首页> 美国卫生研究院文献>OncoTargets and therapy >Comparison of the effectiveness and toxicity of neoadjuvant chemotherapy regimens capecitabine/epirubicin/cyclophosphamide vs 5-fluorouracil/epirubicin/cyclophosphamide followed by adjuvant capecitabine/docetaxel vs docetaxel in patients with operable breast cancer
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Comparison of the effectiveness and toxicity of neoadjuvant chemotherapy regimens capecitabine/epirubicin/cyclophosphamide vs 5-fluorouracil/epirubicin/cyclophosphamide followed by adjuvant capecitabine/docetaxel vs docetaxel in patients with operable breast cancer

机译:在可手术乳腺癌患者中新辅助化疗方案卡培他滨/厄比霉素/环磷酰胺与5-氟尿嘧啶/厄比霉素/环磷酰胺再辅以卡培他滨/多西他赛与多西他赛的疗效和毒性比较

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摘要

The aim of this study was to compare the effectiveness and toxicity of neoadjuvant chemotherapy regimens, xeloda/epirubicin/cyclophosphamide (XEC) vs 5-fluorouracil/epirubicin/cyclophosphamide (FEC), followed by adjuvant chemotherapy regimens, capecitabine/taxotere (XT) vs taxotere (T), in axillary lymph node (LN)-positive early-stage breast cancer. In this randomized, Phase III trial, 137 patients with operable primary breast cancer (T2-0, N0-1) who were tested axillary LN positive through aspiration biopsy of axillary LNs were randomized (1:1) to four 3-weekly cycles of XEC or FEC. Patients underwent surgery within 4–6 weeks after the fourth cycle, followed by four adjuvant cycles of 3-weekly XT or T. The primary end point was tumor pathological complete response. Toxicity profiles were secondary objectives. In total, 131 patients had clinical and radiological evaluation of response and underwent surgery. Treatment with XEC led to an increased rate of pathological complete response in primary tumor (18% vs 6%, respectively, P=0.027) and objective remission rate (87% vs 73%, P=0.048) compared to FEC. Clinical complete response occurred in 20% and 7% for XEC and FEC, respectively. Compared to FEC, XEC was associated with more hand-foot syndrome (57% vs 11%, P<0.001) and 3/4 grade nausea/vomiting/diarrhea (30% vs 14%, P=0.034) but less phlebitis (3% vs 14%, P=0.035). XT and T adjuvant chemotherapy regimens were well tolerated: treatment-related 3/4 grade adverse events occurred in 28% and 17% of patients receiving XT and T, respectively.
机译:这项研究的目的是比较新辅助化疗方案希罗达/厄比霉素/环磷酰胺(XEC)与5-氟尿嘧啶/厄比霉素/环磷酰胺(FEC)的有效性和毒性,然后比较辅助化疗方案卡培他滨/紫杉醇(XT)与腋窝淋巴结(LN)阳性的早期乳腺癌中的泰索帝(T)。在这项随机的III期临床试验中,通过腋窝LN穿刺活检对137例可手术的原发性乳腺癌(T2-0,N0-1)患者进行了腋窝LN阳性检测,这些患者被随机分配(1:1)到四个3周周期XEC或FEC。患者在第四个周期后的4–6周内接受手术,随后是四个辅助周期,每个周期为3周XT或T。主要终点是肿瘤病理完全缓解。毒性概况是次要目标。共有131例患者接受了临床和放射学评估,并接受了手术。与FEC相比,XEC治疗导致原发性肿瘤的病理完全缓解率(分别为18%vs 6%,P = 0.027)和客观缓解率(87%vs 73%,P = 0.048)增加。 XEC和FEC的临床完全缓解率分别为20%和7%。与FEC相比,XEC与手足综合征相关性更高(57%对11%,P <0.001)和3/4级恶心/呕吐/腹泻(30%对14%,P = 0.034)但静脉炎较少(3 %vs 14%,P = 0.035)。 XT和T辅助化疗方案耐受性良好:接受XT和T的患者分别发生与治疗相关的3/4级不良事件,分别占28%和17%。

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