多柔比星联合培美曲塞序贯多西他赛与多柔比星联合环磷酰胺序贯多西他赛新辅助治疗早期乳腺癌的随机 II 期临床试验。
A randomized phase II trial of doxorubicin plus pemetrexed followed by docetaxel versus doxorubicin plus cyclophosphamide followed by docetaxel as neoadjuvant treatment of early breast cancer.
机构信息
Department of Gynecology and Obstetrics, National Center for Tumor Diseases, University of Heidelberg, Heidelberg, Germany.
Department of Gynecology and Obstetrics, National Center for Tumor Diseases, University of Heidelberg, Heidelberg, Germany.
出版信息
Ann Oncol. 2011 Mar;22(3):609-617. doi: 10.1093/annonc/mdq400. Epub 2010 Aug 23.
BACKGROUND
Neoadjuvant systemic therapy (NST) before surgery is a standard option for patients with early breast cancer (EBC) that allows in vivo chemosensitivity testing. Given the promising activity of pemetrexed plus doxorubicin in metastatic breast cancer, it was reasonable to evaluate the utility of this combination as part of an NST regimen in EBC.
PATIENTS AND METHODS
Patients with untreated operable T2-T4a-c N0-2 M0 breast cancer were randomly assigned to receive either four cycles of pemetrexed 500 mg/m(2) plus doxorubicin 60 mg/m(2) every 3 weeks (q3w) followed by four cycles of docetaxel 100 mg/m(2) q3w (AP-D) or four cycles of doxorubicin 60 mg/m(2) plus cyclophosphamide 600 mg/m(2) q3w followed by four cycles of docetaxel 100 mg/m(2) q3w (AC-D). Surgery was carried out within 2 months after last chemotherapy. Primary end point was pathological complete response (pCR) rate in the breast. Secondary end points included clinical response rate, rate of histologically negative axillary lymph nodes, toxicity, and disease-free survival.
RESULTS
From September 2005 to August 2007, 257 patients were randomly allocated to 17 sites. Median age was 48 and 49 years for AP-D and AC-D, respectively. Overall pCR rates were 16.5% for AP-D and 20.2% for AC-D. With AP-D, pCR rate was 17.8% for hormone receptor (HR)-negative patients and 15.9% for HR-positive patients. With AC-D, pCR rates were 42.9% and 7.8% for HR-negative and HR-positive patients, respectively. Clinical response rates were 59.5% in the AP-D group and 68.1% in the AC-D group. The rate of histologically negative axillary lymph nodes was 53% in both groups. Both treatments were well tolerated. Median disease-free survival is currently not mature.
CONCLUSIONS
AP-D and AC-D are well tolerated and active as NST in EBC. Of note, AC-D had a higher pCR rate in HR-negative tumors, whereas AP-D had more activity if HRs were expressed.
背景
新辅助全身治疗（NST）在手术前是早期乳腺癌（EBC）患者的标准选择，可进行体内化疗敏感性测试。鉴于培美曲塞联合多柔比星在转移性乳腺癌中的良好活性，评估该联合方案作为 EBC 中 NST 方案的一部分具有实用性是合理的。
患者和方法
未经治疗的可手术 T2-T4a-c N0-2 M0 乳腺癌患者随机分配接受每 3 周（q3w）接受 4 个周期培美曲塞 500mg/m²加多柔比星 60mg/m²（AP-D）或 4 个周期多柔比星 60mg/m²加环磷酰胺 600mg/m²（AC-D），然后接受 4 个周期多西他赛 100mg/m²q3w。手术在最后一次化疗后 2 个月内进行。主要终点是乳房的病理完全缓解（pCR）率。次要终点包括临床缓解率、腋窝淋巴结病理阴性率、毒性和无病生存。
结果
2005 年 9 月至 2007 年 8 月，257 名患者被随机分配到 17 个站点。中位年龄分别为 AP-D 组 48 岁和 AC-D 组 49 岁。AP-D 的总体 pCR 率为 16.5%，AC-D 为 20.2%。AP-D 组中激素受体（HR）阴性患者的 pCR 率为 17.8%，HR 阳性患者的 pCR 率为 15.9%。AC-D 组中 HR 阴性和 HR 阳性患者的 pCR 率分别为 42.9%和 7.8%。AP-D 组的临床缓解率为 59.5%，AC-D 组为 68.1%。两组腋窝淋巴结病理阴性率均为 53%。两种治疗方法均耐受良好。无病生存的中位时间目前尚未成熟。
结论
AP-D 和 AC-D 作为 EBC 的 NST 方案耐受性良好且有效。值得注意的是，AC-D 在 HR 阴性肿瘤中具有更高的 pCR 率，而 AP-D 在 HR 表达时具有更高的活性。
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