Zoledronate for patients with invasive residual disease after anthracyclines-taxane-based chemotherapy for early breast cancer - The Phase III NeoAdjuvant Trial Add-oN (NaTaN) study (GBG 36/ABCSG 29).
Zoledronate for patients with invasive residual disease after anthracyclines-taxane-based chemotherapy for early breast cancer - The Phase III NeoAdjuvant Trial Add-oN (NaTaN) study (GBG 36/ABCSG 29).
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DOI：
10.1016/j.ejca.2016.05.015
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发表时间：
2016-09
影响因子：
8.4
通讯作者：
G. Minckwitz;M. Rezai;H. Tesch;J. Huober;B. Gerber;D. Zahm;J. Hilfrich;S. Costa;P. Dubsky;J. Blohmer;C. Denkert;C. Hanusch;C. Jackisch;S. Kümmel;P. Fasching;A. Schneeweiss;S. Paepke;M. Untch;N. Burchardi;K. Mehta;S. Loibl;Austrian Breast
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作者：
G. Minckwitz;M. Rezai;H. Tesch;J. Huober;B. Gerber;D. Zahm;J. Hilfrich;S. Costa;P. Dubsky;J. Blohmer;C. Denkert;C. Hanusch;C. Jackisch;S. Kümmel;P. Fasching;A. Schneeweiss;S. Paepke;M. Untch;N. Burchardi;K. Mehta;S. Loibl;Austrian Breast
背景新辅助化疗（NACT）后出现浸润性残留病的患者被认为患有化疗耐药性乳腺癌。双磷酸盐是一种既定的骨转移治疗方法，作为早期乳腺癌的辅助治疗具有潜在益处。患者和方法在至少四个周期的含蒽环类紫杉烷的 NACT 治疗后出现侵袭性肿瘤残留（ypT1-4 和/或 ypN+）的患者有资格参加新辅助试验附加研究。患者在手术后 3 年内被随机分配接受 4 毫克唑来膦酸盐静脉注射。 5年与观察。前 6 个月每 4 周给予唑来膦酸一次，接下来的 2 年每 3 个月给予一次，最后 2.5 年每 6 个月给予一次。主要目标是无病生存率。结果在中位时间 54.7 个月后，唑来膦酸盐组和观察组之间没有观察到无病生存率存在差异（风险比 [HR] 0.960，95% 置信区间 [CI] 0.709–1.30，对数秩 P= 0.789）。对各个亚组进行了检查，但未确定唑来膦酸盐的治疗效果。 55 岁以上的患者显示 HR 为 0.832，有利于唑来膦酸，但结果并不显着 (P= 0.480)。总生存率也得到了类似的结果，HR 为 1.19（95% CI 0.79–1.79；logrankP= 0.408）。唑来膦酸耐受性良好，未发现新的毒性信号。结论 对于早期乳腺癌新辅助蒽环类-紫杉烷类化疗后未达到病理完全缓解的患者，唑来膦酸后新辅助治疗并不能改善预后。
BackgroundPatients with invasive residual disease after neoadjuvant chemotherapy (NACT) are considered to have chemo-resistant breast cancer. Bisphosphonates are an established treatment for bone metastases and are of potential benefit as adjuvant treatment in early breast cancer.Patients and methodsPatients who had invasive tumour residuals (ypT1-4 and/or ypN+) after a minimum of four cycles of anthracycline-taxane-containing NACT were eligible for the NeoAdjuvant Trial Add-oN study. Patients were randomised within 3 years after surgery to receive zoledronate 4 mg i.v. for 5 years versus observation. Zoledronate was given every 4 weeks for the first 6 months, every 3 months for the following 2 years, and every 6 months for the last 2.5 years. Primary objective was disease-free survival.ResultsAfter a median time of 54.7 months no difference in disease-free survival was observed between the zoledronate and observation groups (hazard ratio [HR] 0.960, 95% confidence interval [CI] 0.709–1.30, log rankP= 0.789). Various subgroups were examined without identifying a treatment effect of zoledronate. Patients over 55 years of age showed a HR of 0.832 in favour of zoledronate, but the result was not significant (P= 0.480). A similar result was obtained for overall survival with a HR of 1.19 (95% CI 0.79–1.79; log rankP= 0.408). Zoledronate was well tolerated and no new toxicity signal was identified.ConclusionPostneoadjuvant treatment with zoledronate does not improve outcome in patients without pathological complete response after neoadjuvant anthracycline-taxane-based chemotherapy for early breast cancer.