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转移性乳腺癌患者接受高剂量化疗联合造血干细胞移植:法国多中心随机CMA/PEGASE 04方案的最终结果

High-dose chemotherapy with haematopoietic stem cell transplantation for metastatic breast cancer patients: final results of the French multicentric randomised CMA/PEGASE 04 protocol.

作者信息

Lotz Jean-Pierre, Curé Hervé, Janvier Maud, Asselain Bernard, Morvan François, Legros Michel, Audhuy Bruno, Biron Pierre, Guillemot Maryse, Goubet Jocelyne, Laadem Abderrahmane, Cailliot Christian, Maignan Christine Le, Delozier Thierry, Glaisner Sylvie, Maraninchi Dominique, Roché Henri, Gisselbrecht Christian

机构信息

Tenon and Saint-Louis Hospitals, Assistance Publique-Hôpitaux de Paris, 3 avenue Victoria, 75003 Paris, France.

出版信息

Eur J Cancer. 2005 Jan;41(1):71-80. doi: 10.1016/j.ejca.2004.09.006.

DOI:10.1016/j.ejca.2004.09.006
PMID:15617992
Abstract

The aim of our study was to evaluate the impact on time to progression (TTP) and overall survival (OS) of high-dose chemotherapy (HD-CT) over conventional CT in metastatic breast cancer patients. Between 09/92 and 12/96, 61 patients with chemosensitive metastatic breast cancer were randomised between HD-CT using the CMA regimen (Mitoxantrone, Cyclophosphamide, Melphalan) applied as consolidation (32 patients) or maintenance CT (29 patients). At randomisation, 13 patients were in complete response, 47 in partial response and one had stable disease. The median TTPs from randomisation were 6 and 12 months in the standard and intensive groups, respectively (P < 0.0056), with a relapse rate of 86.2% vs. 62.5% at 2 years, and 100% vs. 81.3% at 5 years. The median OS times were 19.3 and 44.1 months, with an OS rate of 13.8% vs. 36.8% at 5 years (P < 0.0294). The CMA regimen could prolong the TTP of patients with chemosensitive metastatic breast cancer. Further studies are needed to determine if this translates into an effect on OS.

摘要

我们研究的目的是评估在转移性乳腺癌患者中,高剂量化疗(HD-CT)相较于传统化疗(CT)对疾病进展时间(TTP)和总生存期(OS)的影响。在1992年9月至1996年12月期间,61例化疗敏感的转移性乳腺癌患者被随机分为两组,一组接受使用CMA方案(米托蒽醌、环磷酰胺、美法仑)的高剂量化疗作为巩固治疗(32例患者),另一组接受维持性化疗(29例患者)。随机分组时,13例患者完全缓解,47例部分缓解,1例病情稳定。从随机分组开始计算,标准治疗组和强化治疗组的中位TTP分别为6个月和12个月(P < 0.0056),2年时的复发率分别为86.2%和62.5%,5年时分别为100%和81.3%。中位OS时间分别为19.3个月和44.1个月,5年时的OS率分别为13.8%和36.8%(P < 0.0294)。CMA方案可延长化疗敏感的转移性乳腺癌患者的TTP。需要进一步研究以确定这是否会转化为对OS的影响。

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