Breast Cancer, Colon Cancer, Elderly, Kidney Cancer, Lung Cancer, Prostate Cancer, Sarcoma
Conditions
Brief summary
The incidence of cancer among older adults is increasing as a result of longer life expectancy. Therapeutic advances have led oncologists to propose new available treatments for these patients, particularly oral therapies, whether targeted therapies or hormone therapies. However, these patients are more vulnerable and have an increased risk of treatment-related toxicity or inefficacy. Indeed, they more frequently suffer from comorbidities (renal, cardiac, hepatic insufficiency, etc.) and present risk factors (polypharmacy, cognitive disorders, etc.) known to reduce the effectiveness or increase the toxicity of oral therapies due to variations in plasma drug concentrations. For several years, various international recommendations (ASCO, ESMO, etc.) have suggested that specialized geriatatric oncology care is indicated for these patients. Similarly, some studies have shown that pharmacist involvement may have an impact by reducing drug-drug interaction issues or non-adherence. Finally, the introduction of oral therapies in oncology has raised pharmacological challenges: regular pharmacokinetic monitoring could allow dose adjustments in cases of disease progression in undertreated patients or toxicity in overexposed patients. Our hypothesis is that implementing an integrative care pathway in this population could demonstrate a benefit by improving quality of care, reducing toxicity, optimizing efficacy, and maintaining an acceptable cost. This approach could help prevent early treatment discontinuation due to disease progression related to insufficient drug concentrations, as well as certain toxicities related to overdosing (e.g., drug-drug interactions), leading to improved quality of life and a reduction in rehospitalization rates.
Interventions
OTHERExperimental
Pharm-Onco-Geriatric (POG) pathway which allows triple oncogeriatric, pharmaceutical and pharmacological follow-up. The main interventions according to the areas will be the following: Pharmacological (pharmacokinetic assays with a 5mL blood sampling (samples to be collected at trough (pre-dose), dosage adjustment in the event of underexposure or overexposure), Pharmaceutical (understanding of oral anticancer therapy, co-medications, tolerance assessment, adherence assessment) and Geriatric (oncogeriatric Follow-up, monitoring of the appearance of frailty criteria during treatment by the G-CODE tool, collection of hospitalizations data, admission in emergency rooms, incidents, modification of the living address).
Sponsors
Gustave Roussy, Cancer Campus, Grand Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 70 years old * G8 score ≤ 14 * ECOG PS ≤ 3 * Follow-up for a locally advanced or metastatic solid tumor among the following: breast, lung, prostate, colon, kidney, sarcoma, GIST cohorts * With a decision to initiate treatment with oral therapy (Tyrosine Kinase Inhibitor, Hormone Therapy, chemotherapy) from among the following: * Breast cohort: Abemaciclib, Ribociclib, Palbociclib, Everolimus * Lung cohort: Alectinib, Brigatinib, Osimertinib * Prostate cohort: Abiraterone, Enzalutamide, Olaparib * Colon Cohort: Trifluridine+Tipiracil, Capecitabine * Kidney cohort: Axitinib, Cabozantinib, Lenvatinib * Sarcoma/ GIST cohort: Sunitinib, Regorafenib, Pazopanib * Female patients must either be of non reproductive potential or must have a negative serum pregnancy test within 14 days prior to the administration of study drug. Childbearing potential women must have agreed to use one barrier method of contraception, such as condom, plus an additional highly effective method of contraception during treatment on this trial an for up to 6 month after the last dose of study treatment * Sexually active males patients must agree to use condom during the clinical investigation and for at least 6 months after the study treatment. Also, it is recommended the childbearing potential female partner uses a highly effective method of contraception for the same duration * Written, dated and signed informed consent by the patient prior to any specific protocol procedure * Ability to comply with the protocol procedures * Patients must be affiliated to a social security system or beneficiary of the same
Exclusion criteria
* Patient who has already been treated or is currently being treated with the oral therapy studied * Grade 3 or 4 toxicity contraindicating the implementation of oral treatment, according to the NCI-CTCAE version 6.0 * Patient unable to follow treatment program * Mental or psychological illness that does not allow the patient to give informed consent * Patient who has already benefited from specialized oncogeriatric care in the last 12 months * Patient who has already benefited from a pharmacological dosage for the oral therapy studied * Presence of a pathology or condition that makes the patient's participation in the study inappropriate which includes serious unresolved or unstable toxicities from previous administration of another investigational treatment or any medical condition that could interfere with patient safety, obtaining consent, or compliance with study procedures * Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the impact of reinforced multi-professional care pathway in geriatric oncology on the occurrence of grade ≥3 non-hematologic adverse event or grade ≥4 hematologic adverse event (according to NCI-CTCAE Version 6.0) | over a maximum of 24 months after randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events (NCI-CTCAE Version 6.0) | over 24 months, after randomization | To evaluate the impact of the implementation of reinforced and multi-professional care pathway (oncologist, geriatrician, pharmacist, pharmacologist) in geriatric oncology. |
| Overall Survival | over 24 months, after randomization | To evaluate the impact of the implementation of reinforced and multi-professional care pathway (oncologist, geriatrician, pharmacist, pharmacologist) in geriatric oncology. |
| Progression-Free Survival | over 24 months, after randomization | To evaluate the impact of the implementation of reinforced and multi-professional care pathway (oncologist, geriatrician, pharmacist, pharmacologist) in geriatric oncology. |
| Quality of life questionnaires | over 24 months, after randomization | To evaluate the impact of the implementation of reinforced and multi-professional care pathway (oncologist, geriatrician, pharmacist, pharmacologist) in geriatric oncology. |
Countries
France
Contacts
CONTACTArnaud BAYLE
Outcome results
None listed