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  • 1
    In: The Lancet, Elsevier BV, Vol. 393, No. 10184 ( 2019-05), p. 1937-1947
    Type of Medium: Online Resource
    ISSN: 0140-6736
    RVK:
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2019
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  • 2
    In: Diabetes Care, American Diabetes Association, Vol. 45, No. 12 ( 2022-12-01), p. 2991-2998
    Abstract: Finerenone reduced the risk of kidney and cardiovascular events in people with chronic kidney disease (CKD) and type 2 diabetes in the FIDELIO-DKD and FIGARO-DKD phase 3 studies. Effects of finerenone on outcomes in patients taking sodium–glucose cotransporter 2 inhibitors (SGLT2is) were evaluated in a prespecified pooled analysis of these studies. RESEARCH DESIGN AND METHODS Patients with type 2 diabetes and urine albumin-to-creatinine ratio (UACR) ≥30 to ≤5,000 mg/g and estimated glomerular filtration rate (eGFR) ≥25 mL/min/1.73 m2 were randomly assigned to finerenone or placebo; SGLT2is were permitted at any time. Outcomes included cardiovascular composite (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure) and kidney composite (kidney failure, sustained ≥57% eGFR decline, or renal death) end points, changes in UACR and eGFR, and safety outcomes. RESULTS Among 13,026 patients, 877 (6.7%) received an SGLT2i at baseline and 1,113 (8.5%) initiated one during the trial. For the cardiovascular composite, the hazard ratios (HRs) were 0.87 (95% CI 0.79–0.96) without SGLT2i and 0.67 (95% CI 0.42–1.07) with SGLT2i. For the kidney composite, the HRs were 0.80 (95% CI 0.69–0.92) without SGLT2i and 0.42 (95% CI 0.16–1.08) with SGLT2i. Baseline SGLT2i use did not affect risk reduction for the cardiovascular or kidney composites with finerenone (Pinteraction = 0.46 and 0.29, respectively); neither did SGLT2i use concomitant with study treatment. CONCLUSIONS Benefits of finerenone compared with placebo on cardiorenal outcomes in patients with CKD and type 2 diabetes were observed irrespective of SGLT2i use.
    Type of Medium: Online Resource
    ISSN: 0149-5992 , 1935-5548
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2022
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  • 3
  • 4
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. e18539-e18539
    Abstract: e18539 Background: Clinical trials are essential for enhancing cancer care. Participation is concerning in racial and ethnic minority groups historically under-represented in research. So, it is crucial to note that, despite Hispanics and African-Americans being 18.9% and 13.6% of the US population, each only represents 4% of the patients enrolled in clinical trials. We address effective doctor-patient communication as a fundamental clinical function in establishing an effective doctor-patient relationship, and is vital in delivering high-quality care. In this study, we question whether physician-patient language concordance affects clinical trial enrollment. Methods: The study evaluated 982 patients diagnosed with cancer who consented to experimental clinical trials in a private practice in Houston, Texas, from 2008-2022. All trials had approved language translations for English and Spanish. We used logistic regression to model the probability of treatment, while adjusting for the effects of cancer type, gender, race, ethnicity, and language (same or different as provider). Results: 982 patients with multiple cancer types (hematological, breast, thoracic/respiratory, genitourinary, gastrointestinal, head and neck and CNS) were included in the study. The most represented tumor types were GI (32%), Breast (24%) and Thoracic (23%). 66% of patients were successfully enrolled in an experimental clinical trial and started treatment, and 95% spoke the same language as their providers. 14% of patients spoke a different language than English, Spanish being the most commonly spoken language other than English spoken by the patient and provider. The study has adequate minority representation (Caucasian 45%, Hispanic 30%, African-American 18% and Asian 5%), and equal gender distribution (52% were female). After evaluating the results, it was found that there was no statistically significant association between physician-patient language and enrollment rates (p = 0.3). It was also found that there was no impact when the assessment was divided by tumor type, gender (p = 0.8) or ethnicity. It also evaluated the rate of consent withdrawal, with only 4% of patients withdrawing consent, showing no statistically significant association with language concordance. Conclusions: In conclusion, our study confirms no significant difference in cancer patients’ enrollment rate in clinical trials if there is language concordance between physician and patient. The efforts of the medical workforce to use translators and translated versions of informed consents, surveys or outcome assessments, when available, seem enough for our patients to collect all the information required to agree to continue enrollment. It is required to further evaluate more variables that impact enrollment in minorities to stop this disparity in cancer care.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
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  • 5
    Online Resource
    Online Resource
    Spandidos Publications ; 2010
    In:  Oncology Letters Vol. 1, No. 3 ( 2010-5), p. 449-452
    In: Oncology Letters, Spandidos Publications, Vol. 1, No. 3 ( 2010-5), p. 449-452
    Type of Medium: Online Resource
    ISSN: 1792-1074 , 1792-1082
    Language: English
    Publisher: Spandidos Publications
    Publication Date: 2010
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  • 6
    Online Resource
    Online Resource
    Crimson Publishers ; 2018
    In:  Novel Approaches in Cancer Study Vol. 2, No. 1 ( 2018-08-17)
    In: Novel Approaches in Cancer Study, Crimson Publishers, Vol. 2, No. 1 ( 2018-08-17)
    Type of Medium: Online Resource
    ISSN: 2637-773X
    URL: Issue
    Language: Unknown
    Publisher: Crimson Publishers
    Publication Date: 2018
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  • 7
    In: The Oncologist, Oxford University Press (OUP), Vol. 25, No. 8 ( 2020-08-01), p. e1233-e1241
    Abstract: Eflapegrastim, a novel, long-acting recombinant human granulocyte-colony stimulating factor (rhG-CSF), consists of a rhG-CSF analog conjugated to a human IgG4 Fc fragment via a short polyethylene glycol linker. Preclinical and phase I and II pharmacodynamic and pharmacokinetic data showed increased potency for neutrophil counts for eflapegrastim versus pegfilgrastim. This open-label phase III trial compared the efficacy and safety of eflapegrastim with pegfilgrastim for reducing the risk of chemotherapy-induced neutropenia. Materials and Methods Patients with early-stage breast cancer were randomized 1:1 to fixed-dose eflapegrastim 13.2 mg (3.6 mg G-CSF) or standard pegfilgrastim (6 mg G-CSF) following standard docetaxel plus cyclophosphamide chemotherapy for 4 cycles. The primary objective was to demonstrate the noninferiority of eflapegrastim compared with pegfilgrastim in mean duration of severe neutropenia (DSN; grade 4) in cycle 1. Results Eligible patients were randomized 1:1 to study arms (eflapegrastim, n = 196; pegfilgrastim, n = 210). The incidence of cycle 1 severe neutropenia was 16% (n = 31) for eflapegrastim versus 24% (n = 51) for pegfilgrastim, reducing the relative risk by 35% (p = .034). The difference in mean cycle 1 DSN (−0.148 day) met the primary endpoint of noninferiority (p & lt; .0001) and also showed statistical superiority for eflapegrastim (p = .013). Noninferiority was maintained for the duration of treatment (all cycles, p & lt; .0001), and secondary efficacy endpoints and safety results were also comparable for study arms. Conclusion These results demonstrate noninferiority and comparable safety for eflapegrastim at a lower G-CSF dose versus pegfilgrastim. The potential for increased potency of eflapegrastim to deliver improved clinical benefit warrants further clinical study in patients at higher risk for CIN. Implications for Practice Chemotherapy-induced neutropenia (CIN) remains a significant clinical dilemma for oncology patients who are striving to complete their prescribed chemotherapy regimen. In a randomized, phase III trial comparing eflapegrastim to pegfilgrastim in the prevention of CIN, the efficacy of eflapegrastim was noninferior to pegfilgrastim and had comparable safety. Nevertheless, the risk of CIN remains a great concern for patients undergoing chemotherapy, as the condition frequently results in chemotherapy delays, dose reductions, and treatment discontinuations.
    Type of Medium: Online Resource
    ISSN: 1083-7159 , 1549-490X
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2020
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  • 8
    In: Cancer Research, American Association for Cancer Research (AACR), Vol. 83, No. 7_Supplement ( 2023-04-04), p. 5522-5522
    Abstract: Introduction: Clinical trial accrual and enrollment are essential to break disparities seen in minority populations affected by cancer. Despite Hispanics (HI) being 18.9% of the US population and the fastest-growing minority in the US, they only represent 4% of the patients enrolled in clinical trials. These disparities are often explained by different social determinants of health, but could also be due to decreased perceived interest by oncologists in their participation simply due to lack of English proficiency. Effective doctor-patient communication is vital in establishing a healthy doctor-patient relationship, and is vital in delivering high-quality health care. In this study, we explore whether physician-patient language concordance affects clinical trial enrollment. Methods: We evaluated 233 patients diagnosed with breast cancer who consented to experimental clinical trials in a private Oncology practice in Houston, Texas, from 2008-2022. All trials had approved consent in English and Spanish. We used logistic regression to model the probability of treatment, while adjusting for the effects of cancer type, gender, race, ethnicity, and language concordance. Results: Of the 233 patients with breast cancer, 191(82%) were enrolled in a clinical trial, and 96% of these patients spoke the same language as their providers. 42 patients were not enrolled, with 95% of patients speaking the same language as their provider. There were 209 (90%) patients who spoke English, 22 (9%) were Spanish speakers and 2 (1%) were Arabic speakers. Of the Spanish speakers, 18 were enrolled, with 13 (72%) having language concordance with their provider. The ethnicity was evaluated, resulting in 72 (31%) patients being Hispanics, 55 (24%) African American, 94 (40%) Caucasian, 7 (3%) Asian, 4 (2%) Middle Eastern and 1 (0.4%) American Indian. It also evaluated the rate of consent withdrawal, showing only 6 (3%) patients. After evaluating the results, it was noted that there was no statistically significant association of physician-patient language concordance with enrollment rate (p=0.776). There was also no significant difference in consent withdrawal (p=0.626), and no change associated with gender (p=0.344) or ethnicity when evaluated (p=0.13). Conclusion: In conclusion, our analysis confirms no significant difference in breast cancer patients’ enrollment in clinical trials if there is language concordance between physician and patient. The efforts of the medical workforce to use translators and translated versions of informed consents, surveys or outcome assessments, when available, seem enough for our patients to agree to continue enrollment. Citation Format: Daniela Urueta Portillo, Ana M. Mendoza Sanchez, Nitzia E. Quilantan, Lisa Maria Mendoza Sanchez, Marcela Mazo Canola, Jonathan Gelfond, Julio A. Peguero. Does physician-patient language concordance increase clinical trial enrollment in breast cancer patients?: A real-life study in a majority-minority population. [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 5522.
    Type of Medium: Online Resource
    ISSN: 1538-7445
    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2023
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  • 9
    In: Journal for ImmunoTherapy of Cancer, BMJ, Vol. 7, No. 1 ( 2019-12)
    Type of Medium: Online Resource
    ISSN: 2051-1426
    Language: English
    Publisher: BMJ
    Publication Date: 2019
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  • 10
    In: Cancer Research, American Association for Cancer Research (AACR), Vol. 80, No. 4_Supplement ( 2020-02-15), p. P2-14-12-P2-14-12
    Abstract: Background: Eflapegrastim (E) represents the first myeloid growth factor innovation in more than 15 years. A novel, long-acting recombinant human granulocyte-colony stimulating factor (rhG-CSF), E consists of a rhG-CSF analog conjugated to a human IgG4 Fc fragment via a polyethylene glycol linker. Preclinical and Phase I and II pharmacodynamic and pharmacokinetic data showed increased potency for E versus pegfilgrastim (P). Two independent randomized Phase III trials comparing fixed dose E and P (E 3.6 mg G-CSF and P 6.0 mg G-CSF) for the management of chemotherapy-induced neutropenia (CIN) have recently been completed. Both trials met the primary endpoint of non-inferiority for E vs P in Cycle 1 duration of severe neutropenia (P & lt;.001). Here we provide an integrated summary of the safety of E administered at a fixed dose in a pre-filled syringe. Patients and Methods: Patients with early-stage breast cancer (ESBC) who were candidates for adjuvant or neoadjuvant chemotherapy were randomized 1:1 in two open-label Phase III trials to E 13.2 mg (3.6 mg G-CSF) or standard P (6 mg G-CSF) administered on Day 2 following TC (docetaxel/cyclophosphamide) chemotherapy on Day 1 of each of 4 cycles. Blood for CBC and serum chemistry was collected in every cycle. Safety assessments began with the first dose of TC and continued for one year after the last dose of study drug. AEs and laboratory values were graded according to NCI CTCAE version 4.03. Immunogenicity was assessed from blood samples collected on Day 1 of each cycle, at the end-of-treatment visit, and at 6- and 12-month follow-up visits. Results: A total of 660 patients who received at least one dose of eflapegrastim (n=334) or pegfilgrastim (n=326) were included in this integrated safety analysis. The two treatment groups were well balanced for demographics and baseline disease characteristics. The mean age was 59y, ~40% were aged & gt;65y, ~54% weighed & gt;75kg, and ~80% were treated in the adjuvant setting. Median relative dose intensity for T and C was & gt;99% for both groups. A similar percentage of patients in both treatment groups discontinued treatment due to AEs (4% E vs 6% P), with 2% in each group discontinuing due to AEs related to E or P. Serious AEs were similar in both groups (15% each). Incidence of AEs irrespective of causality were also similar between groups (74% E vs. 72% P). No notable differences between groups were observed in the types of study-drug-related AEs. The majority of study-drug-related AEs occurred with an incidence ≤10% for both E and P. As expected with myeloid growth factors, study-drug-related AEs occurring in & gt;10% in either group were bone pain (E vs P: 33% vs 34%), arthralgia (15% vs 10%), back pain (14% vs 9%), myalgia (14% vs 9%), and headache (11% vs 8%). Incidence of febrile neutropenia and neutropenic complications were similar and less than 5% in each treatment group. No leukocytosis, splenic rupture, or anaphylaxis was reported in any patient receiving E or P. The overall incidence of immunogenicity was similar in both groups and there was no demonstrable impact on clinical safety or efficacy. Conclusions: Two large, randomized Phase III trials (Total n=660) of E vs P administered once-per-cycle showed E at a lower G-CSF dose to be safe and effective for the prophylaxis of CIN in patients with ESBC receiving TC chemotherapy. E is a novel long-acting rhG-CSF with increased potency and similar toxicity to P and may provide an attractive alternative for growth factor support of patients at high risk for CIN-related complications. Citation Format: Lee S Schwartzberg, Gajanan Bhat, Julio Peguero, Richy Agajanian, Jayaram Bharadwaj, Alvaro Restrepo, Osama Hlalah, Inderjit Mehmi, Shanta Chawla, Francois Lebel, Patrick W Cobb. Eflapegrastim, a novel long-acting granulocyte-colony stimulating factor: Integrated safety results in patients with early-stage breast cancer treated with TC chemotherapy [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 P2-14-12.
    Type of Medium: Online Resource
    ISSN: 0008-5472 , 1538-7445
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    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2020
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