Lung cancer is the most common malignancy in men and the third most common in women. The most frequent symptoms that patients report upon disease presentation are cough, dyspnea, chest pain, fatigue, chest infection, hemoptysis, and weight loss, all of which greatly overlap with symptoms of other common chronic respiratory conditions and are often only present at later stages of the disease.
The overlap is one cause of the delay between presentation and diagnosis, which means that lung cancer is diagnosed in late stages in half of all cases. The prevalence of late-stage diagnosis is one of the reasons why lung cancer has such a low survival rate: a 5-year overall survival rate of 18.1% in all lung cancer stages and 4.5% in the metastatic stage.
In recent years, we have witnessed a shift in the treatment paradigm of Non-Small Cell Lung Cancer (NSCLC). Specifically, the inclusion of a new pharmacological approach with the inclusion of Immuno-checkpoint inhibitor therapies that focus on the regulation of the immune system to attack the cancer instead of attacking it directly as chemotherapy does. The approval of the combination of chemo and immunotherapy as first line treatment for advanced NSCLC, while providing a clear benefit for NSCLC patients who are not eligible for mono-immunotherapy treatments (with PD-L1 low/negative), poses a new alternative of care for those patients who can now choose between an immunotherapy treatment, plus a chemotherapy treatment in a subsequent line of treatment, and combined chemo-immunotherapy treatment, that has an increased chance of adverse events and more critical side effects, but can be more effective against more aggressive cancers.
Since a direct comparison between the two has not been able to provide evidence of which choice is to be preferred, patient preferences are crucial when choosing between a more “aggressive” approach with a higher toxicity profile or a less intense alternative. PREFER has the objective to identify and evaluate which elements are relevant for patients and should be considered when evaluating the treatment. The study will include NSCLC patients from Italy and Belgium in a different stage to define how preferences evolve according to different stages of the disease. The study will adopt different methods to assess patients’ preferences to evaluate the similarity of the results.
|Therapeutic area||Lung cancer|
|Study led by||European Institute of Oncology|
|PREFER leads team||Gabriella Pravettoni
Serena Oliveri (from January 2020)
|MPLC decision points of interest||Post marketing authorisation|
|PREFER case study acronym||Lung Cancer|
|Clinical objectives||Identify and quantify patient-relevant benefit-risk attributes of LC treatments
Quantify the risk tolerance for experiencing adverse events (Maximum Acceptable Risk) that patients are willing to accept for an increased probability of prolonged survival
|Methods in Qualitative study||Focus Group Discussion with Thematic Analysis
Nominal Group Technique
|Methods in Quantitative study||Discrete Choice Experiment (DCE)
|End-date qualitative data collection||October 2019|
|End-date quantitative data collection||Q3/Q4 2020|