We investigated whether quality of life assessment is common in randomised controlled trials in the setting of metastatic non-small cell lung cancer. This study comes from previous publications in which we found that the rate of assessment of QoL is very low. There is a large fraction of trials that are not assessing quality of life and even when it is assessed the results are not reported in the published papers.

So after this first analysis we also wanted to know whether there is a correlation between the quality of life results and the efficacy results, basically the data about overall survival and progression free survival led by experimental treatments in non-small cell lung cancer. This may be interesting because, as an oncology community, we generally pay a lot of attention in terms of efficacy results or we are excited by new drugs that can lead to increasing survival rates. But sometimes we forget the importance of quality of life in these patients when they receive anti-cancer treatment.

Basically we wanted to understand whether there is a correlation between the results, in terms of efficacy of these new drugs, and how they affect the quality of life. To do this we investigated the literature and which are the publications of randomised controlled trials that we have so far in the literature.

Basically we investigated the PubMed database and we found more than 150 trials that were published from 2012 to 2021. Those were all the trials investigating new drugs in patients with metastatic or locally advanced non-small cell lung cancer. For our analysis we were able to select only 81 trials because those were the only trials in which we had results of quality of life and also we had at least PFS or overall survival data. What we found was that only in less than 40% of trials also had positive quality of life results data. In about 57-59% of the trials that we found there was not a statistically significant benefit in terms of quality of life due to the novel anti-cancer treatment compared to the control arm.

Next, we wanted to investigate whether there is a correlation between the QoL results and efficacy results based on drug classes. We found that there is no correlation between QoL improvement and efficacy results in trials testing chemotherapy or immunotherapy. Instead, we found a positive correlation in terms of progression free survival but not in terms of overall survival in the trials testing targeted therapies. These results are even stronger in terms of statistics for trials testing EGFR or ALK inhibitors.

Finally, we found that we only selected the 51 trials in which we had negative results in terms of QoL but although they were negative based on our analysis, or our interpretation, we found that in studies that were sponsored by industries, by companies, the QoL results were still presented as a positive, or at least they had a positive description, so overestimating the real benefit in terms of quality of life associated with these novel anti-cancer therapies.

These are the main results and we hope to increase in the future the number of papers that we can include in this analysis. Hopefully in the future there will be an increasing number of trials testing quality of life, not only in the methods but we will have an increasing number of trials also publishing the results of quality of life because sometimes some trials lack this important information.

How can these study results impact the treatment of NSCLC?

We think that it may be very important to know whether an improvement in QoL results may predict response to treatment. Because, basically, the response to treatment is assessed using radiological examination, CT scans or MRI, depending on the sites of disease. But we think that if we are able to prospectively evaluate the quality of life using specific tools, specific tests, the data coming from QoL assessment can anticipate the radiological examination. So this may anticipate our understanding of the real benefit that anti-cancer treatment is having in our patients.

Also, we aim to further convince the oncology community, particularly the investigators who are involved in randomised controlled trials, to increase and to improve the assessment of quality of life and, more importantly, to increase the publication of this data because sometimes we do not find this data in publications. You just can think that from the 158 trials that we found published in the last ten years in the field of metastatic non-small cell lung cancer we could only select 81 trials because in all the other trials the QoL data were not published meaning that there’s a large fraction of randomised phase III controlled trials that are lacking this information.

I just hope that this article, but mainly all the works from colleagues who work in the field of quality of life assessment, can further convince our colleagues in the oncology community that assessment of quality of life is very important for our patients. So it is something that we need to improve in our clinical practice but also particularly in phase III trials.