PMID- 20188433
OWN - NLM
STAT- MEDLINE
DCOM- 20110524
LR  - 20221207
IS  - 1872-8332 (Electronic)
IS  - 0169-5002 (Linking)
VI  - 70
IP  - 2
DP  - 2010 Nov
TI  - Sunitinib in combination with gemcitabine plus cisplatin for advanced non-small 
      cell lung cancer: a phase I dose-escalation study.
PG  - 180-7
LID - 10.1016/j.lungcan.2010.01.016 [doi]
AB  - PURPOSE: To determine the maximum tolerated dose (MTD) of sunitinib plus 
      gemcitabine/cisplatin for first-line treatment of patients with advanced 
      non-small cell lung cancer (NSCLC). Safety, pharmacokinetics, and antitumor 
      activities were evaluated. METHODS: Patients >/=18 years with Eastern Cooperative 
      Oncology Group performance status 0/1 and stage IIIB/IV NSCLC were included in 
      this open-label, multicenter, dose-escalation phase I study. Treatment was 
      administered in 3-week cycles: oral sunitinib 37.5 or 50mg/day intermittently 
      (Schedule 2/1: 2 weeks on treatment, 1 week off treatment) or 25mg continuous 
      daily dosing (CDD) schedule with intravenous infusions of gemcitabine (1000 or 
      1250 mg/m(2) days 1, 8) and cisplatin (80 mg/m(2) day 1). RESULTS: A total of 28 
      evaluable patients were assigned to four dose levels. Most adverse events (AEs) 
      on the Schedule 2/1 MTD were mild to moderate. Dose delays due to 
      myelosuppression occurred on both schedules, limiting treatment to a median of 
      four cycles. Four of 18 evaluable patients (22%) on Schedule 2/1 and 1 of 6 
      patients (17%) on the CDD schedule had confirmed partial responses. CONCLUSIONS: 
      The MTD was identified as sunitinib 37.5mg (Schedule 2/1), gemcitabine 1250 
      mg/m(2), and cisplatin 80 mg/m(2), with most AEs being mild to moderate. However, 
      frequent dose delays due to myelosuppression occurred. There was evidence of 
      antitumor activity with this combination.
CI  - Copyright (c) 2010 Elsevier Ireland Ltd. All rights reserved.
FAU - Reck, Martin
AU  - Reck M
AD  - Department of Thoracic Oncology, Hospital Grosshansdorf, Grosshansdorf 22927, 
      Germany. dr.martin.reck@web.de
FAU - Frickhofen, Norbert
AU  - Frickhofen N
FAU - Cedres, Susana
AU  - Cedres S
FAU - Gatzemeier, Ulrich
AU  - Gatzemeier U
FAU - Heigener, David
AU  - Heigener D
FAU - Fuhr, Heinz-Georg
AU  - Fuhr HG
FAU - Thall, Aron
AU  - Thall A
FAU - Lanzalone, Silvana
AU  - Lanzalone S
FAU - Stephenson, Patricia
AU  - Stephenson P
FAU - Ruiz-Garcia, Ana
AU  - Ruiz-Garcia A
FAU - Chao, Richard
AU  - Chao R
FAU - Felip, Enriqueta
AU  - Felip E
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20100225
PL  - Ireland
TA  - Lung Cancer
JT  - Lung cancer (Amsterdam, Netherlands)
JID - 8800805
RN  - 0 (Indoles)
RN  - 0 (Pyrroles)
RN  - 0W860991D6 (Deoxycytidine)
RN  - Q20Q21Q62J (Cisplatin)
RN  - V99T50803M (Sunitinib)
RN  - 0 (Gemcitabine)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy/pathology/physiopathology
MH  - Cisplatin/*administration & dosage/adverse effects/pharmacokinetics
MH  - Clinical Protocols
MH  - Deoxycytidine/administration & dosage/adverse effects/*analogs & 
      derivatives/pharmacokinetics
MH  - Disease Progression
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Indoles/*administration & dosage/adverse effects/pharmacokinetics
MH  - Lung Neoplasms/*drug therapy/pathology/physiopathology
MH  - Male
MH  - Maximum Tolerated Dose
MH  - Middle Aged
MH  - Pyrroles/*administration & dosage/adverse effects/pharmacokinetics
MH  - Sunitinib
MH  - Gemcitabine
EDAT- 2010/03/02 06:00
MHDA- 2011/05/25 06:00
CRDT- 2010/03/02 06:00
PHST- 2009/09/29 00:00 [received]
PHST- 2010/01/21 00:00 [revised]
PHST- 2010/01/24 00:00 [accepted]
PHST- 2010/03/02 06:00 [entrez]
PHST- 2010/03/02 06:00 [pubmed]
PHST- 2011/05/25 06:00 [medline]
AID - S0169-5002(10)00059-0 [pii]
AID - 10.1016/j.lungcan.2010.01.016 [doi]
PST - ppublish
SO  - Lung Cancer. 2010 Nov;70(2):180-7. doi: 10.1016/j.lungcan.2010.01.016. Epub 2010 
      Feb 25.