PMID- 21726819
OWN - NLM
STAT- MEDLINE
DCOM- 20111025
LR  - 20181201
IS  - 1938-0690 (Electronic)
IS  - 1525-7304 (Linking)
VI  - 12
IP  - 4
DP  - 2011 Jul
TI  - Long-term safety and tolerability of sorafenib in patients with advanced 
      non-small-cell lung cancer: a case-based review.
PG  - 212-7
LID - 10.1016/j.cllc.2011.03.021 [doi]
AB  - BACKGROUND: Sorafenib, a small-molecule inhibitor of multiple kinases involved in 
      tumor growth and progression, is approved for the treatment of advanced 
      renal-cell carcinoma and advanced hepatocellular carcinoma. Encouraging activity 
      and good tolerability of daily oral sorafenib, either as a single agent or in 
      combination with gefitinib, have been demonstrated in phase I-II trials in 
      patients with advanced non-small-cell lung cancer (NSCLC). Currently, minimal 
      data are available describing the long-term safety and tolerability of sorafenib 
      in patients with NSCLC. MATERIALS AND METHODS: We describe a series of 12 
      patients with advanced NSCLC (derived from 1 phase I and 2 phase II trials) who 
      achieved long-term (ie, > 12 months) disease control and continued to receive 
      sorafenib alone or in combination with gefitinib beyond the end of the study in 
      which they were enrolled. RESULTS: The safety profile of sorafenib administered 
      on a long-term basis did not differ significantly from that seen previously in 
      the shorter term. The majority of adverse events (AEs) were Grade 1-2 in 
      severity. Five of the 12 patients experienced no >/= Grade 3 AEs. There was no 
      evidence of increased frequency or severity of AEs over time, or of late AEs, and 
      no patient in this series discontinued study treatment because of AEs. 
      CONCLUSION: In patients with advanced NSCLC who achieve a prolonged response or 
      stable disease with sorafenib given as a single agent or as part of a combination 
      regimen, sorafenib treatment could be continued until disease progression without 
      major long-term safety or tolerability problems.
CI  - Copyright (c) 2011. Published by Elsevier Inc.
FAU - Adjei, Alex A
AU  - Adjei AA
AD  - Roswell Park Cancer Institute, Buffalo, NY 14263, USA. alex.adjei@roswellpark.org
FAU - Blumenschein, George R Jr
AU  - Blumenschein GR Jr
FAU - Mandrekar, Sumithra
AU  - Mandrekar S
FAU - Hillman, Shauna
AU  - Hillman S
FAU - Gatzemeier, Ulrich
AU  - Gatzemeier U
FAU - Heigener, David
AU  - Heigener D
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20110428
PL  - United States
TA  - Clin Lung Cancer
JT  - Clinical lung cancer
JID - 100893225
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Benzenesulfonates)
RN  - 0 (Phenylurea Compounds)
RN  - 0 (Pyridines)
RN  - 25X51I8RD4 (Niacinamide)
RN  - 9ZOQ3TZI87 (Sorafenib)
SB  - IM
MH  - Adenocarcinoma/*drug therapy/secondary
MH  - Adenocarcinoma, Bronchiolo-Alveolar/*drug therapy/secondary
MH  - Adult
MH  - Aged
MH  - Antineoplastic Agents/*therapeutic use
MH  - Benzenesulfonates/*therapeutic use
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy/secondary
MH  - Case-Control Studies
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Lung Neoplasms/*drug therapy/pathology
MH  - Male
MH  - Maximum Tolerated Dose
MH  - Middle Aged
MH  - Neoplasm Staging
MH  - Niacinamide/analogs & derivatives
MH  - Phenylurea Compounds
MH  - Pyridines/*therapeutic use
MH  - Retrospective Studies
MH  - Sorafenib
MH  - Survival Rate
MH  - Time Factors
MH  - Treatment Outcome
EDAT- 2011/07/06 06:00
MHDA- 2011/10/26 06:00
CRDT- 2011/07/06 06:00
PHST- 2010/08/11 00:00 [received]
PHST- 2010/09/27 00:00 [revised]
PHST- 2010/10/01 00:00 [accepted]
PHST- 2011/07/06 06:00 [entrez]
PHST- 2011/07/06 06:00 [pubmed]
PHST- 2011/10/26 06:00 [medline]
AID - S1525-7304(11)00022-2 [pii]
AID - 10.1016/j.cllc.2011.03.021 [doi]
PST - ppublish
SO  - Clin Lung Cancer. 2011 Jul;12(4):212-7. doi: 10.1016/j.cllc.2011.03.021. Epub 
      2011 Apr 28.