Toxicity and quality of life in published clinical trials for advanced lung cancer.

Background: In every report on incurable disease, clear presentation of toxicity and of quality of life (QoL) is of essential importance. This postulate was assessed on a series of publications on systemic treatment for advanced lung cancer.

Materials And Methods: The analysis covered papers on original phase II-IV clinical trials published between 2013 and 2015 and included in the PubMed database.

Results: Selected for analysis were 349 publications on 333 trials with a total of 78.977 patients. Only 33 trials (10%) dealt with small cell lung cancer. Most trials (56.5%) included only information on frequency and grade of specific toxic phenomena and did not provide data on the frequency of any serious toxicity. The ratio between the frequency of any grade ≥ 3 toxicity and response rate was often unfavorable, especially for second-line treatment of non-small cell lung cancer (3.0) and second-line treatment of small cell lung cancer (5.3). Assessment of QoL was mentioned in 68 (20.4%) trials, of which only 46 publications provided adequate data.

Conclusions: A substantial proportion of publications on trials for advanced lung cancer do not offer adequate information for decisions in clinical practice. Presentation of toxicity should include information on the frequency of any serious toxicity. Quality of life should be monitored and reported in every trial of an incurable disease. Simple instruments for the assessment of QoL are strongly recommended, so as to alleviate burden to patients and to staff, avoid bias due to poor compliance and enable clear analysis and presentation.