title: Efficacy and safety of temsirolimus in Japanese patients with metastatic renal cell carcinoma on hemodialysis.
abstract: BACKGROUND
  We retrospectively investigated the efficacy and safety of temsirolimus, an inhibitor of the mammalian target of rapamycin, in patients with metastatic renal cell carcinoma (mRCC) on hemodialysis (HD).
  
  
  METHODS
  This study included ten HD patients who were diagnosed with mRCC following radical nephrectomy and subsequently treated with temsirolimus between December 2010 and June 2012. Medical records of these patients were reviewed to evaluate the response to temsirolimus and treatment-related toxicities.
  
  
  RESULTS
  Baseline characteristics of the patients are as follows: median age was 61 years, five patients had a Karnofsky performance status of ≤80, and two, six, and two patients were classified into favorable, intermediate, and poor risk group, respectively, according to the Memorial Sloan-Kettering Cancer Center risk model. Initially, all patients received 25 mg intravenous temsirolimus weekly; however, dose modification was necessary in four patients, resulting in a relative dose intensity of 89.5 % throughout this study. All patients, except for one with progressive disease, were judged to have stable disease following treatment with temsirolimus. Six patients are still under treatment with temsirolimus, whereas four have stopped receiving temsirolimus because of the occurrence of progressive disease in three and that of adverse events (AEs) in one. Although all patients experienced AEs related to temsirolimus, severe AEs corresponding to ≥ grade 3 occurred in only four, including thrombocytopenia in two, anemia in one, and asthenia in one.
  
  
  CONCLUSIONS
  Treatment with temsirolimus is well tolerated and could provide comparatively favorable cancer control in Japanese mRCC patients undergoing HD.
authors.affiliation: Division of Urology, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan, hideakimiyake@hotmail.com.
authors.forename: Hideaki
authors.initials: H
authors.lastname: Miyake
authors.forename: Ken-Ichi
authors.initials: K
authors.lastname: Harada
authors.forename: Yuji
authors.initials: Y
authors.lastname: Kusuda
authors.forename: Masato
authors.initials: M
authors.lastname: Fujisawa
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis / Q000188:drug therapy / Q000473:pathology; D006435:Renal Dialysis; D012189:Retrospective Studies; D020123:Sirolimus / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*
chemical_list: C401859:temsirolimus; D020123:Sirolimus