EORTC Quality of Life study suggests need for international standardization of health related quality of life reporting in non-small cell lung cancer randomized controlled trials

Lung cancer, accounting for 18.2% of cancer deaths in the world, is the most common cancer worldwide in both incidence and mortality for men and women. Not only is the incidence rate high, but the survival rate is low: the one year survival rate of lung cancer patients is only 42%, and the five-year rate is 16%.

Non-small cell lung cancer (NSCLC) comprises 85% of all diagnosed lung cancers, and palliative chemotherapy is the preferred treatment for the majority of patients with advanced stages of this disease. Given this reality, assessment of treatment effectiveness needs to include objective, e.g. progression free survival (PFS) and overall survival (OS), as well as subjective, e.g. patient reported outcomes, components. Using this combined information, clinicians and patients are better equipped to make treatment decisions.

The present EORTC Quality of Life study ¹ is an update of a prior systematic review of health related quality of life (HRQOL) methodology reporting in non-small cell lung cancer (NSCLC) randomized controlled trials. The prior study showed an increase in the quality of HRQOL reporting from 1980 to 2002 ². The objective of the current study was to evaluate HRQOL methodology reporting over the last decade and its benefit for clinical-decision making. Only when HRQOL is reported comprehensively can it be utilized confidently by clinicians and patients when making treatment decisions.

A Medline systematic literature review was performed that only included randomized controlled trials that implemented patient reported HRQOL assessments and included regular oncology treatments for newly diagnosed adult NSCLC patients. Of the 53 trials included in the review, 81% reported that there was no significant difference in OS, yet half of these reported a significant difference in HRQOL scores.

The number of NSCLC trials incorporating HRQOL assessment continues to increase, and HRQOL continues to be valued, especially in studies in which no OS difference is found. In addition, the quality of HRQOL reporting continues to improve, and an EORTC HRQOL questionnaire was used in 57% of the studies.

There remains room for improvement, however, for it was also found that the reporting of HRQOL hypotheses and rationales for choosing HRQOL instruments were significantly less than before 2002 (p < .05). Based on their findings, the authors recommend the development of a CONSORT–like (Consolidated Standards of Reporting Trials) checklist that could be used to ensure that HRQOL data are reported in a consistent and standardized manner.

John Bean

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¹ L. Claassens, J. van Meerbeeck, C. Coens, C. Quinten, I. Ghislain, E.K. Sloan, X.S. Wang, G. Velikova, and A. Bottomley. Health-related quality of life (HRQOL) in non-small cell lung cancer (NSCLC): an update of a systematic review on methodological issues in randomized controlled trials (RCTs). J Clin Oncol DOI: 10.1200/JCO.2010.32.3683, 2011.

² A. Bottomley, F. Efficace, R. Thomas, V. Vanvoorden, and S. Ahmdzai. Health related quality of life in non small cell lung cancer: Methodological issues in randomised controlled trials. J Clin Oncol 21(15):2982-2992, 2003.