title: A study of docetaxel and irinotecan in children and young adults with recurrent or refractory Ewing sarcoma family of tumors.
abstract: BACKGROUND
  Patients with Ewing sarcoma family of tumors (ESFT) who are resistant even to salvage chemotherapy, have dismal prognoses and few therapeutic options. Because the docetaxel/irinotecan (DI) combination has not been previously evaluated in ESFT, we prospectively evaluated its use in patients with recurrent or refractory ESFT.
  
  
  METHODS
  Patients aged <30 years with ESFT, who failed ≥ third-line therapy, were eligible. They received docetaxel 100 mg/m(2) intravenously on day 1, and irinotecan 80 mg/m(2) on days 1 and 8, of a 21-day cycle up to 15 cycles or until disease progressed. The primary objective was objective response rate (ORR); secondary objectives were progression-free survival (PFS) and safety.
  
  
  RESULTS
  We enrolled nine patients (median age: 13 years); four were male. Two patients had recurrent disease and seven had progressive disease. This group had undergone a median of four prior chemotherapy regimens (range: 3-6), and received a total of 51 DI cycles (median: three cycles/per person; range: 1-15 cycles). The nine patients showed one complete response (CR), two partial responses (PRs), one stable disease, and five progressive diseases, for an ORR (CR + PR) of 3/9 (33.3%). Two patients with PR achieved CR with subsequent surgery. Overall median PFS was 2.2 months (range: 0.5-16.9 months). All nine patients had grade 4 neutropenia (100%); grade 3 diarrhea or grade 2/3 neuropathy each occurred in two patients (22%). All toxicities were manageable without serious morbidities or treatment-related mortality.
  
  
  CONCLUSIONS
  The DI combination may be effective and tolerable for patients with heavily pre-treated ESFT.
  
  
  BACKGROUND
  NCT01380275. Registered June 21, 2011.
authors.forename: Jong Hyung
authors.initials: JH
authors.lastname: Yoon
authors.forename: Mi Mi
authors.initials: MM
authors.lastname: Kwon
authors.forename: Hyeon Jin
authors.initials: HJ
authors.lastname: Park
authors.forename: Seog Yun
authors.initials: SY
authors.lastname: Park
authors.forename: Kun Young
authors.initials: KY
authors.lastname: Lim
authors.forename: Jungnam
authors.initials: J
authors.lastname: Joo
authors.affiliation: Center for Pediatric Oncology, National Cancer Center, 323 Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do 410-769, Korea. bkpark@ncc.re.kr.
authors.forename: Byung-Kiu
authors.initials: BK
authors.lastname: Park
mesh_terms: D000293:Adolescent; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D001859:Bone Neoplasms / Q000188:drug therapy* / Q000473:pathology; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D002648:Child; D002675:Child, Preschool; D018572:Disease-Free Survival; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008297:Male; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D011446:Prospective Studies; D012512:Sarcoma, Ewing / Q000188:drug therapy* / Q000473:pathology; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel; D000077146:Irinotecan; D002166:Camptothecin