Phase I trial of bi-weekly docetaxel combined with carboplatin for patients with non-small cell lung cancer.
Phase I trial of bi-weekly docetaxel combined with carboplatin for patients with non-small cell lung cancer.
复制标题
双周多西紫杉醇联合卡铂治疗非小细胞肺癌患者的 I 期试验。
DOI：
10.1200/jco.2004.22.14_suppl.7241
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发表时间：
2004
影响因子：
45.3
通讯作者：
T. Nukiwa
中科院分区：
文献类型：
--
作者：
A. Inoue;T. Ishida;Y. Saijo;M. Maemondo;T. Suzuki;Y. Kimura;S. Ohkouchi;T. Nukiwa
7241背景：多西他赛（D）联合卡铂（C）是治疗晚期非小细胞肺癌（NSCLC）的常用方案。我们进行了这项试验，以确定最大耐受剂量（MTD）的每两周D与C相结合，并评估这种方案的毒性。
方法
经组织学证实的化疗初治NSCLC患者入组本研究。其他入选标准为（1）年龄≤ 75岁，（2）ECOG PS 0-1，（3）WBC ≥ 4000，Neut ≥ 2000，Plts ≥ 100000，Hb ≥ 9.0，GOT，GPT ≤ 1.5上限，Ccr ≥ 40，PaO 2 ≥ 60，（4）预期寿命超过3个月，（5）书面知情同意书。C在第1天给药，D在第1天和第15天给药，每4周一次。药物剂量计划从水平1（C：AUC 5.0，D：30 mg/m2）增加至水平2（C：AUC 5.0，D：35 mg/m2）和水平3（C：AUC 6.0，D：35 mg/m2）。将在3/3或3/6或更多患者中观察到剂量限制性毒性（DLT）（如持续4天的4级中性粒细胞减少症、需要血小板输注、3级或以上非血液学毒性）的水平确定为MTD。
结果
本研究入组了10例患者。各节段均无患者发生DLT。血液学毒性为中度，未观察到贫血性发热（表）。非血液学毒性也为轻度，未观察到3/4级非血液学毒性。2例患者发生2级眩晕，另1例患者发生2级感染。总有效率为20%（2/10）。
结论
每周两次D联合C治疗NSCLC可能有效，毒性相当中等。我们现在正在进行这个方案的第二阶段试验。[图：见正文]无重大财务关系需要披露。
7241 Background: Docetaxel (D) combined with carboplatin (C) is widely used regimen for advanced non-small cell lung cancer (NSCLC). We conducted this trial to determine the maximum tolerated dose (MTD) of bi-weekly D combined with C and to assess toxicities of this regimen.
METHODS
Histologically proven chemotherapy-naïve NSCLC patients were entered to this study. Other entry criteria were (1) age equal or less than 75, (2) ECOG PS 0-1, (3) WBC ≥ 4000, Neut ≥ 2000, Plts ≥ 100000, Hb ≥ 9.0, GOT, GPT ≤ 1.5 upper limit, Ccr ≥ 40, PaO2 ≥ 60, (4) life expectancy more than 3 months, and (5) written informed consent. C was administered on day 1 and D was administered on day 1 and 15 every 4 weeks. Doses of agents were planned to increase from level 1 (C: AUC 5.0, D: 30 mg/m2) to level 2 (C: AUC 5.0, D: 35 mg/m2) and level 3 (C: AUC 6.0, D: 35 mg/m2). The level where dose limiting toxicities (DLT) such as Grade 4 neutropenia lasting for 4 days, needs for platelet transfusion, Grade 3 or more non-hematological toxicities were observed in 3/3 or 3/6 or more patients was determined as MTD.
RESULTS
Ten patients were enrolled in this study. No patient experienced DLT in each level. Hematological toxicities were moderate and no neutropenic fever was observed (Table). Non-hematological toxicities were also mild and no Grade 3/4 non-hematological toxicities were observed. Two patients experienced Grade 2 vertigo and another patient suffered from Grade 2 infection. Overall response rate was 20 % (2/10).
CONCLUSIONS
Bi-weekly D combined with C may be effective for NSCLC with quite moderate toxicities. We are now conducting a phase II trial of this regimen. [Figure: see text] No significant financial relationships to disclose.