OBJECTIVES: Lung cancer continues to be the most prevalent cancer worldwide1. As new treatments are developed there is a greater need for incorporating the patient perspective and a number of patient reported outcomes (PROs) have been developed specifically for lung cancer. This study aimed to conduct a brief review of PROs used in lung cancer clinical trials.
METHODS: A search was conducted using clinicaltrials.gov, to identify lung cancer clinical trials and the primary, secondary and exploratory PRO measures used in these trials. The search was restricted to interventional clinical trials that were currently recruiting and without results.
RESULTS: The search yielded 186 current trials. The PROs most frequently used in these clinical trials were the EORTC-QLQ C30 (n=56), the EORTC-QLQ LC13 (n=32), the FACT-L (n=16), the EQ-5D (n=15) and the MDASI-LC (n=6). In a majority of cases (88%), these were secondary endpoints. The EORTC-QLQ LC13, FACT-L and MDASI-LC were all developed specifically as lung cancer measures, but were not the most frequently used. Each of the PROs was reviewed in accordance with regulatory guidelines, evaluating the advantages and drawbacks of each with respect to context of use. For example, although the EORTC-QLQ LC13 is the most commonly used symptom PRO, it is an additional module to the EORTC-QLQ C30 and used together, these have a total of 43-items. Time to complete this measure and associated patient burden must be considered.
CONCLUSIONS: Selecting the most appropriate PRO measure as an endpoint during cancer clinical trials is important to provide full insight into the condition and treatment benefits. There are multiple existing validated measures developed for lung cancer and a number of comparisons can be made between them. The differences between the most commonly used measures have been summarised in this study and should be considerations when selecting a suitable measure for use in clinical trials.
