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紫杉醇(泰素)与异环磷酰胺(匹服平)用于不可切除非小细胞肺癌的II期研究

Phase II study of paclitaxel (Taxol) and ifosfamide (Holoxan) in inoperable non-small-cell lung cancer.

作者信息

Thongprasert S

机构信息

Department of Medicine, Faculty of Medicine, Chiang Mai University, Thailand.

出版信息

Lung Cancer. 1998 Mar;19(3):185-9. doi: 10.1016/s0169-5002(97)00085-8.

DOI:10.1016/s0169-5002(97)00085-8
PMID:9631366
Abstract

A total of 27 patients with advanced previously untreated non-small-cell lung cancer were treated with paclitaxel and ifosfamide. The starting dose of paclitaxel was 175 mg/m2 given for 3 h by intravenous infusion on day 1. Ifosfamide 4 g/m2 was given for 4 h by intravenous infusion on day 2. Dosage of the two drugs was modified according to nadir white blood count after each cycle. Involved in the treatment were 17 males and 10 female patients. The median age was 61 years (range 47-71 years) and the median Karnofsky performance status was 70% (range 60-90%), 13 cases were stage IIIb and 14 cases were stage IV. One case was not evaluable due to lost follow-up after a single dose of chemotherapy. There were five cases not determined due to a timing error. Of 21 evaluable cases, eight achieved partial response (PR 38%, confidence interval 18.1-61.5%), seven achieved stable disease, two had a minor response. The median survival time of the whole group was 255 days (range from 38 to 567 days). The major toxicities were myalgia; arthralgia and neuropathies. Throughout the study, only three cases (15%) were treated at dose level 0. After the first cycle, 18 cases were treated at dose level 1, after a second cycle, 13 cases were treated at dose level 2. Three cases with grade 3 leukopenia were seen at dose level 0. At dose level 1, two cases had grade 3 leukopenia. At dose level 2, four episodes of grade 3 leukopenia were noted. It is concluded that paclitaxel can be combined safely with ifosfamide at these dosage levels. The response rates were comparable to the other chemotherapy combination in advanced non-small-cell lung cancer. The survival results were acceptable and comparable to the cisplatin-containing regimen. This study indicates that combinations of paclitaxel and/or ifosfamide with other agents, such as gemcitabine and vinorelbine, should be explored.

摘要

共有27例先前未经治疗的晚期非小细胞肺癌患者接受了紫杉醇和异环磷酰胺治疗。紫杉醇的起始剂量为175mg/m²,于第1天静脉输注3小时。异环磷酰胺4g/m²于第2天静脉输注4小时。每个周期后根据最低点白细胞计数调整两种药物的剂量。参与治疗的有17例男性和10例女性患者。中位年龄为61岁(范围47 - 71岁),中位卡氏评分是70%(范围60 - 90%),13例为Ⅲb期,14例为Ⅳ期。1例因单剂量化疗后失访而无法评估。有5例因时间误差未确定。在21例可评估病例中,8例获得部分缓解(PR 38%,置信区间18.1 - 61.5%),7例病情稳定,2例有轻微缓解。全组中位生存时间为255天(范围38至567天)。主要毒性为肌痛、关节痛和神经病变。在整个研究过程中,仅3例(15%)在剂量水平0接受治疗。第一个周期后,18例在剂量水平1接受治疗,第二个周期后,13例在剂量水平2接受治疗。在剂量水平0观察到3例3级白细胞减少。在剂量水平1,2例有3级白细胞减少。在剂量水平2,记录到4次3级白细胞减少发作。结论是在这些剂量水平下,紫杉醇可与异环磷酰胺安全联合使用。缓解率与晚期非小细胞肺癌的其他化疗联合方案相当。生存结果可以接受,与含顺铂方案相当。本研究表明,应探索紫杉醇和/或异环磷酰胺与其他药物如吉西他滨和长春瑞滨的联合使用。

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