Paterson Alexander H G
Tom Baker Cancer Centre, University of Calgary, Calgary, Alberta, Canada.
Oncologist. 2006;11 Suppl 1:13-9. doi: 10.1634/theoncologist.11-90001-13.
Clinical trials are investigating the use of bisphosphonates in patients with early (nonmetastatic) breast cancer. Results from trials of clodronate are generally encouraging but somewhat contradictory. Of the three trials published to date, two reported that clodronate had beneficial effects on both bone metastases and survival. In contrast, the third trial reported that clodronate had no effect on metastases and a negative effect on survival. Small studies of adjuvant pamidronate and zoledronic acid also produced promising data, but these need to be reproduced in a large-scale, randomized trial setting before clinically meaningful conclusions can be drawn. A number of adjuvant trials are in progress to further evaluate the role of oral clodronate and i.v. zoledronic acid and to examine the effects of the newer bisphosphonate, ibandronate (oral formulation), in this setting. One of these trials is the joint Southwest Oncology Group/Intergroup/National Surgical Adjuvant Breast and Bowel Project trial, which is designed to compare the efficacy and safety of all three of these bisphosphonates in approximately 6,000 women with early breast cancer. Patient preference for oral or i.v. therapy will also be assessed.
临床试验正在研究双膦酸盐类药物在早期（非转移性）乳腺癌患者中的应用。氯膦酸盐的试验结果总体上令人鼓舞，但也存在一些矛盾之处。在迄今已发表的三项试验中，两项试验报告氯膦酸盐对骨转移和生存均有有益作用。相比之下，第三项试验报告氯膦酸盐对转移无影响且对生存有负面影响。辅助性帕米膦酸盐和唑来膦酸的小型研究也得出了有前景的数据，但在得出具有临床意义的结论之前，这些数据需要在大规模随机试验环境中重现。多项辅助试验正在进行中，以进一步评估口服氯膦酸盐和静脉注射唑来膦酸的作用，并在此背景下研究新型双膦酸盐伊班膦酸盐（口服制剂）的效果。其中一项试验是西南肿瘤协作组/肿瘤研究组/国家乳腺与肠道外科辅助治疗计划联合试验，旨在比较这三种双膦酸盐在约6000名早期乳腺癌女性中的疗效和安全性。还将评估患者对口服或静脉治疗的偏好。
