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Article ; Online: Metformin to Prevent Anthracycline Cardiotoxicity?: That Would Be Sweet!

El-Rayes, Malak / Nadler, Michelle B / Abdel-Qadir, Husam

JACC. CardioOncology

2023 Volume 5, Issue 5, Page(s) 683–685

Language	English
Publishing date	2023-08-29
Publishing country	United States
Document type	Editorial
ISSN	2666-0873
ISSN (online)	2666-0873
DOI	10.1016/j.jaccao.2023.07.004
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Magnitude of effect and sample size justification in trials supporting anti-cancer drug approval by the US Food and Drug Administration.

Nadler, Michelle B / Wilson, Brooke E / Desnoyers, Alexandra / Valiente, Consolacion Molto / Saleh, Ramy R / Amir, Eitan

Scientific reports

2024 Volume 14, Issue 1, Page(s) 459

Abstract: Approval of drugs is based on randomized trials observing statistically significant superiority of an experimental agent over a standard. Statistical significance results from a combination of effect size and sampling, with larger effect size more likely ...

Abstract	Approval of drugs is based on randomized trials observing statistically significant superiority of an experimental agent over a standard. Statistical significance results from a combination of effect size and sampling, with larger effect size more likely to translate to population effectiveness. We assess sample size justification in trials supporting cancer drug approvals. We identified US FDA anti-cancer drug approvals for solid tumors from 2015 to 2019. We extracted data on study characteristics, statistical plan, accrual, and outcomes. Observed power (P
MeSH term(s)	United States ; Humans ; Female ; Drug Approval/methods ; Sample Size ; United States Food and Drug Administration ; Antineoplastic Agents/therapeutic use ; Breast Neoplasms/drug therapy
Chemical Substances	Antineoplastic Agents
Language	English
Publishing date	2024-01-03
Publishing country	England
Document type	Journal Article
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-023-50694-0
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Article ; Online: Comparative overall survival of CDK4/6 inhibitors in combination with endocrine therapy in advanced breast cancer.

Kappel, Coralea / Elliott, Mitchell J / Kumar, Vikaash / Nadler, Michelle B / Desnoyers, Alexandra / Amir, Eitan

Scientific reports

2024 Volume 14, Issue 1, Page(s) 3129

Abstract: Individual trials of abemaciclib, palbociclib, and ribociclib show a similar impact on progression-free survival yet differing statistical significance for overall survival (OS). A robust comparative evaluation of OS, safety, and tolerability of the ... ...

Abstract	Individual trials of abemaciclib, palbociclib, and ribociclib show a similar impact on progression-free survival yet differing statistical significance for overall survival (OS). A robust comparative evaluation of OS, safety, and tolerability of the three drugs is warranted. A systematic literature search identified phase 3 randomized clinical trials reporting OS of CDK4/6 inhibitors (CDK4/6i) in combination with endocrine therapy in ER-positive/HER2-negative advanced breast cancer. Trial-level data on OS and common and serious adverse events (AE) were extracted for each drug. In the absence of direct comparisons, a network meta-analysis was performed to evaluate pairwise comparative efficacy, safety, and tolerability of each of the CDK4/6i. Seven studies comprising of 4415 patients met the inclusion criteria. Median follow-up was 73.3 months (range: 48.7-97.2 months). There were no statistically significant differences in OS between any of the CDK4/6i. Compared to palbociclib, ribociclib and abemaciclib both showed significantly higher GI toxicity (grade 1-2 vomiting OR 1.87 [95% CI 1.37-2.56] and OR 2.27 [95% CI 1.59-3.23] respectively). Compared to palbociclib, abemaciclib was associated with more grade 3-4 diarrhea OR 118.06 [95% CI 7.28-1915.32]. In contrast, palbociclib was associated with significantly more neutropenia than ribociclib and abemaciclib but significantly lower risk of grade 3-4 infections. Abemaciclib had significantly less grade 3-4 transaminitis and grade 3-4 neutropenia than ribociclib. Treatment discontinuation and death due to AE were significantly higher with abemaciclib than palbociclib and ribociclib. There is no statistically significant difference in OS between CDK4/6i despite differing statistical significance levels of individual trials. Real-world data analyses may help to identify if there is a meaningful inter-drug difference in efficacy. Significant differences between CDK4/6i are observed for safety and tolerability outcomes.
MeSH term(s)	Female ; Humans ; Aminopyridines ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Benzimidazoles ; Breast Neoplasms/drug therapy ; Cyclin-Dependent Kinase 4 ; Cyclin-Dependent Kinase 6 ; Cyclin-Dependent Kinase Inhibitor Proteins ; Neutropenia/chemically induced ; Purines ; Clinical Trials, Phase III as Topic ; Randomized Controlled Trials as Topic
Chemical Substances	abemaciclib (60UAB198HK) ; Aminopyridines ; Benzimidazoles ; CDK4 protein, human (EC 2.7.11.22) ; Cyclin-Dependent Kinase 4 (EC 2.7.11.22) ; Cyclin-Dependent Kinase 6 (EC 2.7.11.22) ; Cyclin-Dependent Kinase Inhibitor Proteins ; Purines ; ribociclib (TK8ERE8P56)
Language	English
Publishing date	2024-02-07
Publishing country	England
Document type	Journal Article ; Meta-Analysis ; Systematic Review
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-024-53151-8
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Differential treatment effect between younger and older adults for new cancer therapies in solid tumors supporting US Food and Drug Administration approval between 2010 and 2021.

Wilson, Brooke E / Desnoyers, Alexandra / Nadler, Michelle B / Amir, Eitan / Booth, Christopher M

Cancer

2023 Volume 129, Issue 20, Page(s) 3318–3325

Abstract: Background: Over one half of cancer diagnoses occur in patients aged 65 and older. The authors quantified how treatment effects differ between older and younger patients in oncology registration trials.: Methods: The authors performed a retrospective ...

Abstract	Background: Over one half of cancer diagnoses occur in patients aged 65 and older. The authors quantified how treatment effects differ between older and younger patients in oncology registration trials. Methods: The authors performed a retrospective cohort study of registration trials supporting US Food and Drug Administration approval of cancer drugs (from January 2010 to December 2021). The primary outcome was differential treatment effect by age (younger than 65 years vs. 65 years or older) for progression-free survival and overall survival. Random effects meta-analysis and a pairwise comparison of outcomes by age group also were performed. Results: Among 263 trials that met the inclusion criteria, 120 trials with 153 end points and 83,152 patients presented age-specific outcome data. Among the included randomized patients, 38% were aged 65 years and older compared with an incidence proportion of 55% in data from the National Cancer Institute's Surveillance, Epidemiology, and End Results program. Studies evaluating prostate cancer had the highest representation of patients aged 65 years or older (73%), whereas breast cancer studies had the lowest (20%). There were no changes in the proportion of patients aged 65 years or older over time (p = .86). Only 7% of end points showed a statistically significant interaction between outcome and age group. In a pooled analysis, there was an association between treatment effect and age for progression-free survival that approached but did not meet significance (hazard ratio, 0.95; p = .06), and there was no difference for overall survival (hazard ratio, 0.97; p = .79). Conclusions: Older adults remain under-represented in oncology registration trials. Significant differences in outcomes by age group were uncommon in individual trials and pooled analyses. However, clinical trial participants differ from real-world patients older than 65 years, and increased enrollment and ongoing research into differential treatment effects by age are needed.
MeSH term(s)	Aged ; Humans ; Male ; Middle Aged ; Antineoplastic Agents/therapeutic use ; Breast Neoplasms/drug therapy ; Drug Approval ; Medical Oncology ; Retrospective Studies ; United States/epidemiology ; United States Food and Drug Administration ; Female
Chemical Substances	Antineoplastic Agents
Language	English
Publishing date	2023-06-20
Publishing country	United States
Document type	Meta-Analysis ; Journal Article
ZDB-ID	1429-1
ISSN	1097-0142 ; 0008-543X ; 1934-662X
ISSN (online)	1097-0142
ISSN	0008-543X ; 1934-662X
DOI	10.1002/cncr.34911
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Article ; Online: Meta-analysis of sex and racial subgroup participation rates and differential treatment effects for trials in solid tumor malignancies leading to US Food and Drug Administration registration between 2010 and 2021.

Wilson, Brooke E / Nadler, Michelle B / Desnoyers, Alexandra / Booth, Christopher M / Amir, Eitan

Cancer

2023 Volume 130, Issue 2, Page(s) 276–286

Abstract: Background: The lack of sociodemographic diversity in clinical trials limits the generalizability of results. The authors examined participation rates and effect modification by sex and race in oncology trials.: Methods: The authors extracted outcome ...

Abstract	Background: The lack of sociodemographic diversity in clinical trials limits the generalizability of results. The authors examined participation rates and effect modification by sex and race in oncology trials. Methods: The authors extracted outcome data stratified by sex and race for registration trials supporting US Food and Drug Administration (FDA) approval (2010-2021). Effect modification by race and sex was examined using quantitative and qualitative methods. A random-effects meta-analysis and pairwise comparison of progression-free survival (PFS) and overall survival (OS) outcomes was conducted by sex and race. Results: Ninety-five trials with 123 end points and 54,365 patients provided information on sex. Trial patients were more often male (n = 35,482; 65% vs. 56% male patients in US Surveillance, Epidemiology, and End Results [SEER] data), although the proportion of male patients was similar after adjusting by tumor type (60% in FDA data vs. 58% in SEER data). There was no difference in pooled outcomes among male versus female patients (PFS: hazard ratio, 0.99; 95% confidence interval, 0.92-1.07; p = .89; OS: hazard ratio, 0.99; 95% confidence interval, 0.93-1.07; p = .90). In total, 111 trials including 74,217 patients provided information on race, and 68% of patients identified as White, compared with 72.3% in US SEER incidence data. Black patients were under-represented compared with US SEER incidence data, although ethnicity was poorly reported throughout the data set. In the authors' network meta-analysis by race, there were no statistically significant differences in PFS or OS outcomes. Conclusions: No significant differences in PFS or OS outcomes were identified when the analyses were stratified by sex or race. Certain racial minorities remain under-represented, and clearer reporting of race and ethnicity is needed. Representation of female patients in FDA trials is similar to that in SEER data after adjusting for tumor type.
MeSH term(s)	Female ; Humans ; Male ; Ethnicity ; Medical Oncology ; Neoplasms/drug therapy ; Neoplasms/epidemiology ; United States/epidemiology ; United States Food and Drug Administration ; Clinical Trials as Topic
Language	English
Publishing date	2023-09-26
Publishing country	United States
Document type	Meta-Analysis ; Journal Article
ZDB-ID	1429-1
ISSN	1097-0142 ; 0008-543X ; 1934-662X
ISSN (online)	1097-0142
ISSN	0008-543X ; 1934-662X
DOI	10.1002/cncr.35035
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Article ; Online: Magnitude of effect and sample size justification in trials supporting anti-cancer drug approval by the US Food and Drug Administration

Michelle B. Nadler / Brooke E. Wilson / Alexandra Desnoyers / Consolacion Molto Valiente / Ramy R. Saleh / Eitan Amir

Scientific Reports, Vol 14, Iss 1, Pp 1-

2024 Volume 9

Abstract: Abstract Approval of drugs is based on randomized trials observing statistically significant superiority of an experimental agent over a standard. Statistical significance results from a combination of effect size and sampling, with larger effect size ... ...

Abstract	Abstract Approval of drugs is based on randomized trials observing statistically significant superiority of an experimental agent over a standard. Statistical significance results from a combination of effect size and sampling, with larger effect size more likely to translate to population effectiveness. We assess sample size justification in trials supporting cancer drug approvals. We identified US FDA anti-cancer drug approvals for solid tumors from 2015 to 2019. We extracted data on study characteristics, statistical plan, accrual, and outcomes. Observed power (P obs ) was calculated based on completed study characteristics and observed hazard ratio (HR obs ). Studies were considered over-sampled if P obs > expected with HR obs similar or worse than expected or if P obs was similar to expected with HR obs worse than expected. We explored associations with over-sampling using logistic regression. Of 75 drug approvals (reporting 94 endpoints), 21% (20/94) were over-sampled. Over-sampling was associated with immunotherapy (OR: 5.5; p = 0.04) and associated quantitatively but not statistically with targeted therapy (OR: 3.0), open-label trials (OR: 2.5), and melanoma (OR: 4.6) and lung cancer (OR: 2.17) relative to breast cancer. Most cancer drug approvals are supported by trials with justified sample sizes. Approximately 1 in 5 endpoints are over-sampled; benefit observed may not translate to clinically meaningful real-world outcomes.
Keywords	Medicine ; R ; Science ; Q
Language	English
Publishing date	2024-01-01T00:00:00Z
Publisher	Nature Portfolio
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Quantifying Withdrawal of Consent, Loss to Follow-Up, Early Drug Discontinuation, and Censoring in Oncology Trials.

Wilson, Brooke E / Nadler, Michelle B / Desnoyers, Alexandra / Amir, Eitan

Journal of the National Comprehensive Cancer Network : JNCCN

2021 Volume 19, Issue 12, Page(s) 1433–1440

Abstract: Background: Censoring due to early drug discontinuation (EDD) or withdrawal of consent or loss to follow-up (WCLFU) can result in postrandomization bias. In oncology, censoring rules vary with no defined standards. In this study, we sought to describe ... ...

Abstract	Background: Censoring due to early drug discontinuation (EDD) or withdrawal of consent or loss to follow-up (WCLFU) can result in postrandomization bias. In oncology, censoring rules vary with no defined standards. In this study, we sought to describe the planned handling and transparency of censoring data in oncology trials supporting FDA approval and to compare EDD and WCLFU in experimental and control arms. Methods: We searched FDA archives to identify solid tumor drug approvals and their associated trials between 2015 and 2019, and extracted the planned handling and reporting of censored data. We compared the proportion of WCLFU and EDD between the experimental and control arms by using generalized estimating equations, and performed logistic regression to identify trial characteristics associated with WCLFU occurring more frequently in the control group. Results: Censoring rules were defined adequately in 48 (59%) of 81 included studies. Only 14 (17%) reported proportions of censored participants clearly. The proportion of WCLFU was higher in the control group than in the experimental group (mean, 3.9% vs 2.5%; β-coefficient, -2.2; 95% CI, -3.1 to -1.3; P<.001). EDD was numerically higher in the experimental arm in 61% of studies, but there was no statistically significant difference in the proportion of EDD between the experimental and control groups (mean, 21.6% vs 19.9%, respectively; β-coefficient, 0.27; 95% CI, -0.32 to 0.87; P=.37). The proportion of EDD due to adverse effects (AEs) was higher in the experimental group (mean, 13.2% vs 8.5%; β-coefficient, 1.5; 95% CI, 0.57-2.45; P=.002). WCLFU was higher in the control group in studies with an active control group (odds ratio [OR], 10.1; P<.001) and in open label studies (OR, 3.00; P=.08). Conclusions: There are significant differences in WCLFU and EDD for AEs between the experimental and control arms in oncology trials. This may introduce postrandomization bias. Trials should improve the reporting and handling of censored data so that clinicians and patients are fully informed regarding the expected benefits of a treatment.
MeSH term(s)	Drug Approval ; Follow-Up Studies ; Humans ; Neoplasms/drug therapy ; Odds Ratio
Language	English
Publishing date	2021-09-03
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2250759-0
ISSN	1540-1413 ; 1540-1405
ISSN (online)	1540-1413
ISSN	1540-1405
DOI	10.6004/jnccn.2021.7015
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Article ; Online: Fragility index of trials supporting approval of anti-cancer drugs in common solid tumours.

Desnoyers, Alexandra / Wilson, Brooke E / Nadler, Michelle B / Amir, Eitan

Cancer treatment reviews

2021 Volume 94, Page(s) 102167

Abstract: Background: The Fragility Indexquantifies the reliability of positive trials by estimating the number of events, which would change statistically significant results to non-significant results.: Methods: We identified randomized trials supporting ... ...

Abstract	Background: The Fragility Indexquantifies the reliability of positive trials by estimating the number of events, which would change statistically significant results to non-significant results. Methods: We identified randomized trials supporting drug approvals by the US FDA between 2009 and 2019 in lung, breast, prostate, and colon cancers and in melanoma. We reconstructed survival tablesand calculated the number of events, which would result in a non-significant result for the primary endpoint. The FI was then compared to the number of patients in each trial who withdrew consent or were lost to follow-up. Regression analyses were used to explore associations between RCT characteristics and FI and trials in which FI was lower or equal to number of participants who withdrew consent or were lost to follow-up. Results: Among 81 RCTs, the median FI was 28. The median number of patients who withdrew consent or were lost to follow up was 27. FI was equal or lower than the number of patients who withdrew consent or were lost to follow-up in 47 trials (58%). There was a modest increase in FI over time (p = 0.02). Trials with overall survival as the primary endpoint (p = 0.006) and those in the palliative setting (p < 0.001) had lower FI. There was no association with trial sample size or duration of follow-up. Findings: Statistical significance of RCTs in common solid tumours can be reversed often with a small number of additional events. Post-approval RCTs or real-world data analyses should be performed to ensure results of registration trials are robust.
MeSH term(s)	Antineoplastic Agents/standards ; Antineoplastic Agents/therapeutic use ; Clinical Trials, Phase II as Topic/standards ; Clinical Trials, Phase II as Topic/statistics & numerical data ; Clinical Trials, Phase III as Topic/standards ; Clinical Trials, Phase III as Topic/statistics & numerical data ; Disease-Free Survival ; Drug Approval/methods ; Drug Approval/statistics & numerical data ; Humans ; Neoplasms/drug therapy ; Randomized Controlled Trials as Topic/standards ; Randomized Controlled Trials as Topic/statistics & numerical data ; Reproducibility of Results
Chemical Substances	Antineoplastic Agents
Language	English
Publishing date	2021-02-16
Publishing country	Netherlands
Document type	Journal Article ; Review
ZDB-ID	125102-8
ISSN	1532-1967 ; 0305-7372
ISSN (online)	1532-1967
ISSN	0305-7372
DOI	10.1016/j.ctrv.2021.102167
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Zs.A 1022: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: A retrospective analysis of changes in distant and breast cancer related disease-free survival events in adjuvant breast cancer trials over time.

Wilson, Brooke E / Desnoyers, Alexandra / Al-Showbaki, Laith / Nadler, Michelle B / Amir, Eitan

Scientific reports

2022 Volume 12, Issue 1, Page(s) 6352

Abstract: Disease-free survival (DFS) comprises both breast cancer and non-breast cancer events. DFS has not been validated as a surrogate endpoint for overall survival (OS) in most breast cancer subtypes. We assessed changes to the type of events contributing to ... ...

Abstract	Disease-free survival (DFS) comprises both breast cancer and non-breast cancer events. DFS has not been validated as a surrogate endpoint for overall survival (OS) in most breast cancer subtypes. We assessed changes to the type of events contributing to DFS over time. We identified adjuvant studies in breast cancer (BC) from 2000 to 2020 where the endpoint was DFS. We examined change in distant DFS events and the BC-related DFS using univariable and multivariable linear regression. Data were reported quantitatively using the Burnand criteria irrespective of statistical significance. We included 84 studies (88 cohorts), comprising 212,191 participants, 41,604 DFS events and 23,205 distant DFS events. The DFS event rate/100 participants/year has declined modestly over time (ß - 0.34, p = 0.001). Start year was negatively associated with distant DFS events (ß - 0.58, p < 0.0001); however, the effect was lost after adjusting for follow-up time (ß - 0.18, p = 0.096). The average number of BC-related events/100 participants/year also declined over time (ß - 0.28, p = 0.009). In multivariable analysis, start year and ER expression were quantitatively associated with distant DFS events and BC-related DFS events. DFS events have declined over time driven by a reduction in BC related events. As DFS events are increasingly defined by non-BC events, there will be limited surrogacy between DFS and OS.
MeSH term(s)	Breast Neoplasms/drug therapy ; Chemotherapy, Adjuvant ; Disease-Free Survival ; Female ; Humans ; Progression-Free Survival ; Retrospective Studies
Language	English
Publishing date	2022-04-15
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-022-09949-5
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Article ; Online: Towards a Postgraduate Oncology Training Model for Family Medicine: Mixed Methods Evaluation of a Breast Oncology Rotation.

Nadler, Michelle B / Hofbauer, Brooke E / Wu, Melinda / Hum, Susan / Elser, Christine / Nyhof-Young, Joyce

Current oncology (Toronto, Ont.)

2022 Volume 29, Issue 9, Page(s) 6485–6495

Abstract: Background: Family physicians have low knowledge and preparedness to manage patients with cancer. A breast oncology clinical rotation was developed for family medicine residents to address this gap in medical education.: Objectives and methods: A ... ...

Abstract	Background: Family physicians have low knowledge and preparedness to manage patients with cancer. A breast oncology clinical rotation was developed for family medicine residents to address this gap in medical education. Objectives and methods: A breast oncology rotation for family residents was evaluated using a pre-post knowledge questionnaire and semi-structured interviews comparing rotation (RRs) versus non-rotation (NRRs) residents. Quantitative and qualitative data were collected via a pre-post knowledge questionnaire and semi-structured interviews, respectively. Analysis: Quantitative data were analysed using descriptive statistics and paired t-tests to compare pre-post-rotation knowledge and preparedness. Qualitative data were coded inductively, analysed, and grouped into categories and themes. Data sets were integrated. Results: The study was terminated early due to the COVID-19 pandemic. Six RRs completed the study; 19 and 2 NRRs completed the quantitative and qualitative portions, respectively. RRs' knowledge scores did not improve, but there was a non-significant increase in preparedness (5.3 to 8.4, Discussion and conclusion: Important educational outcomes were obtained despite no change in knowledge scores. This rotation can be adapted to other training programs including an oncology primer to enable trainee integration of new information.
MeSH term(s)	COVID-19 ; Family Practice/education ; Humans ; Internship and Residency ; Medical Oncology ; Pandemics
Language	English
Publishing date	2022-09-10
Publishing country	Switzerland
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1236972-x
ISSN	1718-7729 ; 1198-0052
ISSN (online)	1718-7729
ISSN	1198-0052
DOI	10.3390/curroncol29090510
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