title: Angiogenesis inhibitor therapies for advanced renal cell carcinoma: toxicity and treatment patterns in clinical practice from a global medical chart review.
abstract: The aim of this study was to assess the treatment patterns and safety of sunitinib, sorafenib and bevacizumab in real-world clinical settings in US, Europe and Asia. Medical records were abstracted at 18 community oncology clinics in the US and at 21 tertiary oncology centers in US, Europe and Asia for 883 patients ≥ 18 years who had histologically/cytologically confirmed diagnosis of advanced RCC and received sunitinib (n=631), sorafenib (n=207) or bevacizumab (n=45) as first-line treatment. No prior treatment was permitted. Data were collected on all adverse events (AEs) and treatment modifications, including discontinuation, interruption and dose reduction. Treatment duration was estimated using Kaplan-Meier analysis. Demographics were similar across treatment groups and regions. Median treatment duration ranged from 6.1 to 10.7 months, 5.1 to 8.5 months and 7.5 to 9.8 months for sunitinib, sorafenib and bevacizumab patients, respectively. Grade 3/4 AEs were experienced by 26.0, 28.0 and 15.6% of sunitinib, sorafenib and bevacizumab patients, respectively. Treatment discontinuations occurred in 62.4 (Asia) to 63.1% (US) sunitinib, 68.8 (Asia) to 90.0% (Europe) sorafenib, and 66.7 (Asia) to 81.8% (US) bevacizumab patients. Globally, treatment modifications due to AEs occurred in 55.1, 54.2 and 50.0% sunitinib, sorafenib and bevacizumab patients, respectively. This study in a large, global cohort of advanced RCC patients found that angiogenesis inhibitors are associated with high rates of AEs and treatment modifications. Findings suggest an unmet need for more tolerable agents for RCC treatment.
authors.affiliation: Dana-Farber Cancer Institute, Boston, MA, USA.
authors.forename: William K
authors.initials: WK
authors.lastname: Oh
authors.forename: David
authors.initials: D
authors.lastname: McDermott
authors.forename: Camillo
authors.initials: C
authors.lastname: Porta
authors.forename: Antonin
authors.initials: A
authors.lastname: Levy
authors.forename: Reza
authors.initials: R
authors.lastname: Elaidi
authors.forename: Florian
authors.initials: F
authors.lastname: Scotte
authors.forename: Robert
authors.initials: R
authors.lastname: Hawkins
authors.forename: Daniel
authors.initials: D
authors.lastname: Castellano
authors.forename: Joaquim
authors.initials: J
authors.lastname: Bellmunt
authors.forename: Sun Young
authors.initials: SY
authors.lastname: Rha
authors.forename: Jong-Mu
authors.initials: JM
authors.lastname: Sun
authors.forename: Paul
authors.initials: P
authors.lastname: Nathan
authors.forename: Bruce A
authors.initials: BA
authors.lastname: Feinberg
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Scott
authors.forename: Ray
authors.initials: R
authors.lastname: McDermott
authors.forename: Jin-Hee
authors.initials: JH
authors.lastname: Ahn
authors.forename: John
authors.initials: J
authors.lastname: Wagstaff
authors.forename: Yen-Hwa
authors.initials: YH
authors.lastname: Chang
authors.forename: Yen-Chuan
authors.initials: YC
authors.lastname: Ou
authors.forename: Paul
authors.initials: P
authors.lastname: Donnellan
authors.forename: Chao-Yuan
authors.initials: CY
authors.lastname: Huang
authors.forename: John
authors.initials: J
authors.lastname: McCaffrey
authors.forename: Po-Hui
authors.initials: PH
authors.lastname: Chiang
authors.forename: Cheng-Keng
authors.initials: CK
authors.lastname: Chuang
authors.forename: Caroline
authors.initials: C
authors.lastname: Korves
authors.forename: Maureen P
authors.initials: MP
authors.lastname: Neary
authors.forename: Jose R
authors.initials: JR
authors.lastname: Diaz
authors.forename: Faisal
authors.initials: F
authors.lastname: Mehmud
authors.forename: Mei Sheng
authors.initials: MS
authors.lastname: Duh
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage* / Q000009:adverse effects; D001208:Asia; D000068258:Bevacizumab; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000453:epidemiology / Q000473:pathology; D064420:Drug-Related Side Effects and Adverse Reactions / Q000473:pathology; D005060:Europe; D005260:Female; D006801:Humans; D007211:Indoles / Q000008:administration & dosage* / Q000009:adverse effects; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009536:Niacinamide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D010671:Phenylurea Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D011758:Pyrroles / Q000008:administration & dosage* / Q000009:adverse effects; D000077157:Sorafenib; D000077210:Sunitinib; D016896:Treatment Outcome; D014481:United States
chemical_list: D020533:Angiogenesis Inhibitors; D061067:Antibodies, Monoclonal, Humanized; D007211:Indoles; D010671:Phenylurea Compounds; D011758:Pyrroles; D009536:Niacinamide; D000068258:Bevacizumab; D000077157:Sorafenib; D000077210:Sunitinib