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临床实践中紫杉醇在晚期卵巢癌中的应用:541 例患者分析。一项德国多中心观察性研究的结果。

Use of paclitaxel for advanced ovarian cancer in clinical practice: analysis of 541 patients. Results from a German multi-centre observational study.

机构信息

Department of Gynecology and Obstetrics, Charité/Campus Virchow-Klinikum, University of Berlin, Berlin, Germany.

出版信息

Anticancer Res. 2010 Oct;30(10):4245-50.

PMID:21036748
Abstract

UNLABELLED

Paclitaxel is one of the most common antitumour agents paclitaxel for the treatment of primary and relapsed ovarian cancer. Based on a German multicentre observational study, this article reflects the use of paclitaxel in German daily clinical practice.

PATIENTS AND METHODS

Data for a total of 541 patients in Germany were analysed, including 315 patients with primary ovarian cancer and 226 patients treated with paclitaxel with relapsed ovarian cancer.

RESULTS

The mean age was 61.2 years, ranging from 22 to 85 years. No unexpected toxicities were ascertained. In general, grade III/IV haematological toxicities were rare. Only 15% of the patients suffered from grade III/IV leucopenia and 5% from thrombocytopenia. Alopecia and polyneuropathy were the most frequent non-haematological side-effects noticed. Response evaluation was provided in 183 patients with primary ovarian cancer (CR 39.8%, of these achieved a complete response (CR), and 27.9% a partial response (PR), resulting in an overall response rate (ORR) of 67.7%. In 13.7%, stable disease (SD) and in 19.7%, tumour progression (PD) were documented. In 196 patients with recurrent ovarian cancer, response evaluation was provided. A total of 28.6% of the patients achieved a CR, and 31.6% a PR, which produced an ORR of 60.2%. In 33.2%, SD and in 6.6%, PD were documented.

CONCLUSION

Paclitaxel is broadly used in the management of patients with primary and relapsed ovarian cancer. The toxicity profile observed seems to be within the range of the results of clinical phase-III studies. The doses applied and the schedules based on the official recommendation of the working groups seem to have been influenced by international studies.

摘要

未注明

紫杉醇是治疗原发性和复发性卵巢癌最常用的抗肿瘤药物之一。基于一项德国多中心观察性研究,本文反映了紫杉醇在德国日常临床实践中的应用。

患者和方法

共分析了德国 541 名患者的数据,包括 315 名原发性卵巢癌患者和 226 名复发性卵巢癌患者接受紫杉醇治疗。

结果

平均年龄为 61.2 岁,年龄范围为 22 至 85 岁。未发现意外毒性。一般来说,III/IV 级血液学毒性罕见。只有 15%的患者出现 III/IV 级白细胞减少症,5%的患者出现血小板减少症。脱发和多发性神经病是最常见的非血液学副作用。183 名原发性卵巢癌患者进行了疗效评价(CR39.8%,其中完全缓解(CR)39.8%,部分缓解(PR)27.9%,总缓解率(ORR)为 67.7%。13.7%的患者疾病稳定(SD),19.7%的患者疾病进展(PD)。196 名复发性卵巢癌患者进行了疗效评价。总共有 28.6%的患者达到了 CR,31.6%的患者达到了 PR,ORR 为 60.2%。33.2%的患者疾病稳定(SD),6.6%的患者疾病进展(PD)。

结论

紫杉醇广泛用于原发性和复发性卵巢癌患者的治疗。观察到的毒性谱似乎在 III 期临床试验结果的范围内。应用的剂量和基于工作组官方建议的方案似乎受到了国际研究的影响。

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