表阿霉素
医学
唑来膦酸
乳腺癌
内科学
随机对照试验
环磷酰胺
化疗
临床终点
肿瘤科
骨吸收
癌症
胃肠病学
泌尿科
作者
Yoshie Hasegawa,Hirokazu Tanino,Jun Horiguchi,Daishu Miura,Takashi Ishikawa,Mitsuhiro Hayashi,Shintaro Takao,Seung Jin Kim,Keiko Yamagami,Masaru Miyashita,Muneharu Konishi,Yasushi Shigeoka,Masato Suzuki,Tetsuya Taguchi,Tomoyuki Kubota,Kouhei Akazawa,Norio Kohno
出处
期刊:PLOS ONE
[Public Library of Science]
日期:2015-12-03
卷期号:10 (12): e0143643-e0143643
被引量:22
标识
DOI:10.1371/journal.pone.0143643
摘要
Zoledronic acid (ZOL) is a nitrogen-containing bisphosphonate that induces osteoclast apoptosis and inhibits bone resorption by inhibiting the mevalonate pathway. Its benefit for the prevention of skeletal complications due to bone metastases has been established. However, the antitumor efficacy of ZOL, although suggested by multiple preclinical and clinical studies, has not yet been clinically proven. We performed the present randomized Phase 2 trial to investigate the antitumor effect of ZOL with chemotherapy (CT).Asian patients with HER2-negative invasive breast cancer were randomly assigned to either the CT or CT+ZOL (CTZ) group. One hundred and eighty-eight patients were randomized to either the CT group (n = 95) or the CTZ group (n = 93) from March 2010 to April 2012, and 180 patients were assessed. All patients received four cycles of FEC100 (fluorouracil 500 mg/m2, epirubicin 100 mg/m2, and cyclophosphamide 500 mg/m2), followed by 12 cycles of paclitaxel at 80 mg/m2 weekly. ZOL (4 mg) was administered three to four times weekly for 7 weeks to the patients in the CTZ group. The primary endpoint was the pathological complete response (pCR) rate, which was defined as no invasive cancer in the breast tissue specimen. Safety was assessed in all patients who received at least one dose of the study drug.This randomized controlled trial indicated that the rates of pCR in CTZ group (14.8%) was doubled to CT group (7.7%), respectively (one-sided chi-square test, p = 0.068), though the additional efficacy of zoledronic acid was not demonstrated statistically. The pCR rate in postmenopausal patients was 18.4% and 5.1% in the CTZ and CT groups, respectively (one-sided Fisher's exact test, p = 0.071), and that in patients with triple-negative breast cancer was 35.3% and 11.8% in the CTZ and CT groups, respectively (one-sided Fisher's exact test, p = 0.112). Thus the addition of ZOL to neoadjuvant CT has potential anticancer benefits in postmenopausal patients and patients with triple-negative breast cancer. Further investigation is warranted.University Hospital Medical Information Network. UMIN000003261.
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