Lung cancer is a frequent type of malignant disease with 4,600 patients diagnosed every year in Denmark. It is estimated that approximately 50% of newly diagnosed cases occur in patients older than 70 years of age. These patients often have significant comorbidities mainly because of smoking, but also because of advances age at the time of diagnosis. In general, older patients with cancer have been underrepresented in clinical trials. As such, treatment of this group of patients represents a unique challenge since knowledge of older patients' tolerance to and benefit of cancer treatment is limited. Approximately 85% of all lung cancers are NSCLC. Lung cancer has a poor prognosis with an overall 5-year survival of approximately 15%. However, 25% of patients with NSCLC are diagnosed at an early stage and thus have a chance at being cured. Historically, the gold standard of treatments for patients with localized NSCLC has been lobectomy. However, some older patients are considered medically inoperable due to multimorbidity or they simply refuse surgery, and adjustment of treatment must be done according to the patients' health condition. During the past decades, SBRT has emerged as an alternative to surgery, showing comparable local control of the tumour with fewer people experiencing complications or toxicity. SBRT is a high precision hypo-fractionated treatment of tumors located outside the brain, involving extremely precise delivery of very intense doses of radiation to the tumor, while sparing the surrounding normal tissue. Danish data from the Department of Oncology, OUH, showed a 5-year overall survival at 35-40% for patients treated with SBRT compared with 6% in an untreated group. However, data also indicated that many of the lung cancer patients treated with SBRT die of other causes than lung cancer, probably due to age-related comorbidity. The general population is aging, and more patients are expected to suffer from comorbidites that will impact mortality. However, ageing is a heterogenous process and patients within the same chronological age group may reflect differen physiological ages. The International Society of Geriatric Oncology (SIOG) recommend performin a CGA in older patients with cancer to optimize the individual patient's general health status. The CGA was developed by geriatricians as a multidimensional interdisciplinary diagnostic process focused on determining frailty of an older person in order to develop a care plan for treatment and long-term follow-up. It consists of different domains of medical, functional, cognitive and social assessment, including medical history and physical examination with the potential to guide targeted interventions which could improve the older cancer patients' general health status. All domains are assessed with different validated instruments. A CGA identifies important deficits in the older cancer population and is considered a better assessment for predicting tolerance for cancer treatment than the performance status frequently used by oncologists. Improved survival and a decreased need for hospital admission has been demonstrated in older patients with non-malignant diseases who had undergone a CGA. A randomized pilot study at OUH investigated the impact of CGA in patients with localized NSCLC treated with SBRT. Indication of a small differences in quality of life and overall survival in favour of patients who recieved CGA were found, however such differences can only be validated in a larger study. This national randomized study aims to investigate if a CGA when added upfront to SBRT for patients with localized NSCLC will have an impact on QoL, overall survival, physical functionality and unplanned admissions to hospital. Improving the general health status of older patients with localized NSCLC through a CGA might lead to improved quality of life and overall survival.
Older patients with non-small cell lung cancer (NSCLC) treated with stereotactic body radiation therapy (SBRT) often die from other causes than lung cancer due to age-related comorbidities. This national randomized study will include 130 patients throughout 5 Danish cancer centres and investigate if a comprehensive geriatric intervention (CGA) when added upfront to SBRT for patients with localized NSCLC will have an impact on quality of life (QoL), overall survival, physical functionality and unplanned hospital admissions. If an upfront CGA improves patients' general health status, this study could lead to implementation of a CGA in standard clinical practice as well as further research on older patients receiving radiotherapy.
|Effective start/end date
|14/09/2020 → 14/09/2022
- Odense University Hospital (lead)
- Sygehus Lillebælt (Project partner)
- Aarhus University Hospital (Project partner)
- Rigshospitalet (Project partner)
- Herlev Hospital (Project partner)