Phase II study of troxacitabine (BCH-4556) in patients with advanced non-small-cell lung cancer

被引：0

作者：

Dent S.F. ^{[1
,3
]}

Arnold A. ^{[1
]}

Stewart D.J. ^{[1
]}

Gertler S. ^{[1
]}

Ayoub J. ^{[1
]}

Batist G. ^{[1
]}

Goss G. ^{[1
]}

Nevile A. ^{[1
]}

Soulieres D. ^{[1
]}

Jolivet J. ^{[2
]}

Mclntosh L. ^{[1
]}

Seymour L. ^{[1
]}

机构：

[1] National Cancer Institute of Canada (Clinical Trials Group), Kingston, Ont.

[2] Shire Pharmaceutical Development Ltd., Montreal, Que.

[3] Ottawa Regional Cancer Center, Ottawa, Ont. K1H 1C4

来源：

Lung | 2005年 / 183卷 / 4期

关键词：

Non-small-cell lung cancer; Phase II; Troxacitabine;

D O I：

10.1007/s00408-004-2539-7

中图分类号：

学科分类号：

摘要：

Troxacitabine. a promising new L-nucleoside, inhibits DNA polymerase and leads to complete DNA chain termination. The National Cancer Institute of Canada Clinical Trials Group (NCIC-CTG) conducted a phase II study to assess the efficacy and toxicity of troxacitabine in untreated patients with advanced non-small-cell lung cancer (NSCLC). Previously untreated patients were eligible if they had inoperable stage IIIB or IV NSCLC, ECOG PS ≤ 2, adequate hematology and biochemistry, and at least one bidimensionally measurable lesion. Patients with prior malignancy or brain metastases were excluded. Troxacitabine (10 mg/m2) was administered intravenously over 30 minutes every 3 weeks. Between June 1999 and May 2000, 17 eligible patients received treatment. Patient characteristics included: median age 64 years; female 41%; stage IV (94%); PS 0 (12%), 1 (59%), and 2 (29 %), 3 or more disease sites (59%). In 17 patients, there were 8 stable disease, 9 disease progression, and no objective responses. Median duration of stable disease was 3.6 months (range = 2.0-7.1). A total of 56 cycles were administered (median = 3), and 88% of patients received 90% or more of the planned dose intensity. The majority (82%) of patients experienced skin rash. Hematologic and biochemical toxicities, grade 3/4 (%) were: granulocytopenia (41), anemia (12), thrombocytopenia (6), and hyperglycemia (6). Troxacitabine appears to have little activity in NSCLC in the dose and schedule tested. © Springer Science+Business Media, Inc. 2005.

引用

页码：265 / 272

页数：7

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