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Evidence-based approaches for the management of side-effects of adjuvant endocrine therapy in patients with breast cancer lancet 2021

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Physical Exercise and the Hallmarks of Breast Cancer 2022

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Hallmarks of aging  An expanding universe  2023

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OPAS decada do envelhecimento saudavel 2020-2030

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World Health Organization WHO Regional websites

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Unfortunately, the increase in the number of older people living with cancer has not been mirrored by a proportional increase in public awareness of the burden, or by investments in the health services required to respond to the unique needs of this group. Some of the key challenges are:

limited integration of older people in discussions about cancer, including integration of older people into national multi-stakeholder cancer partnerships;

uneven inclusion of geriatric cancer in national cancer control plans (NCCPs);

limited awareness and uptake of existing guidelines, educational resources and inclusion of older adults in cancer research;

limited availability of specialists in geriatric oncology, unsystematic inclusion of gerontologists in cancer management and cancer care pathways, limited information on geriatric oncology[ii].

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The global 'longevity revolution' will continue to impact cancer control as cancer is more prevalent in older adults.

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jornada pernambucana masto 2023 - manejo cancer de mama mulher idosa sab final ajustes

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Bellera CA, Rainfray M, Mathoulin-Pelissier S ´ et al. Screening older cancer patients: First evaluation of the G-8 geriatric screening tool. Ann Oncol 2012;23:2166 - 2172

Validation of G8 and its acuracy as a predictor of object in oncological patients with age of ≥ 60 YEARS. prospective cohort of 889 brazilian elderly cancer patients.

Jurema Telles O Lima, Raissa Viana, Letícia telles Sales, Mirella Rebello, José Natal Figueiroa, Anke Bergmann, Zilda Cavalcanti, Amanda L LINS Mello, Maria Julia Gonçalves Mello, Luiz Claudio Santos Thuler, and BROG- Brazilian Research Oncologic Geriatric Group Journal of Clinical Oncology 2019 37:15_suppl, e23036-e23036.

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CASO SIMP oncogeriatria LACOG parte 1 JUREMA TELLES.pdf

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Purpose

Project Silver is a public health initiative established by the FDA Oncology Center of Excellence (OCE) to increase representation of older adults (65 years and older) in cancer clinical trials with the goal of improving their treatment, care, and outcome through evidence base data.

Why is this important?

Clinical trials are the key step in advancing potential new cancer treatments from the research setting to the cancer care clinic. Differences may exist between younger and older patients in drug response and toxicity. Also, older adults often have several health conditions requiring medications that could impact efficacy or the incidence and severity of adverse events.

Adults 65 years and older are a growing segment of the oncology population. Cancer incidence is expected to increase by 67% from 2010 to 2030 in people age 65 and older. Given the aging U.S. population, it's particularly important now more than ever to ensure that older adults are also enrolling in cancer clinical trials. Adequate representation of older adults who share a disproportionate burden of the cancer disease will allow generalizability of trial results which can then be conveyed to patients and health care providers.

However, older adults-particularly adults 75 years and older-have been historically underrepresented in clinical trials.

Project Silver Initiatives

Regulatory Policy

Encourage sponsors to conduct inclusive and representative trials early in development

Evaluate regulatory submissions for data in age subgroups

Consider need for additional data post approval

Develop Guidance for Industry

Science and Research

Actively engage in scientific collaboration with clinicians, social scientists and statisticians across FDA

Evaluate geriatric assessment tools and other measures for physiologic age

Foster opportunities for FDA oncology reviewers related to geriatric oncology

Global Engagement

Engage with global regulatory agencies to identify global strategies to increase evidence base for older adults

Collaborate with global regulatory agencies through Project Orbis on review of demographic age subgroup information in applications and prescribing information

Advocacy and Outreach

Engage with patient advocacy groups to assess opportunities to improve clinical trial enrollment

Identify inclusive clinical trial opportunities including decentralized trials, etc.

Engage with older adults to understand treatment goals and outcomes

Meet the Team

Project Lead: Harpreet Singh, MD, Associate Director, Oncology in Older Adults and Special Populations, Oncology Center of Excellence

Clinical Team Lead: Bindu Kanapuru, MD, Division of Hematological Malignancies II, Office of Oncologic Diseases, Center for Drug Evaluation and Research

Project Management: Pamela Balcazar, MS, Health Scientist, Oncology Center of Excellence

Select Events

FDA has sponsored multiple public workshops to further engage with the stakeholders and the broader community on the importance of diverse representation in cancer clinical trials.

FDA Guidance Documents

Select Publications

Harpreet S., Kanapuru B., Smith Che, Fashoyin-Aje L., Myers A., Kim G., and Pazdur, R.FDA analysis of enrollment of older adults in clinical trials for cancer drug registration: A 10-year experience by the U.S. Food and Drug Administration. Journal of Clinical Oncology 2017 35:15_suppl, 10009-10009

Kanapuru B., Harpreet S., Myers A., Beaver, J., Kwitkowski, V., Farrell, A., and Pazdur, R. Enrollment of Older Adults in Clinical Trials Evaluating Patients with Hematologic Malignancies - the Food and Drug Administration (FDA) Experience Blood, Volume 130, Supplement 1, 2017, Page 861

Levit LA, Singh H, Klepin HD, Hurria A. Expanding the Evidence Base in Geriatric Oncology: Action Items From an FDA-ASCO Workshop J Natl Cancer Inst. 2018 Nov 1;110(11):1163-1170. doi: 10.1093/jnci/djy169.

Kanapuru B, Singh H, Kwitkowski V, Blumenthal G, Farrell AT, Pazdur R. Older adults in hematologic malignancy trials: Representation, barriers to participation and strategies for addressing underrepresentation Blood Rev. 2020 Sep;43:100670. doi:10.1016/j.blre.2020.100670

Singh H, Beaver JA, Kim G, Pazdur R. Enrollment of older adults on oncology trials: An FDA perspective J Geriatr Oncol. 2017 May;8(3):149-150. doi: 10.1016/j.jgo.2016.11.001. Epub 2016 Dec 23

Improving the Evidence Base for Treatment Decision Making for Older Adults with Cancer: Proceedings of a Workshop - in Brief \ Improving the Evidence Base for Treatment Decision Making for Older Adults with Cancer: Proceedings of a Workshop-in Brief \ The National Academies Press nap.edu

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Improving the Evidence Base for the Treatment of Older Adults with Cancer

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Practical Assessment and Management of Vulnerabilities in Older Patients Receiving Systemic Cancer Therapy: ASCO Guideline Update 2023

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Practical Assessment and Management of Vulnerabilities in Older Patients Receiving Systemic Cancer Therapy: ASCO Guideline Update 2023

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Practical Assessment and Management of Vulnerabilities in Older Patients Receiving Systemic Cancer Therapy: ASCO Guideline Update slides

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Practical Assessment and Management of Vulnerabilities in Older Patients Receiving Systemic Cancer Therapy: ASCO Guideline Update slides

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Practical Assessment and Management of Vulnerabilities in Older Patients Receiving Systemic Cancer Therapy: ASCO Guideline Update chat action 

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Practical Assessment and Management of Vulnerabilities in Older Patients Receiving Systemic Cancer Therapy: ASCO Guideline Update chat action 

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ASCO daily 08/23 2023  Practical Assessment and Management of Vulnerabilities in Older Patients Receiving Systemic Cancer Therapy: ASCO Guideline Update

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ASCO daily 08/23 2023  Practical Assessment and Management of Vulnerabilities in Older Patients Receiving Systemic Cancer Therapy: ASCO Guideline Update

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The Francilian Oncogeriatric Group (FROG) is happy and proud to present the 4th edition of the book "Geriatric Oncology for Daily Practice" published under the auspices of the French speaking Society of Geriatric Oncology (SoFOG) and the International Society of Geriatric Oncology (SIOG).

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pesquisa pessoa idosa com cancer FDA 2022

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pesquisa pessoa idosa com cancer FDA 2022

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FDA News Release

FDA's Industry Recommendations and Cancer Moonshot Aim to Improve Lives of Patients and Their Families

Today, the U.S. Food and Drug Administration issued three final guidances to industry regarding cancer clinical trials that parallel the goals of President Biden's recently announced effort to renew and build upon his 2016 Cancer Moonshot initiative to facilitate continued advancement in cancer prevention, detection, research, and patient care.
"With today's actions the FDA is recommending important principles that involve addressing inequities, targeting the right treatments to the right patients, speeding progress against the most deadly and rare cancers, and learning from the experience of all patients," said Richard Pazdur, M.D., Director for the FDA's Oncology Center for Excellence. "All of these are tenets of Cancer Moonshot's mission."
Inspired by medical advancements in the field since 2016, the President's new goals for this iteration are to reduce the death rate from cancer by at least 50 percent over the next 25 years; to improve the experience of people and their families living with and surviving cancer; and, by doing this and more, to end cancer as we know it today.

The first guidance, " Inclusion of Older Adults in Cancer Clinical Trials," provides recommendations to sponsors and institutional review boards for including older adult patients, aged 65 years and older, in the clinical trials of drugs for the treatment of cancer. It recommends enrolling older adults in early phase studies of cancer clinical trials, if appropriate, to obtain information that better informs later phase studies. It also includes recommendations for trial design, recruitment strategies, information collection, and developing and reporting more discrete age groups to encourage enrollment of this historically excluded population.

It is vital to have older adult patients in clinical trials because differences may exist between younger and older patients in drug response and toxicity. Older adults often have other diseases or conditions and may be taking medications that could impact the efficacy of either the cancer drug or other drugs they are taking and may also impact the incidence and the severity of adverse events. There could also be important differences in efficacy in older adult patients compared to the younger or general population.

The second guidance for industry " Expansion Cohorts: Use in First-in-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics," provides advice on designing and conducting trials with multiple expansion cohorts that allow for concurrent accrual of patients into different cohorts to assess safety, pharmacokinetics, and anti-tumor activity of first-in human cancer drugs. Pharmaceutical companies and researchers can use trials with expansion cohort design to assess many different aspects of a drug in a single clinical trial to efficiently expedite the clinical development of the drug.

This guidance provides the FDA's recommendations regarding:

characteristics of drug products best suited for consideration for development under a multiple expansion cohort trial;

information to include in investigational new drug application submissions to support the design of individual expansion cohorts;

when to interact with FDA on planning and conduct of multiple expansion cohort studies; and

safeguards to protect patients enrolled in these expansion cohort studies.

Finally, the " Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics " guidance addresses master protocol design including information on what sponsors should submit to the FDA as part of these trial design approaches. It also directs how sponsors should interact with the FDA to facilitate efficient review and mitigate risks to patients. These clinical trials can help expedite the clinical development of a drug to treat cancer because they allow more than one investigational drug or biologic, more than one disease type, or more than one patient population, to be evaluated under a single clinical trial structure.

The standard approach to generating evidence has become more expensive and challenging to execute and, as a result, answers to important clinical questions are often delayed. Well-designed master protocols can provide answers more quickly and efficiently than traditional clinical trials. Because of the complexity of these trials and the potential regulatory impact, it's important that the FDA is providing this guidance on how to conduct well designed trials that protect patient safety and obtain quality data needed to support drug approval.

Related Information

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FDA Clinical Trial Guidances Share Biden Administration's Goals for Advancing Development of Cancer Treatments

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FDA Clinical Trial Guidances Share Biden Administration's Goals for Advancing Development of Cancer Treatments

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Age Gap Decision Tool -BREAST CANCER OLDER 

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Age Gap Decision Tool -BREAST CANCER OLDER 

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Age Gap Decision Tool feedback survey

We would appreciate it if you could take 2 minutes to provide feedback by completing either the Clinician or Patient survey.

Your feedback will be anonymous. Thank you.

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Age Gap Decision Tool feedback survey We would appreciate it if you could take 2 minutes to provide feedback by completing either the Clinician or Patient survey. Your feedback will be anonymous. Thank you.

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How a Vast Demographic Shift Will Reshape the World

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The most powerful countries have benefited from large work forces for decades. What happens when they retire?

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Older women with breast cancer may benefit from genetic testing

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Older women with breast cancer may benefit from genetic testing

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Postmenopausal women with breast cancer are as likely as Ashkenazi Jewish women to carry inherited breast-cancer mutations that can inform treatment, a Stanford study found.

- By Krista Conger

About 1 in 40 postmenopausal women diagnosed with breast cancer before age 65 have cancer-associated mutations in their BRCA1 or BRCA2 genes, according to a study led by researchers at the Stanford School of Medicine.

The prevalence of the mutations in this group is similar to that of Ashkenazi Jewish women, whom the U.S. Preventive Service Task Force suggests should discuss their cancer risk with their physicians to determine if genetic testing is warranted. Currently, most guidelines don't address testing postmenopausal women with breast cancer in the absence of other risk factors.

The finding is the first to suggest that postmenopausal women who have been newly diagnosed with breast cancer but who don't have any hereditary risk factors, such as close family members diagnosed with breast cancer before age 50, may still benefit from genetic testing for inherited cancer-associated mutations.

Identifying women with inherited cancer-associated mutations, particularly in the BRCA1 and BRCA2 genes, is important because some of the mutations also substantially increase the risk of other cancers, including ovarian cancer. Because these mutations are passed through families, knowing that a woman carries one of these mutations may encourage her healthy relatives to discuss their own risk factors with their doctors.

"There's been a lot of controversy in the field as to whether every woman with breast cancer should receive genetic testing," said Allison Kurian, MD, MSc, associate professor of medicine and of epidemiology and population health at Stanford, "in part because we didn't know how prevalent cancer-associated mutations are in this largest subgroup of newly diagnosed people - that is, women who develop breast cancer after menopause without the presence of any known hereditary risk factors."

Kurian is the lead author of the study, which was published March 10 in JAMA. Marcia Stefanick, PhD, professor of medicine and of obstetrics and gynecology at Stanford, is the senior author of the study.

Cancer-associated variants

Unlike mutations that accumulate over time, specifically in cancer cells, germline mutations are inherited and are found in every cell of the body.

Physicians primarily consider a woman's age at diagnosis and her family's cancer history when determining whether to recommend genetic testing. A woman diagnosed with breast cancer before age 50, for example, or a healthy woman with several close family members who have had breast or ovarian cancer, is more likely to be referred for genetic testing than a postmenopausal woman with breast cancer and no other risk factors.

For the study, Kurian and Stefanick and their colleagues set out to compare the prevalence of cancer-associated mutations in 10 breast-cancer risk genes, including BRCA1 and BRCA2. They compared 2,195 women who were diagnosed with breast cancer at an average age of 73 with 2,322 women without breast cancer.

The data for the study came from more than 4,500 participants in the long-running Women's Health Initiative. The initiative enrolled more than 160,000 women ages 50 to 79 throughout the United States between 1993 to 1998 to conduct the largest study of postmenopausal health in the country. Stefanick served as chair of the initiative's steering committee for most of the project.

The researchers found that about 3.5% of the women with breast cancer in their study had a cancer-associated mutation in at least one of the 10 genes, compared with about 1.3% of women without cancer. When they narrowed their focus to just the BRCA1 and BRCA2 genes in women diagnosed before age 65, they found that about 2.2% of women with breast cancers had cancer-associated mutations, versus about 1.1% of those without breast cancer.

Only about 31% of those women with cancer and 20% of those without cancer, both with BRCA1 or BRCA2 mutations, were likely to have been recommended for testing under the current guidelines of the National Comprehensive Cancer Network.

"Now we know that the prevalence of cancer-associated BRCA1 and BRCA2 mutations in women diagnosed with breast cancer after menopause rivals that in women of Ashkenazi Jewish descent - a population that is currently encouraged to discuss genetic testing with their doctors," Kurian said. "We finally have a read on the likely benefit of testing this most common subgroup of breast cancer patients."

Researchers from Myriad Genetics Inc., the University of California-San Diego and the State University of New York contributed to the study.

The research was supported by Myriad Genetics, the Suzanne Pride Bryan Fund for Breast Cancer Research, the Jan Weimer Faculty Chair in Breast Oncology and the BRCA Foundation.

Media Contacts

About Stanford Medicine

Stanford Medicine is an integrated academic health system comprising the Stanford School of Medicine and adult and pediatric health care delivery systems. Together, they harness the full potential of biomedicine through collaborative research, education and clinical care for patients. For more information, please visit med.stanford.edu.

How the environment and health interact

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Older women with breast cancer may benefit from genetic testing

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Postmenopausal women with breast cancer are as likely as Ashkenazi Jewish women to carry inherited breast-cancer mutations that can inform treatment, a Stanford study found.

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https://www.avantenestle.com.br/servicos/calculadoras/mna

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Instrumento de triagem nutricional para idosos hospitalizados ou em instituições de longa permanência. Esse instrumento inclui seis questões de triagem para identificar o risco nutricional.

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Links
ePrognosis' Sister Site:

Other sites with prognosis calculators:

Cancer:

Breast Cancer Prediction

EFFECT In-hospital Heart Failure Mortality Prediction

Hodgkin Lymphoma

Cancer Survival Rates

Cardiology:

10-year Framingham risk to decide on statin treatment

Atrial Fibrillation Risk

Cardiovascular Risk Assessment in adults (10-year, MESA 2015, with or without CAC score)

Cerebrovascular:

Grace Score for 6-month mortality after ACS

Seattle Heart Failure

CHADSVasc2

GO-FAR Calculator for neurologically intact survival after in-hospital arrest

HAS-BLED Score

Endocrine:

Risk of TIA Progression

Stroke Risk Female

Stroke Risk Male

Gastrointestinal:

FRAX probability of fracture

Child Pugh Score for Severity of Liver Disease

General Life Expectancy:

Liver Failure MELD Score

MD Calc

Nephrology:

Non-medical actuarial calculator for life expectancy

Cohen Index 6-month mortality for patients on hemodialysis

Pulmonary:

CURB-65 Pneumonia Severity Score

Urology:

IPSS score for prostate symptoms

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European Cancer Organisation’sInequalities Network: Putting CancerInequalities on the European Policy Map -AGEISMO

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European Cancer Organisation’sInequalities Network: Putting CancerInequalities on the European Policy Map -AGEISMO

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Inclusion of Older Adults in Cancer Clinical TrialsGuidance for Industry FDA 2022 

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Inclusion of Older Adults in Cancer Clinical TrialsGuidance for Industry FDA 2022 

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The Francilian Oncogeriatric Group (FROG) is happy and proud to present the 4th edition of the book "Geriatric Oncology for Daily Practice" published under the auspices of the French speaking Society of Geriatric Oncology (SoFOG) and the International Society of Geriatric Oncology (SIOG).

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Caso clínico PARTE II oncogeriatria lacog parte 2.pdf

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* Eastern Cooperative Oncology Group (ECOG)

Martinez-Tapia C, Canoui-Poitrine F, Bastuji-Garin S, et al. Optimizing the G8 Screening Tool for Older Patients With Cancer: Diagnostic Performance and Validation of a Six-Item Version. Oncologist. 2016;21(2):188-195. doi:10.1634/theoncologist.2015-0326

Camara DB, Lima JTO, Bezerra MR, et al. Prognostic performance of the modified-G8 screening instrument for patients aged 60 years or older: A prospective cohort of 889 Brazilian patients. J Geriatr Oncol. 2020;11(3):533-535. doi:10.1016/j.jgo.2019.10.021

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Eastern Cooperative Oncology Group (ECOG) Martinez-Tapia C, Canoui-Poitrine F, Bastuji-Garin S, et al. Optimizing the G8 Screening Tool for Older Patients With Cancer: Diagnostic Performance and Validation of a Six-Item Version. Oncologist. 2016;21(2):188-195. doi:10.1634/theoncologist.2015-0326 Camara DB, Lima JTO, Bezerra MR, et al.