Simone Mathoulin-Pélissier, MD/PhD

Older adults with cancer remain underrepresented in cancer clinical trials that establish new standards of care. Geriatric assessment (GA) is defined by geriatricians as a multidimensional interdisciplinary assessment of the general health stat us of the older patient, reviewing the medical, psychosocial, functional and environmental domains. For each domain, several tools are available, but consensus is lacking on which tool to use and the optimal cut-offs or threshold scores. The literature supports the prognostic value of the GA and its utility in weighing the benefits and risks of cancer treatments in older adults. However, GA has not been implemented in routine oncology practice or in cancer clinical trials.

The objective of this project is to develop a set of geriatric data, the Geriatric Core Dataset (G-CODE), to be collected in cancer trials of older patients. The methods rely on a consensus process involving international experts in the field of oncology and geriatrics.

Although cancer is prevalent in the older segment of the population, older adults with cancer remain underrepresented in cancer clinical trials that establish new standards of care. As a result, robust data on the benefit/risk balance are lacking for many treatment strategies in these patients.

Ageing is a heterogeneous process that stresses the clinical need to identify comorbid conditions and ageing-related physiologic changes, both well-known factors increasing the risk of treatment side-effects and poor outcomes.

Geriatric assessment (GA) is defined by geriatricians as a multidimensional interdisciplinary assessment of the general health stat us of the older patient, reviewing the medical, psychosocial, functional and environmental domains. For each domain, several tools are available, but consensus is lacking on which tool to use and the optimal cut-offs or threshold scores. The literature supports the prognostic value of the GA and its utility in weighing the benefits and risks of cancer treatments in older adults. However, GA has not been implemented in routine oncology practice or in cancer clinical trials.

In 2011, after a workshop on clinical trial methodology in older adults with cancer, the Elderly Task Force of the European Organization for Research and Treatment of Cancer (EORTC) recommended the use of a standardised minimum data set (minDS) for assessing the global health and functional status of older populations. This minDS consisted of the G8 screening tool, the Instrumental Activities of Daily Living Following a consensus approach, a panel of 14 geriatricians from oncology clinics identified seven domains of importance in geriatric assessment. Based on the international recommendations, geriatricians selected the mostly commonly used tools/items for geriatric assessment by domain. The Geriatric Core Dataset (G-CODE) was progressively developed according to RAND appropriateness ratings and feedback during three successive Delphi rounds. The face validity of the G-CODE was assessed with two large panels of health professionals (55 national and 42 international experts) involved both in clinical practice and cancer trials.

Geriatric Core Dataset (G-CODE) for Clinical Research in Elderly Cancer Patients

Multidisciplinary Development of the Geriatric Core Dataset for Clinical Research in Older Patients With Cancer: A French Initiative With International Survey

Plate-forme PACAN (Elderly and Cancer Platform)

European Georges Pompidou Hospital

Hospital Ambroise Paré Paris

Institut Curie

Centre Leon Berard

Institut Claudius Regaud

Saint-Louis Hospital, Paris, France

Hospital Avicenne

Göteborg University

Oslo University Hospital

City of Hope Comprehensive Cancer Center

Institut Bergonié

National panel of experts involved in the scoring of the items/tools to be included in the G-CODE.

National Panel of Experts

>= 18 years

Age, Customized

Sex: Female, Male

Pr S Mathoulin-Pélissier

Number of Experts Who Considered That the Question "Do You Live Alone ?" Should be Retained in the G-CODE

Number of Experts Who Considered That the Question "do You Have a Person or Caregiver Able to Provide Care and Support" Should be Retained in the G-CODE

Number of Experts Who Considered That the Tool "ADL (Activities of Daily Living)" Should be Retained in the G-CODE

Number of Experts Who Considered That the Tool "4-IADL (Instrumental Activities of Daily Living)" Should be Retained in the G-CODE

Number of Experts Who Considered That the Test "Timed Up and Go" Should be Retained in the G-CODE

Number of Experts Who Considered That the Items "Weight Loss During the Past 6 Months and Body Mass Index (BMI)" Should be Retained in the G-CODE

Number of Experts Who Considered That the Item "One Cognitive Scale (Mini-Cog)" Should be Retained in the G-CODE

Number of Experts Who Considered That the Item "Char Lson Comorbidity Index" Should be Retained in the G-CODE

Overall Study

Behaviors and Mental Disorders

All Conditions

Quality of Life

Amélie Anota, PhD

In oncology a number of supportive care therapies are proposed to patients. This study will identify the different therapies and prioritize these therapies from the patients' perspectives. This study will provide a framework for optimizing supportive care strategies and identifying those therapies that need to be validated by clinical trials.

In oncology, supportive care should be used along with curative treatment or palliative care in order to improve patients' health-related quality of life, overall survival and to better support treatment side effects as well as the disease evolution. Unfortunately, they are not widely used in clinical practice.

A direct assessment of the needs perceived unmet by patients could allow to assess the magnitude of expectations to better target treatments as example. A prospective assessment of the expectations and needs of the patients is thus essential. This would also allow help to highlight the convergence between supportive care proposed and used and those expected by patients. The first step to understanding how to optimize the use of resources and to improve the quality of care is to identify patient's expectations. Moreover, it is now well recognized that patients should play a key role in the research and that their active participation in research can increase the relevance of the research.

In this context, the CyPRES project aims to:

1. assess through national consensus the patients' expectations in terms of supportive care in order to help both clinicians and health care services;
2. prioritize them and to arrange resources according to priority needs identified;
3. identify supportive care for which no previous research (evidence-based medicine) has demonstrated their usefulness. A randomized clinical trial will thus be proposed;
4. Involve patients in the written, conduct and analyses, as well as communications of the randomized clinical trial.

A Patient Consensus for the Research in Supportive Care in French Cancer Care Centers: the CyPRES Project

Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

Expectations and needs of the patients: completion of questionnaire N°1

Prioritize supportive care therapies: completion of questionnaire N°2 Expectations and needs of the patients questionnaire n°2 completed

Ligue contre le cancer, France

French National Platform Quality of Life and Cancer

Association Francophone des Soins Oncologiques de Support

UNICANCER

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

HOUEDE Nadine

Cabazitaxel is a second line chemotherapy drug recently approved for the treatment of metastatic castration-resistant prostate cancer. To investigate whether the precautions for the use of cabazitaxel (contraindications, hepatic function, premedication for hypersensitivity, prophylactic treatments, dose and dose adjustment, as well as conditions of administration) are respected in routine practice, an observational cohort study will be implemented in 32 oncology centres of South-West region of France (CABOBS study). The primary objective of this cohort is to evaluate the conformity of cabazitaxel prescriptions with the Summary of Product haracteristics (SPC) in clinical practice (indications and monitoring methods) and according to the conditions of use. Panel of experts were convened to assess the conformity of prescription of cabazitaxel with a Delphi consensus method. The Delphi method is most suited to areas where a limited number of evidences are available to enable a recommendation or guidelines to be drawn. Moreover, all the evaluated items came from an official document provided by the EMA, the SPC of cabazitaxel. Thus, it is expected from the experts to select the most relevant items. In the frame of the CABOBS study, this method will allow to select items of the SPC list according to their importance, and to define the primary objective of conformity to cabazitaxel conditions of use.

For metastatic castration-resistant prostate cancer (mCRPC) patients, treatment usually consists in a first line chemotherapy with docetaxel followed by a second line treatment with either second generation hormonal therapies (abiraterone acetate or enzalutamide) or the new taxane derivative cabazitaxel. Cabazitaxel (Jevtana) is a semi-synthetic taxane with a mechanism of action different to that of docetaxel and paclitaxel. It is an antineoplastic agent that stabilises the microtubules network via its binding to tubulins and the inhibition of microtubules disassembly. Cabazitaxel has demonstrated a broad spectrum of antitumour activity against advanced human tumours xenografted in mice. It is active in docetaxel-sensitive tumours and in tumour models resistant to chemotherapy, including docetaxel. The efficacy of cabazitaxel has been demonstrated in the pivotal clinical trial TROPIC, a randomized, open-label, phase III study that compared cabazitaxel (n = 378) to mitoxantrone (n = 377), both associated with prednisone or prednisolone in patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel containing regimen. The median overall survival (OS) was significantly increased in the cabazitaxel-treated group compared to the mitoxantrone-treated group. Most common adverse event that can lead to a treatment discontinuation are haematological (neutropenia 82%), gastrointestinal (diarrhoea 6%) and general disorders (asthenia 5%). A recent study analysed the data of the TROPIC study on efficacy and toxicity observed in the subgroup of patients included in French centres. These results are comparable to those reported for the overall population and the safety profile remains favourable without any toxic death related to cabazitaxel.

Following TROPIC trial, cabazitaxel (in combination with prednisone or prednisolone) was approved by the U.S. Food and Drug Administration (FDA) on June 2010 and by the European Medicines Agency (EMA) on March 2011 for the treatment of hormone-refractory prostate cancer. In France cabazitaxel was approved in 2012 but made available only in 2014.

To investigate whether the precautions for the use of cabazitaxel (contraindications, hepatic function, premedication for hypersensitivity, prophylactic treatments, dose and dose adjustment, as well as conditions of administration) are respected in routine practice, an observational cohort study will be implemented in 32 oncology centres of South-West region of France (CABOBS study). The primary objective of this cohort is to evaluate the conformity of cabazitaxel prescriptions with the Summary of Product Characteristics (SPC) in clinical practice (indications and monitoring methods) and according to the conditions of use.

Based on the SPC, Specifications for prescription include 26 items divided into "baseline" (14) criteria and "cycle 2" (12) criteria, which include requirements for the second and all following cycles. Because of such high number of specific items, strict adherence to prescription indications might be unsatisfactory or not appropriate from the clinical point of view, each criterion has a different relevance on the appropriateness of prescription; therefore, it is necessary to select the criteria based on their relevance and according to the opinion of the clinical experts.

For this purpose, two independent panels of experts in the field of uro-oncology, one French panel and a European panel from EORTC, were solicited in order to define the importance of each criterion of the SPC and to allow a qualitative assessment of conformity using a formal consensus method.

Consensus methods provide means of synthesising information and compare contradictory opinions or evidences on a specific issue. Their purpose is to assess the extent of agreement and to resolve disagreement among a group of selected individuals by identifying and selecting, through iterative ratings with feedback, specific points on which there is disagreement or uncertainty.

The Delphi method, a consensus method which originated in 1948, is an attempt to obtain expert opinion in a systematic manner. The survey is conducted over "rounds" in which questionnaires are administered to the experts individually and anonymously. After each round, the results are listed and reported to the group. A Delphi is considered complete when there is a convergence of opinion. In a modified Delphi usually a predefined number of rounds and a final round, in which experts meet to resolve and summarise the results of the consensus, are held.

The Sponsor relied on the Delphi method as it is most suited to areas where a limited number of evidences are available to enable a recommendation or guidelines to be drawn. Moreover, all the evaluated items came from an official document provided by the EMA, the SPC of cabazitaxel. Thus, it is expected from the experts to select the most relevant items. In the frame of the CABOBS study, this method will allow to select each of the 26 items of the SPC list according to their importance, and to define the primary objective of conformity to cabazitaxel conditions of use.

Consensus Method to Evaluate the Conformity of Prescription of a Chemotherapy

Formal Consensus Method to Evaluate the Conformity of Prescription of a Recently Approved Chemotherapy Treatment in an Observatory Study

Items selected by the consensus process to assess the conformity of prescription of cabazitaxel based on the the 26 items included in the Summary of Product Characteristics (SPC). Two independent panels of experts in the field of uro-oncology, one French panel and a European panel from the Genito-Urinary group of the European Organization for Research and Treatment of Cancer (EORTC-GU), were solicited in order to define the importance of each criterion of the SPC and to allow a qualitative assessment of conformity using a formal consensus method. The purpose of consensus methods is to assess the extent of agreement and to resolve disagreement among a group of selected individuals by identifying and selecting, through iterative ratings with feedback, specific points on which there is disagreement or uncertainty. We relied on the Delphi method as it is most suited to areas where a limited number of evidences are available to enable a recommendation or guidelines to be drawn.

Sanofi

GECEM

All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.

Study title	NCT ID	Conditions	Eligibility	Organization
Geriatric Core Dataset (G-CODE) for Clinical Research in Elderly Cancer Patients	NCT03976531	Cancer	18 Years -	Institut Bergonié
A Patient Consensus for the Research in Supportive Care in French Cancer Care Centers: the CyPRES Project	NCT03320161	Cancer Patients	18 Years -	UNICANCER
Consensus Method to Evaluate the Conformity of Prescription of a Chemotherapy	NCT02882178	Prostate Cancer	18 Years -	Institut Bergonié
A Patient Consensus for the Research in Supportive Care in French Cancer Care Centers: the CyPRES Project	NCT03320161	Cancer Patients	18 Years -	UNICANCER

Spots Global Cancer Trial Database for consensus

Every month we try and update this database with for consensus cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for consensus

Every month we try and update this database with for consensus cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for consensus cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.