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首页> 外文期刊>Journal of Clinical Oncology >Docetaxel is a major cytotoxic drug for the treatment of advanced breast cancer: a phase II trial of the Clinical Screening Cooperative Group of the European Organization for Research and Treatment of Cancer.
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Docetaxel is a major cytotoxic drug for the treatment of advanced breast cancer: a phase II trial of the Clinical Screening Cooperative Group of the European Organization for Research and Treatment of Cancer.

机译:多西紫杉醇是一种用于治疗晚期乳腺癌的主要细胞毒性药物:欧洲癌症研究与治疗组织临床筛查合作组的一项II期试验。

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PURPOSE: This trial investigated the toxicity and efficacy of docetaxel as first-line chemotherapy in women with heavily pretreated advanced breast cancer. PATIENTS AND METHODS: From April 1992 to August 1992, 35 patients with advanced breast cancer from 29 to 65 years of age with a performance status of 0 to 2 were entered onto the study. Docetaxel 100 mg/m2 was administered every 3 weeks as a 1-hour infusion on day 1 without routine premedication for hypersensitivity reactions. Thirty-one patients were assessable for response. Previous adjuvant chemotherapy had been given to 11 patients. RESULTS: Five complete responses (CRs) and 16 partial responses (PRs) were observed, for an overall response rate of 67.7% (95% confidence interval, 49% to 83%). A CR occurred at 13 of 45 assessable sites (four liver, two lung, three breast, three lymph node, and one skin). The median duration of response was 44+ weeks, the median time to disease progression 37+ weeks, and the median overall survival time 16+ months.Among 34 patients assessable for toxicity (177 cycles; median, five cycles per patient), the following side effects were reported: nadir neutropenia grade 3 (three patients); grade 4 (31 patients); no grade 3 to 4 infection, acute hypersensitivity-like reaction (10 patients); grade 2 to 3 alopecia (all patients); and grade 2 to 3 nausea and vomiting (six patients). Fluid retention occurred in 26 patients and consisted of weight gain, edema alone (15 patients), or edema associated with serous effusion (11 patients). This side effect led to treatment discontinuation in 16 of 21 responding patients after a median of five cycles and a median cumulative dose of docetaxel of 574 mg/m2. CONCLUSION: Our data suggest that docetaxel has major antitumor activity when used as a single cytotoxic agent as first-line chemotherapy in advanced breast cancer.
机译:目的:该试验研究了多西紫杉醇作为一线化疗对严重预处理的晚期乳腺癌妇女的毒性和疗效。患者与方法:从1992年4月至1992年8月,将35例29岁至65岁,状态为0至2的晚期乳腺癌患者纳入研究。第3天每1周输注多西他赛100 mg / m2,每次1小时,无超敏反应的常规处方。评估了31名患者的反应。先前已对11例患者进行了辅助化疗。结果:观察到5个完全缓解(CR)和16个部分缓解(PR),总缓解率为67.7%(95%置信区间为49%至83%)。在45个可评估部位中的13个部位(四个肝脏,两个肺,三个乳房,三个淋巴结和一个皮肤)发生CR。中位反应持续时间为44+周,中位疾病进展时间为37+周,中位总生存时间为16+个月。在34例可评估毒性的患者中(177个周期;中位数,每个患者5个周期),以下据报道有副作用:最低点中性粒细胞减少3级(3例); 4级(31例);无3至4级感染,急性超敏样反应(10例); 2至3级脱发(所有患者); 2至3级恶心和呕吐(6例患者)。体液retention留发生在26例患者中,包括体重增加,仅浮肿(15例)或浆液性积液引起的水肿(11例)。这种副作用导致中位5个周期和多西他赛的中位累积剂量为574 mg / m2之后,在21位有反应的患者中有16位中止了治疗。结论:我们的数据表明,多西紫杉醇作为单一细胞毒剂作为晚期乳腺癌的一线化疗药物时,具有重要的抗肿瘤活性。

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