Document Detail

An exploratory study of sunitinib plus paclitaxel as first-line treatment for patients with advanced breast cancer.
MedLine Citation:
PMID:  20032126     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Sunitinib has shown single-agent activity in patients with previously treated metastatic breast cancer (MBC). We investigated the safety of the combination of sunitinib and paclitaxel in an exploratory study of patients with locally advanced or MBC.
METHODS: Patients received oral sunitinib 25 mg/day (with escalation to 37.5 mg/day as tolerated) on a continuous daily dosing schedule and paclitaxel 90 mg/m(2) on days 1, 8, and 15 of each 28-day cycle. Study endpoints included safety (primary endpoint), pharmacokinetics, and antitumor activity.
RESULTS: Twenty-two patients were enrolled. The most frequent adverse events (AEs) were fatigue/asthenia (77%), dysgeusia (68%), and diarrhea (64%). Grade 3 AEs included neutropenia (43%), fatigue/asthenia (27%), neuropathy (18%), and diarrhea (14%). No drug-drug interaction was observed on the basis of pharmacokinetic analysis. Of 18 patients with measurable disease at baseline, 7 (38.9%) achieved objective responses (including 2 complete and 5 partial responses). Clinical responses were observed in three of nine patients with triple-negative receptor status (estrogen receptor negative, progesterone receptor negative, and human epidermal growth factor receptor-2 negative).
CONCLUSIONS: These data indicate that sunitinib and paclitaxel in combination are well tolerated in patients with locally advanced or MBC. No drug-drug interaction was detected and there was preliminary evidence of antitumor activity.
M Kozloff; E Chuang; A Starr; P A Gowland; P E Cataruozolo; M Collier; L Verkh; X Huang; K A Kern; K Miller
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Publication Detail:
Type:  Journal Article     Date:  2009-12-23
Journal Detail:
Title:  Annals of oncology : official journal of the European Society for Medical Oncology / ESMO     Volume:  21     ISSN:  1569-8041     ISO Abbreviation:  Ann. Oncol.     Publication Date:  2010 Jul 
Date Detail:
Created Date:  2010-06-24     Completed Date:  2010-09-30     Revised Date:  2013-05-31    
Medline Journal Info:
Nlm Unique ID:  9007735     Medline TA:  Ann Oncol     Country:  England    
Other Details:
Languages:  eng     Pagination:  1436-41     Citation Subset:  IM    
Department of Oncology, Cancer Research Center, Ingalls Memorial Hospital, Harvey, IL60426, USA.
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MeSH Terms
Antineoplastic Combined Chemotherapy Protocols / pharmacokinetics,  therapeutic use*
Bone Neoplasms / drug therapy*,  secondary
Breast Neoplasms / drug therapy*,  pathology
Carcinoma, Ductal, Breast / drug therapy*,  pathology
Carcinoma, Lobular / drug therapy*,  pathology
Indoles / administration & dosage
Liver Neoplasms / drug therapy*,  secondary
Lung Neoplasms / drug therapy*,  secondary
Lymphatic Metastasis
Maximum Tolerated Dose
Middle Aged
Paclitaxel / administration & dosage
Pilot Projects
Pyrroles / administration & dosage
Survival Rate
Tissue Distribution
Treatment Outcome
Reg. No./Substance:
0/Indoles; 0/Pyrroles; 0/sunitinib; 33069-62-4/Paclitaxel

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