Elderly patients (>70 years old) presenting with cancer and treated with oral therapy in cohorts: • 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
Conditions
Brief summary
Rate of subjects who had at least one grade ≥3 non-hematologic or grade ≥4 hematologic adverse event assessed during oncologist consultations according to the National Cancer Institute Common Toxicity Scale Criteria for Adverse Events Version 6.0 (NCI-CTCAE Version 6.0) on the duration of treatment with oral anticancer drug started at inclusion. The adverse events will be collected at M1, M3 then every 3 months.
Detailed description
For all patients : •Number of adverse events •Averall survival • Progression-free survival •Time to discontinuation of oral anticancer treatment • Rate of subjects having had at least one hospitalization in the 24 months following inclusion.• The incremental net monetary benefit (INMB) and incremental cost-effectiveness ratio (ICER) (cost-effectiveness analysis).• Quality of life questionnaires (EORTC QLQ-C30 and EuroQol EQ5D-5L questionnaires) at baseline (M0), M1, M3, M6, M12 and M24, For patients in the interventional arm: • The average number of pharmaceutical interventions performed for the oncologist and the general practitioner • The proportion of patients with at least one potentially inappropriate drug prescription before and 3 months after pharmaceutical maintenance• The average number of medications prescribed per patient before and after the pharmaceutical interview • The complexity of the drug prescription assessed according to the MRCI score before and after
Interventions
DRUGABEMACICLIB
DRUGPAZOPANIB
DRUGCAPECITABINE
DRUGAXITINIB
DRUGOLAPARIB
DRUGTIPIRACIL
DRUGTRIFLURIDINE
DRUGOSIMERTINIB
DRUGENZALUTAMIDE
DRUGPALBOCICLIB
DRUGRIBOCICLIB
DRUGLENVATINIB
DRUGBRIGATINIB
DRUGEVEROLIMUS
DRUGCABOZANTINIB
DRUGSUNITINIB
DRUGALECTINIB HYDROCHLORIDE
DRUGABIRATERONE ACETATE
DRUGREGORAFENIB
Sponsors
Institut Gustave Roussy
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of subjects who had at least one grade ≥3 non-hematologic or grade ≥4 hematologic adverse event assessed during oncologist consultations according to the National Cancer Institute Common Toxicity Scale Criteria for Adverse Events Version 6.0 (NCI-CTCAE Version 6.0) on the duration of treatment with oral anticancer drug started at inclusion. The adverse events will be collected at M1, M3 then every 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| For all patients : •Number of adverse events •Averall survival • Progression-free survival •Time to discontinuation of oral anticancer treatment • Rate of subjects having had at least one hospitalization in the 24 months following inclusion.• The incremental net monetary benefit (INMB) and incremental cost-effectiveness ratio (ICER) (cost-effectiveness analysis).• Quality of life questionnaires (EORTC QLQ-C30 and EuroQol EQ5D-5L questionnaires) at baseline (M0), M1, M3, M6, M12 and M24, For patients in the interventional arm: • The average number of pharmaceutical interventions performed for the oncologist and the general practitioner • The proportion of patients with at least one potentially inappropriate drug prescription before and 3 months after pharmaceutical maintenance• The average number of medications prescribed per patient before and after the pharmaceutical interview • The complexity of the drug prescription assessed according to the MRCI score before and after | — |
Outcome results
None listed