Green Marjorie C, Buzdar Aman U, Smith Terry, Ibrahim Nuhad K, Valero Vicente, Rosales Marguerite F, Cristofanilli Massimo, Booser Daniel J, Pusztai Lajos, Rivera Edgardo, Theriault Richard L, Carter Cynthia, Frye Debra, Hunt Kelly K, Symmans W Fraser, Strom Eric A, Sahin Aysegul A, Sikov William, Hortobagyi Gabriel N
The University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd, Box 424, Houston, TX 77030, USA.
J Clin Oncol. 2005 Sep 1;23(25):5983-92. doi: 10.1200/JCO.2005.06.232. Epub 2005 Aug 8.
To determine the impact a change in schedule of paclitaxel administration from once every 3 weeks to frequent administration would have on the pathologic complete response (pCR) rate in the breast and lymph nodes for patients with invasive breast cancer treated with primary systemic chemotherapy (PST).
Patients with clinical stage I-IIIA breast cancer were randomly assigned to receive PST of paclitaxel doses administered either weekly (for a total of 12 doses of paclitaxel) or once every 3 weeks (four cycles), followed by four cycles of fluorouracil/doxorubicin/cyclophosphamide (FAC) in standard doses every 3 weeks. Two different doses of paclitaxel were used based on lymph node status defined by ultrasound and fine needle aspiration. Clinical response and extent of residual disease in the breast and lymph nodes was assessed after completion of all chemotherapy.
A total of 258 patients were randomly assigned to receive doses of paclitaxel administered either weekly or once every 3 weeks, followed by FAC. Of these 258 patients, 110 patients had histologic lymph node involvement and 148 patients had clinical N0 disease. Weekly paclitaxel followed by FAC was administered to 127 patients and once-every-3-weeks paclitaxel followed by FAC was administered to 131 patients. Clinical response to treatment was similar between groups (P = .25). Patients receiving weekly paclitaxel had a higher pCR rate (28.2%) than patients treated with once-every-3-weeks paclitaxel (15.7%; P = .02), with improved breast conservation rates (P = .05).
The change in schedule of paclitaxel from once every 3 weeks to a more frequent administration significantly improved the ability to eradicate invasive cancer in the breast and lymph nodes.
确定将紫杉醇给药方案从每3周一次改为频繁给药，对接受原发性全身化疗（PST）的浸润性乳腺癌患者的乳腺和淋巴结病理完全缓解（pCR）率有何影响。
临床I-IIIA期乳腺癌患者被随机分配接受紫杉醇给药的PST，给药方式为每周一次（共12剂紫杉醇）或每3周一次（四个周期），随后每3周接受四个周期标准剂量的氟尿嘧啶/阿霉素/环磷酰胺（FAC）。根据超声和细针穿刺确定的淋巴结状态使用两种不同剂量的紫杉醇。在所有化疗完成后评估乳腺和淋巴结的临床反应及残留疾病范围。
共有258例患者被随机分配接受每周一次或每3周一次的紫杉醇给药，随后接受FAC。在这258例患者中，110例患者有组织学淋巴结受累，148例患者临床N0期疾病。127例患者接受每周一次紫杉醇后再接受FAC，131例患者接受每3周一次紫杉醇后再接受FAC。两组间治疗的临床反应相似（P = 0.25）。接受每周一次紫杉醇治疗的患者pCR率（28.2%）高于接受每3周一次紫杉醇治疗的患者（15.7%；P = 0.02），保乳率有所提高（P = 0.05）。
紫杉醇给药方案从每3周一次改为更频繁给药显著提高了根除乳腺和淋巴结浸润性癌的能力。
