title: Dosing patterns, toxicity, and outcomes in patients treated with first-line sunitinib for advanced renal cell carcinoma in community-based practices.
abstract: BACKGROUND
  This retrospective study by McKesson Specialty Health (MSH)/US Oncology Network (USON) evaluates dosing patterns of first-line sunitinib for patients with advanced renal cell carcinoma (aRCC) and its association with toxicities and clinical outcomes in community practices.
  
  
  METHODS
  Patients with aRCC who started first-line sunitinib between June 1, 2007, and May 31, 2011, were identified from 17 MSH/USON practices. Clinical data were extracted from iKnowMed electronic medical records linked to the MSH/USON pharmacy database.
  
  
  RESULTS
  In total, 134 patients were included; mean age was 63.9 years, 85% of the patients had an Eastern Cooperative Oncology Group performance score of 0 or 1, 82% had clear-cell renal cell carcinoma, and 65% had undergone nephrectomy. The median treatment duration was 4 cycles (range, 1-19). Overall, 113 patients discontinued sunitinib, mainly because of disease progression (45.1%) or toxicities (16.8%). Of all discontinuations, 77% occurred within the first 5 cycles. A total of 45 patients were dose-reduced, mostly because of toxicities (93%); 67% of all dose reductions occurred in the first 3 cycles. The objective response rate was 16.4%, median overall survival (OS) was 15.5 months, and progression-free survival (PFS) was 7.5 months. Multivariate analysis showed that OS and PFS were associated with sunitinib treatment duration.
  
  
  CONCLUSIONS
  Patients with aRCC from community practices undergo sunitinib dose reductions more frequently because of toxicities and discontinue therapy sooner than in clinical trials. Clinical outcomes were inferior to those reported in clinical trials, potentially because of shorter duration of therapy. Sunitinib therapy optimization remains an important challenge in community practices.
authors.affiliation: Compass Oncology, Tualatin, OR; McKesson Specialty Health, The Woodlands, TX. Electronic address: Ian.Schnadig@USONCOLOGY.com.
authors.forename: Ian D
authors.initials: ID
authors.lastname: Schnadig
authors.affiliation: Texas Oncology at Baylor Charles A. Sammons Cancer Center, Dallas, TX.
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Hutson
authors.affiliation: McKesson Specialty Health, The Woodlands, TX.
authors.forename: Hsingwen
authors.initials: H
authors.lastname: Chung
authors.affiliation: McKesson Specialty Health, The Woodlands, TX.
authors.forename: Rahul
authors.initials: R
authors.lastname: Dhanda
authors.affiliation: McKesson Specialty Health, The Woodlands, TX.
authors.forename: Melissa
authors.initials: M
authors.lastname: Halm
authors.affiliation: McKesson Specialty Health, The Woodlands, TX.
authors.forename: Michael
authors.initials: M
authors.lastname: Forsyth
authors.affiliation: Comprehensive Cancer Centers of Nevada, Las Vegas, NV.
authors.forename: Nicholas J
authors.initials: NJ
authors.lastname: Vogelzang
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000401:mortality; D005260:Female; D006801:Humans; D007211:Indoles / Q000008:administration & dosage* / Q000009:adverse effects; D053208:Kaplan-Meier Estimate; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D011758:Pyrroles / Q000008:administration & dosage* / Q000009:adverse effects; D012189:Retrospective Studies; D000077210:Sunitinib; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D007211:Indoles; D011758:Pyrroles; D000077210:Sunitinib
keywords: Efficacy; Kidney cancer; Sunitinib; Tolerability; VEGF receptor TKI