Aihara Tomohiko, Yokota Isao, Hozumi Yasuo, Aogi Kenjiro, Iwata Hiroji, Tamura Motoshi, Fukuuchi Atsushi, Makino Haruhiko, Kim Ryungsa, Andoh Masashi, Tsugawa Koichiro, Ohno Shinji, Yamaguchi Takuhiro, Ohashi Yasuo, Watanabe Toru, Takatsuka Yuichi, Mukai Hirofumi
Breast Center, Aihara Hospital, 3-4-30, Makiochi, Minoh, Osaka, 562-0004, Japan,
Breast Cancer Res Treat. 2014 Nov;148(2):337-43. doi: 10.1007/s10549-014-3155-8. Epub 2014 Oct 16.
Aromatase inhibitors are superior to tamoxifen as adjuvant therapy in postmenopausal patients with hormone-responsive breast cancer. We report the follow-up efficacy results from the N-SAS BC 03 trial (UMIN CTRID: C000000056) where anastrozole was compared with tamoxifen as adjuvant therapy in postmenopausal Japanese patients with hormone-responsive early breast cancer. The full analysis set contained 696 patients (anastrozole arm, n = 345; tamoxifen arm, n = 351). The log-rank test was used to compare the two groups in terms of disease-free survival (DFS) and relapse-free survival (RFS); Kaplan-Meier estimates were calculated. The treatment effects were estimated by Cox's proportional hazards model. To examine time-varying effect of hazard ratios, we estimated time-varying hazard ratios at time t [HR(t)] using data from time t up to 12 months. After a median follow-up of 98.5 months, hazard ratios (95% CIs) were 0.90 (0.65-1.24; log-rank p = 0.526) for DFS and 0.83 (0.56-1.23; log-rank p = 0.344) for RFS. Hazard ratios (95% CIs) for DFS and RFS up to 36 months were 0.69 (0.40-1.17) and 0.54 (0.27-1.06) and those after 36 months were 1.06 (0.70-1.59) and 1.05 (0.64-1.73), respectively. Time-varying hazard ratios for both DFS and RFS showed that hazard ratios were initially in favor of anastrozole and approached 1.0 at around 36 months. Superior efficacy of anastrozole to tamoxifen suggested by the initial analysis was not confirmed in the present analysis after a long-term follow-up period. Advantage of anastrozole was the greatest immediately after switching from tamoxifen and then decreased thereafter.
对于激素反应性乳腺癌的绝经后患者，芳香化酶抑制剂作为辅助治疗优于他莫昔芬。我们报告了N-SAS BC 03试验（UMIN CTRID：C000000056）的随访疗效结果，该试验比较了阿那曲唑与他莫昔芬作为日本绝经后激素反应性早期乳腺癌患者的辅助治疗。完整分析集包含696例患者（阿那曲唑组，n = 345；他莫昔芬组，n = 351）。采用对数秩检验比较两组的无病生存期（DFS）和无复发生存期（RFS）；计算Kaplan-Meier估计值。通过Cox比例风险模型估计治疗效果。为了检验风险比的时间变化效应，我们使用从时间t到12个月的数据估计时间t时的时间变化风险比[HR(t)]。在中位随访98.5个月后，DFS的风险比（95%CI）为0.90（0.65-1.24；对数秩p = 0.526），RFS的风险比为0.83（0.56-1.23；对数秩p = 0.344）。至36个月时DFS和RFS的风险比（95%CI）分别为0.69（0.40-1.17）和0.54（0.27-1.06），36个月后分别为1.06（0.70-1.59）和1.05（0.64-1.73）。DFS和RFS的时间变化风险比均显示，风险比最初有利于阿那曲唑，在36个月左右接近1.0。长期随访后的本次分析未证实初始分析所提示的阿那曲唑优于他莫昔芬的疗效。阿那曲唑的优势在从他莫昔芬转换后立即最大，此后逐渐降低。
