title: Phase II trial of concurrent sunitinib and image-guided radiotherapy for oligometastases.
abstract: BACKGROUND
  Preclinical data suggest that sunitinib enhances the efficacy of radiotherapy. We tested the combination of sunitinib and hypofractionated image-guided radiotherapy (IGRT) in a cohort of patients with historically incurable distant metastases.
  
  
  METHODS
  Twenty five patients with oligometastases, defined as 1-5 sites of active disease on whole body imaging, were enrolled in a phase II trial from 2/08 to 9/10. The most common tumor types treated were head and neck, liver, lung, kidney and prostate cancers. Patients were treated with the recommended phase II dose of 37.5 mg daily sunitinib (days 1-28) and IGRT 50 Gy (days 8-12 and 15-19). Maintenance sunitinib was used in 33% of patients. Median follow up was 17.5 months (range, 0.7 to 37.4 months).
  
  
  RESULTS
  The 18-month local control, distant control, progression-free survival (PFS) and overall survival (OS) were 75%, 52%, 56% and 71%, respectively. At last follow-up, 11 (44%) patients were alive without evidence of disease, 7 (28%) were alive with distant metastases, 3 (12%) were dead from distant metastases, 3 (12%) were dead from comorbid illness, and 1 (4%) was dead from treatment-related toxicities. The incidence of acute grade ≥ 3 toxicities was 28%, most commonly myelosuppression, bleeding and abnormal liver function tests.
  
  
  CONCLUSIONS
  Concurrent sunitinib and IGRT achieves major clinical responses in a subset of patients with oligometastases.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00463060.
authors: Department of Radiation Oncology, Mount Sinai Medical Center, New York, New York, United States of America.
authors: Charles C L
authors: CC
authors: Tong
authors: Eric C
authors: EC
authors: Ko
authors: Max W
authors: MW
authors: Sung
authors: Jamie A
authors: JA
authors: Cesaretti
authors: Richard G
authors: RG
authors: Stock
authors: Stuart H
authors: SH
authors: Packer
authors: Kevin
authors: K
authors: Forsythe
authors: Eric M
authors: EM
authors: Genden
authors: Myron
authors: M
authors: Schwartz
authors: K H Vincent
authors: KH
authors: Lau
authors: Matthew
authors: M
authors: Galsky
authors: Junko
authors: J
authors: Ozao-Choy
authors: Shu-Hsia
authors: SH
authors: Chen
authors: Johnny
authors: J
authors: Kao
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D059248:Chemoradiotherapy; D019583:Dose Fractionation, Radiation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007211:Indoles / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009369:Neoplasms / Q000473:pathology / Q000628:therapy*; D011379:Prognosis; D011758:Pyrroles / Q000627:therapeutic use*; D061089:Radiotherapy, Image-Guided; D000077210:Sunitinib; D015996:Survival Rate
chemical_list: D000970:Antineoplastic Agents; D007211:Indoles; D011758:Pyrroles; D000077210:Sunitinib