Analysis of trastuzumab and chemotherapy in advanced breast cancer after the failure of at least one earlier combination: an observational study.

Analysis of trastuzumab and chemotherapy in advanced breast cancer after the failure of at least one earlier combination: an observational study.
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至少一种早期组合失败后,晚期乳腺癌中曲妥珠单抗和化学疗法的分析:一项观察性研究。

DOI:
10.1186/1471-2407-6-63
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发表时间:
2006-03-15
期刊:
影响因子:
3.8
通讯作者:
Steger GG
Steger GG
中科院分区:
医学2区
文献类型:
--
作者:
Bartsch R;Wenzel C;Hussian D;Pluschnig U;Sevelda U;Koestler W;Altorjai G;Locker GJ;Mader R;Zielinski CC;Steger GG

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联合曲妥珠单抗和化疗是her 2/neu过度表达的晚期乳腺癌的标准治疗。然而,尚未确定在一种早期联合治疗失败后是否应继续曲妥珠单抗治疗。在这项试验中,我们报告了我们在疾病进展后继续治疗的经验。纳入了54例患者,中位年龄46岁,范围25-73岁。我们分析了一线、二线和二线以上治疗的肿瘤进展时间(TTP)、缓解率和总生存期。中位观察时间为24个月,范围为7-51个月。一线治疗的反应率为7.4%完全缓解(CR)、35.2%部分缓解(PR)、42.6%稳定疾病> 6个月(SD)和14.8%尽管治疗仍经历疾病进展(PD)的患者。二线治疗的CR、PR、SD和PD分别为3.7%、22.2%、42.6%和31.5%;二线以上治疗人数(60例治疗,33例三线患者,18例四线患者,6例五线患者,2例六线患者和1例七线患者)为1.7% CR,28.3% PR,SD和PD分别为28.3%和41.6%。一线治疗的中位TTP为6个月(m),二线及二线以上治疗的中位TTP也为6个月。在1例患者中观察到无症状的左心室射血分数下降至50%以下。未观察到症状性充血性心力衰竭病例。这些数据清楚地加强了患者确实从持续曲妥珠单抗治疗中获益的证据。尤其值得注意的是,TTP从一线治疗到二线治疗后并未显著降低。尽管如此,随机试验是必要的。
Combining trastuzumab and chemotherapy is standard in her2/neu overexpressing advanced breast cancer. It is not established however, whether trastuzumab treatment should continue after the failure of one earlier combination. In this trial, we report our experience with continued treatment beyond disease progression. Fifty-four patients, median age 46 years, range 25–73 years, were included. We analysed for time to tumour progression (TTP) for first, second and beyond second line treatment, response rates and overall survival. Median time of observation was 24 months, range 7–51. Response rates for first line treatment were 7.4% complete remission (CR), 35.2% partial remissions (PR), 42.6% stable disease > 6 months (SD) and 14.8% of patients experienced disease progression despite treatment (PD). Corresponding numbers for second line were 3.7% CR, 22.2% PR, 42.6% SD and 31.5% PD; numbers for treatment beyond second line (60 therapies, 33 pts 3rd line, 18 pts 4th line, 6 pts 5th line, 2 pts 6th line and 1 patient 7th line) were 1.7% CR, 28.3% PR, 28.3% SD and 41.6% PD respectively. Median TTP was 6 months (m) in the first line setting, and also 6 m for second line and beyond second line. An asymptomatic drop of left ventricular ejection fraction below 50% was observed in one patient. No case of symptomatic congestive heart failure was observed. The data presented clearly strengthen evidence that patients do profit from continued trastuzumab treatment. The fact that TTP did not decrease significantly from first line to beyond second line treatment is especially noteworthy. Still, randomized trials are warranted.