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个体化剂量密集型与标准辅助化疗治疗高危早期乳腺癌:随机 PANTHER 试验的研究结束时结果。

Tailored Dose-Dense Versus Standard Adjuvant Chemotherapy for High-Risk Early Breast Cancer: End-of-Study Results of the Randomized PANTHER Trial.

机构信息

Oncology/Pathology Department, Karolinska Institutet, Stockholm, Sweden.

Breast Center, Karolinska Comprehensive Cancer Center, Stockholm, Sweden.

出版信息

J Clin Oncol. 2024 Sep 10;42(26):3077-3082. doi: 10.1200/JCO.24.00178. Epub 2024 Jul 17.

DOI:10.1200/JCO.24.00178
PMID:39018515
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11379357/
Abstract

JCO .Although dose-dense adjuvant chemotherapy administered once every 2 weeks leads to superior outcomes compared with standard regimens once every 3 weeks, the observed improvement is largely limited to studies using the suboptimal paclitaxel schedule once every 3 weeks as control. PANTHER is an international phase III trial which compared sequential epirubicin/cyclophosphamide and docetaxel administered either once every 2 or once every 3 weeks, with tailored dosing at the dose-dense schedule according to hematologic toxicity. In this end-of-study analysis, the median follow-up was 10.3 years. Compared with standard adjuvant chemotherapy, dose-dense treatment improved breast cancer recurrence-free survival (hazard ratio [HR], 0.80 [95% CI, 0.65 to 0.98]; = .030), event-free survival (HR, 0.78 [95% CI, 0.65 to 0.94]; = .009), and distant disease-free survival (HR, 0.79 [95% CI, 0.64 to 0.98]; = .030) while the improvement in overall survival was not statistically significant (HR, 0.82 [95% CI, 0.65 to 1.04]; = .109). To our knowledge, this is the first trial that confirms the benefit of a dose-dense regimen over a control regimen containing docetaxel once every 3 weeks.

摘要

JCO。虽然每 2 周给予一次的密集辅助化疗与每 3 周给予一次的标准方案相比可带来更好的结果,但观察到的改善主要局限于使用非最佳紫杉醇方案(每 3 周一次)作为对照的研究。PANTHER 是一项国际 III 期试验,比较了每 2 周或每 3 周一次给予序贯表柔比星/环磷酰胺和多西他赛,根据血液学毒性在密集剂量方案中进行个体化剂量调整。在这项研究结束时的分析中,中位随访时间为 10.3 年。与标准辅助化疗相比,密集治疗改善了乳腺癌无复发生存(风险比 [HR],0.80 [95%CI,0.65 至 0.98]; =.030)、无事件生存(HR,0.78 [95%CI,0.65 至 0.94]; =.009)和远处无病生存(HR,0.79 [95%CI,0.64 至 0.98]; =.030),而总生存的改善无统计学意义(HR,0.82 [95%CI,0.65 至 1.04]; =.109)。据我们所知,这是第一项证实密集方案优于含多西他赛(每 3 周一次)的对照方案可带来获益的试验。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/153d/11379357/0edef81ce795/jco-42-3077-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/153d/11379357/eafa139afd0b/jco-42-3077-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/153d/11379357/0edef81ce795/jco-42-3077-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/153d/11379357/eafa139afd0b/jco-42-3077-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/153d/11379357/0edef81ce795/jco-42-3077-g003.jpg

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