PMID- 30987807
OWN - NLM
STAT- MEDLINE
DCOM- 20200327
LR  - 20200327
IS  - 1938-0682 (Electronic)
IS  - 1558-7673 (Linking)
VI  - 17
IP  - 3
DP  - 2019 Jun
TI  - Real-world Experience of Cabozantinib as Second- or Subsequent Line Treatment in 
      Patients With Metastatic Renal Cell Carcinoma: Data From the Polish Managed 
      Access Program.
PG  - e556-e564
LID - S1558-7673(19)30046-1 [pii]
LID - 10.1016/j.clgc.2019.02.002 [doi]
AB  - BACKGROUND: Cabozantinib is an approved treatment for metastatic renal cell 
      carcinoma (mRCC). This report presents an analysis of the safety profile and 
      efficacy of cabozantinib in an unselected population from Poland. PATIENTS AND 
      METHODS: Patients with mRCC, who had been treated with at least 1 previous agent 
      targeting the vascular endothelial growth factor pathway, were eligible to 
      receive cabozantinib at a once-daily dose of 60 mg orally, according to the 
      Managed Access Program (MAP). Data were collected in 4 Polish centers. Patients 
      who had received >/= 1 dose of cabozantinib were monitored for adverse events (AEs) 
      using Common Terminology Criteria for Adverse Events (CTCAE) v.4.0. RESULTS: A 
      total of 115 patients were enrolled between October 2016 and March 2018, 
      including 50% with bone metastases, 10% with brain metastases and 4.3% with 
      non-clear-cell RCC; 76% had received >/= 2 lines of therapy. The median time of 
      follow-up was 12.6 months (95% confidence interval [CI], 11.5-14.1 months). The 
      most common grade 3 and 4 AEs were fatigue (23%), hand-foot syndrome (12%), and 
      diarrhea (10%). Only 4% of patients discontinued treatment owing to AEs, and 
      there were no treatment-related deaths. Partial response was observed in 19% of 
      patients, whereas 56% had stable disease. The median progression-free survival 
      was 12.5 months (95% CI, 9.2-14.2 months), with a 12-month overall survival rate 
      of 70.4% (95% CI, 60.2%-78.5%). CONCLUSIONS: Cabozantinib demonstrated acceptable 
      tolerability and activity in a large unselected population of patients with mRCC 
      under clinical conditions.
CI  - Copyright (c) 2019 Elsevier Inc. All rights reserved.
FAU - Bodnar, Lubomir
AU  - Bodnar L
AD  - Department of Oncology, Military Institute of Medicine, Warsaw, Poland. 
      Electronic address: lubo@esculap.pl.
FAU - Kopczynska, Anna
AU  - Kopczynska A
AD  - University Hospital of Lord's Transfiguration, Poznan, Poland.
FAU - Zolnierek, Jakub
AU  - Zolnierek J
AD  - Department of Clinical Oncology and Chemotherapy, Magodent Hospital Elblaska, 
      Warsaw, Poland.
FAU - Wieczorek-Rutkowska, Magdalena
AU  - Wieczorek-Rutkowska M
AD  - Regional Oncology Centre in Gdansk, Copernicus CO, Gdansk, Poland.
FAU - Chrom, Pawel
AU  - Chrom P
AD  - Department of Oncology, Military Institute of Medicine, Warsaw, Poland.
FAU - Tomczak, Piotr
AU  - Tomczak P
AD  - Clinical Hospital Number 1 of Poznan University of Medical Sciences, Poznan, 
      Poland.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20190220
PL  - United States
TA  - Clin Genitourin Cancer
JT  - Clinical genitourinary cancer
JID - 101260955
RN  - 0 (Anilides)
RN  - 0 (Protein Kinase Inhibitors)
RN  - 0 (Pyridines)
RN  - 1C39JW444G (cabozantinib)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Anilides/*administration & dosage/adverse effects
MH  - Carcinoma, Renal Cell/*drug therapy
MH  - Disease-Free Survival
MH  - Female
MH  - Humans
MH  - Kidney Neoplasms/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Metastasis
MH  - Poland
MH  - Protein Kinase Inhibitors/*administration & dosage/adverse effects
MH  - Pyridines/*administration & dosage/adverse effects
MH  - Retrospective Studies
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Cabozantinib
OT  - Predictor factor
OT  - Renal cell carcinoma
EDAT- 2019/04/17 06:00
MHDA- 2020/03/28 06:00
CRDT- 2019/04/17 06:00
PHST- 2018/12/14 00:00 [received]
PHST- 2019/01/28 00:00 [revised]
PHST- 2019/02/05 00:00 [accepted]
PHST- 2019/04/17 06:00 [pubmed]
PHST- 2020/03/28 06:00 [medline]
PHST- 2019/04/17 06:00 [entrez]
AID - S1558-7673(19)30046-1 [pii]
AID - 10.1016/j.clgc.2019.02.002 [doi]
PST - ppublish
SO  - Clin Genitourin Cancer. 2019 Jun;17(3):e556-e564. doi: 
      10.1016/j.clgc.2019.02.002. Epub 2019 Feb 20.