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多西他赛和顺铂每周给药方案用于非小细胞肺癌患者的II期研究。

Phase II study of weekly docetaxel and cisplatin in patients with non-small cell lung cancer.

作者信息

Kaira Kyoichi, Takise Atsushi, Minato Koichi, Iwasaki Yasuki, Ishihara Shinichi, Takei Yoshikazu, Tsuchiya Satoshi, Saito Ryusei, Sato Koji, Mori Masatomo

机构信息

Department of Respiratory Medicine, Maebashi Red Cross Hospital, Gunma, Japan.

出版信息

Anticancer Drugs. 2005 Apr;16(4):455-60. doi: 10.1097/00001813-200504000-00013.

Abstract

We conducted a phase II study to examine the efficacy and safety of weekly docetaxel and cisplatin in the treatment of advanced non-small cell lung cancer (NSCLC). Forty chemotherapy-naive patients (10 with stage IIIB and 30 with stage IV NSCLC) with an Eastern Cooperative Oncology Group performance status of 0-2 and adequate organ functions were enrolled. Chemotherapy consisted of cisplatin (80 mg/m2) on day 1, and docetaxel (35 mg/m2) on days 1, 8 and 15, delivered in 4-week cycles consisting of three weekly treatments followed by 1 week of rest. There were 18 partial responses, with an overall response rate of 45% (95% confidence interval 29.6-60.4%) in 40 treated patients. The median survival period was 19.9 months, median progression-free survival was 5.5 months and 1-year survival rate was 69.4%. Hematologic toxicities were mild and included grade 3 or 4 neutropenia in 37.5%. There were no severe infections or septic deaths. Non-hematologic toxicities were generally mild. Grade 3 or 4 transaminase elevations were observed in two patients. Grade 3 events included two cases each of vomiting, and one case each of hypokalemia, diarrhea and creatinine elevations. Weekly docetaxel and cisplatin is an effective and safe combination in the treatment of patients with advanced NSCLC.

摘要

我们开展了一项II期研究,以检验每周使用多西他赛和顺铂治疗晚期非小细胞肺癌(NSCLC)的疗效和安全性。纳入了40例未接受过化疗的患者(10例IIIB期和30例IV期NSCLC),其东部肿瘤协作组体能状态为0 - 2,且器官功能良好。化疗方案为第1天给予顺铂(80 mg/m²),第1、8和15天给予多西他赛(35 mg/m²),每4周为一个周期,包括3次每周治疗,随后休息1周。40例接受治疗的患者中有18例部分缓解,总缓解率为45%(95%置信区间29.6 - 60.4%)。中位生存期为19.9个月,中位无进展生存期为5.5个月,1年生存率为69.4%。血液学毒性较轻,37.5%的患者出现3级或4级中性粒细胞减少。无严重感染或败血症死亡。非血液学毒性一般较轻。2例患者出现3级或4级转氨酶升高。3级事件包括呕吐各2例,低钾血症、腹泻和肌酐升高各1例。每周使用多西他赛和顺铂联合治疗晚期NSCLC患者有效且安全。

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