Pharmacogenomics guided dosing for fluoropyrimidine and irinotecan chemotherapies for patients with cancer (PACIFIC-PGx)

Interventions: The intervention comprises of single time-point pharmacogenetics screening for:
1. DPYD gene test for patients newly commencing on 5-fluorouracil and capecitabine chemotherapy
2. UGT1A1*28 gene test for patients newly commencing on irinotecan chemotherapy
Genetic samples will be collected via blood draw or cheek swab. Interventions will be delivered by a pharmacogenetics pharmacist on referral from the treating medical oncologist. Screening occurs at single time point prior to commencement of 5-fluorouracil, capecitabine or irinotecan. Patients will be followed to cycle 3 of chemotherapy for adverse event, toxicity and health resource utilisation data, and to 12 months after commencement of chemotherapy for response and survival outcomes. All chemotherapy treatments will be administered (dose, route, frequency) according to standard guidelines at the treating institution. Treating clinicians will be provided chemotherapy dosing recommendations based on genetic screening according to protocol specified adjustments based on CPIC/DPWG guidelines, however it is it is the responsibility and choice of the treating clinician to implement/not implement dosing recommendations and to manage all aspects of cancer treatment. Decision to implement/ not implement will be recorded as part of trial outcomes.
The study includes 3 main timepoints:
1. TimePoint 1: Baseline visit - Referral details to Pharmacogenetic (PG) screening clinic, consent to PG program testing for DPYD gene +/- UGT1A1 gene testing +/- research sample collection
Demographics and clinical characteristics (medical, disease and treatment history)
Eastern Cooperative Oncology Group (ECOG) performance status
DNA sample (blood or cheek swab)
EQ-5D-5L questionnaire for health economic stu
Primary outcome(s): Operational feasibility: proportion of patients with pre-emptive pharmacogenetic screening among all patients newly treated with 5-fluorouracil, capecitabine and/or irinotecan chemotherapies). [12-months]
Study Design: Purpose: Prevention; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety