and was generally consistent with published norms for individuals diagnosed with cancer. The presence of depression (CES-D-10) was low and did not change substantially over time. Mean pain and fatigue scores using an 11-point numeric rating scale were low and remained stable. Patients, on average, reported neutral or positive moods. Patient-reported QOL and overall health was primarily “Good,” “Very good,” or “Excellent.” Findings were consistent regardless of patient experience with neutropenia. Conclusions Patients treated with palbociclib, on average, reported consistently low levels of pain and fatigue as well as good QOL and overall health that remained stable throughout the first 6 months of treatment regardless of episodes of neutropenia.
    Type of Medium: Online Resource
    ISSN: 0167-6806 , 1573-7217
    URL: Article
    DOI: 10.1007/s10549-020-06082-7
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2021
    detail.hit.zdb_id: 2004077-5
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  • 9
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    Correction to: Real-World Tumor Response of Palbociclib Plus Letrozole Versus Letrozole for Metastatic Breast Cancer in US Clinical Practice
    Springer Science and Business Media LLC ; 2021
    In:  Targeted Oncology Vol. 16, No. 6 ( 2021-11), p. 865-865
    Details
    In: Targeted Oncology, Springer Science and Business Media LLC, Vol. 16, No. 6 ( 2021-11), p. 865-865
    Type of Medium: Online Resource
    ISSN: 1776-2596 , 1776-260X
    URL: Article
    DOI: 10.1007/s11523-021-00847-w
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2021
    detail.hit.zdb_id: 2222136-0
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  • 10
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    Plugoma and the Prolene Hernia System
    Ovid Technologies (Wolters Kluwer Health) ; 2011
    In:  Journal of the American College of Surgeons Vol. 212, No. 3 ( 2011-03), p. 424-
    Details
    In: Journal of the American College of Surgeons, Ovid Technologies (Wolters Kluwer Health), Vol. 212, No. 3 ( 2011-03), p. 424-
    Type of Medium: Online Resource
    ISSN: 1072-7515
    URL: Article
    DOI: 10.1016/j.jamcollsurg.2010.11.011
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2011
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