Patients in the "standard care" arm will use an electronic adherence monitor (MEMS®) without any feedback (electronic data will be blinded to patients, clinicians and investigators until the analysis)

Patients in the "adherence program" will use the MEMS® and the pharmacist will provide an electronic feedback on medication adherence since the last visit. The identified determinants of medication adherence will be discussed with the patient.

This program combines adherence evaluation using an electronic monitor (MEMS®) and feedback with repeated medication adherence interviews with the pharmacist.

Adherence program

Chantal Csajka, PharmD, PhD

Chantal Csajka, PharmD PhD

The study includes an observational pharmacokinetic study and an interventional medication adherence study. The purpose of this study is 1) to describe the concentration-time profiles of targeted anticancer drugs and to characterize the concentration-effect/toxicity relationships in the target population of patients (observational study) and 2) to characterize patterns of adherence to oral targeted anticancer drugs and identify key-driver modifiable adherence factors in patients participating in an adherence program (interventional study).

Targeted anticancer therapies are often prescribed at the same dosage regimen in all patients. However, it is known that the marked interindividual variability in drug level may affect treatment outcomes. Several factors are known to modulate drug levels, such as weight, genetics host-drug and drug-drug interaction. The identification of these factors could give the possibility to propose better adjusted dosage regimens according to patient's individual characteristics. Moreover, the presence of high or low drug concentrations may partially explain toxicity or lack of efficacy of targeted anticancer drugs in some patients. The characterization of the relationship between drug levels and treatment response (efficacy and toxicity) would allow an optimized and a more individualized patient management with targeted anticancer drugs.

Oral targeted therapies must be taken on the long term and adherence issues have been shown to compromise treatment efficacy. Side effects and lifestyle management are among factors affecting treatment adherence. The characterization of adherence over time and the identification of factors susceptible to improve it will represent a great benefit for healthcare professionals and patients.

Optimization of the Targeted Anticancer Therapies

Optimization of Targeted Anticancer Therapies: a Systematic Collection and Modeling of Pharmacokinetic Data and Elaboration of an Adherence Program

During their medical visits, from 1 to 8 blood samples will be collected per patients at the same moment as routine blood sampling. Drug concentration will be measured by HPLC-MS/MS.

Adverse events are assessed during the routine medical visits according the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE scale).

The progression free survival (PFS) is used to evaluate the drug efficacy. The PFS is defined as the time interval between the first dose of drug and the date of progression or any cause death. Patient without progression at the study end will be censored.

Adherence to oral anticancer therapies will be monitored thanks to Electronic monitoring Systems (MEMS, AARDEX) during maximum 12 months. This is a 1:1 randomized medication adherence intervention, which compares an intervention group vs. usual care. The intervention consists in monthly motivational interviewing sessions between the patient and the pharmacist, along with the delivering of oral targeted anticancer drugs in electronic pill bottles (Electronic Event Monitoring EEM, MEMSTM, AARDEX Ltd.). The patient meet the pharmacist after each clinical visits (usually once per month).

Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

Krebsforschung Schweiz, Bern, Switzerland

Centre Hospitalier Universitaire Vaudois

Director and Professor of the Center for Research and Innovation in Clinical Pharmaceutical Sciences

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Paclitaxel

Albumin-Bound Paclitaxel

Busulfan

Afatinib

Crizotinib

Lapatinib

Imatinib Mesylate

Ceritinib

Tubulin Modulators

Antimitotic Agents

Alkylating Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

The use of antineoplastic agents depends on the clinical practice.

Busulfan, Paclitaxel, Afatinib, Ceritinib, Crizotinib (Antineoplastic drugs)

Zhao Wei, Ph.D

The purpose is to study the population pharmacokinetics, effectiveness and safety of antineoplastic drugs (Busulfan, Paclitaxel, Afatinib, Ceritinib, Crizotinib, Imatinib, Lapatinib, etc) in elderly patients and recommend optimized dosage regimens.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Optimization of the Targeted Anticancer Therapies	NCT04484064	Cancer	Adherence progr...	18 Years -	Centre Hospitalier Universitaire Vaudois
Antineoplastic Drugs in Elderly Patients	NCT05467189	Cancer	Busulfan, Pacli...	65 Years - 100 Years	Shandong University
Antineoplastic Drugs in Elderly Patients	NCT05467189	Cancer	Busulfan, Pacli...	65 Years - 100 Years	Shandong University
Optimization of the Targeted Anticancer Therapies	NCT04484064	Cancer	Adherence progr...	18 Years -	Centre Hospitalier Universitaire Vaudois

Spots Global Cancer Trial Database for population pharmacokinetics