title: Safety of everolimus by treatment duration in patients with advanced renal cell cancer in an expanded access program.
abstract: OBJECTIVE
  To retrospectively analyze the effects of treatment duration on outcomes of everolimus treatment of patients in the RAD001 Expanded-Access Clinical Trial in RCC (REACT) program.
  
  
  METHODS
  Patients with metastatic renal cell carcinoma refractory to vascular endothelial growth factor receptor-tyrosine kinase inhibitor received everolimus (10 mg once daily), with dosing interruption or modifications allowed for toxicity. All serious and grade 3/4 adverse events and grade 1/2 adverse events leading to a change in drug administration were reported. Tumor response was evaluated using Response Evaluation Criteria In Solid Tumors.
  
  
  RESULTS
  The study stratified 1367 evaluable patients into treatment duration groups of <3 months, ≥3 and <6 months, ≥6 months and <1 year, and ≥1 year. Pneumonia, noninfectious pneumonitis, and hyperglycemia occurred more frequently in patients receiving everolimus for ≥1 year but did not result in treatment discontinuations. First occurrence of adverse events presented early in the treatment course for most patients. Treatment duration of ≥6 months was associated with improved disease control rates.
  
  
  CONCLUSIONS
  Everolimus is well tolerated in patients with metastatic renal cell carcinoma for treatment durations≥1 year and not associated with cumulative toxicity.
authors.affiliation: VU University Medical Center, Amsterdam, The Netherlands. vandeneertwegh@vumc.nl
authors.forename: Alfonsus J M
authors.initials: AJ
authors.lastname: van den Eertwegh
authors.forename: Pierre
authors.initials: P
authors.lastname: Karakiewicz
authors.forename: Sevil
authors.initials: S
authors.lastname: Bavbek
authors.forename: Sun Young
authors.initials: SY
authors.lastname: Rha
authors.forename: Sergio
authors.initials: S
authors.lastname: Bracarda
authors.forename: Amit
authors.initials: A
authors.lastname: Bahl
authors.forename: Yen-chuan
authors.initials: YC
authors.lastname: Ou
authors.forename: Dennis
authors.initials: D
authors.lastname: Kim
authors.forename: Ashok
authors.initials: A
authors.lastname: Panneerselvam
authors.forename: Oezlem
authors.initials: O
authors.lastname: Anak
authors.forename: Viktor
authors.initials: V
authors.lastname: Grünwald
mesh_terms: D000368:Aged; D000740:Anemia / Q000139:chemically induced; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000556:secondary; D018450:Disease Progression; D004417:Dyspnea / Q000139:chemically induced; D000068338:Everolimus; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D006801:Humans; D006943:Hyperglycemia / Q000139:chemically induced; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011014:Pneumonia / Q000139:chemically induced; D020123:Sirolimus / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D013280:Stomatitis / Q000139:chemically induced; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D000068338:Everolimus; D020123:Sirolimus