Efficacy of trastuzumab in routine clinical practice and after progression for metastatic breast cancer patients: the observational Hermine study.
Efficacy of trastuzumab in routine clinical practice and after progression for metastatic breast cancer patients: the observational Hermine study.
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DOI：
10.1634/theoncologist.2009-0029
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发表时间：
2010
期刊：
影响因子：
--
通讯作者：
Namer M
中科院分区：
文献类型：
--
作者：
Extra JM;Antoine EC;Vincent-Salomon A;Delozier T;Kerbrat P;Bethune-Volters A;Guastalla JP;Spielmann M;Mauriac L;Misset JL;Serin D;Campone M;Hebert C;Remblier C;Bergougnoux L;Campana F;Namer M
Hermine研究的结果检查了在常规实践中使用曲妥珠单抗治疗转移性乳腺癌患者，包括接受曲妥珠单抗治疗超过进展的患者。还报告了曲妥珠单抗在这种情况下的心脏安全性。Hermine研究观察了曲妥珠单抗在常规实践中用于转移性乳腺癌（MBC）的情况，包括接受曲妥珠单抗治疗超过进展（TBP）的患者。该研究观察了623例患者≥2年。根据肿瘤学家的正常临床实践给予治疗。终点包括治疗持续时间、疗效和心脏安全性。TBP亚组分析比较了177例接受一线曲妥珠单抗治疗的患者的总生存期（OS），这些患者在疾病进展后继续接受曲妥珠单抗治疗≥30天或在疾病进展时或之前停止曲妥珠单抗治疗。中位治疗持续时间为13.3个月。在一线、二线和三线或以上治疗组中，中位至疾病进展时间（TTP）分别为10.3个月、9.0个月和6.3个月，中位OS时间分别为30.3个月、27.1个月和23.2个月。在2.6%的患者中观察到心力衰竭，但未发生心脏相关死亡。在TBP亚组分析中，继续接受曲妥珠单抗TBP治疗的患者（分别为>27.8个月和21.3个月）从治疗开始的中位OS持续时间和疾病进展时间长于停止治疗的患者（分别为16.8个月和4.6个月）。然而，两组并不完全可比，因为继续曲妥珠单抗TBP的患者在治疗开始时的病情更好。继续曲妥珠单抗TBP治疗的患者中位TTP（10.2个月）长于停止治疗的患者（7.1个月）。Hermine研究结果证实，MBC患者中一线曲妥珠单抗治疗的关键试验适用于临床实践。亚组分析表明，曲妥珠单抗TBP为接受一线曲妥珠单抗治疗的MBC患者提供了生存获益。
Results of the Hermine study examining the use of trastuzumab for metastatic breast cancer patients in routine practice, including patients who received trastuzumab treatment beyond progression, are reported. The cardiac safety of trastuzumab in this setting is also reported. The Hermine study observed the use of trastuzumab for metastatic breast cancer (MBC) in routine practice, including patients who received trastuzumab treatment beyond progression (TBP). The study observed 623 patients for ≥2 years. Treatment was given according to oncologists' normal clinical practices. Endpoints included duration of treatment, efficacy, and cardiac safety. The TBP subanalysis compared overall survival (OS) in 177 patients who received first-line trastuzumab and either continued trastuzumab for ≥30 days following progression or stopped at or before progression. The median treatment duration was 13.3 months. In the first-, second-, and third-line or beyond treatment groups, the median time to progression (TTP) were 10.3 months, 9.0 months, and 6.3 months, and the median OS times were 30.3 months, 27.1 months, and 23.2 months, respectively. Heart failure was observed in 2.6% of patients, although no cardiac-associated deaths occurred. In the TBP subanalysis, the median OS duration from treatment initiation and time of disease progression were longer in patients who continued receiving trastuzumab TBP (>27.8 months and 21.3 months, respectively) than in those who stopped (16.8 months and 4.6 months, respectively). However, the groups were not completely comparable, because patients who continued trastuzumab TBP had better prognoses at treatment initiation. The median TTP was longer in patients who continued trastuzumab TBP (10.2 months) than in those who stopped (7.1 months). The Hermine findings confirm that the pivotal trials of first-line trastuzumab treatment in MBC patients are applicable in clinical practice. The subanalysis suggests that trastuzumab TBP offers a survival benefit to MBC patients treated with first-line trastuzumab.
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45.3
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