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一项针对符合单周期入选标准的转移性乳腺癌患者进行的两周期高剂量化疗联合自体干细胞支持的II期研究。

A phase II study of two cycles of high-dose chemotherapy with autologous stem cell support in patients with metastatic breast cancer who meet eligibility criteria for a single cycle.

作者信息

Bashey A, Corringham S, Garrett J, Lane T A, Gilpin E A, Corringham R E, Law P, Ho A D

机构信息

Blood and Marrow Transplantation Program, University of California, San Diego, La Jolla, CA 92093-7621, USA.

出版信息

Bone Marrow Transplant. 2000 Mar;25(5):519-24. doi: 10.1038/sj.bmt.1702172.

DOI:10.1038/sj.bmt.1702172
PMID:10713629
Abstract

Multi-cycle high-dose chemotherapy with autologous stem cell support (HDC-ASCS) may improve the results obtained with single-cycle HDC-ASCS in metastatic breast cancer (MBC). However, the tolerability and efficacy of additional cycles of HDC-ASCS in patients selected using standard eligibility criteria for single cycle HDC-ASCS is uncertain. Twenty-nine patients with MBC and a CR or PR to induction chemotherapy were selected by standard institutional eligibility criteria for single-cycle HDC-ASCS. Cycle 1 HDC-ASCS (cyclophosphamide 6 g/m2; mitoxantrone 70 mg/m2; carboplatin 800 mg/m2) was followed by a planned second cycle (etoposide 1.6 g/m2; thiotepa 800 mg/m2; carboplatin 800 mg/m2 modulated by tamoxifen 120 mg/m2/day x 5 days) with a median interval of 3.2 months. CR rate was 20% after induction chemotherapy and 33% and 54% after HDC cycles I and II, respectively. Sixteen patients (55%) failed to complete HDC cycle II within 200 days because of disease progression, toxicity, inadequate stem cell collection, insurance denials or patient choice. Median progression-free survival (PFS) for all 29 patients entered is 301 days from date of HDC cycle I and actuarial PFS at 2 years is 35%. For the 13 patients who received the two cycles of HDC-ASCS, actuarial PFS at 2 years was 54% (P = NS compared to those receiving only one cycle). These data show that a second cycle of full-dose intensity HDC-ASCS may increase the proportion of patients with MBC that achieve CR and may increase PFS. However, a large proportion of patients that complete HDC-ASCS cycle I may fail to proceed to cycle II in a timely fashion. Bone Marrow Transplantation (2000) 25, 519-524.

摘要

多周期高剂量化疗联合自体干细胞支持(HDC - ASCS)可能会改善转移性乳腺癌(MBC)单周期HDC - ASCS的治疗效果。然而,对于使用单周期HDC - ASCS标准入选标准所选择的患者,额外周期的HDC - ASCS的耐受性和疗效尚不确定。29例对诱导化疗达到完全缓解(CR)或部分缓解(PR)的MBC患者,通过单周期HDC - ASCS的标准机构入选标准进行选择。第1周期HDC - ASCS(环磷酰胺6 g/m²;米托蒽醌70 mg/m²;卡铂800 mg/m²)之后计划进行第2周期(依托泊苷1.6 g/m²;噻替派800 mg/m²;卡铂800 mg/m²,由他莫昔芬120 mg/m²/天×5天进行调整),中位间隔时间为3.2个月。诱导化疗后的CR率为20%,HDC第1周期和第2周期后的CR率分别为33%和54%。16例患者(55%)由于疾病进展、毒性、干细胞采集不足、保险拒绝或患者选择等原因,未能在200天内完成HDC第2周期。所有入组的29例患者从HDC第1周期开始计算的中位无进展生存期(PFS)为301天,2年的精算PFS为35%。对于接受两个周期HDC - ASCS的13例患者,2年的精算PFS为54%(与仅接受一个周期的患者相比,P =无显著性差异)。这些数据表明,全剂量强度的HDC - ASCS第2周期可能会增加达到CR的MBC患者比例,并可能增加PFS。然而,很大一部分完成HDC - ASCS第1周期的患者可能无法及时进入第2周期。《骨髓移植》(2000年)25卷,519 - 524页 。

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