乳腺癌相关生物学指标对紫杉类药物治疗晚期乳腺癌疗效预测作用分析

目的:回顾性研究雌激素受体(ER)、p53、bcl-2和mdr-1对乳腺癌应用紫杉类药物化疗疗效的预测作用。方法:182例晚期乳腺癌患者应用紫杉类化疗,其中单药紫杉醇组37例,单药泰索帝组22例,紫杉醇联合组78例,泰索帝联合组45例。应用免疫组化的方法对所有患者的ER、p53、bcl-2和mdr-1生物学指标在蛋白水平进行检测。结果:KPS评分、解救情况以及既往蒽环类及转移部位多少对紫杉类药物疗效均无预测作用。ER阳性患者有效率为33.01%(34/103),ER阴性患者有效率为50·63%(40/79),两组相比差异有统计学意义,χ2=5·755,P=0·022;而p53、bcl-2、mdr-1等阳性组与阴性组有效率之间相比,差异无统计学意义(p53χ2=0·004,P=0·950;bcl-2χ2=0·651,P=0·451;mdr-1χ2=0·177,P=0·751;)。多因素分析显示,ER阳性差异仍有统计学意义,P=0·027。而KPS评分、既往应用蒽环类药物、转移部位数目、差异均无统计学意义。结论:ER阴性对紫杉类药物的疗效可能有预测作用,而p53、bcl-2和mdr-1对紫杉类药物无预测作用。     

紫杉类新辅助治疗人表皮生长因子受体2阳性乳腺癌的近期疗效分析

目的探讨HER-2阳性乳腺癌对含紫杉类新辅助化疗的敏感性。方法回顾分析159例HER-2阳性的进展期乳腺癌新辅助化疗疗效,采用X2检验比较蒽环类为主化疗方案（蒽环组）和紫杉类为主化疗方案（紫杉组）病理完全缓解率和化疗有效率的差异。结果葸环组和紫杉组的病理完全缓解率分别为7．4％和25．6％,紫杉组明显高于葸环组（X2=9．658,P=0．002）;化疗有效率分别为85．2％和80．8％,两组间差异无统计学意义（x2=0．550,P=0．458）。结论HER-2阳性的进展期乳腺癌患者选择含紫杉类药物联合化疗方案可取得更好的病理完全缓解率。     

紫杉类药物治疗晚期乳腺癌疗效及其分子指标的相关性研究

目的探讨晚期乳腺癌患者应用含紫杉醇联合化疗方案的疗效评价及与分子指标的相关性。方法经病理确诊的170例患者入组,经紫杉醇单药或含紫杉醇联合方案化疗,至少治疗2个周期后,评价疗效和不良反应及与分子指标的相关性研究。结果ER阳性有效率为33.3%,ER阴性为48.5%,两者差异有显著性(P=0.018);当HER-2过表达定义为≥++时,有效率为55.7%,低表达者和阴性患者为33.3%,两者比较差异有显著性(P=0.004)。而PR、p53、MDR-1、BCL-2的阳性、阴性表达组间没有明显差别。对ER及HER-2的共表达进一步分层分析显示,在ER阴性同时HER-2过表达患者的有效率高达65.7%,其他各组均在35%左右,两者比较差异有显著性(P= 0.001);而其他三组差异无显著性。结论ER阴性患者有效率显著高于ER阳性患者,HER-2过表达的患者紫杉类药物敏感性较高。     

新辅助化疗对乳腺癌雌激素受体和HER-2的影响及意义

[目的]探讨雌激素受体（ER）和HER-2在新辅助化疗乳腺癌组织的表达及临床意义。[方法]采用免疫组织化学方法检测100例乳腺癌患者新辅助化疗前后肿瘤组织中ER及HER-2的表达,并与疗效作相关性分析。[结果]新辅助化疗总有效率79%,ER阴性表达者化疗有效率明显高于ER阳性者（P〈0.05）,HER-2表达与疗效无明显关系（P〉0.05）。化疗后ER、HER-2的表达未见显著性变化（P〉0.05）。[结论]新辅助化疗对ER、HER-2表达状态无显著影响。ER对乳腺癌新辅助化疗疗效有一定预测价值。     

新辅助化疗对局部晚期乳腺癌组织中雌激素受体孕激素受体和人表皮生长因子受体2表达的影响

目的探讨新辅助化疗对晚期乳腺癌组织中雌激素受体(ER)、孕激素受体(PR)和人表皮生长因子受体2(HER-2)表达的影响。方法收集ⅡB^ⅢB期的局部晚期乳腺癌患者48例,应用免疫组化方法检测ER、PR和HER-2的表达后,给予表阿霉素(EPI)加多西紫杉醇(DOX)方案进行新辅助化疗,3个疗程后行根治手术,将术后标本中ER、PR和HER-2的表达与化疗前表达情况进行对照,分析新辅助化疗对免疫表达的影响。结果新辅助化疗前ER阳性表达率为33.3%,化疗后ER阳性表达率为52.1%;化疗前PR阳性表达率为35.4%,化疗后PR阳性表达率为50.0%。ER和PR阴性表达的患者在新辅助化疗后转为阳性表达的比例高于化疗前阳性转为阴性的比例,但差异没有统计学意义(P>0.05)。新辅助化疗前HER-2阳性表达率为62.5%,化疗后HER-2阳性表达率为52.1%,新辅助化疗后阳性转阴率略高于阴性转阳率,差异无统计学意义(P>0.05)。结论新辅助化疗能使部分乳腺癌组织中ER、PR和HER-2的表达发生改变,为乳腺癌的治疗提供了一定的依据。     

乳腺癌新辅助化疗对雌激素受体孕激素受体人表皮生长因子受体和Ki67抗原标记指数表达的影响及意义

目的探讨新辅助化疗对乳腺癌患者雌激素受体(ER)、孕激素受体(PR)、人表皮生长因子受体-2(HER-2)和Ki67抗原标记指数表达的影响及意义。方法选取89例单侧女性乳腺癌患者,行氟尿嘧啶、表阿霉素和环磷酰胺(FEC化疗方案)新辅助化疗,采用免疫组化S-P法对化疗前后ER、PR、HER-2和Ki67的表达进行测定。观察其变化及与疗效间的关系。结果 NAC后完全缓解11例(12.4%);部分缓解51例(57.3%);病情稳定23例(25.8%);病情发展4例(4.5%)。行新辅助化疗后,ER阴性组、PR阴性组、Ki67阴性组的临床有效率显著升高,与阳性组比较差异均有统计学意义(P<0.05)。行新辅助化疗前后ER与Ki67的表达差异有统计学意义(P<0.05)。结论新辅助化疗前后ER、PR、HER-2和Ki67表达的变化可作为制定乳腺癌患者后期治疗方案、评估预后的指标。     

乳腺癌生物标记物表达水平对新辅助化疗疗效的预测价值

目的探讨乳腺癌生物标记物雌激素受体(ER)、人类表皮生长因子受体-2(HER-2)、P53和Ki67的表达与新辅助化疗疗效之间的关系。方法对2007年10月至2009年9月在北京大学第一医院乳腺疾病中心接受4～6个周期紫杉类联合蒽环类方案新辅助化疗的165例乳腺癌患者资料进行回顾性分析。用免疫组织化学方法检测新辅助化疗前肿瘤病灶ER、HER-2、P53和Ki67的表达情况,用术后病理评价新辅助化疗疗效,病理学反应级别为G4、G5则认为化疗有效。用四格表资料的χ2检验法分析上述指标与新辅助化疗疗效之间的关系。结果 165例患者中56.4%(93/165)新辅助化疗有效。ER阳性者有效率为43.5%(20/46),ER阴性者有效为61.3%(73/119),两组之间差异有统计学意义(χ2=4.31,P=0.04);HER-2过表达者有效率为72.0%(36/50),低表达者为49.6%(57/115),二者差异有统计学意义(χ2=7.13,P=0.01);P53阳性者有效率为66.7%(30/45),阴性者为53.4%(47/88),两组间差异无统计学意义(χ2=2.15,P=0.14);Ki67过表达者化疗有效率为62.4%(68/109),低表达者为44.0%(22/50),两组间差异有统计学意义(χ2=4.72,P=0.03)。结论 ER阴性、HER-2及Ki67过表达者对紫杉联合蒽环方案的新辅助化疗更敏感,ER、HER-2及Ki67表达情况对新辅助化疗疗效有预测作用。     

乳腺癌穿刺活检对HR和HER-2及Ki-67评价可靠性以及化疗对其影响研究

目的：研究乳腺癌空芯针穿刺活检（coreneedle biopsy,CNB）对激素受体（hormone receptor,HR）、HER-2及Ki-67表达状况评价的可靠性,探讨新辅助化疗（neoadjuvantchemotherapy,NAC）对乳腺癌分子生物学信息表达的影响,分析上述生物学指标对NAC疗效的预测价值。方法：选择2012-03-01-2013-01～31山东省肿瘤医院外科收治的乳腺癌患者177例,其中行NAc者95例作为NAC组,未行NAC者82例作为对照组。免疫组织化学SP法检测两组患者CNB和治疗性手术切除标本中ER、PR、HER-2及Kb67的表达状况,依据Miller-Payne分级系统评价化疗后病理反应,依据实体瘤反应评价标准（response evaluation criteria in solid tumors,RECIST）进行新辅助化疗的疗效评价。结果：对照组患者cNB和手术切除标本ER表达一致率为97．6％（80／82）,PR为95．1％（78／82）,HER-2为97．6％（80／82）,Ki-67为92．7％（76／82）,Spearman等级相关系数均〉0．8,P均〈0．05。NAC组和对照组CNB和手术切除标本比较,ER表达状况改变率分别为12．4％（10／79）和3．9％（2／82）,差异有统计学意义,P=0．014;PR表达状况改变率分别为24．0％（19／79）和2．4％（4／82）,差异有统计学意义,P=0．001;HER-2表达状况改变率分别为5．1％（4／79）和2．4％（2／82）,差异无统计学意义,P=0．379;Ki=67表达状况改变率分别为38．0％（30／79）和7．3％（6／82）,差异有统计学意义,Pd0．001。NAC前后ER阳性率分别为64。6％和53．2％,差异无统计学意义,P=0．146;PR阳性率分别为63．3％和45．6o／,差异有统计学意义,P=0．025;Ki-67高表达率分别为45．6％和15．2％,差异有统计学意义,P=0．017。化疗反应分级与ER、PR、HER-2表达变化无相关性,P均〉0．05;与Ki-67表达变化明显相关,P=0．008。ER和PR表达状况与NAC疗效无相关性,P均〉0．05;HER-2阳性的乳腺癌患者NAC有效率为81．8％,阴性者有效率为50．7％,差异有统计学意义,P=0．010;Ki-67高表达乳腺癌患者NAC有效率为70．2％,低表达者有效率为45．5％,差异有统计学意义,P=0．029。结论：cNB与手术切除标本在判断HR、HER-2和Ki-67表达状况上有很好的一致性;NAC能改变乳腺癌患者HR和Ki-67的表达状况,NAc使PR的阳性率降低,Ki-67的表达下降,ER阳性率有降低趋势,NAc对HER-2的表达无显著影响;HER-2阳性和Ki-67高表达的患者对化疗更敏感。     

不同分子亚型浸润性乳腺癌中p53基因及Ki-67抗原的表达及意义

目的探讨p53基因及Ki-67抗原在不同分子亚型浸润性乳腺癌中的表达及意义。方法采用免疫组化法检测275例浸润性乳腺癌组织中雌激素受体（ER）、孕激素受体（PR）、人表皮生长因子受体2（HER-2）、p53基因及Ki-67抗原的表达水平。结果p53在激素受体阳性组（175例）、HER-2受体阳性组（60例）、三阴性乳腺癌组（40例）中的表达率分别为29．7％,55．0％和75．0％,三组间差异有统计学意义（χ^2=32．924,P〈0．05）,以三阴性组表达最高。Ki-67在激素受体阳性组、HER-2受体阳性组、三阴性乳腺癌组中的表达率分别为74．3％,95．0％和95．0％,三组间差异有统计学意义（χ^2=18．355,P〈0．05）,以三阴性组和HER2阳性组表达最高。p53基因和Ki-67抗原的表达阳性率在有腋窝淋巴结转移的乳腺癌组中高于无腋窝淋巴结转移组,差异有统计学意义（χ^2=5．257,P〈0．05;χ^2=12．664,P〈0．05）。结论在乳腺癌的分子亚型中联合检测p53基因及Ki-67抗原可以作为乳腺癌发生、发展的评价指标,更有助于指导其临床治疗和判断预后。     

激素受体和HER-2及Ki-67预NSL腺癌新辅助化疗疗效价值的分析

目的：探讨乳腺癌组织中雌激素受体（ER）、孕激素受体（PR）、人表皮生长因子受体2（HER-2）及Ki-67的表达状态对新辅助化疗反应的预测作用以及化疗前后其表达差异对疗效的影响。方法：免疫组织化学方法检测新辅助化疗前后118例乳腺癌组织的ER、PR、HER-2及Ki-67的表达情况,并分析其与新辅助化疗疗效的关系。结果：118例新辅助化疗乳腺癌病例中,ER-和PR-组pCR分别为26．1％和27．1％,明显高于ER＋组11．1％和PR＋组6．8％,P-0．003。HER-2和Ki-67的表达对新辅助化疗疗效无显著影响。新辅助化疗前ER、PR与Ki-67的表达呈明显负相关,P〈0．001;新辅助化疗后Ki-67的高表达病例数显著减少,P-0．001。结论：ER-／PR-的患者对新辅助化疗更为敏感,Ki-67在化疗后发生了显著下调,提示新辅助化疗能降低肿瘤的增殖活性。ER、PR及Ki-67可以作为新辅助化疗疗效的预测指标。     

Decreased response to paclitaxel versus docetaxel in HER-2/neu transfected human breast cancer cells

Taxanes are effective in the treatment of metastatic breast cancer. Docetaxel has been shown to be more potent than paclitaxel in inducing bcl-2 phosphorylation and apoptosis and is clinically active in some paclitaxel-resistant breast tumors. HER-2/neu overexpression has been shown to correlate with resistance to hormonal therapy as well as chemotherapy. Using a HER-2/neu transfected MCF-7 human breast cancer cell line, we investigated the role of HER-2/neu overexpression on resistance to paclitaxel and docetaxel treatment. A control vector transfected MCF-7 human breast cancer cell line (MCF/neo) and a HER-2/neu transfected MCF-7 line (MCF/18) were treated with various concentrations of docetaxel or paclitaxel. Cell number was assessed using the MTT tetrazolium dye assay. In the control vector transfected MCF/neo cell line, paclitaxel and docetaxel gave similar dose-dependent growth inhibition ( p = 0.175). In HER-2/neu transfected MCF/18 cells, docetaxel treatment resulted in a dose-dependent inhibition similar to that seen in MCF/neo cells. Paclitaxel, however, gave significantly less growth inhibition than docetaxel in the HER-2/neu overexpressing MCF/18 cells (p = 0.0003). These data suggest that HER-2/neu overexpression may contribute to paclitaxel resistance. In contrast, the cytotoxic effects of docetaxel in these breast carcinoma cells are not affected by HER-2/neu expression. Therefore, docetaxel may be the preferred taxane therapy in HER-2/neu overexpressing breast tumors.     

三阴性乳腺癌白蛋白结合型紫杉醇与多西他赛新辅助化疗临床对照研究

目的：评价白蛋白结合型紫杉醇、表柔比星联合环磷酰胺对比多西他赛、表柔比星联合环磷酰胺新辅助化疗治疗三阴性乳腺癌的临床效果。方法：将东莞市人民医院2009—01—03—2012—01—31经病理学确诊的三阴性乳腺癌患者42例分为PEC组21例,给予白蛋白结合型紫杉醇260mg／m2,静脉滴入,表柔比星70mg／m2,静脉滴入,环磷酰胺500mg／m2,静脉滴入,3周重复,不做抗过敏预处理;TEC组21例,给予多西他赛75mg／m2,静脉滴入,表柔比星与环磷酰胺应用方法同PEC方案,3周重复,使用多西他赛前1d开始口服地塞米松片7．5mg,2次／d,连服3d。结果：两组患者均完成4个周期新辅助化疗。PEC组RR19例（90．5％）、CR8例（38．1％）、PR 11例（52．4％）、SD2例（9．5％）;TEC组RR18例（85．7％）、CR8例（38．1％）、PR10例（47．6％）和SD3例（14．3％）,两组差异均无统计学意义,P〉0．05;PEC组pCR为28．6％优于TEC组的19．1％,P=0．049。随访截止2013—04—01,中位随访时间25个月（12～48个月）,随访率为100．0％。毒副作用两组中性粒细胞下降、血小板减少、便秘、心脏毒性、肝功能异常、外周神经毒性、肝肾功能异常发生率相比差异均无统计学意义,P〉0．05。结论：白蛋白结合型紫杉醇、表柔比星联合环磷酰胺新辅助治疗局部晚期三阴性乳腺癌疗效显著,毒副作用可耐受,值得进一步研究。     

Randomized phase II study of weekly docetaxel plus trastuzumab versus weekly paclitaxel plus trastuzumab in patients with previously untreated advanced nonsmall cell lung carcinoma

BACKGROUND: Trastuzumab is a monoclonal antibody directed against the human epidermal growth factor receptor-2 (HER-2). Nonsmall cell lung carcinoma (NSCLC) overexpresses HER-2 protein in approximately 20% of cases. In the current study, the authors combined trastuzumab with weekly taxanes in an attempt to improve outcomes over standard chemotherapy in patients with advanced NSCLC. METHODS: The primary objective was to determine whether docetaxel plus trastuzumab or paclitaxel plus trastuzumab was the superior regimen based on response and toxicity, and to determine whether either regimen was appropriate for further testing in a randomized Phase III trial. After stratification based on the results of HER-2 immunohistochemistry, chemotherapy-naive patients were randomized to receive trastuzumab plus docetaxel or trastuzumab plus paclitaxel. The study was designed so patients with or without HER-2 overexpression would be distributed equally between the study arms. RESULTS: Immunohistochemistry for HER-2 protein expression was attempted for 182 pathologic samples from 169 patients. Twenty-eight of the 179 evaluable samples (16%) revealed 2+ or 3+ staining. The objective response rate was 23% (7 of 30 patients) in the patients treated with docetaxel plus trastuzumab and 32% (11 of 34 patients) in the patients treated with paclitaxel plus trastuzumab (P=0.76, Wilcoxon test). No difference was noted in the median survival (16 mos vs. 14 mos) or 1-year survival (57% vs. 55%) (P=0.998). Toxicities were mild in both treatment arms. No difference with regard to response rates or survival was noted between HER-2-positive (2+ or 3+) and HER-2-negative (0-1+) patients. CONCLUSIONS: The expression of HER-2 protein in patients with advanced NSCLC in this study was found to be similar to that reported in previous series. The response rates and toxicities for patients treated with docetaxel and trasuzumab or paclitaxel and trasuzumab were not significantly different, though survival in both arms was better than expected. HER-2 expression status did not appear to affect outcomes for this uniform group of patients who were treated in a comparable fashion. Because of the infrequency of HER-2 overexpression, and the absence of improved outcomes in patients with NSCLC who were treated with trastuzumab plus chemotherapy in other studies, neither regimen tested will be advanced to a Phase III trial.     

AIB1、HER - 2 表达与乳腺癌他莫西芬耐药的关系

目的：探讨HER-2和AIB1在ER阳性乳腺癌他莫西芬耐药中的作用.方法：选择复发转移后接受他莫西芬治疗的女性乳腺癌患者70例,采用免疫组化SP法检测的乳腺癌组织中HER-2和AIB1的表达,分析二者与他莫西芬疗效的关系.结果：他莫西芬治疗总有效率42.9%.HER-2（＋）组治疗有效率28.6%,HER-2（-）组治疗有效率52.4%,有统计学差异（P=0.041）.AIB1（＋）组治疗有效率28.6%,AIB1（-）组治疗有效率64.3%,有统计学差异（P=0.003）.他莫西芬在HER-2（＋）AIB1（＋）、HER-2（-）AIB1（＋）、HER-2（＋）AIB1（-）、HER-2（-）AIB1（-）四组中的治疗有效率分别为27.3%、30.0%、33.3%、72.7%,有显著差异（P=0.008）.结论：HER-2和AIB1的表达均与乳腺癌他莫西芬治疗疗效有关,二者共表达提示他莫西芬耐药.     

Expression of c-erbB2, cyclin D1 and estrogen receptor and their clinical implications in the invasive ductal carcinoma of the breast

BACKGROUND: C-erbB2 and estrogen receptors (ER) are well known for their cell proliferative capacity. Cyclin D1 is a major downstream target of both c-erbB2 and ER. This study was designed to analyze the expression of c-erbB2, cyclin D1 and ER and their prognostic implications in invasive ductal carcinoma of the breast. METHODS: The c-erbB2 status was evaluated by fluorescence in situ hybridization and immunohistochemistry (IHC) and cyclin D1 and ER were evaluated by IHC in 333 invasive breast cancer specimens. RESULTS: The results of FISH and IHC for c-erbB2 showed 86.7% concordance. The overexpression of c-erbB2 was associated with the high expression of cyclin D1 and the negative expression of ER (P < 0.01 for both). The high expression of cyclin D1 was associated with the positive expression of ER (P < 0.01). When the group of patients who overexpressed c-erbB2 were analyzed, the patients with the low expression of cyclin D1 showed a significantly higher mortality than those with the high expression of cyclin D1 (RR = 3.2; 95% CI, 1.6-6.6). When the group of the high cyclin D1 expression was analyzed, the patients with negative expression of ER showed a significantly higher mortality than those with the positive expression of ER (RR = 2.1; 95% CI, 1.1-3.8). CONCLUSIONS: Higher expression of cyclin D1 was associated with better prognosis in patients with c-erbB2 overexpression, and positive expression of ER was associated with better prognosis in patients with high cyclin D1 expression.     

贵州省720例乳腺癌HER-2的表达情况及抗HER-2治疗的回顾性分析

背景与目的：乳腺癌是严重威胁女性生命的恶性肿瘤之一,在我国汉族与其他少数民族乳腺癌的发病率及其HER-2基因表达差异成为学者关注的问题。该研究旨在分析贵州省乳腺癌HER-2基因表达的民族差异性,评价应用曲妥珠单抗行分子靶向治疗的临床疗效,探讨多种临床因素对贵州省乳腺癌患者生存预后的影响。方法：回顾性分析2007年1月—2013年12月在贵州医科大学附属肿瘤医院接受治疗的720例女性乳腺癌患者的随访情况,采用SPSS 17.0中的Kaplan-Meier法对患者进行生存分析,统计患者无病生存期(disease free survival,DFS)及总生存期(overall survival,OS),采用Log-rank检验进行因素间比较。采用Cox回归模式进行多因素检验,分析乳腺癌的独立预后因素。结果：入组的720例患者中,HER-2阴性表达520例(72.2%),HER-2阳性表达200例(27.8%)。200例HER-2阳性乳腺癌患者中,汉族177例(177/645,27.4%),少数民族23例(23/75,30.7%)。200例HER-2阳性乳腺癌患者中,行抗HER-2治疗37例(18.5%),未行抗HER-2治疗163例(81.5%),可分为治疗组及对照组。统计分析显示,治疗组与对照组的DFS和OS差异均有统计学意义(P=0.041和0.022)。Cox回归分析提示,雌激素受体(estrogen receptor,ER)和Ki-67是入组乳腺癌患者的独立预后因素(P=0.03和0.016),孕激素受体(progesterone receptor,PR和HER-2不是独立预后因素(P均>0.05);其中汉族乳腺癌患者的ER和Ki-67是独立预后因素(P=0.018和0.031),PR和HER-2不是独立预后因素(P均>0.05);少数民族乳腺癌患者的ER、PR、HER-2和Ki-67均不是独立的预后因素(P均>0.05)。结论：HER-2基因阳性表达不具有民族差异性。HER-2阳性患者应用曲妥珠单抗行抗HER-2治疗可明显改善预后,延长DFS及OS,但目前贵州省行抗HER-2治疗人群不足20%。本研究初步提示ER、Ki-67作为乳腺癌独立的预后因素具有民族差异性的趋势。     

Do we need HER-2/neu testing for all patients with primary breast carcinoma?

BACKGROUND: HER-2/neu is a valuable prognostic marker in primary breast carcinoma. Controversy surrounds the correlation between HER-2/neu expression and other prognostic markers, as has been discussed in preclinical and clinical studies. The objective of the current study was to investigate the probability, calculated using parameters that are assessed routinely in clinical practice, that patients with breast carcinoma had positive HER-2/neu status. METHODS: The authors evaluated HER-2/neu status in 923 consecutive patients with breast carcinoma by immunohistochemical methods. Correlations involving HER-2/neu status, estrogen receptor (ER) and progesterone receptor (PR) status, tumor grade, patient age, lymph node involvement, and tumor size were evaluated using the Mantel-Haenszel chi-square test and the Spearman correlation. The authors created a simple scoring system (i.e., the diagnostic instrument for validation of HER-2/neu score) to define subgroups of patients with breast carcinoma and to determine the likelihood of HER-2/neu positivity. RESULTS: HER-2/neu overexpression was correlated significantly with negative ER (P = 0.0001) and PR status (P = 0.0001), Grade 3 (G3) lesions (P = 0.0001), and young age (P = 0.006). The likelihood of HER-2/neu positivity in a patient with positive ER and PR status and G1/G2 disease was approximately 6.1%. CONCLUSIONS: The authors demonstrated in a large patient series that HER-2/neu overexpression was associated with negative hormone receptor status, G3, and young age. In a subgroup of patients presenting with hormone-responsive and G1/G2 tumors, the likelihood of HER-2/neu overexpression was very small. Therefore, the assessment of HER-2/neu status in this subgroup of patients with breast carcinoma may be considered unnecessary, unless the role of HER-2/neu status in adjuvant treatment has been proven.