TY - JOUR
T1 - Long-term safety and tolerability of sorafenib in patients with advanced non-small-cell lung cancer
T2 - A case-based review
AU - Adjei, Alex
AU - Blumenschein, George
AU - Mandrekar, Sumithra
AU - Hillman, Shauna
AU - Gatzemeier, Ulrich
AU - Heigener, David
N1 - Copyright:
Copyright 2019 Elsevier B.V., All rights reserved.
PY - 2011/7/1
Y1 - 2011/7/1
N2 - 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.
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.
KW - Anti-angiognesis
KW - Epidermal growth factor receptor
KW - Gefitinib
KW - Multikinase inhibitor
KW - Toxicity
KW - Tyrosine kinase
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U2 - 10.1016/j.cllc.2011.03.021
DO - 10.1016/j.cllc.2011.03.021
M3 - Article
C2 - 21726819
AN - SCOPUS:79960343099
SN - 1525-7304
VL - 12
SP - 212
EP - 217
JO - Clinical lung cancer
JF - Clinical lung cancer
IS - 4
ER -