Abstract
9005 Background: There is increasing interest in the use of methylphenidate (MP) for the treatment of cancer related fatigue. However there is limited literature on the patient specific factors associated with response to methylphenidate. Methods: In this study we reviewed patients who received MP as a part of two prospective controlled clinical trials on the use MP for cancer related fatigue conducted by our group, we defined clinical response as D FACIT-F score of ≥ 7 from baseline to day 8. Baseline patient characteristics and symptoms (as assessed by Edmonton Symptom Assessment Scale (ESAS) and response (change in fatigue) at the end of day 1 treatment were analyzed to determine their association with response to methylphenidate. Results: A total of 82 advanced cancer patients received MP. The median age was 55, 66% were female, 74% were white, most common cancer type was breast 37%. 63/82 (77%) patients were responders at Day 8 (primary end point). The intensity of baseline fatigue positively correlates with response to MP (p<0.001). Response to methylphenidate was not associated to intensity of baseline depression, anxiety drowsiness. Higher improvement of fatigue after MP treatment for 1 Day was associated with higher improvement of fatigue at Day 8 as assessed by FACIT-F (p = 0.0004) and ESAS (p = 0.0001). In addition 42/63(67%) patients with ESAS change of fatigue ≥ 1 after Day 1 treatment demonstrated a response of ≥ 7 points change in the FACIT-F score at Day 8 (p = 0.03). The positive predictive value, sensitivity and specificity of Day 1 response being a predictor of response to Day 7 response is 0.67, 0.84, and 0.6 respectively. Conclusions: In this study we found clinical response to methylphenidate in advanced cancer patients with fatigue to be 77% and response at Day 8 (primary end point) is associated with response at Day 1, and severity of baseline fatigue score. No significant financial relationships to disclose.
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