Prediction of Chemotherapy Toxicity and Survival in Elderly Cancer Patients by CARG Score

Assiut University

Status: Not yet enrolling

Conditions: Solid Tumors ,Adults

Treatments: Other: calculating CARG score

Study type: Observational

Funder types: Other

Identifiers

NCT05432726

CARG Score in Elderly Patients

Details and patient eligibility

About

Prediction of chemotherapy toxicity and survival in elderly (aged ≥65 years old) patients with advanced solid tumors receiving systemic chemotherapy by using CARG risk score.

Full description

Elderly patients (age ≥65 years) with cancer represent a growing proportion of patients in oncology clinical practice, primarily due to increasing life-spans as well as medical progress contributing to decreased morbidity and mortality from other causes.

Treatment decision-making for elderly patients with advanced cancer is often more complex than decision-making in younger cancer patients. The elderly population is heterogeneous in terms of their overall health status beyond their cancer diagnosis.

The risk of severe chemotherapy toxicity is one of the most important factors oncologists consider when recommending a treatment plan, and in elderly patients with advanced cancers, 25% to 60% of patients are treated with a planned dose reduction for their first chemotherapy cycle. These dose reductions are usually made on the basis of chronologic age and ECOG performance status, variables well known to be poor predictors of chemotherapy toxicity risk and tolerability of treatment.

Clinical prediction tools provide physicians with more accurate means for identifying patients who are at low or high risk of adverse outcomes.

The cancer Aging Research Group (CARG) risk score, developed by Hurria and colleagues, is a validated geriatric assessment tool that predicts for significant chemotherapy-related toxicities (grades 3-5) in older North American adults aged ≥65 years starting on chemotherapy.

The CARG score uses 5 key geriatric assessment (GA) domains, selected laboratory test values, age, tumor type, and treatment intensity to categorize patients into 3 risk groups for severe chemotherapy toxicity (grade 3-5): low risk (score 0-5; 30% grade 3-5 toxicity), medium risk (score 6-9; 52%), or high risk (score ≥10; 83%).

The CARG risk score has been validated in other countries and in specific tumour sites to varying degrees. It is included in ASCO Guideline and NCCN guidelines for Geriatric Oncology to predict severe chemotherapy-related toxicity. However its applicability in Egyptian patients is unknown as geriatric assessment is not routinely used for elderly patients.

The investigators may provide an evidence for validating the CARG risk score in Elderly patients with advanced solid tumors receiving systemic chemotherapy.

Enrollment: 63 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: ≥65 years.
• Sex: male, female.
• ECOG performance status 0,1,2
• Type of malignancy: solid tumor malignancies planned for systemic chemotherapy alone.
• Stage: Advanced stage (metastatic first line, recurrent, unresectable locally advanced).
• Type of Systemic therapy: chemotherapy alone not combined with immunotherapy or radiotherapy.
• Able to comprehend and complete questionnaire.

Exclusion criteria

• Receiving concurrent radiotherapy or immunotherapy.
• ECOG performance status >2.

Trial design

63 participants in 1 patient group

Elderly patients

Description:

Elderly patients (aged ≥65 year's old) planned to receive first-line chemotherapy for advanced solid tumor malignancies, presenting to the clinical oncology department, Assiut University Hospitals, Assiut, Egypt.

Treatment:

Other: calculating CARG score