|The following article features coverage from the IASLC 2019 World Conference on Lung Cancer meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
Results from a systematic review of all published phase 3 clinical trials across 11 major journals evaluating anticancer therapies in lung cancer between 2012 and 2018 showed that quality of life (QoL) was not included as an end point in approximately one-third of studies evaluated. These findings were reported at the IASLC 2019 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer in Barcelona, Spain.
Given the high symptom burden and potentially limited life expectancies of patients with lung cancer, particularly those with advanced disease, the importance of measuring the impact of cancer treatment not only on survival, but also on patient QoL, is well recognized.
Of the 122 publications identified in the review, QoL was not included as a study end point in 58.8%, 27.8%, 24.4%, and 40.0% of publications of phase 3 clinical trials involving treatment of early-stage/localized non-small cell lung cancer (NSCLC), first-line treatment for advanced NSCLC, second- and higher-lines of therapy for advanced NSCLC, and treatment for patients with small-cell lung cancer (SCLC), respectively.
Another interesting finding was that of the 83 identified phase 3 trials mentioning QoL as a study end point, the results of QoL assessments were not reported in 43.4% of the primary publications of these studies. Furthermore, this type of omission of QoL information was twice as likely to occur during 2016 to 2018 compared with 2012 to 2015 (P =.005).
While no difference was observed in the availability QoL results between publications of studies funded with “for-profit” or “non-for-profit” resources, trials funded by “not-for-profit” entities were more likely to avoid listing QoL as a study end point (54.8%) compared with trials utilizing “for-profit” funding (20.0%).
“Overall, QoL data were not available in 65/122 (61.5%) primary publications, due to the absence as end point or unpublished results,” the study authors noted.
Notably, the absence of QoL data was more common in those studies listing overall survival (OS) as a primary study end point (70.6%) compared to studies where OS was not a primary study end point (50.0%).
Interestingly, for the publications listing QoL end points as part of the study design, the likelihood of a secondary publication was 6.3%, 30.1%, and 49.8% at 1, 2, and 3 years after publication of the primary study. Furthermore, no improvement in these rates was noted when the periods covering 2012 to 2015 and 2016 to 2018 were compared.
For those studies evaluating QoL, the most common QoL tools used were the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life (QLQ) Questionnaire-C30 (EORTC QLQ-C30; 50.6%), the EORTC QLQ Lung Cancer 13 (EORTC LM 13; 47.0%), and the Euro QoL 5D (EQ-5D; 44.6%).
In their concluding remarks, the study authors emphasized that “the timely inclusion of QoL results in primary publications [of phase 3 trials evaluating anticancer therapy in lung cancer] is worsening in recent years.”
Read more of Cancer Therapy Advisor‘s coverage of the IASLC annual meeting by visiting the conference page.
Reale ML, De Luca E, Lombardi P, et al. Quality of life (QoL) analysis in lung cancer: A systematic review of phase III trials. Presented at: IASLC 2019 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer; September 7-10, 2019; Barcelona, Spain. Abstract OA07.07.