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多西他赛在转移性去势抵抗性多西他赛敏感前列腺癌患者中的再引入:一项回顾性多中心研究。

Docetaxel reintroduction in patients with metastatic castration-resistant docetaxel-sensitive prostate cancer: a retrospective multicentre study.

机构信息

Institut Jean Godinot, Medical Oncology Department, Reims, France.

出版信息

BJU Int. 2010 Oct;106(7):974-8. doi: 10.1111/j.1464-410X.2010.09296.x. Epub 2010 Mar 9.

Abstract

OBJECTIVE

To investigate the potential benefit of reintroducing docetaxel chemotherapy in patients with progressive metastatic castration-resistant prostate cancer (mCRPC) who had initially responded to first-line docetaxel-based regimen.

PATIENTS AND METHODS

Records were evaluated retrospectively from French patients with mCRPC who had been included in seven controlled clinical studies of docetaxel as first-line treatment. We identified patients who were confirmed as responders to first-line treatment, discontinued for reasons other than disease progression or unacceptable toxicity, and who received further docetaxel chemotherapy for disease progression. The primary objective was to assess efficacy in terms of the prostate-specific antigen (PSA) response after resuming a docetaxel-based chemotherapy. Secondary objectives were overall survival and tolerance.

RESULTS

Of the 148 patients who responded to first-line docetaxel, 50 received further therapy with docetaxel and were analysed. The median (range) response duration to first-line docetaxel was 10.3 (4.6-45.7) months and the median docetaxel-free interval was 18.4 (5.0-46.7) months. Docetaxel was reintroduced as second-line therapy in 52% of patients and as further lines in 48%. After docetaxel reintroduction, 24 patients (48%) had a 50% decrease in PSA level (95% confidence interval, CI, 34.1-61.8%). The median (95% CI) overall survival from docetaxel reintroduction was 16 (13-20) months. Re-treatment was well tolerated (6% of grade 3-4 haemotoxicity).

CONCLUSION

Docetaxel reintroduction appears to be effective, with favourable tolerance profiles, in patients with mCRPC having responded to first-line docetaxel, and should be prospectively assessed in clinical trials against alternative therapies or investigational agents given alone or in combination, to define further management.

摘要

目的

探讨在一线多西紫杉醇治疗方案初治后获得缓解的转移性去势抵抗性前列腺癌(mCRPC)患者中重新引入多西紫杉醇化疗的潜在获益。

患者和方法

回顾性评估了来自法国的 mCRPC 患者的病历记录,这些患者曾参与过七项多西紫杉醇作为一线治疗的对照临床试验。我们确定了一线治疗应答确认、因疾病进展或不可接受的毒性以外的原因停药、并因疾病进展而接受进一步多西紫杉醇化疗的患者。主要目标是评估恢复多西紫杉醇化疗后前列腺特异性抗原(PSA)应答的疗效。次要目标是总生存期和耐受性。

结果

在一线多西紫杉醇应答的 148 例患者中,有 50 例接受了进一步的多西紫杉醇治疗并进行了分析。一线多西紫杉醇的中位(范围)应答持续时间为 10.3(4.6-45.7)个月,多西紫杉醇无治疗间隔的中位时间为 18.4(5.0-46.7)个月。52%的患者将多西紫杉醇作为二线治疗药物,48%的患者作为三线治疗药物重新引入。多西紫杉醇重新引入后,24 例患者(48%)PSA 水平下降了 50%(95%置信区间,CI,34.1-61.8%)。多西紫杉醇重新引入后的中位(95%CI)总生存期为 16(13-20)个月。重新治疗的耐受性良好(3-4 级血液毒性发生率为 6%)。

结论

在一线多西紫杉醇治疗获得缓解的 mCRPC 患者中,重新引入多西紫杉醇似乎具有疗效,且耐受性良好,应在临床试验中与其他治疗方案或单独或联合使用的研究性药物进行前瞻性评估,以进一步明确治疗策略。

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