Lancet oncol:卡巴他赛联合卡铂治疗去雄耐受性的转移性前列腺癌

2019-09-10 MedSci MedSci原创

在单组临床研究中,紫杉醇-铂联合治疗去势耐药的转移性前列腺癌显示出良好的活性,但尚无相关随机试验。研究人员开展一个1/2期开放性随机试验,招募进展期的去雄耐受性的转移性前列腺癌患者,评估卡巴他赛联合卡铂是否可提高这类患者的预后。1期目的是明确最大耐受剂量和剂量限制性毒性,2期评估无进展存活期。2012年8月17日-2015年5月11日,9位患者如期完成了1期试验,随后2期160位患者被随机分至卡巴

在单组临床研究中,紫杉醇-铂联合治疗去势耐药的转移性前列腺癌显示出良好的活性,但尚无相关随机试验。

研究人员开展一个1/2期开放性随机试验,招募进展期的去雄耐受性的转移性前列腺癌患者,评估卡巴他赛联合卡铂是否可提高这类患者的预后。1期目的是明确最大耐受剂量和剂量限制性毒性,2期评估无进展存活期。

2012年8月17日-2015年5月11日,9位患者如期完成了1期试验,随后2期160位患者被随机分至卡巴他赛组(79位)或卡巴他赛联合卡铂组(81位)。在1期过程中,3级副反应事件有贫血(2例)、疲劳(1例)、血小板减少症(1例)、低镁血症(1例)、腹泻(1例)、低钾血症(1例)、厌食(1例)和脱水(1例),无4级副反应事件发生。无剂量限制性毒性,因此,最大耐受剂量定为卡巴他赛 25mg/m2、AUC的卡铂 4mg/ml·min,用于2期试验。中位随访31个月(IQR 20.5-37.1)时,联合组将中位无进展存活期从4.5个月(95% CI 3.5-5.7)延长至7.3个月(5.5-8.5;风险比0.69,95% CI 0.50-0.95,p=0.018).在2期研究中,最常见的3-5级副反应事件有疲劳(卡巴他赛组 vs 联合组:7例[9%] vs 16例[20%])、贫血(3[4%] vs 19[23%])、中性粒细胞减少(3[4%] vs 13[16%])、血小板减少症(1[1%] vs 11[14%])。无治疗相关死亡。

对于去雄耐受性转移性前列腺癌患者,与单用卡巴他赛相比,卡巴他赛联合卡铂可提高临床治疗效果。联合治疗的副反应事件发生率较高,但总体耐受性尚可。

原始出处:

Paul G Corn,et al.Cabazitaxel plus carboplatin for the treatment of men with metastatic castration-resistant prostate cancers: a randomised, open-label, phase 1–2 trial.The Lancet Oncology. September 09, 2019. https://doi.org/10.1016/S1470-2045(19)30408-5

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    2019-12-25 minlingfeng
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    2019-12-31 howi
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    2019-09-11 anti-cancer

    谢谢梅斯分享这么多精彩信息

    0

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    2019-09-11 misszhang

    前列腺癌相关研究,学习了,谢谢梅斯

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