Predictive Value Of Bother By Side Effects Of Treatment Prior To Protocol Therapy For Early Treatment Discontinuation In Clinical Trials.

e19132 Background: The Functional Assessment of Cancer Therapy–General has an item about patient tolerability of treatment: “I am bothered by side effects of treatment” (GP5). We examined the predictive value of this single item for early treatment discontinuation in clinical trials. Methods: GP5 level prior to protocol therapy (rated using a 5-point Likert scale) and treatment start/end dates and off treatment reason data at each treatment phase were drawn from five phase III clinical trials conducted by ECOG-ACRIN. In the present analysis, GP5 was dichotomized as 0 = “Not at all”/“A little bit” and 1 = “Somewhat”/“Quite a bit”/“Very Much”. Early treatment discontinuation was defined either as receiving less than protocol specified cycles of treatment when maximum cycles specified in the protocol (E1A06 induction, E1912 induction, E1609 induction, E1105 induction, E5103 adjuvant), analyzed using logistic regression via odds ratio [OR]), or treatment cessation for reasons other than progressive disease or death when treatment continued until progression or intolerability (E1A06 maintenance, E1912 maintenance, E1609 maintenance, E1105 maintenance), analyzed using Cox proportional hazard model via hazard ratio [HR]. Results: GP5 prior to treatment was significantly associated with early discontinuation of E1A06 maintenance, E1609 maintenance, E1912 maintenance, and E1912 induction. No significant association was found for other therapies examined in the study. Conclusions: High GP5 level prior to treatment is associated with higher likelihood of early treatment discontinuation in patients who have received previous treatment. The limited predictive value of GP5 for treatment naïve patients is more limited, serial on-treatment assessment should be considered in this setting. Clinical trial information: NCT00602641 . [Table: see text]