Phase I study of irinotecan and gemcitabine in previously untreated patients with advanced non-small cell lung cancer.
Phase I study of irinotecan and gemcitabine in previously untreated patients with advanced non-small cell lung cancer.
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DOI：
10.1093/jjco/hym030
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发表时间：
2007-05
影响因子：
2.4
通讯作者：
H. Takatani;H. Soda;Yoichi Nakamura;A. Kinoshita;M. Fukuda;S. Nagashima;M. Fukuda;Y. Soejima;H. Nakano;M. Oka;S. Kohno
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文献类型：
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作者：
H. Takatani;H. Soda;Yoichi Nakamura;A. Kinoshita;M. Fukuda;S. Nagashima;M. Fukuda;Y. Soejima;H. Nakano;M. Oka;S. Kohno
背景伊立替康和吉西他滨对非小细胞肺癌有效。我们在既往未经治疗的晚期非小细胞肺癌患者中进行了伊立替康和吉西他滨联合使用的I期研究，以确定剂量限制性毒性和最大耐受剂量。方法患者先接受伊立替康治疗，然后接受吉西他滨治疗，第1天和第8天，每3周1次。吉西他滨剂量固定为1000 mg/m2，伊立替康剂量从60 mg/m2增加。结果共纳入16例患者。确定了伊立替康的最大耐受剂量，直至水平3（伊立替康100 mg/m2）。在日本，伊立替康的最大获批每周剂量为100 mg/m2，因此这是使用的剂量。仅观察到非常轻度的血液学和非血液学毒性。结论：每3周一次，第1天和第8天使用100 mg/m2伊立替康，随后使用1000 mg/m2吉西他滨，需要进行II期研究。
BACKGROUND Irinotecan and gemcitabine are effective against non-small cell lung cancer. We conducted a phase I study of the combined use of irinotecan and gemcitabine in previously untreated patients with advanced non-small cell lung cancer to determine dose-limiting toxicities and maximum tolerated dose. METHODS Patients were treated with irinotecan followed by gemcitabine on days 1 and 8 every 3 weeks. Gemcitabine dose was fixed at 1000 mg/m2, and irinotecan dose was increased from 60 mg/m2. RESULTS A total of 16 patients was enrolled. Maximum tolerated dose of irinotecan was determined up to level 3 (irinotecan 100 mg/m2). In Japan, the maximum approved weekly dose of irinotecan is 100 mg/m2, so this was the dose that was used. Only very mild hematological and non-hematological toxicities were noted. CONCLUSION Use of 100 mg/m2 irinotecan followed by 1000 mg/m2 gemcitabine on days 1 and 8 every 3 weeks warrants a phase II study.