First-line gefitinib for elderly patients with advanced NSCLC harboring EGFR mutations. A combined analysis of North-East Japan Study Group studies

被引:26
作者
Morikawa, Naoto [1 ]
Minegishi, Yuji [2 ]
Inoue, Akira [3 ]
Maemondo, Makoto [4 ]
Kobayashi, Kunihiko [5 ]
Sugawara, Shunichi [6 ]
Harada, Masao [7 ]
Hagiwara, Koichi [5 ]
Okinaga, Shoji [3 ]
Oizumi, Satoshi [8 ]
Nukiwa, Toshihiro [9 ]
Gemma, Akihiko [2 ]
机构
[1] Iwate Med Univ, Sch Med, Div Pulm Med Allergy & Rheumatol, Dept Internal Med, Morioka, Iwate 0208505, Japan
[2] Nippon Med Sch, Tokyo 113, Japan
[3] Tohoku Univ, Sendai, Miyagi 980, Japan
[4] Miyagi Canc Ctr, Natori, Miyagi, Japan
[5] Saitama Med Univ, Moroyama, Saitama, Japan
[6] Sendai Kousei Hosp, Sendai, Miyagi, Japan
[7] Natl Hosp Org, Hokkaido Canc Ctr, Sapporo, Hokkaido, Japan
[8] Hokkaido Univ, Sapporo, Hokkaido 060, Japan
[9] AntiTB Assoc, Tokyo, Japan
关键词
EGFR tyrosine kinase inhibitors; elderly patients; gefitinib; NSCLC; CELL LUNG-CANCER; GROWTH-FACTOR RECEPTOR; OPEN-LABEL; CARBOPLATIN-PACLITAXEL; PHASE-III; CHEMOTHERAPY; ERLOTINIB; MULTICENTER; SURVIVAL; TRIAL;
D O I
10.1517/14656566.2015.1002396
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
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.
引用
收藏
页码:465 / 472
页数:8
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