title: Long-term Duration of First-Line Axitinib Treatment in Advanced Renal Cell Carcinoma.
abstract: We conducted a retrospective analysis of two clinical trials in treatment-naïve patients (n = 402) with advanced renal cell carcinoma (RCC) treated with axitinib. Our objective was to compare duration of treatment (DT) and clinical outcome in patients who achieved DT >18 months (longer DT) versus ≤18 months (shorter DT).
  
  
  
  DT, objective response rate (ORR), tumor shrinkage, and overall survival (OS) were summarized for patients with longer and shorter DT.
  
  
  
  Overall, 152 patients (37.8%) had longer DT and 250 (62.2%) had shorter DT (median, 34.7 vs. 6.5 months, respectively). ORR in all 402 patients with advanced RCC was 43.5%. ORR was 75% for longer DT versus 24.4% for shorter DT (p < 0.0001). More patients with longer DT versus shorter DT had ≥10% tumor shrinkage at first scan (74.8% vs. 55.3%; p = 0.0001) and maximum on-study tumor shrinkage was greater in longer-DT versus shorter-DT group (-51.8% vs. -22.1%; p < 0.0001). Median OS was 32.6 months in the overall population while in the patients with longer DT the median was not reached. Treatment-related adverse events (AEs) grade ≥3 were more frequent in longer-DT versus shorter-DT and included hypertension (25.7% vs. 18.8%), diarrhea (15.1% vs. 4.4%), and weight decrease (11.2% vs. 3.2%); however, these AEs decreased over time in both groups. Eastern Cooperative Oncology Group performance status 0, favorable hematology values, no bone or liver metastases, and baseline tumor burden below the overall median were associated with longer DT.
  
  
  
  Longer duration (>18 months) of axitinib treatment was associated with increased frequency of early tumor shrinkage, greater magnitude of tumor shrinkage, and a favorable OS.
authors.affiliation: Department of Hematology and Oncology, Cleveland Clinic Taussig Cancer Institute, 9500 Euclid Ave., Desk R35, Cleveland, OH, 44195, USA. rinib2@ccf.org.
authors.forename: Brian I
authors.initials: BI
authors.lastname: Rini
authors.affiliation: Hannover Medical School, Hannover, Germany.
authors.forename: Victor
authors.initials: V
authors.lastname: Gruenwald
authors.affiliation: Department of Genitourinary Oncology, Division of Cancer Medicine, The University of Texas M. D. Anderson Cancer Center, Houston, TX, USA.
authors.forename: Eric
authors.initials: E
authors.lastname: Jonasch
authors.affiliation: H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
authors.forename: Mayer N
authors.initials: MN
authors.lastname: Fishman
authors.affiliation: Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Tomita
authors.affiliation: Massachusetts General Hospital Cancer Center, Boston, MA, USA.
authors.forename: M Dror
authors.initials: MD
authors.lastname: Michaelson
authors.affiliation: Pfizer Oncology, La Jolla, CA, USA.
authors.forename: Jamal
authors.initials: J
authors.lastname: Tarazi
authors.affiliation: Pfizer Oncology, Pfizer Inc, New York, NY, USA.
authors.forename: Laura
authors.initials: L
authors.lastname: Cisar
authors.affiliation: Pfizer Oncology, Pfizer Inc, New York, NY, USA.
authors.forename: Subramanian
authors.initials: S
authors.lastname: Hariharan
authors.affiliation: Pfizer Oncology, La Jolla, CA, USA.
authors.forename: Angel H
authors.initials: AH
authors.lastname: Bair
authors.affiliation: Pfizer Oncology, La Jolla, CA, USA.
authors.forename: Brad
authors.initials: B
authors.lastname: Rosbrook
authors.affiliation: Baylor-Sammons Cancer Center, Genitourinary Oncology Program, Dallas, TX, USA.
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Hutson
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000077784:Axitinib; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000494:pharmacology / Q000627:therapeutic use*; D007191:Indazoles / Q000494:pharmacology / Q000627:therapeutic use*; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D020797:Receptor, Platelet-Derived Growth Factor beta / Q000037:antagonists & inhibitors; D040262:Receptors, Vascular Endothelial Growth Factor / Q000037:antagonists & inhibitors; D012189:Retrospective Studies; D016019:Survival Analysis; D047368:Tumor Burden; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D007093:Imidazoles; D007191:Indazoles; D000077784:Axitinib; D020797:Receptor, Platelet-Derived Growth Factor beta; D040262:Receptors, Vascular Endothelial Growth Factor