TY - JOUR
T1 - First-line gefitinib for elderly patients with advanced NSCLC harboring EGFR mutations. A combined analysis of North-East Japan Study Group studies
AU - Morikawa, Naoto
AU - Minegishi, Yuji
AU - Inoue, Akira
AU - Maemondo, Makoto
AU - Kobayashi, Kunihiko
AU - Sugawara, Shunichi
AU - Harada, Masao
AU - Hagiwara, Koichi
AU - Okinaga, Shoji
AU - Oizumi, Satoshi
AU - Nukiwa, Toshihiro
AU - Gemma, Akihiko
N1 - Funding Information:
K Kobayashi and K Hagiwara have received research support from AstraZeneca. The NEJ002 study was supported by Grants-in-Aid from the Japan Society for Promotion of Science and the Japanese Foundation for Multidisciplinary Treatment of Cancer and a grant from the Tokyo Cooperative Oncology Group. We wish to thank William Ng for providing medical writing support, which was funded by AstraZeneca K.K. (Osaka, Japan) according to a publication support agreement. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Publisher Copyright:
© 2015 Informa UK, Ltd.
PY - 2015/3/1
Y1 - 2015/3/1
N2 - Objective: To assess outcomes of elderly patients with advanced NSCLC harboring an EGFR mutation treated with gefitinib, as well as safety and impact on quality of life (QoL).Methods: We performed a retrospective analysis of pooled data from one Phase III and two Phase II studies of 71 patients aged ≥ 70 years with a performance status of 0-2. The main outcome measures were progression-free survival (PFS), overall survival (OS) and response rate (RR), as well as incidence of adverse events and time to 9.1% deterioration in QoL.Results: Median PFS (14.3 vs 5.7 months, p < 0.001) and overall RR (73.2 vs 26.5%, p < 0.001) in the gefitinib group were superior to those in the standard chemotherapy group, whereas median OS was not significantly different (30.8 vs 26.4 months, p = 0.42). Elevation of aspartate transaminase and/or alanine transaminase (18.3%) was the most common adverse event, and one treatment-related death (pneumonitis) occurred. Time to 9.1% deterioration in the QoL domains of pain and dyspnea, anxiety, and daily functioning was similar between the two age groups.Conclusion: First-line gefitinib is efficacious with acceptable toxicity in relatively fit elderly patients with advanced NSCLC harboring an EGFR mutation.
AB - Objective: To assess outcomes of elderly patients with advanced NSCLC harboring an EGFR mutation treated with gefitinib, as well as safety and impact on quality of life (QoL).Methods: We performed a retrospective analysis of pooled data from one Phase III and two Phase II studies of 71 patients aged ≥ 70 years with a performance status of 0-2. The main outcome measures were progression-free survival (PFS), overall survival (OS) and response rate (RR), as well as incidence of adverse events and time to 9.1% deterioration in QoL.Results: Median PFS (14.3 vs 5.7 months, p < 0.001) and overall RR (73.2 vs 26.5%, p < 0.001) in the gefitinib group were superior to those in the standard chemotherapy group, whereas median OS was not significantly different (30.8 vs 26.4 months, p = 0.42). Elevation of aspartate transaminase and/or alanine transaminase (18.3%) was the most common adverse event, and one treatment-related death (pneumonitis) occurred. Time to 9.1% deterioration in the QoL domains of pain and dyspnea, anxiety, and daily functioning was similar between the two age groups.Conclusion: First-line gefitinib is efficacious with acceptable toxicity in relatively fit elderly patients with advanced NSCLC harboring an EGFR mutation.
KW - EGFR tyrosine kinase inhibitors
KW - Elderly patients
KW - Gefitinib
KW - NSCLC
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U2 - 10.1517/14656566.2015.1002396
DO - 10.1517/14656566.2015.1002396
M3 - Article
C2 - 25597331
AN - SCOPUS:84922895833
SN - 1465-6566
VL - 16
SP - 465
EP - 472
JO - Expert Opinion on Pharmacotherapy
JF - Expert Opinion on Pharmacotherapy
IS - 4
ER -