Final results of a phase I trial of fasting prior to platinum-based chemotherapy.

9632 Background: Fasting confers dramatic protection against chemotherapy toxicity in mice (PNAS 2008). We studied safety and feasibility of escalated fasting duration prior to platinum doublet chemotherapy in cancer patients (pts). Insulin, glucose, ketones and insulin-like growth factor (IGF) were measured as potential biomarkers of the fasting state. Methods: 3 fasting cohorts were evaluated: 24, 48 and 72 hours (hr) (48 pre/24 post chemotherapy). Subjects recorded all calories consumed during the fast period. Feasibility was defined as 4/6 subjects in each cohort consuming < 200 kCal/24 hr without excess fasting toxicity (using CTCAE v4.0). Results: Primary cancer: Urothelial 5, breast 5, ovarian 7, uterine 1, NSCLC 1. Regimens: gemcitabine+ cisplatin 6, docetaxel + carboplatin (C) + trastuzumab 5, C + paclitaxel 8. Median age: 61y (31-73). 4/6 pts, 5/7 pts and 4/6 pts in the 24, 48 and 72 hr groups were fasting compliant <200 kCal/24 hr with no significant toxicities. Median weight change was 0 after...