Comprehensive Geriatric Assessment in Elderly Non-Small Cell Lung Cancer Patients

University of Hull

Status: Withdrawn

Conditions: Non-small Cell Lung Cancer; Lung Cancer

Treatments: Other: Questionnaires about symptoms

Study type: Observational

Funder types: Other

Identifiers

NCT05230888

V1.1 10.09.2021

Details and patient eligibility

About

Lung cancer is responsible for one of the highest incidences of cancer-related mortality globally, and non-small cell lung cancer (NSCLC) accounts for the biggest subtype of lung cancer. In recent years, the use of immunotherapy has revolutionised the management of NSCLC, with better response rates and survival outcomes reported in the literature, compared to traditional cytotoxic chemotherapy. Despite this, doubts remain regarding the true efficacy of immunotherapy in patients > 75 years old, given that this age subgroup is mis-represented in prospective phase III trials, in terms of numbers and baseline functional status, compared to real-world experience.

Furthermore, the use of immune checkpoint inhibitors (ICIs) is associated with a spectrum of immune-related adverse events (irAEs), affecting a range of organ systems. Once again, there are doubts about the safety of the use of these agents in patients > 75 years old, and whether baseline performance status and comorbidities are good predictors of efficacy and safety outcomes in this elderly patient subgroup.

Comprehensive Geriatric Assessment (CGA) and the vulnerable elders survey (VES-13) are assessment tools that provide a good indication of functional status in elderly patients, in a similar capacity to performance status and comorbidities. This study therefore aims to prospectively examine patients > 70 years old with a diagnosis of NSCLC, commencing immunotherapy. It will assess CGA and VES-13 scores at baseline, and correlate this with certain outcomes such as the incidence of severe adverse effects from immunotherapy at 3 and 6 months, any admissions to hospital arising from immunotherapy toxicities (and the subsequent length of inpatient stay), and mortality within 30 days. In doing so, it will help to determine if CGA and VES-13 scores can be used as a reliable indication of possible future efficacy and toxicity outcomes in this elderly patient subgroup.

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients ≥70 years old with advanced NSCLC due to start first or second line ICI therapy.
2. Patients able to give informed consent.

Exclusion criteria

1. Patients already on treatment with ICIs.
2. Patients with CNS or leptomeningeal spread / disease progression.
3. ECOG performance status III/IV.
4. Patients with severe autoimmune diseases.
5. Patients who are recruited and then stop treatment after receiving ≤3 cycles of ICI therapy, secondary to disease progression.

Trial design

0 participants in 1 patient group

Cohort

Description:

The effect of immunotherapy treatment will be assessed using the comprehensive geriatric assessment (CGA) and vulnerable elders survey (VES-13) in 100 non-small cell lung cancer patients, aged ≥70 years old, receiving immune checkpoint inhibitor (ICI) treatment.

Treatment:

Other: Questionnaires about symptoms