Pusztai Lajos, Esteva Francisco J
Department of Breast Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas 77030-4009, USA.
Cancer Invest. 2006 Mar;24(2):187-91. doi: 10.1080/07357900500524629.
Whether to continue trastuzumab after objective evidence of disease progression or not is an important unanswered clinical question for women with metastatic disease. This question is also relevant for those who relapse after adjuvant trastuzumab-containing therapy. Unfortunately, there is little evidence to guide decision-making. The modest toxicity and the possible, but unproven, benefit from the continued use of trastuzumab may account for the currently wide spread practice of continued administration of this drug after progression. However, there is no convincing evidence to support the use of extended trastuzumab therapy after progression. At least two randomized trials with no trastuzumab in the control arms were attempted but failed to accrue patients. In the absence of results from a randomized clinical trial, a central registry program that collects information longitudinally from a large number of patients with HER-2 positive breast cancer during the course of their disease was initiated (RegistHER, www.registher.com) to learn about the long term side effects and benefits of prolonged trastuzumab therapy. The anticipated introduction of second generation HER2-targeted agents into the clinic also raises a new question; will switching to these agents be more effective than continuation of trastuzumab? Clinical trials are currently planned to address question prospectively.
对于患有转移性疾病的女性，在有客观疾病进展证据后是否继续使用曲妥珠单抗是一个重要的尚未解决的临床问题。这个问题对于那些在含曲妥珠单抗的辅助治疗后复发的患者也同样适用。不幸的是，几乎没有证据可指导决策。曲妥珠单抗毒性较小，持续使用可能有益（但未经证实），这或许可以解释目前疾病进展后继续使用该药的广泛做法。然而，没有令人信服的证据支持进展后使用延长疗程的曲妥珠单抗治疗。至少有两项对照臂不含曲妥珠单抗的随机试验尝试开展，但未能招募到患者。在缺乏随机临床试验结果的情况下，启动了一项中央注册项目（RegistHER，www.registher.com），该项目在疾病过程中纵向收集大量HER-2阳性乳腺癌患者的信息，以了解延长曲妥珠单抗治疗的长期副作用和益处。预计第二代HER2靶向药物引入临床也引发了一个新问题：改用这些药物是否比继续使用曲妥珠单抗更有效？目前正在计划开展临床试验以前瞻性地解决这个问题。
