title: Real-world dosing and drug costs with everolimus or axitinib as second targeted therapies for advanced renal cell carcinoma: a retrospective chart review in the US.
abstract: OBJECTIVE
  To describe dosing patterns and to compare the drug costs per month spent in progression-free survival (PFS) among patients with advanced renal cell carcinoma (aRCC) treated with everolimus or axitinib following a first tyrosine kinase inhibitor (TKI).
  
  
  METHODS
  A medical record retrospective review was conducted among medical oncologists and hematologists/oncologists in the US. Patient eligibility criteria included: (1) age ≥18 years; (2) discontinuation of first TKI (sunitinib, sorafenib, or pazopanib) for medical reasons; (3) initiation of axitinib or everolimus as a second targeted therapy during February 2012-January 2013. Real-world dosing patterns were summarized. Dose-specific drug costs (as of October 2014) were based on wholesale acquisition costs from RED BOOK Online. PFS was compared between everolimus and axitinib using a multivariable Cox proportion hazards model. Everolimus and axitinib drug costs per month of PFS were compared using multivariable gamma regression models.
  
  
  RESULTS
  A total of 325 patients received everolimus and 127 patients received axitinib as second targeted therapy. Higher proportions of patients treated with axitinib vs everolimus started on a higher than label-recommended starting dose (14% vs 2%) or experienced dose escalation (11% vs 1%) on second targeted therapy. The PFS did not differ significantly between patients receiving everolimus or axitinib (adjusted hazard ratio (HR) = 1.16; 95% confidence interval [CI] = 0.73-1.82). After baseline characteristics adjustment, axitinib was associated with 17% ($1830) higher drug costs per month of PFS compared to everolimus ($12,467 vs $10,637; p < 0.001).
  
  
  CONCLUSIONS
  Retrospective observational study design and only drug acquisition costs considered in drug costs estimates.
  
  
  CONCLUSIONS
  Patients with aRCC receiving axitinib as second targeted therapy were more likely to initiate at a higher than label-recommended dose and were more likely to dose escalate than patients receiving everolimus. With similar observed durations of PFS, drug costs were significantly higher-by 17% per month of PFS-with axitinib than with everolimus.
authors.affiliation: a a City of Hope Comprehensive Cancer Center , Duarte , CA , USA.
authors.forename: Sumanta K
authors.initials: SK
authors.lastname: Pal
authors.affiliation: b b MD Anderson Cancer Center , Houston , TX , USA.
authors.forename: Eric
authors.initials: E
authors.lastname: Jonasch
authors.affiliation: c c Analysis Group, Inc. , Boston , MA , USA.
authors.forename: James E
authors.initials: JE
authors.lastname: Signorovitch
authors.affiliation: c c Analysis Group, Inc. , Boston , MA , USA.
authors.forename: William M
authors.initials: WM
authors.lastname: Reichmann
authors.affiliation: c c Analysis Group, Inc. , Boston , MA , USA.
authors.forename: Nanxin
authors.initials: N
authors.lastname: Li
authors.affiliation: d d Novartis Pharmaceuticals Corporation , East Hanover , NJ , USA.
authors.forename: Zhimei
authors.initials: Z
authors.lastname: Liu
authors.affiliation: d d Novartis Pharmaceuticals Corporation , East Hanover , NJ , USA.
authors.forename: Jose Ricardo
authors.initials: JR
authors.lastname: Perez
authors.affiliation: e e US Oncology Research, Comprehensive Cancer Centers of Nevada , Las Vegas , NV , USA.
authors.forename: Nicholas J
authors.initials: NJ
authors.lastname: Vogelzang
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000191:economics* / Q000627:therapeutic use; D000077784:Axitinib; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000473:pathology; D015897:Comorbidity; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D000068338:Everolimus / Q000191:economics* / Q000627:therapeutic use; D005252:Fees, Pharmaceutical / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000191:economics* / Q000627:therapeutic use; D007191:Indazoles / Q000191:economics* / Q000627:therapeutic use; D007211:Indoles / Q000627:therapeutic use; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009536:Niacinamide / Q000031:analogs & derivatives / Q000627:therapeutic use; D010671:Phenylurea Compounds / Q000627:therapeutic use; D016016:Proportional Hazards Models; D047428:Protein Kinase Inhibitors / Q000191:economics* / Q000627:therapeutic use; D011743:Pyrimidines / Q000627:therapeutic use; D011758:Pyrroles / Q000627:therapeutic use; D012189:Retrospective Studies; D000077157:Sorafenib; D013449:Sulfonamides / Q000627:therapeutic use; D000077210:Sunitinib
chemical_list: D000970:Antineoplastic Agents; D007093:Imidazoles; D007191:Indazoles; D007211:Indoles; D010671:Phenylurea Compounds; D047428:Protein Kinase Inhibitors; D011743:Pyrimidines; D011758:Pyrroles; D013449:Sulfonamides; D009536:Niacinamide; C516667:pazopanib; D000068338:Everolimus; D000077157:Sorafenib; D000077784:Axitinib; D000077210:Sunitinib
keywords: Advanced renal cell carcinoma; Axitinib; Costs; Dosing; Everolimus; Targeted therapy; Treatment patterns