Smith Ian C, Heys Steven D, Hutcheon Andrew W, Miller Iain D, Payne Simon, Gilbert Fiona J, Ah-See Antoinne K, Eremin Oleg, Walker Leslie G, Sarkar Tarun K, Eggleton S Peter, Ogston Keith N
Department of Academic Radiology, University of Aberdeen, Foresterhill, Aberdeen, Scotland, United Kingdom.
J Clin Oncol. 2002 Mar 15;20(6):1456-66. doi: 10.1200/JCO.2002.20.6.1456.
To compare the efficacy of neoadjuvant (NA) docetaxel (DOC) with anthracycline-based therapy and determine the efficacy of NA DOC in patients with breast cancer initially failing to respond to anthracycline-based NA chemotherapy (CT).
Patients with large or locally advanced breast cancer received four pulses of cyclophosphamide 1,000 mg/m(2), doxorubicin 50 mg/m(2), vincristine 1.5 mg/m(2), and prednisolone 40 mg (4 x CVAP) for 5 days. Clinical tumor response was assessed. Those who responded (complete response [CR] or partial response [PR]) were randomized to receive further 4 x CVAP or 4 x DOC (100 mg/m(2)). All nonresponders received 4 x DOC.
One hundred sixty-two patients were enrolled; 145 patients completed eight cycles of NA CT. One hundred two patients (66%) achieved a clinical response (PR or CR) after 4 x CVAP. After randomization, 50 patients received 4 x CVAP and 47 patients received 4 x DOC. In patients who received eight cycles of CT, the clinical CR (cCR) and clinical PR (cPR) (94% v 66%) and pathologic CR (pCR) (34% v 16%) response rates were higher (P =.001 and P =.04) in those who received further DOC. Intention-to-treat analysis demonstrated cCR and cPR (85% v 64%; P =.03) and pCR (31% v 15%; P =.06). Axillary lymph node examination revealed residual tumor in 33% of patients who received 8 x CVAP and 38% of patients who received further DOC. In patients who failed to respond to the initial CVAP, 4 x DOC resulted in a cCR and cPR rate of 55% and a pCR rate of 2%. Forty-four percent of these patients had residual tumor within axillary lymph nodes.
NA DOC resulted in substantial improvement in responses to DOC.
比较新辅助（NA）多西他赛（DOC）与蒽环类药物为基础的治疗的疗效，并确定NA DOC对最初对蒽环类药物为基础的新辅助化疗（CT）无反应的乳腺癌患者的疗效。
患有大型或局部晚期乳腺癌的患者接受4个疗程的环磷酰胺1000mg/m²、阿霉素50mg/m²、长春新碱1.5mg/m²和泼尼松龙40mg（4×CVAP），持续5天。评估临床肿瘤反应。有反应的患者（完全缓解[CR]或部分缓解[PR]）被随机分配接受进一步的4×CVAP或4×DOC（100mg/m²）。所有无反应者接受4×DOC。
162例患者入组；145例患者完成了8个周期的NA CT。102例患者（66%）在4×CVAP后达到临床反应（PR或CR）。随机分组后，50例患者接受4×CVAP，47例患者接受4×DOC。在接受8个周期CT的患者中，接受进一步DOC的患者的临床完全缓解（cCR）和临床部分缓解（cPR）（94%对66%）以及病理完全缓解（pCR）（34%对16%）反应率更高（P = 0.001和P = 0.04）。意向性分析显示cCR和cPR（85%对64%；P = 0.03）以及pCR（31%对15%；P = 0.06）。腋窝淋巴结检查显示，接受8×CVAP的患者中有33%以及接受进一步DOC的患者中有38%存在残留肿瘤。在对初始CVAP无反应的患者中，4×DOC导致cCR和cPR率为55%，pCR率为2%。这些患者中有44%在腋窝淋巴结内有残留肿瘤。
NA DOC导致对DOC的反应有实质性改善。
