Phase I/II study of cisplatin combined with weekly paclitaxel in patients with advanced non-small-cell lung cancer

被引:0
作者
N Yoshimura
S Kudoh
T Mukohara
S Yamauchi
M Yamada
T Kawaguchi
Y Nakaoka
K Hirata
J Yoshikawa
机构
[1] Graduate School of Medicine,Department of Respiratory Medicine
[2] Osaka City University,undefined
[3] 1-4-3,undefined
[4] Asahi-machi,undefined
[5] Abeno-ku,undefined
[6] Internal Medicine,undefined
[7] Osaka City Sumiyoshi Hospital,undefined
[8] 1-2-16,undefined
[9] Higasikagaya,undefined
[10] Suminoe-ku,undefined
[11] Internal Medicine,undefined
[12] Osaka City Kita Hospital,undefined
[13] 5-4-8,undefined
[14] Nishikujyou,undefined
[15] Konohana-ku,undefined
[16] Osaka Japan Railway Hospital,undefined
[17] 1-2-22,undefined
[18] Matsuzaki-cyou,undefined
[19] Abeno-ku,undefined
来源
British Journal of Cancer | 2004年 / 90卷
关键词
weekly paclitaxel; cisplatin; non-small-cell lung cancer (NSCLC);
D O I
暂无
中图分类号
学科分类号
摘要
To determine the maximum-tolerated dose (MTD) and the recommended dose (RD) of paclitaxel administered weekly with a fixed dose of cisplatin, and to assess the toxicity and activity of this combination, we conducted a phase I/II trial in patients with advanced non-small-cell lung cancer (NSCLC). In this study, patients with stage IIIB/IV NSCLC were eligible. Paclitaxel, at a starting dose of 40 mg m−2 week−1 on days 1, 8, and 15, was combined with a fixed dose of cisplatin 80 mg m−2 on day 1. Chemotherapy was given in a 4-week cycle. In this phase I/II study, 38 patients were enrolled. Dose-limiting toxicities (DLT) were neutropenia, fatigue, and omission of treatment due to leucopenia, thrombocytopenia, or febrile neutropenia. The MTD and RD were estimated to be 70 mg m−2. Of the 37 assessable patients, 23 had a partial response and one had a complete response. Overall response rate was 62.1% (95% confidence interval (CI): 46.5–77.7%). The progression-free survival, the median survival time, and the 1-year survival rate were 5.5 months, 13.7 months, and 56.9%, respectively. This regimen is tolerable and very active against advanced NSCLC, and its efficacy should be confirmed in a phase III study.
引用
收藏
页码:1184 / 1189
页数:5
相关论文
共 176 条
[1]  
Abratt RP(1998)Combined cisplatin and gemcitabine for non-small cell lung cancer: influence of scheduling on toxicity and drug delivery Semin Oncol 25 35-43
[2]  
Sandler A(2003)Weekly, high-dose paclitaxel in advanced lung carcinoma: a phase II study with pharmacokinetics by the Cancer and Leukemia Group B Cancer 97 2480-2486
[3]  
Crino L(2001)Interim analysis of a phase II study of induction weekly paclitaxel/carboplatin regimens followed by maintenance weekly paclitaxel for advanced and metastatic non-small cell lung cancer Semin Oncol 28 14-16
[4]  
Steward WP(1997)Cisplatin–gemcitabine combination in advanced non-small-cell lung cancer: a phase II study J Clin Oncol 15 297-303
[5]  
Shepherd FA(1997)Paclitaxel cytotoxicity against human lung cancer cell lines increases with prolonged exposure durations Clin Cancer Res 3 449-454
[6]  
Green MR(2002)Early results of a randomized phase III trial of platinum-containing doublets Semin Oncol 29 47-49
[7]  
Nguyen B(1993) a nonplatinum doublet in the treatment of advanced non-small cell lung cancer: European Organization for Research and Treatment of Cancer 08975 J Clin Oncol 11 1866-1872
[8]  
Peters GJ(2001)Chemotherapy for advanced non-small-cell lung cancer: how much benefit is enough? J Clin Oncol 19 3210-3218
[9]  
Akerley W(1995)Randomized phase III trial of paclitaxel plus carboplatin J Clin Oncol 13 1860-1870
[10]  
Herndon JE(1998) vinorelbine plus cisplatin in the treatment of patients with advanced non-small-cell lung cancer: a Southwest Oncology Group trial Eur J Cancer 34 2032-2036