Framework for Implementing Individualised Dosing of Anti-Cancer Drugs in Routine Care: Overcoming the Logistical Challenges

SIMPLE SUMMARY: Many anti-cancer drugs are prescribed at a ‘one-size fits all’ starting dose, without considering individual differences. This is a problem for many cancer patients as this fixed dose might be too much for an individual which could lead to adverse effects and toxicity. Similarly, the fixed-dose might not be enough for some patients which could lead to therapeutic failure. Achieving the right amount of anti-cancer drugs in the body is critical, however, currently, the anti-cancer drug concentrations are not monitored in routine care. Our group used our extensive experience, existing published frameworks and recommendations to establish our own framework to implement a program that enables individualized dosing of anti-cancer drugs in routine care. This paper describes this framework with a simple 6-step process that can be utilised for the implementation of individualised dosing programs for anti-cancer drugs. ABSTRACT: Precision medicine in oncology involves identifying the ‘right drug’, at the ‘right dose’, for the right person. Currently, many orally administered anti-cancer drugs, particularly kinase inhibitors (KIs), are prescribed at a standard fixed dose. Identifying the right dose remains one of the biggest challenges to optimal patient care. Recently the Precision Dosing Group established the Accurate Dosing of Anti-cancer Patient-centred Therapies (ADAPT) Program to address individualised dosing; thus, use existing anti-cancer drugs more safely and efficiently. In this paper, we outline our framework, based on the Medical Research Council (MRC) framework, with a simple 6-step process and strategies which have led to the successful implementation of the ADAPT program in South Australia. Implementation strategies in our 6-step process involve: (1) Evaluate the evidence and identify the cancer drugs: Literature review, shadowing other experts, establishing academic partnerships, adaptability/flexibility; (2) Establishment of analytical equipment for drug assays for clinical purposes: assessment for readiness, accreditation, feasibility, obtaining formal commitments, quality assurance to all stakeholders; (3) Clinical preparation and education: educational material, conducted educational meetings, involve opinion leaders, use of mass media, promote network weaving, conduct ongoing training; (4) Blood collection, sample preparation and analyses: goods received procedures, critical control points (transport time); (5) Interpret and release results with recommendations: facilitate the relay of clinical data to providers; (6) Clinical application: providing ongoing consultation, identify early adopters, identify, and prepare champions. These strategies were selected from the 73 implementation strategies outlined in the Expert Recommendations for Implementing Change (ERIC) study. The ADAPT program currently provides routine plasma concentrations for patients on several orally administered drugs in South Australia and is currently in its evaluation phase soon to be published. Our newly established framework could provide great potential and opportunities to advance individualised dosing of oral anti-cancer drugs in routine clinical care.