紫杉醇序贯疗法治疗高危且淋巴结阴性乳腺癌安全有效

背景：蒽环类药物加紫杉醇的序贯疗法改善了可手术的淋巴结阳性的乳腺癌患者的临床结局，但是多数的乳腺癌患者在诊断当时是淋巴结阴性的，紫杉醇序贯疗法在这些患者中的作用尚不清楚。

方法：随机对照临床试验，符合标准的患者纳入研究，随即分配到两个治疗组（FAC x6组和FAC x4wP x8组）中，主要的研究指标为无病生存期，同时观察毒性反应。

结果：两个治疗组（FAC vs FACwP）中最常见的3-4度的毒性反应（每组约为3%）依次为中性粒细胞减少(25%vs 22%)，中性粒细胞减少患者中两组分别有4%和3%的患者同时伴有发热，疲乏(3% vs 8%)，感觉神经病(0 vs 5%)，呕吐(每组4%)。经过中位数为5.3年的随访之后，无病状态的患者比率在两组（FACwP组和FAC组）分别为93%和90%（复发危险比为0.732,95%CI为0.542 ～0.990；log-rank p值50.0423）。

结论：辅助的FACwP化疗方案相对于FAC方案，对于提高高危并淋巴结阴性的乳腺癌患者的无病生存状态有较弱但统计学显著的作用，同时毒性在可控制范围内。

摘要号：LBA1000

题目：NSABP B-38: Definitive analysis of a randomized adjuvant trial comparing dose-dense (DD) AC→paclitaxel (P) plus gemcitabine (G) with DD AC→P and with docetaxel, doxorubicin, and cyclophosphamide (TAC) in women with operable, node-positive breast cancer.

NSABP B-38：剂量密集AC序贯紫杉醇(P)联合吉西他滨(G)对比剂量密集AC序贯紫杉醇(P)以及TAC治疗可手术、淋巴结阳性乳腺癌的临床随机研究最终分析结果

摘要：

Background: The primary aims were to determine whether adjuvant DD AC→PG will be superior to DD AC→P as well as to TAC in DFS and to compare the relative DFS of TAC and DD AC→P. Secondary endpoints include survival and toxicity.

Methods: From Nov 3, 2004 to May 3, 2007, 4894 women were randomized; 1630 to TAC (docetaxel [T] 75 mg/m2, doxorubicin [A] 50 mg/m2, cyclophosphamide [C] 500 mg/m2 q3 wks x 6), 1634 to DD AC→P (A 60 mg/m2 and C 600 mg/m2 q2 wks x 4 followed by P 175 mg/m2 q2 wks x 4), and 1630 to DD AC→PG (A 60 mg/m2 and C 600 mg/m2 q2 wks x 4 → P 175 mg/m2 + G 2000 mg/m2q2 wks x 4). Primary G-CSF support was required and erythropoiesis-stimulating agents (ESA) were used at investigator discretion. 52% were postmenopausal, 65% had 1 - 3 positive nodes, and 80% had HR+ breast cancer. Log-rank tests were used for pair-wise comparisons of the primary (DFS) and secondary (OS) endpoints among the three treatment arms.

Results: With 64 months median follow-up, 5-year DFS in DD AC→PG group was 80.6% compared with 82.2% in DD AC→P group (HR=1.1; p=0.27) and 80.1 % (HR=0.97; p=0.71) in TAC group. 5-year OS was 90.8% in DD AC→PG group as compared with 89.1% (HR=.89; p=0.25) in DD AC→P group and 89.6 % (HR=0.90; p=0.32) in TAC group. HR for DFS and OS of DD AC→P vs. TAC were 0.89 (p=0.14) and 1.01 (p=0.92) respectively. Toxicities for TAC, DD AC→P, DD AC→PG, respectively: febrile neutropenia (Gr 3/4: 9%, 4%, 4% [p<0.001]), sensory neuropathy (Gr 3/4: <1%, 7%, 6% [p<0.001]), diarrhea (Gr 3/4: 8 %, 2%, 2% [p<0.001]). Hgb was <10 in 12%, 26%, 33% with ESA use in 35.2%, 47%, 51.6% and transfusions in 3.7%, 6.3%, 9.4%. Deaths on treatment: N=13, 5, 7 (p=0.2). AML/MDS: N=5, 8, 11. All cycles completed in 91% for TAC and 88% for DD regimens.

Conclusions: Addition of G to DD AC→P did not improve outcomes. No significant differences in efficacy endpoints were identified between DD AC→P and TAC, though toxicity profiles differed.

编辑: xy 作者:丁香园通讯员

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