Patient selection in high-dose chemotherapy trials: relevance in high-risk breast cancer.
Patient selection in high-dose chemotherapy trials: relevance in high-risk breast cancer.
复制标题
高剂量化疗试验中的患者选择：与高风险乳腺癌的相关性。
DOI：
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发表时间：
1997
影响因子：
45.3
通讯作者：
H. Cortés
中科院分区：
文献类型：
--
作者：
R. García;M. Hidalgo;L. Paz;J. Calzas;H. Gómez;J. Guerra;R. Hitt;J. Hornedo;R. Colomer;H. Cortés
目的
目的：评价目前高剂量巩固化疗(HDCT)试验中所使用的选择标准对接受常规辅助化疗的高危乳腺癌患者预后的影响。
患者和方法
从1975年到1995年，我所收治的265例乳腺癌患者中，有10个或更多腋窝淋巴结阳性。在这些患者中，171人接受了标准辅助联合化疗，但没有接受HDCT巩固，并且是我们研究的对象。128名患者符合血液支持HDCT的标准选择标准(60岁，没有明显的伴随疾病，辅助治疗期间没有进展)，而43名患者没有。以无病生存期(DFS)和总生存期(OS)为终点分析临床结果。为了评估HDCT的短期疗效，我们还评估了过去4年中符合HDCT标准并在辅助化疗后实际接受HDCT治疗的39名患者的结果。
结果
平均随访时间为4.4年(从0.7到17.2年)，171名患者中有112人复发，87人死亡。估计5年DFS为32.3%，OS为49.4%。符合HDCT标准的患者的DFS(5年时为36.6%)显著高于不符合HDCT标准的患者(5年时为15.8%；P<；0.05)。符合HDCT标准的患者的OS(5年时为55.4%)也明显高于不符合HDCT标准的患者(5年时为22.7%；P<；0.01)。我们进行了多变量分析，以调整其他潜在的预后因素，发现符合HDCT标准和接受过局部放疗是唯一显著的DFS和OS的独立预测因素。最后，我们比较了128名符合HDCT标准并只接受常规辅助化疗的患者和39名符合标准并实际接受HDCT治疗的患者的结果，我们没有观察到这些组之间DFS或OS的显著差异。
结论
符合HDCT纳入标准是高危乳腺癌患者预后良好的独立指标。根据这些标准选择患者可能至少部分解释了高危乳腺癌非随机化辅助HDCT试验有希望的短期结果。
PURPOSE
To evaluate the impact of the selection criteria that are used in current high-dose consolidation chemotherapy (HDCT) trials on the outcome of high-risk breast cancer patients treated with conventional adjuvant chemotherapy.
PATIENTS AND METHODS
From 1975 to 1995, 265 breast cancer patients at our institution showed involvement of ten or more positive axillary lymph nodes. Of these, 171 received standard adjuvant combination chemotherapy, but not HDCT consolidation, and were the subjects of our study. One hundred twenty-eight patients met the standard selection criteria for HDCT with hematological support (< 60 years, no significant concomitant disease, and no progression during adjuvant treatment), whereas 43 did not. Clinical outcome was analyzed by using disease-free survival (DFS) and overall survival (OS) as endpoints. To provide an assessment of the short-term efficacy of HDCT, we also evaluated the outcome in a cohort of 39 patients from the last 4 years who met the criteria for, and were actually treated with, HDCT after adjuvant chemotherapy.
RESULTS
With a median follow-up of 4.4 years (range, 0.7 to 17.2 years), 112 of the 171 patients have had a relapse, and 87 have died. The estimated 5-year DFS was 32.3%, and OS was 49.4%. DFS was significantly higher for patients who met the HDCT criteria (36.6% at 5 years) than for those who did not (15.8% at 5 years; P < .05). OS was also significantly more favorable in patients meeting HDCT criteria (55.4% at 5 years) than in patients not meeting HDCT criteria (22.7% at 5 years; P < .01). We performed a multivariate analysis to adjust for other potential prognostic factors and found that meeting the HDCT criteria and having undergone locoregional radiotherapy were the only significant independent predictors for DFS and OS. Finally, we compared the outcome of the 128 patients who met the HDCT criteria and were treated with conventional adjuvant chemotherapy only with that of the 39 patients who met the criteria and who actually underwent HDCT, and we did not observe significant differences in the DFS or OS between these groups.
CONCLUSIONS
Meeting HDCT inclusion criteria is an independent indicator of favorable prognosis in high-risk breast cancer patients. The selection of patients by these criteria may explain, at least in part, the promising short-term results of nonrandomized adjuvant HDCT trials in high-risk breast cancer.
对可手术淋巴结阳性乳腺癌女性进行五种和三种药物化疗和化学免疫治疗的随机试验。
DOI：
10.1200/jco.1983.1.2.138
发表时间：
1983
期刊：
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
影响因子：
--
作者：
Tormey,DC;Weinberg,VE;Holland,JF;Weiss,RB;Glidewell,OJ;Perloff,M;Falkson,G;Falkson,HC;Henry,PH;Leone,LA
通讯作者：
Leone,LA
影响因子：
158.5
作者：
WOOD, WC;BUDMAN, DR;HENDERSON, IC
通讯作者：
HENDERSON, IC