Financial, social and time toxicity in early-phase cancer clinical trials: The PEARLER study.

Abstract

11119 Background: Early phase clinical trials (EP-CTs) provide patients with access to novel therapeutics once standard of care options are exhausted or not available. In addition to the drug related potential benefits and risks with participating in such studies, patients are also exposed to hidden toxicities which often go unnoticed. Hidden toxicities have been classed into a number of major categories which include but are not limited to time, financial, and social. Currently there are no prospective studies assessing these hidden toxicities in the EP-CT space. Methods: The PEARLER (Patient Experience in eARLy phasE cancer clinical tRials) study was conducted with a key aim of focusing on assessing time toxicity, financial toxicity and social toxicity in a multi-centre prospective cohort setting. All participants completed a baseline demographic survey on cycle 1 day 1 along a time toxicity survey and the EORTC-QLQ-C30 on day 1 of cycles 1 through 6. Multilevel models were used to analyse trend over time for financial toxicity and social toxicity. Results: A total of 122 participants were recruited. Median age was 62 years (25 – 83 years) with 63 (52%) participants identifying as female. A total of 47 (39%) participants were enrolled in immuno-oncology EP-CTs whilst the remainder participated in targeted-therapy focused EP-CTs. The median time toxicity was 26%. Of 122 participants, 20 (16%) reported subjective time toxicity with 17 (85%) reporting this occurring at either cycle 1 or 2. Under half (54/122, 44%) reported any degree of financial toxicity whilst participating in their EP-CT; with 9 of this 54 (17%) reporting the maximum score of ‘4’. Financial toxicity remained largely stable throughout EP-CT participation (p=0.136), with 6/122 (5%) participants reporting higher financial burdens at the end of their clinical trial compared with baseline. Most participants (87/122, 71%) reported any degree of reduced social function, whilst participating in their EP-CT. However, 26/122 (21%) participants reported lower social functional scores at conclusion of their EP-CT compared with baseline whilst 24/122 (20%) reported higher social functional scores. Conclusions: PEARLER is the first prospective cohort study investigating financial, social and time toxicity in EP-CTs. Although time toxicity remains a concern of EP-CTs, the majority of subjects did not subjectively note this to be a concern. Financial and social toxicity remained stable during EP-CT participation thereby suggesting that EP-CTs may not negatively affect the majority of participants. However almost half of patients experienced financial toxicity and more than half experienced social toxicity due to cancer related treatment and greater efforts to identify and support patients financially and socially is needed.