title: Clinical and pharmacokinetic study of sunitinib and docetaxel in women with advanced breast cancer.
abstract: BACKGROUND
  This exploratory study examined the pharmacokinetics, safety, and antitumor activity of sunitinib plus docetaxel in patients with HER-2-negative advanced breast cancer.
  
  
  METHODS
  Patients with HER-2-negative disease who had received prior adjuvant anthracycline-based therapy received docetaxel (75 mg/m(2)) on day 1 of each 3-week cycle followed by sunitinib (37.5 mg/day for 2 weeks on Schedule 2/1) starting on day 2 (day 3 on cycle 2).
  
  
  RESULTS
  Twenty-two patients were enrolled. No clinically significant drug-drug interactions were observed. The most common non-hematologic AE (any grade) was fatigue/asthenia. Grade 4 neutropenia occurred in 20/22 patients (91%; n = 7 had neutropenic fever). The safety profile was similar to each agent given individually. 14/19 (73.7%) evaluable patients had a PR and 5/19 (26.3%) had SD.
  
  
  CONCLUSIONS
  Sunitinib plus docetaxel on Schedule 2/1 did not result in any clinically significant drug-drug interactions. This combination was manageable and exhibited antitumor activity.
authors.affiliation: Karolinska Institutet and University Hospital, Stockholm, Sweden.
authors.forename: Jonas
authors.initials: J
authors.lastname: Bergh
authors.forename: Gabriella
authors.initials: G
authors.lastname: Mariani
authors.forename: Fatima
authors.initials: F
authors.lastname: Cardoso
authors.forename: Annelie
authors.initials: A
authors.lastname: Liljegren
authors.forename: Ahmad
authors.initials: A
authors.lastname: Awada
authors.forename: Lucia
authors.initials: L
authors.lastname: Viganò
authors.forename: Xin
authors.initials: X
authors.lastname: Huang
authors.forename: Lev
authors.initials: L
authors.lastname: Verkh
authors.forename: Kenneth A
authors.initials: KA
authors.lastname: Kern
authors.forename: Carla
authors.initials: C
authors.lastname: Giorgetti
authors.forename: Luca
authors.initials: L
authors.lastname: Gianni
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000493:pharmacokinetics / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism; D018270:Carcinoma, Ductal, Breast / Q000188:drug therapy* / Q000378:metabolism; D018275:Carcinoma, Lobular / Q000188:drug therapy* / Q000378:metabolism; D000077143:Docetaxel; D004334:Drug Administration Schedule; D004347:Drug Interactions; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007211:Indoles / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D011758:Pyrroles / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism; D000077210:Sunitinib; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D000077143:Docetaxel; D007211:Indoles; D011758:Pyrroles; D018719:Erb-b2 Receptor Tyrosine Kinases; D000077210:Sunitinib; D043823:Taxoids; C508053:ERBB2 protein, human