PMID- 20032126
OWN - NLM
STAT- MEDLINE
DCOM- 20100930
LR  - 20211020
IS  - 1569-8041 (Electronic)
IS  - 0923-7534 (Print)
IS  - 0923-7534 (Linking)
VI  - 21
IP  - 7
DP  - 2010 Jul
TI  - An exploratory study of sunitinib plus paclitaxel as first-line treatment for 
      patients with advanced breast cancer.
PG  - 1436-1441
LID - S0923-7534(19)39480-3 [pii]
LID - 10.1093/annonc/mdp565 [doi]
AB  - 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.
FAU - Kozloff, M
AU  - Kozloff M
AD  - Department of Oncology, Cancer Research Center, Ingalls Memorial Hospital, 
      Harvey, IL. Electronic address: mfkozloff@aol.com.
FAU - Chuang, E
AU  - Chuang E
AD  - Division of Hematology/Oncology, Department of Medicine, Weill Cornell Medical 
      College, New York, NY.
FAU - Starr, A
AU  - Starr A
AD  - Department of Oncology, Cancer Research Center, Ingalls Memorial Hospital, 
      Harvey, IL.
FAU - Gowland, P A
AU  - Gowland PA
AD  - Department of Oncology, Cancer Research Center, Ingalls Memorial Hospital, 
      Harvey, IL.
FAU - Cataruozolo, P E
AU  - Cataruozolo PE
AD  - Research and Development, Pfizer Oncology, La Jolla, CA.
FAU - Collier, M
AU  - Collier M
AD  - Research and Development, Pfizer Oncology, La Jolla, CA.
FAU - Verkh, L
AU  - Verkh L
AD  - Research and Development, Pfizer Oncology, La Jolla, CA.
FAU - Huang, X
AU  - Huang X
AD  - Research and Development, Pfizer Oncology, La Jolla, CA.
FAU - Kern, K A
AU  - Kern KA
AD  - Research and Development, Pfizer Oncology, La Jolla, CA.
FAU - Miller, K
AU  - Miller K
AD  - Division of Hematology-Oncology, Department of Medicine, Indiana University 
      Melvin and Bren Simon Cancer Center, Indianapolis, IN, USA.
LA  - eng
PT  - Journal Article
DEP - 20091223
PL  - England
TA  - Ann Oncol
JT  - Annals of oncology : official journal of the European Society for Medical 
      Oncology
JID - 9007735
RN  - 0 (Indoles)
RN  - 0 (Pyrroles)
RN  - P88XT4IS4D (Paclitaxel)
RN  - V99T50803M (Sunitinib)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antineoplastic Combined Chemotherapy Protocols/pharmacokinetics/*therapeutic use
MH  - Bone Neoplasms/*drug therapy/secondary
MH  - Breast Neoplasms/*drug therapy/pathology
MH  - Carcinoma, Ductal, Breast/*drug therapy/pathology
MH  - Carcinoma, Lobular/*drug therapy/pathology
MH  - Female
MH  - Humans
MH  - Indoles/administration & dosage
MH  - Liver Neoplasms/*drug therapy/secondary
MH  - Lung Neoplasms/*drug therapy/secondary
MH  - Lymphatic Metastasis
MH  - Maximum Tolerated Dose
MH  - Middle Aged
MH  - Paclitaxel/administration & dosage
MH  - Pilot Projects
MH  - Pyrroles/administration & dosage
MH  - Sunitinib
MH  - Survival Rate
MH  - Tissue Distribution
MH  - Treatment Outcome
PMC - PMC2890319
EDAT- 2009/12/25 06:00
MHDA- 2010/10/01 06:00
PMCR- 2009/12/23
CRDT- 2009/12/25 06:00
PHST- 2009/12/25 06:00 [entrez]
PHST- 2009/12/25 06:00 [pubmed]
PHST- 2010/10/01 06:00 [medline]
PHST- 2009/12/23 00:00 [pmc-release]
AID - S0923-7534(19)39480-3 [pii]
AID - 10.1093/annonc/mdp565 [doi]
PST - ppublish
SO  - Ann Oncol. 2010 Jul;21(7):1436-1441. doi: 10.1093/annonc/mdp565. Epub 2009 Dec 
      23.