TY - JOUR
T1 - A phase II study of irinotecan as a third- or fourth-line treatment for advanced non-small cell lung cancer
T2 - NJLCG0703
AU - Matsubara, Nobumichi
AU - Maemondo, Makoto
AU - Inoue, Akira
AU - Ishimoto, Osamu
AU - Watanabe, Kana
AU - Sakakibara, Tomohiro
AU - Fukuhara, Tatsuro
AU - Morikawa, Naoto
AU - Tanaka, Masashi
AU - Sugawara, Shunichi
AU - Nukiwa, Toshihiro
PY - 2013/3
Y1 - 2013/3
N2 - Background: We aimed to evaluate the efficacy and safety of irinotecan monotherapy as a third- or fourth-line treatment for advanced non-small cell lung cancer (NSCLC) patients. Methods: Patients with advanced NSCLC refractory to 2 or more previous regimens were treated with 80mg/m2 irinotecan on days 1, 8, and 15, every 4 weeks. The primary endpoint was the overall response rate (ORR), whereas secondary endpoints included progression-free survival (PFS), overall survival (OS), and toxicity profiles. Results: From December 2007 to April 2009, 32 patients (median age, 60 years) were enrolled. Most of the patients (75.0%) were male, and 18.8% had a performance status of 2. Six partial responses to irinotecan monotherapy were observed (ORR, 18.8%: 95% confidence interval, 5.3%-32.3%). The disease control rate (DCR) was 78.1%, median PFS was 4.0 months, and median survival time (MST) was 10.4 months. Grade 3-4 neutropenia was observed in 22% of patients, but other toxic effects were moderate. No cases of grade 3-4 diarrhea or treatment-related death were noted. Of the 15 patients for whom progressive disease represented the best response to previous treatment regimens, 2 exhibited a partial response and 9 showed stable disease after irinotecan monotherapy, with a DCR of 73.3%, median PFS of 4.4 months, and MST of 8.2 months. Conclusions: Irinotecan monotherapy is effective for advanced NSCLC patients who have previously failed 2 or more treatment regimens.
AB - Background: We aimed to evaluate the efficacy and safety of irinotecan monotherapy as a third- or fourth-line treatment for advanced non-small cell lung cancer (NSCLC) patients. Methods: Patients with advanced NSCLC refractory to 2 or more previous regimens were treated with 80mg/m2 irinotecan on days 1, 8, and 15, every 4 weeks. The primary endpoint was the overall response rate (ORR), whereas secondary endpoints included progression-free survival (PFS), overall survival (OS), and toxicity profiles. Results: From December 2007 to April 2009, 32 patients (median age, 60 years) were enrolled. Most of the patients (75.0%) were male, and 18.8% had a performance status of 2. Six partial responses to irinotecan monotherapy were observed (ORR, 18.8%: 95% confidence interval, 5.3%-32.3%). The disease control rate (DCR) was 78.1%, median PFS was 4.0 months, and median survival time (MST) was 10.4 months. Grade 3-4 neutropenia was observed in 22% of patients, but other toxic effects were moderate. No cases of grade 3-4 diarrhea or treatment-related death were noted. Of the 15 patients for whom progressive disease represented the best response to previous treatment regimens, 2 exhibited a partial response and 9 showed stable disease after irinotecan monotherapy, with a DCR of 73.3%, median PFS of 4.4 months, and MST of 8.2 months. Conclusions: Irinotecan monotherapy is effective for advanced NSCLC patients who have previously failed 2 or more treatment regimens.
KW - Irinotecan
KW - Non-small cell lung cancer
KW - Salvage
KW - Third-line therapy
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UR - http://www.scopus.com/inward/citedby.url?scp=84876699187&partnerID=8YFLogxK
U2 - 10.1016/j.resinv.2012.09.004
DO - 10.1016/j.resinv.2012.09.004
M3 - Article
C2 - 23561256
AN - SCOPUS:84876699187
VL - 51
SP - 28
EP - 34
JO - Respiratory Investigation
JF - Respiratory Investigation
SN - 2212-5345
IS - 1
ER -
