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卡巴他赛对 TROPIC 试验中转移性去势抵抗性前列腺癌男性患者的 2 年生存率和肿瘤相关疼痛缓解的影响。

Impact of cabazitaxel on 2-year survival and palliation of tumour-related pain in men with metastatic castration-resistant prostate cancer treated in the TROPIC trial.

机构信息

Bristol Haematology and Oncology Centre, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.

出版信息

Ann Oncol. 2013 Sep;24(9):2402-8. doi: 10.1093/annonc/mdt194. Epub 2013 May 30.

Abstract

BACKGROUND

Cabazitaxel significantly improves overall survival (OS) versus mitoxantrone in patients with metastatic castration-resistant prostate cancer after docetaxel failure. We examined patient survival at 2 years and tumour-related pain with cabazitaxel versus mitoxantrone.

METHODS

Updated TROPIC data (cut-off 10 March 2010) were used to compare 2-year survival between treatment groups and assess patient demographics and disease characteristics. Factors prognostic for survival ≥2 years were assessed. Pain and Eastern Cooperative Oncology Group performance status were evaluated in the overall patient population.

RESULTS

Median follow-up was 25.5 months. After 2 years, more patients remained alive following cabazitaxel than mitoxantrone [odds ratio 2.11; 95% confidence interval (CI) 1.33-3.33]. Treatment with cabazitaxel was prognostic for survival ≥2 years. Demographics/baseline characteristics were balanced between treatment arms irrespective of survival. Pain at baseline and pain response were comparable between treatment groups. Average daily pain performance index was lower for cabazitaxel versus mitoxantrone (all cycles; 95% CI -0.27 to -0.01; P = 0.035) and analgesic scores were similar. Grade ≥3 peripheral neuropathies were uncommon and comparable between treatment groups.

CONCLUSIONS

Cabazitaxel prolongs OS at 2 years versus mitoxantrone and has low rates of peripheral neuropathy. Palliation benefits of cabazitaxel were comparable to those of mitoxantrone. The study was registered with www.ClinicalTrials.gov (NCT00417079).

摘要

背景

多西他赛治疗失败后,卡巴他赛显著提高转移性去势抵抗性前列腺癌患者的总生存期(OS)。我们检测了卡巴他赛和米托蒽醌治疗患者的 2 年生存率和肿瘤相关性疼痛。

方法

使用 TROPIC 更新数据(截止日期 2010 年 3 月 10 日)比较两组患者的 2 年生存率,并评估患者的人口统计学和疾病特征。评估对 2 年生存有预测价值的因素。在所有患者中评估疼痛和东部肿瘤协作组表现状态。

结果

中位随访时间为 25.5 个月。2 年后,卡巴他赛组的患者存活更多[比值比 2.11;95%置信区间(CI)1.33-3.33]。卡巴他赛治疗与 2 年以上的生存有关。无论生存情况如何,两组之间的人口统计学/基线特征均平衡。基线疼痛和疼痛反应在治疗组之间相似。卡巴他赛组的平均每日疼痛表现指数低于米托蒽醌组(所有周期;95%CI -0.27 至 -0.01;P = 0.035),且镇痛评分相似。≥3 级周围神经病变不常见,且两组之间相当。

结论

与米托蒽醌相比,卡巴他赛可将 OS 延长至 2 年,并具有较低的周围神经病变发生率。卡巴他赛的姑息治疗益处与米托蒽醌相当。本研究在 www.ClinicalTrials.gov 上注册(NCT00417079)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/baea/3755329/94fa2dfa4d6b/mdt19401.jpg

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