Ishikawa Takashi, Akazawa Kouhei, Hasegawa Yoshie, Tanino Hirokazu, Horiguchi Jun, Miura Daishu, Hayashi Mitsuhiro, Kohno Norio
Department of Breast Surgery and Oncology, Tokyo Medical University, Tokyo, Japan.
Department of Medical Informatics, Niigata University Medical and Dental Hospital, Niigata, Japan.
J Surg Res. 2017 Dec;220:46-51. doi: 10.1016/j.jss.2017.05.066. Epub 2017 Jul 26.
A randomized phase 2 trial in women with HER2-negative breast cancer has shown that adding zoledronic acid (ZOL) to neoadjuvant chemotherapy (CT) has potential anticancer benefits in postmenopausal and triple-negative (TN) breast cancer patients. We report the data for the secondary end point of disease-free survival (DFS).
Patients were randomly assigned to receive CT or CT + ZOL (CT-Z). All patients received four cycles of FEC100 followed by 12 cycles of paclitaxel weekly. ZOL (4 mg) was administered 3-4 times weekly for 7 wk to the CT-Z group patients. The primary end point was pathologic complete response (pCR). The secondary end points were the clinical response rates, rate of breast-conserving surgery, safety, and DFS.
Of the 188 patients enrolled, 95 were assigned to the CT group and 93 to the CT-Z group. DFS and overall survival were analyzed in 92 and 88 patients with the mean times of 5.15 y and 5.38 y, respectively. The 3-y DFS rate was 84.6% in the CT group and 90.8% in the CT-Z group (P = 0.188). The particular benefit from ZOL for the neoadjuvant CT seen as improvement of the pCR rate was indicated in the 3-y DFS period for TN cancer cases (CT versus CT-Z: 70.6% versus 94.1%) but not for postmenopausal cases.
ZOL did not improve DFS when combined with CT. However, the improvement of the pCR rate translated to survival outcomes in TN breast cancer. The short-term application of ZOL may not be sufficient to improve the outcome in postmenopausal patients.
一项针对HER2阴性乳腺癌女性患者的随机2期试验表明，在新辅助化疗（CT）中添加唑来膦酸（ZOL）对绝经后和三阴性（TN）乳腺癌患者具有潜在的抗癌益处。我们报告无病生存期（DFS）这一次要终点的数据。
患者被随机分配接受CT或CT + ZOL（CT-Z）治疗。所有患者接受4个周期的FEC100，随后每周接受12个周期的紫杉醇治疗。CT-Z组患者每周3至4次给予ZOL（4mg），共7周。主要终点是病理完全缓解（pCR）。次要终点是临床缓解率、保乳手术率、安全性和DFS。
在纳入的188例患者中，95例被分配到CT组，93例被分配到CT-Z组。分别对92例和88例患者进行DFS和总生存期分析，平均时间分别为5.15年和5.38年。CT组的3年DFS率为84.6%，CT-Z组为90.8%（P = 0.188）。在TN癌症病例的3年DFS期内，ZOL对新辅助CT的特别益处表现为pCR率的提高（CT组与CT-Z组：70.6%对94.1%），但绝经后病例未出现这种情况。
ZOL与CT联合使用时并未改善DFS。然而，pCR率的提高转化为TN乳腺癌的生存结果。ZOL的短期应用可能不足以改善绝经后患者的结局。
