A Phase I Study of Gemcitabine Plus Irinotecan for Advanced NSCLC: Japan Clinical Oncology Group Trial (JCOG9904)

被引:1
作者
Kurata, Takayasu [1 ]
Yamamoto, Nobuyuki [1 ]
Komiya, Takefumi [1 ]
Tsurutani, Junji [1 ]
Miyazaki, Masaki [1 ]
Tamura, Kenji [1 ]
Takeda, Koji [2 ]
Nakagawa, Kazuhiko [1 ]
Fukuoka, Masahiro [1 ]
机构
[1] Kinki Univ, Sch Med, Dept Med Oncol, Osaka 5898511, Japan
[2] Osaka City Gen Hosp, Dept Clin Oncol, Osaka, Japan
关键词
combination Phase I study; maximum tolerated dose; gemcitabine; irinotecan; NSCLC; CELL LUNG-CANCER; CHEMOTHERAPY;
D O I
10.1093/jjco/hyq079
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
A combination Phase I study of gemcitabine and irinotecan in patients with previously untreated advanced non-small-cell lung cancer was conducted. Patients received gemcitabine and irinotecan on Days 1 and 8 every 3 weeks. A total of 11 patients were enrolled. Three of six patients who received the starting dose (gemcitabine, 800 mg/m(2); irinotecan, 80 mg/m(2)) experienced dose-limiting toxicities (Grade 4 neutropenia, Grade 3 elevation of transaminase and Grade 5 interstitial pneumonia). At the reduced dose level (gemcitabine, 800 mg/m(2); irinotecan, 60 mg/m(2)), all two assessable patients could not meet the administration criteria of Day 8 (one, Grade 2 elevation of transaminase; the other, Grade 1 diarrhea). No objective response was observed in eight evaluable patients. We could not determine the recommended dose of this combination because of intolerable toxicities and no efficacy. Therefore, it is difficult to forward this combination chemotherapy toward further studies.
引用
收藏
页码:992 / 994
页数:3
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