Clinical results in 2001 show high dose therapy and hematopoietic progenitor cell transplantation as a therapeutic option for breast cancer.
Clinical results in 2001 show high dose therapy and hematopoietic progenitor cell transplantation as a therapeutic option for breast cancer.
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2001年的临床结果表明，高剂量治疗和造血祖细胞移植是乳腺癌的一种治疗选择。
作者：
P. Pedrazzoli;S. Siena
我们回顾并评论了迄今为止报道的随机研究数据，并试图指出这个故事的下一步可能是什么。我们还建议可能是什么态度，我们应该采取在我们的日常临床实践。可手术的高危乳腺癌（辅助治疗）在20世纪90年代早期，来自几个中心和欧洲和美国登记处的II期研究显示，移植后4-5年，高危可手术乳腺癌患者的无病生存率（DFS）为60-65%。13-15由于这些数据似乎比标准剂量治疗后的数据更好，几个中心和合作小组开始了III期试验，将移植与最佳常规治疗进行比较。荷兰癌症研究所和MD安德森癌症中心的两项早期III期随机研究已经发表。16，17 HDC没有任何优势。然而，这两项研究都旨在检测高剂量与常规辅助治疗之间无复发生存期（RFS）的乐观30%差异，并且太小（分别随机化81和78例患者），无法评估无法排除的较小差异。18在这方面，值得注意的是，在随后的荷兰癌症研究所III期研究中，HDC组在研究的前284例患者中的总生存率（OS）获益约为10%，详见下文。在排除了一项误导性和不可靠的试验后，迄今为止有11项随机研究（5项）在2000年和2001年ASCO会议上发表或介绍了大量患者招募（表1）。斯堪的纳维亚研究小组多中心试验19随机分配了525名高风险原发性BC患者接受3个周期的氟尿嘧啶（5-FU）治疗，环磷酰胺-最近美国临床肿瘤学会（ASCO）评估乳腺癌（BC）自体造血祖细胞移植（APCT）高剂量治疗（HDC）的III期试验的报告会议促使我们对他们的结果发表评论，并审查以前可用的临床数据。在过去的十年中，我们观察到临床医生对HDC与APCT治疗BC的热情非常特殊的高潮和低谷。基于有利的实验室和临床指标，1，2在20世纪80年代开始的HDC早期试验表明，HDC与APCT可能对可手术的高风险和转移性BC的病程产生有利影响。3项II期研究在医生和患者中产生了积极的期望，以至于HDC与APCT一起被广泛用作治疗选择。
we review and comment on the data from ran-domized studies so far reported and try to indicate what could be next in this story. We also suggest what may be the attitude we should take in our everyday clinical practice. Operable, high-risk breast cancer (adjuvant therapy) In the early 1990s phase II studies from several centers and the European and American registries showed a 60-65% disease-free survival (DFS) for patients with high-risk operable BC at 4-5 years post-transplant. 13-15 Since these data appeared better than those following standard dose therapy , several centers and cooperative groups began phase III trials, comparing transplant to best available conventional therapy. Two early phase III ran-domized studies from the Netherlands Cancer Institute and the MD Anderson Cancer Center have been published. 16,17 No advantage of HDC has emerged. However, both studies were designed to detect an optimistic 30% difference in relapse-free survival (RFS) between high-dose versus conventional adjuvant therapy and were too small (81 and 78 patients randomized, respectively) to assess smaller differences that cannot be excluded. 18 In this regard it is interesting to note that, in the subsequent larger Netherlands Cancer Institute phase III study, the HDC arm gave an overall survival (OS) benefit of about 10% in the first 284 patients studied, as detailed below in this article. After excluding a misleading and unreliable trial, 11 to date 5 randomized studies with large patient accrual have been either published or presented at the 2000 and 2001 ASCO Meetings (Table 1). The Scandinavian Study Group multicenter trial 19 randomized 525 high risk primary BC patients to receive 3 cycles of fluorouracil (5-FU), cyclophos-P resentations of phase III trials evaluating high dose therapy (HDC) with autologous hemato-poietic progenitor cell transplantation (APCT) for breast cancer (BC) at the recent American Society of Clinical Oncology (ASCO) Meetings prompted us to comment on their results and review previously available clinical data. In the last decade, we have observed very peculiar highs and lows in the enthusiasm of clinicians for HDC with APCT for treatment of BC. Early trials of HDC, based on favorable laboratory and clinical indicators, 1,2 initiated in the 1980s, suggested that HDC with APCT might favorably affect the course of operable high-risk and metastatic BC. 3 Phase II studies created positive expectations among physicians and their patients, to such an extent that HDC with APCT became widely used as a therapeutic option also …
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常规剂量化疗与高剂量化疗联合自体造血干细胞移植治疗转移性乳腺癌的经济分析。
DOI：
10.1038/sj.bmt.1703795
发表时间：
2003
期刊：
Bone marrow transplantation.
影响因子：
--
作者：
Schulman,KA;Stadtmauer,EA;Reed,SD;Glick,HA;Goldstein,LJ;Pines,JM;Jackman,JA;Suzuki,S;Styler,MJ;Crilley,PA;Klumpp,TR;Mangan,KF;Glick,JH
通讯作者：
Glick,JH
大剂量环磷酰胺、塞替派和羟基脲联合自体造血干细胞拯救：早期转移性乳腺癌的有效巩固化疗方案。
影响因子：
4.8
作者：
Vaughan,WP;Reed,EC;Edwards,B;Kessinger,A
通讯作者：
Kessinger,A
对有反应的转移性乳腺癌女性进行紫杉醇、美法仑、环磷酰胺、塞替派和卡铂序贯高剂量化疗以及外周血祖细胞支持的 II 期试验。
影响因子：
4.8
作者：
Vahdat,LT;Balmaceda,C;Papadopoulos,K;Frederick,D;Donovan,D;Sharpe,E;Kaufman,E;Savage,D;Tiersten,A;Nichols,G;Haythe,J;Troxel,A;Antman,K;Hesdorffer,CS
通讯作者：
Hesdorffer,CS
乳腺癌造血祖细胞移植：现状和未来方向。
影响因子：
2.4
作者：
Lazarus,HM
通讯作者：
Lazarus,HM
高剂量白消安和环磷酰胺随后对晚期乳腺癌患者进行自体移植。
影响因子：
4.8
作者：
Demirer,T;Buckner,CD;Appelbaum,FR;Clift,R;Storb,R;Myerson,D;Lilleby,K;Rowley,S;Bensinger,WI
通讯作者：
Bensinger,WI