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1

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A phase II single‐arm trial of memantine for prevention of cognitive decline during chemotherapy in patients with early breast cancer: Feasibility, tolerability, acceptability, and preliminary effects

Nakamura, Zev M. ; Deal, Allison M. ; Park, Eliza M. ; [et al.]

Wiley ; 2023

In: Cancer Medicine Vol. 12, No. 7 ( 2023-04), p. 8172-8183

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In: Cancer Medicine, Wiley, Vol. 12, No. 7 ( 2023-04), p. 8172-8183

Abstract: Cognitive difficulties have been described after chemotherapy for breast cancer, but there is no standard of care to improve cognitive outcomes in these patients. This trial examined the feasibility, tolerability, acceptability, and preliminary effects of memantine to prevent cognitive decline during chemotherapy for breast cancer. Methods Patients with stage I–III breast cancer, scheduled for neo/adjuvant chemotherapy, completed a cognitive battery prior to and 4 weeks after completing chemotherapy. Memantine (10 mg BID) was administered concurrent with chemotherapy. Our primary cognitive outcome was visual working memory assessed by the Delayed Matching to Sample test. We used the Brief Medication Questionnaire to assess acceptability. Results Of 126 patients approached, 56 (44%) enrolled. Forty‐five (80%) received ≥1 dose of memantine and completed pre‐post assessments. Seventy‐six percent reported taking ≥90% of scheduled doses. Participants were mean age of 56, 77% White, and 57% had stage I disease. Sixty‐four percent had stable or improved Delayed Matching to Sample test scores. Stable or improved cognition was observed in 87%–91% across objective cognitive domain composite measures. Sixty‐six percent self‐reported stable or improved cognitive symptoms. There were seven greater than or equal to grade 3 adverse events; two were possibly related to memantine. Only 5% reported that taking memantine was a disruption to their lives. Conclusions Memantine was well‐tolerated and consistently taken by a large majority of patients receiving breast cancer chemotherapy. The majority demonstrated stable or improved cognition from pre‐ to post‐assessment. Randomized trials are needed to determine memantine's efficacy to ameliorate cognitive loss. Trial Registration ClinicalTrials.gov NCT04033419.

Type of Medium: Online Resource

ISSN: 2045-7634 , 2045-7634

URL: Issue

URL: Article

DOI: 10.1002/cam4.v12.7

DOI: 10.1002/cam4.5619

Language: English

Publisher: Wiley

Publication Date: 2023

detail.hit.zdb_id: 2659751-2

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Genotype-Guided Tamoxifen Dosing Increases Active Metabolite Exposure in Women With Reduced CYP2D6 Metabolism: A Multicenter Study

Irvin, William J. ; Walko, Christine M. ; Weck, Karen E. ; [et al.]

American Society of Clinical Oncology (ASCO) ; 2011

In: Journal of Clinical Oncology Vol. 29, No. 24 ( 2011-08-20), p. 3232-3239

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In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 29, No. 24 ( 2011-08-20), p. 3232-3239

Abstract: We examined the feasibility of using CYP2D6 genotyping to determine optimal tamoxifen dose and investigated whether the key active tamoxifen metabolite, endoxifen, could be increased by genotype-guided tamoxifen dosing in patients with intermediate CYP2D6 metabolism. Patients and Methods One hundred nineteen patients on tamoxifen 20 mg daily ≥ 4 months and not on any strong CYP2D6 inhibiting medications were assayed for CYP2D6 genotype and plasma tamoxifen metabolite concentrations. Patients found to be CYP2D6 extensive metabolizers (EM) remained on 20 mg and those found to be intermediate (IM) or poor (PM) metabolizers were increased to 40 mg daily. Eighty-nine evaluable patients had tamoxifen metabolite measurements repeated 4 months later. Results As expected, the median baseline endoxifen concentration was higher in EM (34.3 ng/mL) compared with either IM (18.5 ng/mL; P = .0045) or PM (4.2 ng/mL; P 〈 .001). When the dose was increased from 20 mg to 40 mg in IM and PM patients, the endoxifen concentration rose significantly; in IM there was a median intrapatient change from baseline of +7.6 ng/mL (−0.6 to 23.9; P 〈 .001), and in PM there was a change of +6.1 ng/mL (2.6 to 12.5; P = .020). After the dose increase, there was no longer a significant difference in endoxifen concentrations between EM and IM patients (P = .84); however, the PM endoxifen concentration was still significantly lower. Conclusion This study demonstrates the feasibility of genotype-driven tamoxifen dosing and demonstrates that doubling the tamoxifen dose can increase endoxifen concentrations in IM and PM patients.

Type of Medium: Online Resource

ISSN: 0732-183X , 1527-7755

URL: Article

DOI: 10.1200/JCO.2010.31.4427

RVK:

XA 52760

RVK:

XA 10000

Language: English

Publisher: American Society of Clinical Oncology (ASCO)

Publication Date: 2011

detail.hit.zdb_id: 2005181-5

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The interaction of post‐traumatic growth and post‐traumatic stress symptoms in predicting depressive symptoms and quality of life

Morrill, E. Forrest ; Brewer, Noel T. ; O'Neill, Suzanne C. ; [et al.]

Wiley ; 2008

In: Psycho-Oncology Vol. 17, No. 9 ( 2008-09), p. 948-953

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In: Psycho-Oncology, Wiley, Vol. 17, No. 9 ( 2008-09), p. 948-953

Abstract: Objective : We sought to explore whether post‐traumatic growth (PTG) (positive change or benefit finding resulting from trauma) moderates relationships between post‐traumatic stress symptoms (PTSS) and both depression and quality of life (QOL) among breast cancer survivors. Methods : We interviewed 161 women previously treated for early stage breast cancer. We assessed PTG using the Post‐traumatic Growth Inventory, PTSS using the PTSD Checklist, depressive symptoms using the CES‐D and QOL using the FACT‐B. Results : Higher PTSS was associated with greater depressive symptoms and lower QOL ( p 〈 0.01). The relationship between PTSS and depression was attenuated among women with higher levels of PTG (PTSS × PTG interaction, p 〈 0.05). The same pattern of results was found for QOL (interaction p 〈 0.01). Conclusions : We report the novel finding that PTG moderated relationships between PTSS and both depression and QOL. We speculate that finding positive meaning in response to a distressing event, such as diagnosis of cancer, may be psychologically protective and could indirectly influence the long‐term occurrence of depressive symptoms and impaired QOL. Copyright © 2008 John Wiley & Sons, Ltd.

Type of Medium: Online Resource

ISSN: 1057-9249 , 1099-1611

URL: Issue

URL: Article

DOI: 10.1002/pon.v17:9

DOI: 10.1002/pon.1313

Language: English

Publisher: Wiley

Publication Date: 2008

detail.hit.zdb_id: 1495115-0

SSG: 5,2

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Patient‐reported symptom severity, interference with daily activities, and adverse events in older and younger women receiving chemotherapy for early breast cancer

Nyrop, Kirsten A. ; Deal, Allison M. ; Chen, Yi Tang ; [et al.]

Wiley ; 2021

In: Cancer Vol. 127, No. 6 ( 2021-03-15), p. 957-967

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In: Cancer, Wiley, Vol. 127, No. 6 ( 2021-03-15), p. 957-967

Abstract: In the current study, women receiving chemotherapy for early breast cancer rate the severity of 17 symptoms and symptom interference with their activities of daily living. Older (aged ≥65 years) and younger (aged 〈 65 years) women who received identical chemotherapy regimens generally experienced similar levels of symptom severity, symptom‐related interference with daily activities, and adverse events.

Type of Medium: Online Resource

ISSN: 0008-543X , 1097-0142

URL: Issue

URL: Article

DOI: 10.1002/cncr.v127.6

DOI: 10.1002/cncr.33329

Language: English

Publisher: Wiley

Publication Date: 2021

detail.hit.zdb_id: 1479932-7

detail.hit.zdb_id: 2599218-1

detail.hit.zdb_id: 2594979-2

detail.hit.zdb_id: 1429-1

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Development and validation of an integrative pan-solid tumor predictor of PD-1/PD-L1 blockade benefit

Tomlins, Scott A. ; Khazanov, Nickolay A. ; Bulen, Benjamin J. ; [et al.]

Springer Science and Business Media LLC ; 2023

In: Communications Medicine Vol. 3, No. 1 ( 2023-02-07)

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In: Communications Medicine, Springer Science and Business Media LLC, Vol. 3, No. 1 ( 2023-02-07)

Abstract: Anti-PD-1 and PD-L1 (collectively PD-[L]1) therapies are approved for many advanced solid tumors. Biomarkers beyond PD-L1 immunohistochemistry, microsatellite instability, and tumor mutation burden (TMB) may improve benefit prediction. Methods Using treatment data and genomic and transcriptomic tumor tissue profiling from an observational trial (NCT03061305), we developed Immunotherapy Response Score (IRS), a pan-tumor predictive model of PD-(L)1 benefit. IRS real-world progression free survival (rwPFS) and overall survival (OS) prediction was validated in an independent cohort of trial patients. Results Here, by Cox modeling, we develop IRS—which combines TMB with CD274 , PDCD1 , ADAM12 and TOP2A quantitative expression—to predict pembrolizumab rwPFS (648 patients; 26 tumor types; IRS-High or -Low groups). In the 248 patient validation cohort (248 patients; 24 tumor types; non-pembrolizumab PD-[L]1 monotherapy treatment), median rwPFS and OS are significantly longer in IRS-High vs. IRS-Low patients (rwPFS adjusted hazard ratio [aHR] 0.52, p = 0.003; OS aHR 0.49, p = 0.005); TMB alone does not significantly predict PD-(L)1 rwPFS nor OS. In 146 patients treated with systemic therapy prior to pembrolizumab monotherapy, pembrolizumab rwPFS is only significantly longer than immediately preceding therapy rwPFS in IRS-High patients (interaction test p = 0.001). In propensity matched lung cancer patients treated with first-line pembrolizumab monotherapy or pembrolizumab+chemotherapy, monotherapy rwPFS is significantly shorter in IRS-Low patients, but is not significantly different in IRS-High patients. Across 24,463 molecularly-evaluable trial patients, 7.6% of patients outside of monotherapy PD-(L)1 approved tumor types are IRS-High/TMB-Low. Conclusions The validated, predictive, pan-tumor IRS model can expand PD-(L)1 monotherapy benefit outside currently approved indications.

Type of Medium: Online Resource

ISSN: 2730-664X

URL: Article

DOI: 10.1038/s43856-023-00243-7

Language: English

Publisher: Springer Science and Business Media LLC

Publication Date: 2023

detail.hit.zdb_id: 3096949-9

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Effects of Breast Cancer Adjuvant Chemotherapy Regimens on Expression of the Aging Biomarker, p16INK4a

Shachar, Shlomit S ; Deal, Allison M ; Reeder-Hayes, Katherine E ; [et al.]

Oxford University Press (OUP) ; 2020

In: JNCI Cancer Spectrum Vol. 4, No. 6 ( 2020-11-15)

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In: JNCI Cancer Spectrum, Oxford University Press (OUP), Vol. 4, No. 6 ( 2020-11-15)

Abstract: Although chemotherapy saves lives, increasing evidence shows that chemotherapy accelerates aging. We previously demonstrated that mRNA expression of p16INK4a, a biomarker of senescence and molecular aging, increased early and dramatically after beginning adjuvant anthracycline-based regimens in early stage breast cancer patients. Here, we determined if changes in p16INK4a expression vary by chemotherapy regimen among early stage breast cancer patients. Methods We conducted a study of stage I-III breast cancer patients receiving adjuvant or neoadjuvant chemotherapy. p16INK4a expression was analyzed prechemotherapy and postchemotherapy (median 6.2 months after the last chemotherapy) in peripheral blood T lymphocytes. Chemotherapy-induced change in p16INK4a expression was compared among regimens. All statistical tests were 2-sided. Results In 146 women, chemotherapy was associated with a statistically significant increase in p16INK4a expression (accelerated aging of 17 years; P & lt; .001). Anthracycline-based regimens were associated with the largest increases (accelerated aging of 23 to 26 years; P ≤ .008). Nonanthracycline-based regimens demonstrated a much smaller increase (accelerated aging of 9 to 11 years; P ≤ .15). In addition to the type of chemotherapy regimen, baseline p16INK4a levels, but not chronologic age or race, were also associated with the magnitude of increases in p16INK4a. Patients with lower p16INK4a levels at baseline were more likely to experience larger increases. Conclusions Our findings suggest that the aging effects of chemotherapy may be influenced by both chemotherapy type and the patient’s baseline p16INK4a level. Measurement of p16INK4a expression is not currently available in the clinic, but nonanthracycline regimens offering similar efficacy as anthracycline regimens might be favored.

Type of Medium: Online Resource

ISSN: 2515-5091

URL: Article

DOI: 10.1093/jncics/pkaa082

Language: English

Publisher: Oxford University Press (OUP)

Publication Date: 2020

detail.hit.zdb_id: 2975772-1

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Phase II Study of Lapatinib in Combination With Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer: Clinical Outcomes and Predictive Value of Early [ 18 F]Fluorodeoxyglucose Positron Emission Tomography Imaging (TBCRC 003)

Lin, Nancy U. ; Guo, Hao ; Yap, Jeffrey T. ; [et al.]

American Society of Clinical Oncology (ASCO) ; 2015

In: Journal of Clinical Oncology Vol. 33, No. 24 ( 2015-08-20), p. 2623-2631

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In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 33, No. 24 ( 2015-08-20), p. 2623-2631

Abstract: Lapatinib plus trastuzumab improves outcomes relative to lapatinib alone in heavily pretreated, human epidermal growth factor receptor 2–positive metastatic breast cancer (MBC). We tested the combination in the earlier-line setting and explored the predictive value of [ 18 F]fluorodeoxyglucose positron emission tomography ([ 18 F]FDG-PET) for clinical outcomes. Patients and Methods Two cohorts were enrolled (cohort 1: no prior trastuzumab for MBC and ≥ 1 year from adjuvant trastuzumab, if given; cohort 2: one to two lines of chemotherapy including trastuzumab for MBC and/or recurrence 〈 1 year from adjuvant trastuzumab). The primary end point was objective response rate by RECIST v1.0; secondary end points included clinical benefit rate (complete response plus partial response plus stable disease ≥ 24 weeks) and progression-free survival. [ 18 F]FDG-PET scans were acquired at baseline, week 1, and week 8. Associations between metabolic response and clinical outcomes were explored. Results Eighty-seven patients were registered (85 were evaluable for efficacy). The confirmed objective response rate was 50.0% (95% CI, 33.8% to 66.2%) in cohort 1 and 22.2% (95% CI, 11.3% to 37.3%) in cohort 2. Clinical benefit rate was 57.5% (95% CI, 40.9% to 73.0%) in cohort 1 and 40.0% (95% CI, 25.7% to 55.7%) in cohort 2. Median progression-free survival was 7.4 and 5.3 months, respectively. Lack of week-1 [ 18 F]FDG-PET/computed tomography ([ 18 F]FDG-PET/CT) response was associated with failure to achieve an objective response by RECIST (negative predictive value, 91% [95% CI, 74% to 100%] for cohort 1 and 91% [95% CI, 79% to 100%] for cohort 2). Conclusion Early use of lapatinib and trastuzumab is active in human epidermal growth factor receptor 2–positive MBC. Week-1 [ 18 F]FDG-PET/CT may allow selection of patients who can be treated with targeted regimens and spared the toxicity of chemotherapy.

Type of Medium: Online Resource

ISSN: 0732-183X , 1527-7755

URL: Article

DOI: 10.1200/JCO.2014.60.0353

RVK:

XA 52760

RVK:

XA 10000

Language: English

Publisher: American Society of Clinical Oncology (ASCO)

Publication Date: 2015

detail.hit.zdb_id: 2005181-5

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8

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Women's Interest in Gene Expression Analysis for Breast Cancer Recurrence Risk

O'Neill, Suzanne C. ; Brewer, Noel T. ; Lillie, Sarah E. ; [et al.]

American Society of Clinical Oncology (ASCO) ; 2007

In: Journal of Clinical Oncology Vol. 25, No. 29 ( 2007-10-10), p. 4628-4634

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In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 25, No. 29 ( 2007-10-10), p. 4628-4634

Abstract: Genomic and other technologies are improving the accuracy with which clinicians can estimate risk for recurrence (RFR) of breast cancer and make judgments about potential benefits of chemotherapy. Little is known of how patients will respond to genomic RFR testing or interact with their physicians to make informed decisions regarding treatment. We assessed interest in genomic RFR testing and patient preferences for incorporating results into treatment decision making. Patients and Methods One hundred thirty-nine women previously treated for early-stage breast cancer completed surveys that presented hypothetical scenarios reflecting different test outcomes and potential decisions. We assessed women's attitudes toward RFR testing, how results would affect their choices about adjuvant treatment, and potential concerns about and perceived benefits of testing. Results The majority of participants said they would “definitely” want to be tested (76%), receive their results (87%), and discuss these results with their physicians. They were willing to pay, on average, $997 for testing. Those who expressed more concerns about testing were less interested in testing and in incorporating results into treatment decision making. Participants were more likely to want chemotherapy when presented with high-risk results and would worry more about those results. They were least likely to trust and most likely to express potential anticipated regret in response to intermediate RFR results. Conclusion Participants expressed strong interest in testing. Although these decisions were sensitive to RFR, participants’ complex reactions to intermediate RFR suggest care is needed when communicating such results.

Type of Medium: Online Resource

ISSN: 0732-183X , 1527-7755

URL: Article

DOI: 10.1200/JCO.2006.09.6255

RVK:

XA 52760

RVK:

XA 10000

Language: English

Publisher: American Society of Clinical Oncology (ASCO)

Publication Date: 2007

detail.hit.zdb_id: 2005181-5

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A randomized phase 2 study of neoadjuvant carboplatin and paclitaxel with or without atezolizumab in triple negative breast cancer (TNBC) - NCI 10013

Ademuyiwa, Foluso O. ; Gao, Feng ; Street, Cherease R. ; [et al.]

Springer Science and Business Media LLC ; 2022

In: npj Breast Cancer Vol. 8, No. 1 ( 2022-12-30)

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In: npj Breast Cancer, Springer Science and Business Media LLC, Vol. 8, No. 1 ( 2022-12-30)

Abstract: Atezolizumab with chemotherapy has shown improved progression-free and overall survival in patients with metastatic PD-L1 positive triple negative breast cancer (TNBC). Atezolizumab with anthracycline- and taxane-based neoadjuvant chemotherapy has also shown increased pathological complete response (pCR) rates in early TNBC. This trial evaluated neoadjuvant carboplatin and paclitaxel with or without atezolizumab in patients with clinical stages II-III TNBC. The co-primary objectives were to evaluate if chemotherapy and atezolizumab increase pCR rate and tumor infiltrating lymphocyte (TIL) percentage compared to chemotherapy alone in the mITT population. Sixty-seven patients (ages 25–78 years; median, 52 years) were randomly assigned – 22 patients to Arm A, and 45 to Arm B. Median follow up was 6.6 months. In the modified intent to treat population (all patients evaluable for the primary endpoints who received at least one dose of combination therapy), the pCR rate was 18.8% (95% CI 4.0–45.6%) in Arm A, and 55.6% (95% CI 40.0–70.4%) in Arm B (estimated treatment difference: 36.8%, 95% CI 8.5–56.6%; p = 0.018). Grade 3 or higher treatment-related adverse events occurred in 62.5% of patients in Arm A, and 57.8% of patients in Arm B. One patient in Arm B died from recurrent disease during the follow-up period. TIL percentage increased slightly from baseline to cycle 1 in both Arm A (mean ± SD: 0.6% ± 21.0%) and Arm B (5.7% ± 15.8%) ( p = 0.36). Patients with pCR had higher median TIL percentages (24.8%) than those with non-pCR (14.2%) ( p = 0.02). Although subgroup analyses were limited by the small sample size, PD-L1-positive patients treated with chemotherapy and atezolizumab had a pCR rate of 75% (12/16). The addition of atezolizumab to neoadjuvant carboplatin and paclitaxel resulted in a statistically significant and clinically relevant increased pCR rate in patients with clinical stages II and III TNBC. (Funded by National Cancer Institute).

Type of Medium: Online Resource

ISSN: 2374-4677

URL: Article

DOI: 10.1038/s41523-022-00500-3

Language: English

Publisher: Springer Science and Business Media LLC

Publication Date: 2022

detail.hit.zdb_id: 2843288-5

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Phase I Study of Aurora A Kinase Inhibitor MLN8237 in Advanced Solid Tumors: Safety, Pharmacokinetics, Pharmacodynamics, and Bioavailability of Two Oral Formulations

Dees, E. Claire ; Cohen, Roger B. ; von Mehren, Margaret ; [et al.]

American Association for Cancer Research (AACR) ; 2012

In: Clinical Cancer Research Vol. 18, No. 17 ( 2012-09-01), p. 4775-4784

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In: Clinical Cancer Research, American Association for Cancer Research (AACR), Vol. 18, No. 17 ( 2012-09-01), p. 4775-4784

Abstract: Purpose: This phase I study evaluated the safety, pharmacokinetics, pharmacodynamics, and efficacy of the investigational oral drug MLN8237 (alisertib), a small-molecule Aurora A kinase (AAK) inhibitor, in 87 adult patients with advanced solid tumors. Experimental Design: Sequential cohorts of patients received MLN8237 5 to 150 mg orally once daily or twice daily for 7, 14, or 21 days, followed by 14 days' rest per cycle. MLN8237 pharmacokinetics was characterized, and the relative bioavailability of an enteric-coated tablet (ECT) formulation was evaluated in reference to the original powder-in-capsule (PIC) formulation. Pharmacodynamic effects of MLN8237 on inhibition of AAK activity were evaluated in skin biopsies. Tolerability and response to treatment were assessed. Results: Common toxicities included fatigue, nausea, and neutropenia. Plasma exposures increased dose proportionally (5–150 mg/d), and were similar for PIC and ECT. The terminal half-life was 23 hours. At the maximum tolerated dose of 50 mg twice daily on the 7-day schedule, the mitotic index of the skin basal epithelium was increased within 24 hours after MLN8237 administration on days 1 and 7, a finding consistent with AAK inhibition. One (1%) patient achieved a partial response lasting for more than 1 year and received MLN8237 for 51 cycles; 20 (23%) patients achieved stable disease for ≥3 months. Conclusions: This first-in-human trial of MLN8237 showed tolerability and favorable pharmacokinetics in this patient population. The recommended phase II dose of MLN8237 is 50 mg twice daily orally for 7 days in 21-day cycles, which is being evaluated further in the treatment of various solid tumors and hematologic malignancies. Clin Cancer Res; 18(17); 4775–84. ©2012 AACR.

Type of Medium: Online Resource

ISSN: 1078-0432 , 1557-3265

URL: Article

DOI: 10.1158/1078-0432.CCR-12-0589

RVK:

XA 36791

Language: English

Publisher: American Association for Cancer Research (AACR)

Publication Date: 2012

detail.hit.zdb_id: 1225457-5

detail.hit.zdb_id: 2036787-9

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Kooperativer Bibliotheksverbund

Berlin Brandenburg