title: Feasibility trial for daily oral administration of the hypoxic sensitizer AK-2123 (Sanazole) in radiotherapy.
abstract: BACKGROUND
  To examine the feasibility of daily oral administration of the hypoxic tumor radiation sensitizer, sanazole (AK-2123).
  
  
  METHODS
  We analyzed the toxicity associated with 44 treatments of 42 patients, who received daily oral administration of 1 g/day sanazole (level A, 1-9g, 12 treatments; Level B, 10 g, 33 treatments) 2 h before radiotherapy. Eligibility criteria were as follows: Patients who were unable to receive standard treatment because of older age and/or fragile status and/or refractory disease. Five patients with advanced tumors treated with pre- or postoperative adjuvant radiotherapy were also included.
  
  
  RESULTS
  Toxicity was assessed during 44 treatment sessions. Eight patients (18%) showed sanazole-related paresthesia in the extremities, similar to the rate (15%) reported in a preceding multi-institutional international phase III study, which used intravenous administration. No sanazole-related toxicity rated grade 3 or higher was observed. Forty out of the 44 treatment sessions (91%) were completed.
  
  
  CONCLUSIONS
  This study validates the feasibility of daily oral administration of sanazole. Further studies to establish suitable applications are warranted.
authors: Department of Radiology, Kyoto Prefectural University of Medicine, 465 Kajiicho Kawaramachi Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan. hideya10@hotmail.com
authors: Hideya
authors: H
authors: Yamazaki
authors: Satoaki
authors: S
authors: Nakamura
authors: Kana
authors: K
authors: Kobayashi
authors: Takuji
authors: T
authors: Tsubokura
authors: Naohiro
authors: N
authors: Kodani
authors: Norihiro
authors: N
authors: Aibe
authors: Ken
authors: K
authors: Yoshida
authors: Tsutomu
authors: T
authors: Kagiya
authors: Masahiko
authors: M
authors: Koizumi
authors: Kei
authors: K
authors: Yamada
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003131:Combined Modality Therapy; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy; D011838:Radiation-Sensitizing Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D014230:Triazoles / Q000008:administration & dosage* / Q000009:adverse effects*
chemical_list: D011838:Radiation-Sensitizing Agents; D014230:Triazoles; C072690:AK 2123