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  • 1
    Online Resource
    Online Resource
    Ovid Technologies (Wolters Kluwer Health) ; 2023
    In:  Medicine & Science in Sports & Exercise Vol. 55, No. 9S ( 2023-9), p. 647-648
    In: Medicine & Science in Sports & Exercise, Ovid Technologies (Wolters Kluwer Health), Vol. 55, No. 9S ( 2023-9), p. 647-648
    Type of Medium: Online Resource
    ISSN: 1530-0315 , 0195-9131
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2023
    detail.hit.zdb_id: 2031167-9
    SSG: 31
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  • 2
    In: Cancer Epidemiology, Biomarkers & Prevention, American Association for Cancer Research (AACR), Vol. 32, No. 1_Supplement ( 2023-01-01), p. A034-A034
    Abstract: Background: Prostate cancer (PC) is the most diagnosed non-skin cancer among men in the United States, with African American (AA) men experiencing the highest incidence of all racial/ethnic groups. Screening and treatment advances for PC have resulted in men living years beyond their diagnosis; however, side effects of PC treatments can impact health-related quality of life (QoL). African American PC survivors (AAPCS) may be at increased risk of experiencing lower QoL. Lifestyle interventions show potential for improving QoL through changes in health behavior and symptom improvement, yet few have focused on AAPCS. This study explores QoL of AAPCS enrolled in Men Moving Forward (MMF), a randomized trial to improve body composition through lifestyle change. Methods: Baseline data from 83 AAPCS enrolled in MMF were used in analysis. Participants completed Patient-Reported Outcomes Measurement Information System (PROMIS) computerized adaptive tests for physical function, anxiety, depression, fatigue, sleep disturbance, social function, and pain intensity. Standardized T scores (U.S. general population mean = 50, SD =10) were generated for all domains except pain intensity (0-10), and summary scores for physical and mental health were generated. A higher score reflects more of a construct being measured. Thus, for symptoms, scores above the mean are worse, while for functioning domains, scores below the mean are worse. Summary scores for physical and mental QoL were also calculated. Questionnaires related to physical activity, self-efficacy, perceived stress, social support, and resilience were also collected. We compare sample means to published norms of U.S. PC survivors, considering a difference of 3 points (1/3 SD) as clinically meaningful. Multiple linear regression analyses were used to examine factors associated with physical and mental health summary scores. Results: AAPCS scores were similar to the U.S. PCS means for depression (45.6 vs 45.4), fatigue (47.9 vs 47.3), sleep disturbance (48.4 vs 48.2), and physical function (50.4 vs 50.2). AAPCS scores were worse than the U.S. PCS means for anxiety (49.4 vs 45.9) and social participation (51.2 vs 55.1). The average mental health summary score for AAPCS was better than the U.S. general population (53.4 vs 50), while the physical health summary score was similar (51.4 vs 50). Perceived stress (p & lt;0.000) was negatively associated with mental health. Comorbidities (p=0.002) were negatively associated with physical health, while physical activity (p=0.034) was positively associated with physical health. Conclusions: Our sample of AAPCS was similar to U.S. PCS except for worse anxiety and social function. We also found that factors that could be impacted by a lifestyle intervention were associated with physical and mental health. Future work will examine additional correlates and explore the impact of the MMF lifestyle intervention on changes in QoL. Citation Format: Iwalola Awoyinka, Kathryn E. Flynn, Anjishnu Banerjee, Alexis Visotcky, Sophia Aboagye, Margaret Tovar, Deepak Kilari, Kathryn A. Bylow, Paula Papanek, Patricia M. Sheean, Melinda R. Stolley. Health-related quality of life among African American prostate cancer survivors enrolled in a lifestyle intervention program [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr A034.
    Type of Medium: Online Resource
    ISSN: 1538-7755
    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2023
    detail.hit.zdb_id: 2036781-8
    detail.hit.zdb_id: 1153420-5
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  • 3
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2017
    In:  Journal of Clinical Oncology Vol. 35, No. 6_suppl ( 2017-02-20), p. e575-e575
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 35, No. 6_suppl ( 2017-02-20), p. e575-e575
    Abstract: e575 Background: Aggressive variant PC (AVPC) is a well-described subtype of PC which portends a poor prognosis. Studies have shown an increase in progression-free survival(PFS) when Pt is added to taxane-based treatment in AVPC. Clinical features including visceral metastasis, lytic bone lesions, low PSA, short responses to androgen suppression and high Gleason score at diagnosis predict response to upfront docetaxel (D) and Pt (Aparicio et. al. Clin Cancer Res 2013). Our objective was to study the effect of baseline characteristics on PFS with D+Pt in D-pretreated CRPC. Methods: A retrospective review of D-pretreated mCRPC men who received D (60-75 mg/m2) and carboplatin (C, AUC 4-5) at our institution between 2008- 2015 were included in this analysis. All patients had metastatic CRPC, were heavily pre- treated (median treatments = 4) and received at least one cycle of D+C. Numerical data was analyzed using Student’s T-test; binary data was analyzed with Z-proportions test. Results: 28 patients were identified. The median age was 60 yrs(48-73); median PSA at diagnosis was 21ng/dl(0.3-5000); median PSA at the start of D+C was 115.32 ng/dl( 0.65-1395). The response rate was 60.7% and the median time to response was 1 mo. The median reduction in PSA was 48.13%. The median PFS was 6 mo, and median OS was 10 mo. Common treatment – related side effects included grade 1 fatigue (82.14%), pancytopenia (42.86%), and febrile neutropenia (10.71%). Correlation of baseline characteristics to PFS was evaluated. Short response to ADT 〈 1 yr (p 〈 0.05), prior response to D (PFS 〉 6 months) ( p = 0.037), and presence of visceral mets (p 〈 0.05) predicted better response to D+C. Age (p = 0.27), Gleason score at diagnosis (p = 0.08), performance status at start of therapy (p = 0.27), PSA at diagnosis (p = 0.35), and PSA at start of D+C (p = 0.420) did not predict response. Conclusions: D+C is effective and safe in D pretreated CRPC. Response to prior D, short response to ADT, and the presence of visceral metastasis predicted response to D+C. These are features of AVPC. Prospective studies to validate our findings and identify molecular characteristics of Pt responders are needed in this heavily pre-treated “real world” patient population.
    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: 2017
    detail.hit.zdb_id: 2005181-5
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  • 4
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 6_suppl ( 2022-02-20), p. TPS220-TPS220
    Abstract: TPS220 Background: Androgen deprivation therapy (ADT) achieved with gonadotropin releasing hormone (GnRH) agonist or antagonist is considered the standard of care for men with prostate cancer (PC) who develop biochemical recurrence (BCR) after definitive treatment. ADT is associated with significant adverse effects in this asymptomatic population, and hence there is an unmet need for alternate non-hormonal options. Androgen receptor (AR) and its variants (AR-V) are persistently expressed in the majority of the cells in recurrent PCs and drives PC growth. Jak2-Stat5 signaling has been shown to sustain PC cell viability and is critical for PC tumor growth. Stat5 activation in PC at the time of surgery predicts early PC recurrence. Our investigation of the molecular targets downstream of Jak2-Stat5 signaling have revealed the AR gene as a critical target, and the Jak2-Stat5 pathway represents a target to inhibit expression of diverse AR and AR-V species and thereby control of PC growth. Pacritinib (PAC) is a novel JAK2 inhibitor that suppresses wild-type Jak2 in cell-based assays and has demonstrated promising antitumor activity in myelofibrosis. We hypothesize that PAC inhibition of Jak2-Stat5 signaling will induce biochemical responses in men with recurrent PC by depleting AR and AR-V. Methods: BLAST (NCT04635059) is a single arm, open-label, phase 2 study of PAC (200mg BID) for patients with PC who underwent definitive treatment and developed BCR. Eligibility criteria include histologically confirmed PC, BCR with a PSA doubling time ≤ 9 months, PSA 〉 0.5 ng/mL, and serum testosterone 〉 150 ng/dL. 46 subjects will be enrolled with a primary objective to assess the effect of PAC on time to PSA progression. The primary endpoint is six-month PSA progression free survival per PCWG3 criteria. The null hypothesis that the median PSA-progression-free survival is six months will be tested against a one-sided alternative for the six-month PSA-progression-free survival probability exceeding 50%. Secondary endpoints include time to subsequent therapy, safety and toxicity. Exploratory endpoints include effect of PAC on geriatric domains. An interim analysis will be performed when 10 patients have been treated and followed for six months. Accrual began in July 2021. Clinical trial information: NCT04635059.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
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  • 5
    In: Practical Radiation Oncology, Elsevier BV, Vol. 11, No. 6 ( 2021-11), p. 527-533
    Type of Medium: Online Resource
    ISSN: 1879-8500
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2021
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  • 6
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 35, No. 6_suppl ( 2017-02-20), p. 179-179
    Abstract: 179 Background: Older men are at a high risk for adverse events (AEs) from androgen deprivation therapy (ADT). In prior studies, peripheral androgen blockade with bicalutamide and Fin was better tolerated but less efficacious than ADT in HNSPCa. The potential syngerism of Enz (a potent antiandrogen) and Dut/Fin (5-a reductase inhibitors for conversion of testosterone [T] to dihydrotestosterone [DHT] ) provided the rationale for this Phase II study that examined the clinical efficacy and safety of Enz with Dut/Fin in men 〉 65 years with HNSPCa. Methods: Eligible patients were 〉 65 years (y) ; at a high risk of AE from ADT by comprehensive geriatric assessment or treating physicians; had metastatic (M1) or biochemical recurrent (M0) HNSPCa with a PSA doubling time 〈 9 months; and had T 〉 50ng/dl. They received Enz (160mg daily) and Dut (0.5mg daily) or Fin (5mg daily) until disease progression according to the Prostate Cancer Working Group 2 guidelines. The primary study endpoint is time to PSA progression. The secondary endpoints are time to PSA nadir and treatment-related AEs. Results: As of July 31, 2016, 24 patients were screened (3 ineligible) and 21 were enrolled with a median follow-up of 31 weeks (7-79). Median age at enrollment was 79.5 y (66-94) and 14 %, 72% and 14% had ECOG performance status of 0, 1, and 2, respectively. 57% (n = 12) had M0 and 43% (n = 9) had M1 HNSPCa, with 18%, 62%, 5%, and 10% having Gleason 6, 7, 8, and 9 disease, respectively (5% with unkown Gleason sum). The median PSA at enrollment was 12 ng/ml (2-102). The median time to 90% PSA decline after treatment initiation was 7 weeks (7-20) and 92% achieved 80% DHT decline in 9 months. At the time of analysis, all patients had ongoing PSA decline of 〉 90% without radiographic evidence of disease progression. Common Grade 1 AEs included gynecomastia (28%), fatigue (28%), hot flashes (19%) and paresthesias (15%). One patient withdrew from the study due to Grade 2 paresthesia. None had Grade 3 or 4 treatment-related AEs. One patient died due to colitis unrelated to study treatments. Conclusions: Enz with Dut/Fin appears to have clinical activity for older patients with M0 and M1 HNSPCa with acceptable side effects. Clinical trial information: NCT02213107.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2017
    detail.hit.zdb_id: 2005181-5
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  • 7
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. TPS4618-TPS4618
    Abstract: TPS4618 Background: ABACUS and PURE-01 trials demonstrated the activity of single agent atezolizumab and pembrolizumab respectively as neoadjuvant therapy for muscle invasive bladder carcinoma (MIBC). However, downstaging to non-muscle invasive disease was noted in only 50 percent of patients. Resistance to programmed death (PD)- 1/L1 antibodies is likely to include factors such as impaired dendritic cell maturation/function, infiltration of T-Regs and myeloid derived suppressor cells, impaired T-cell priming and T-cell trafficking in tumors. Cabozantinib is a tyrosine kinase inhibitor which targets MET, AXL, MER, Tyro3 and VEGFR2. Cabozantinib has a unique immunomodulatory profile and has demonstrated clinical activity as monotherapy and in combination with PD-1/L1 antibodies in various solid tumors including urothelial cancer (UC), renal cell, castrate- resistant prostate and non-small cell lung cancer. We hypothesize that the combination of cabozantinib and atezolizumab as neoadjuvant therapy for MIBC would improve rates of pathologic downstaging compared to single-agent checkpoint inhibitors. Methods: ABATE is an open-label, single arm, multi-center study to assess the efficacy and safety of cabozantinib with atezolizumab as neoadjuvant therapy for cT2-T4aN0/xM0 MIBC. An estimated 42 patients will be enrolled to obtain 38 evaluable patients, and the study will have over 80% power to declare the investigational combination to be successful using a Bayesian evaluation at 90% posterior probability cutoff, if the response probability is 59%, i.e., 20% higher than the 39% response rate with the single agent atezolizumab. Eligible patients will receive cabozantinib 40 mg PO daily with atezolizumab 1200mg every 3 weeks for a total duration of 9 weeks (3 cycles) followed by radical cystectomy. Adults (≥18 years) with resectable MIBC who are either cisplatin-ineligible or decline cisplatin-based chemotherapy are eligible. Patients are required to have an ECOG PS of 0-2 and provide tumor tissue for PD-L1 expression analysis. UC should be predominant component (≥ 50%). Previous systemic anticancer therapies for MIBC are not permitted. CT/MRI will be performed before investigational therapy and cystectomy. Primary endpoint is pathologic response rate defined as the absence of residual muscle-invasive cancer in the surgical specimen ( 〈 pT2). Secondary endpoints are safety and toxicity, pathologic complete response rate and event-free survival. Exploratory end points include patient-reported outcomes and outcome associations with biomarkers. Accrual began May 2020. Clinical trial information: NCT04289779.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
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  • 8
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 37, No. 15_suppl ( 2019-05-20), p. e16518-e16518
    Abstract: e16518 Background: Older men are at a high risk for adverse events (AEs) from androgen deprivation therapy (ADT). In this phase II study, we evaluated Enz and Dut/Fin in lieu of ADT for at-risk older patients with HNSPCa. Methods: Eligible patients were ≥65 years (y); at high risk of AEs from ADT by GA or treating physicians; metastatic (M1) or non-metastatic (M0) HNSPCa with a PSA doubling time ≤ 9 months and testosterone 〉 50ng/dl. They received Enz 160 mg/day and Dut 0.5 mg/day or Fin 5 mg/day until disease progression. GA was performed at baseline and week (wk) 61 and/or at the time of progression. GA included validated tests: Instrumental Activities of Daily Living (IADL), fall history, Short Physical Performance Battery (SPPB), Geriatric Depression Scale (GDS), and Montreal Cognitive Assessment (MOCA). The prevalence of impairment for each assessment was calculated; change in prevalence from baseline to wk 61 was analyzed using paired sample t-test. Results: 43 patients were enrolled in the study. Median age at enrollment was 78 y (range 66-94) and 93% were ECOG 0-1; 37% (n = 16) had M0 and 63% (n = 27) had M1 HNSPCa, with the majority (67%) having Gleason 6 or 7 disease. At baseline, 18.6% met the cutoff for impairment for IADLs, 53.7% for SPPB, 7.9% for GDS and 64.3% for MOCA; 9.8% had a recent fall. Median baseline PSA was 11.38 ng/ml (range: 2-145). At the time of analysis, 29 men (67.4%) remain on study treatment. 95.3%, 74.4% and 46.5% of patients reported at least one Grade 1, 2 or 3 AE respectively. No patient had a Grade 4 AE and one Grade 5 AE was reported but was an unrelated event. The most common Grade 3 AEs were hypertension (27.8%), GI (19.4%), and cardiac (8.3%); all Grade 3 GI AEs reported were deemed unrelated to the study drugs. Only impairment in ≥ 1 IADL showed a statistically significant increase in prevalence at wk 61 of treatment (40.6%) compared to baseline (18.6%, p = 0.036). Conclusions: For older men with HNSPCa, Enz with Dut/Fin demonstrated efficacy with reasonable toxicity profile, and no significant impact on the majority of GA domains. Clinical trial information: NCT02213107.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2019
    detail.hit.zdb_id: 2005181-5
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  • 9
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 32, No. 15_suppl ( 2014-05-20), p. e15516-e15516
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2014
    detail.hit.zdb_id: 2005181-5
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  • 10
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. e17007-e17007
    Abstract: e17007 Background: Outcomes of patients (pts) with mUC with EOM have not thoroughly been described in the age of immuno-oncology. We hypothesized that EOM is associated with worse outcomes when compared to pts with non-osseous metastases (NOM). Methods: We used a multi-institutional database of pts with mUC who received systemic treatment (trt) between March 2005 and August 2019, to assess survival and palliative outcomes of pts with EOM vs NOM at the time of metastatic diagnosis (met dx). Wilcoxon rank-sum and chi-square tests were performed. Survival was estimated by Kaplan-Meier method, Cox regression analysis was performed. Results: We identified 270 pts, 72% men, mean age 67 ± 11 years, 28% never smokers. At met dx, 27% (n = 72) had ≥ 1 EOM; these pts were more likely to have de novo metastases vs. those with recurrent metastases (42% vs 19%, p 〈 0.001). Pts with EOM were more likely to have a change or stop in 1st line trt due to clinical progression (30.6% vs 15.7%, p = 0.006), and received fewer total lines of systemic trt, median of 1.0 (1.0-5.0) vs. 2.0 (1.0-8.0), p = 0.05. Pts with EOM had shorter median overall survival (OS) vs. those with NOM, (6.1 vs 13.7 months, p 〈 .0001), HR = 2.79 (95% CI:1.95-3.97, p 〈 .0001). Median OS was shorter for pts with EOM who received 1 st line immune checkpoint inhibitor (n = 14) vs platinum-based chemotherapy (n = 43), (1.6 vs 9.1 months, p = 0.003). Pts with EOM received higher opioid analgesic doses at the first and last oncology outpatient visits compared to pts with NOM with mean morphine milligram equivalent (MME) dose of 60 ± 91 vs 28 ± 65 at first visit, p = 0.004, and 171 ± 214 vs. 94 ± 229 at last visit, p 〈 0.001. Conclusions: The presence of EOM in mUC is associated with worse outcomes vs. pts with NOM. Pts with EOM may benefit from 1 st line platinum-based chemotherapy vs. checkpoint immunotherapy. Furthermore, pts with EOM experience more pain than pts with NOM and may benefit from early engagement with palliative care. Pts with EOM represent a population with a highly unmet need for systemic, targeted and/or radiation interventions. Molecular subtypes may further define these pts and analysis is planned. We encourage ongoing clinical trials to report outcomes in pts with EOM. A consensus on reporting of non-measurable disease is also needed. [Table: see text]
    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: 2020
    detail.hit.zdb_id: 2005181-5
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