Clinical Utility of a Chemotherapy-Toxicity Prediction Tool for Elderly Cancer Patients in a Community Oncology Setting The GO trial

Transcription

1 Clinical Utility of a Chemotherapy-Toxicity Prediction Tool for Elderly Cancer Patients in a Community Oncology Setting The GO trial FHA Research Week 2017 Caroline Mariano Medical Oncologist, RCH Clinical Associate Professor UBC Caroline.mariano@fraserhealth.ca

2 Outline Background Trial design Preliminary results Tools and tips THANKS to FHA for seed grant support

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5 Very brief Introduction Cancer is a disease of ageing Treatment guidelines both palliative and curative are based on data from RCTs Older patients consistently under-represented in clinical trials How to apply the Data? Comprehensive Geriatric Assessment proven to be helpful in making treatment decisions multidimensional, interdisciplinary diagnostic process focusing on determining an older person's medical, psychosocial, and functional capabilities to develop a coordinated and integrated plan for treatment and long-term follow-up Resource and time intensive

6 Brief Geriatric assessments Multiple shortened tools developed Meant to screen for patients who may need CGA Answer specific questions Who is at risk for toxicity from treatment Who may die early on treatment Surgical risks

7 Chemotherapy toxicity prediction Hurria et al JCO patients Cytotoxic chemotherapy for solid tumours Geriatric Assessment (20 mins) Follow up for toxicity (Grade 3 or higher)

8 Hurria Predictive Model

9 Can we apply this in a busy practice? Geriatric oncology expertise extremely limited in Canada Availability of Geriatrics also extremely limited Most patients treated outside of large academic centers Can we use a the Hurria tool to help guide treatment decisions in a community oncology practice

10 The GO Trial Implement CARG-CPT tool at RCH, RMH, BH, LGH and RH oncology units Primary Objective To determine if the use of the CARG-CPT tool in the community oncology setting will affect treatment decisions in elderly patients undergoing chemotherapy. Null Hypothesis: The CARG-CPT will not affect oncologists chemotherapy treatment decisions in elderly patients. Alternative Hypothesis: The CARG-CPT will change chemotherapy treatment decisions for at least 15% of elderly patients.

11 Secondary Objectives To determine whether oncologist initial assessment of potential chemotherapy toxicity correlates with risk determined by CARG-CPT To assess whether CARG-CPT prompts oncologists to increase supports for geriatric patients To assess the incidence of serious toxicity during chemotherapy for elderly patients in the community setting before and after CARG-CPT tool is implemented To determine what factors influence physician decision making in elderly patients

12 Eligibility Criteria Inclusion 70 years of age Primary diagnosis of solid tumor or lymphoma within last 12 months Scheduled outpatient cytotoxic chemotherapy of over at least 2 cycles New start or new therapy English speaking or translator Exclusions <70 years of age Primary treatment is hormonal therapy Concurrent chemo-radiation therapy Hospitalized patients at the time of assessment

13 Practicalities Patients >70 years of age new start of chemotherapy for solid malignancy or lymphoma Goal :209 patients Opened summer 2016 Patient screened and consented at time of first MD visit or chemotherapy teaching visits HCPs rewarded with starbucks cards for filling in forms Data entry into red cap by medical student Thanks FHA Baseline questionnaire: What do you think patients risk of toxicity is? CARG Questionnaire completed by allied health Physician Questionnaire: Did this change your plan for the patient At each follow up visit: Did patient experience grade 3 or higher toxicity?

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16 Preliminary results N= 145 patients! Data from 132 patients Median age 76 2/3 palliative 1/3 adjuvant or curative MD Rate risk of toxicity 43% low, 41% medium 15% high CARG Risk for toxicity 16% low, 60% medium 24% high In first 2 follow ups 17% of patients had experienced some toxicity Change treatment or prompted extra-consideration in 33% of patients

17 Moving forward Complete recruitment (likely by September 2017) Complete data collection Clean up +/- chart review to complete follow up data Submission to clinical oncology Coming soon Phase 3 RCT comparing CGA to usual care in similar patient population Multi site Canadian study supported by Canadian Cancer Society Impact grant Recruitment from RCH and FVCC

18 Super helpful research resources FHA team Harmonized ethics review UBC medical student Flex program RedCap Challenges - Lack of research coordinator - Oncology black box

19 Thank you! Magdalena Newman, Samar Hejazi from FHA Team: Jeremy Ho, David Telio, Puneet Bains, Michelle Dyke Jenifer Wan, Clarissa Cheng Rakim Jamal