Background: Patients with Ewing sarcoma family of tumors (ESFT) who are resistant even to salvage chemotherapy,\nhave dismal prognoses and few therapeutic options. Because the docetaxel/irinotecan (DI) combination has not been\npreviously evaluated in ESFT, we prospectively evaluated its use in patients with recurrent or refractory ESFT.\nMethods: Patients aged <30 years with ESFT, who failed ? third-line therapy, were eligible. They received docetaxel\n100 mg/m2 intravenously on day 1, and irinotecan 80 mg/m2 on days 1 and 8, of a 21-day cycle up to 15 cycles or until\ndisease progressed. The primary objective was objective response rate (ORR); secondary objectives were progression-free\nsurvival (PFS) and safety.\nResults: We enrolled nine patients (median age: 13 years); four were male. Two patients had recurrent disease and\nseven had progressive disease. This group had undergone a median of four prior chemotherapy regimens (range: 3-6),\nand received a total of 51 DI cycles (median: three cycles/per person; range: 1-15 cycles). The nine patients showed\none complete response (CR), two partial responses (PRs), one stable disease, and five progressive diseases, for an ORR\n(CR + PR) of 3/9 (33.3%). Two patients with PR achieved CR with subsequent surgery. Overall median PFS was\n2.2 months (range: 0.5-16.9 months). All nine patients had grade 4 neutropenia (100%); grade 3 diarrhea or grade 2/3\nneuropathy each occurred in two patients (22%). All toxicities were manageable without serious morbidities or\ntreatment-related mortality.\nConclusions: The DI combination may be effective and tolerable for patients with heavily pre-treated ESFT.\nTrial registration: NCT01380275. Registered June 21, 2011.
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