Methodology of phase II clinical trials in metastatic elderly breast cancer: a literature review

Mourey, Loïc; Balardy, L.; Kanoun, Dorra; Roché, Henri; Boher, Jean-Marie; Rougé‐Bugat, Marie‐Ève; Filleron, Thomas

doi:10.1007/s10549-017-4278-5

Cited by 8 publications

(5 citation statements)

References 49 publications

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“…2 Toulouse School of Economics, University of Toulouse Capitole, Toulouse, France. 3 Biostatistics Unit, Institut Paoli-Calmettes, Marseille, France. 4 • support for research data, including large and complex data types • gold Open Access which fosters wider collaboration and increased citations maximum visibility for your research: over 100M website views per year…”

Section: Abbreviationsmentioning

confidence: 99%

“…The most common barriers cited were: stringent eligibility criteria, oncologists concerns for toxicity, patients and family refusal [ 1 ]. Given the challenges of conducting randomized phase III trials in older patients, several authors have previously suggested conducting single-arm phase II trials to assess the feasibility of a treatment that has been shown to be effective in a younger population [ 2 , 3 ]. Indeed, perhaps more importantly than in any other population, cancer care should not compromise quality of life or autonomy [ 2 , 3 ].…”

Section: Introductionmentioning

confidence: 99%

“…Given the challenges of conducting randomized phase III trials in older patients, several authors have previously suggested conducting single-arm phase II trials to assess the feasibility of a treatment that has been shown to be effective in a younger population [ 2 , 3 ]. Indeed, perhaps more importantly than in any other population, cancer care should not compromise quality of life or autonomy [ 2 , 3 ]. Treatment feasibility can be evaluated with a composite endpoint combining multiple clinical dimensions (e.g.…”

Section: Introductionmentioning

confidence: 99%

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A stratified adaptive two-stage design with co-primary endpoints for phase II clinical oncology trials

Leconte

Sfumato

Boher

et al. 2022

BMC Med Res Methodol

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Background Given the inherent challenges of conducting randomized phase III trials in older cancer patients, single-arm phase II trials which assess the feasibility of a treatment that has already been shown to be effective in a younger population may provide a compelling alternative. Such an approach would need to evaluate treatment feasibility based on a composite endpoint that combines multiple clinical dimensions and to stratify older patients as fit or frail to account for the heterogeneity of the study population to recommend an appropriate treatment approach. In this context, stratified adaptive two-stage designs for binary or composite endpoints, initially developed for biomarker studies, allow to include two subgroups whilst maintaining competitive statistical performances. In practice, heterogeneity may indeed affect more than one dimension and incorporating co-primary endpoints, which independently assess each individual clinical dimension, would therefore appear quite pertinent. The current paper presents a novel phase II design for co-primary endpoints which takes into account the heterogeneity of a population. Methods We developed a stratified adaptive Bryant & Day design based on the Jones et al. and Parashar et al. algorithm. This two-stage design allows to jointly assess two dimensions (e.g. activity and toxicity) in two different subgroups. The operating characteristics of this new design were evaluated using examples and simulation comparisons with the Bryant & Day design in the context where the study population is stratified according to a pre-defined criterion. Results Simulation results demonstrated that the new design minimized the expected and maximum sample sizes as compared to parallel Bryant & Day designs (one in each subgroup), whilst controlling type I error rates and maintaining a competitive statistical power as well as a high probability of detecting heterogeneity. Conclusions In a heterogeneous population, this two-stage stratified adaptive phase II design provides a useful alternative to classical one and allows to identify a subgroup of interest without dramatically increasing sample size. As heterogeneity is not limited to older populations, this new design may also be relevant to other study populations such as children or adolescents and young adults or the development of targeted therapies based on a biomarker.

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Section: Abbreviationsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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A stratified adaptive two-stage design with co-primary endpoints for phase II clinical oncology trials

Leconte

Sfumato

Boher

et al. 2022

BMC Med Res Methodol

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“…Most studies evaluating the benefits of chemotherapy in 'older women' use a lower cut off age of 65 or 70 with few phase II trials jointly assessing efficacy and tolerance to treatment, e.g., toxicity, quality of life etc. [24]. In frail patients or patients with multiple comorbidities, aggressive treatment may not result in a survival benefit compared to younger women.…”

Section: Locally Advanced Metastatic Disease and Chemotherapymentioning

confidence: 99%

Breast cancer treatment in women over the age of 80: A tailored approach

Glaser

Marinopoulos²,

Dimitrakakis

2018

Maturitas

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Breast cancer treatment in women over the age of 80 remains a complex issue due to pre-existing comorbidities, therapy-related toxicities, and the lack of evidence-based data in this population, leading to both overtreatment and under treatment. The average life expectancy of an 80-year-old woman is 9.7 years and chronologic age alone should not be a factor in withholding therapy. Women over age 80 should be treated on an individual basis, taking into account their overall health and life expectancy, their risk of dying from breast cancer versus other causes, and the benefits versus toxicities of therapies for their tumor. Invaluable online tools are readily available to easily assess life expectancy (ePrognosis), as well as the absolute survival benefits for every tumor type and stage in individual patients (PREDICT, Ajuvant!). This information should be presented to the patient so that they are able to make an informed decision based on their goals, wishes and quality of life. Vulnerable patients should not be bullied or scared into taking unwanted or unnecessary treatments.

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“…Until recently elderly breast cancer patients were used to be underrepresented in clinical trials ( 6 , 7 ). It is promising that more specific trials are being tailored mainly addressing older women with both localized and metastatic breast cancer ( 8 - 12 ). As more detailed information about clinicopathological features of breast cancer in the elderly is obtained, it becomes more important it is to understand that it differs in a unique way from the features of breast cancer in the younger population ( 13 ).…”

Section: Introductionmentioning

confidence: 99%

Treatment and patient related quality of life issues in elderly and very elderly breast cancer patients

Depboylu¹

2020

Transl Cancer Res TCR

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As the number of aging population increases, a significant amount of elderly cancer patients need more personalized care for their cancer treatment. Breast cancer is the most common cancer in women, and almost half of the newly diagnosed patients are older than the age of 65 years. With their peculiar characteristics, elderly patients with breast cancer should be held with a comprehensive geriatric assessment. It is vital to make the choice of correct treatment more delicately, to better predict the prognosis of the patient and risks associated with specific treatments. The current article focuses on how various methods of treatment in elderly breast cancer affect their quality of life and the challenges they experience among age from 70 to 79 and age from 80 and over subgroups of this population. Treatment (surgery, radiation therapy, chemotherapy, and endocrine therapy) and patient-related (mental health, physical function, frailty, cognitive function, nutrition) quality of life issues are revisited in the light of recent literature.

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Methodology of phase II clinical trials in metastatic elderly breast cancer: a literature review

Cited by 8 publications

References 49 publications

A stratified adaptive two-stage design with co-primary endpoints for phase II clinical oncology trials

A stratified adaptive two-stage design with co-primary endpoints for phase II clinical oncology trials

Breast cancer treatment in women over the age of 80: A tailored approach

Treatment and patient related quality of life issues in elderly and very elderly breast cancer patients

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