【摘要】：背景及目的：貧血是一種常見的惡性腫瘤合并癥,既往研究提示貧血可能是乳腺癌化療后不良結(jié)局的預(yù)測因子,但是大多數(shù)研究主要關(guān)注貧血與術(shù)后輔助化療結(jié)局的關(guān)系,這種情況下常不能直觀評價療效,很難準(zhǔn)確評價貧血與化療的相關(guān)性。新輔助化療又稱術(shù)前化療,是乳腺癌的重要治療手段,可提供腫瘤化療體內(nèi)療效的直接證據(jù),在新輔助化療中可更好地探究貧血對化療療效的真實(shí)影響。治療前貧血是否與乳腺癌新輔助化療結(jié)局相關(guān)尚無定論,本研究擬評價治療前貧血作為臨床因素對乳腺癌新輔助化療病理學(xué)療效及遠(yuǎn)期生存的影響,即明確治療前貧血是否為乳腺癌新輔助化療的療效預(yù)測因素和預(yù)后因素。方法：本研究共納入可手術(shù)或局部晚期乳腺癌(Ⅱa-Ⅲc期)患者655人,所有患者均在1999年1月至2011年12月期間于我院接受含蒽環(huán)類聯(lián)合紫杉類方案的新輔助化療。根據(jù)治療前血紅蛋白(hemoglobin, Hb)水平將患者分為貧血組(Hb12.0g/dL)和非貧血組(Hb≥12.0g/dL)。主要研究終點(diǎn)為病理學(xué)完全緩解(pathological complete remission, pCR),次要研究終點(diǎn)為無復(fù)發(fā)生存(relapse-free survival RFS)、腫瘤特異性生存(cancer-specific survival, CSS)和總生存(overall survival, OS)。對比貧血組和非貧血組的pCR率、RFS、CSS和OS,并通過多因素回歸分析明確包括貧血在內(nèi)的多種臨床因素是否為乳腺癌新輔助化療療效預(yù)測因素和預(yù)后因素。結(jié)果：166人(25.3%)合并治療前貧血。貧血組pCR率明顯低于非貧血組(5.4% vs.11.7%；p=0.024)；治療前貧血為pCR的獨(dú)立預(yù)測因素,且與pCR呈負(fù)相關(guān)(OR 0.428,95% C10.198-0.927,p=0.031)；基線Hb水平作為連續(xù)變量與新輔助化療病理學(xué)療效之間無顯著相關(guān)性(OR 1.007,95% CI 0.990-1.024, p=0.452);年齡(OR 4.805,95% CI 1.845-12.515, p=0.001)和ER表達(dá)(OR 4.199,95% CI 1.904-9.261, p0.001)也是pCR的獨(dú)立預(yù)測因素。與非貧血組相比,貧血組的10年RFS(59.1% vs 66.0%,p=0.022)、OS(75.3% vs 90.9%,p0.001)和CSS(82.4% vs 94.4%,p0.001)均明顯下降；多因素分析提示治療前貧血是乳腺癌新輔助化療后RFS(HR 1.453,95% CI 1.077-1.962, p=0.015)、OS(HR 2.873,95% CI 1.757-4.699, p0.001)和CSS(HR 2.961, 95% CI 1.679-5.222, p0.001)的獨(dú)立預(yù)后因素；將基線Hb水平作為連續(xù)變量進(jìn)行評價時發(fā)現(xiàn)基線Hb水平高者CSS (HR 0.979,95% CI 0.961-0.997, p=0.021)和OS(HR 0.977,95% CI 0.962-0.992, p=0.003)優(yōu)于Hb水平低者,基線Hb水平亦為乳腺癌預(yù)后因素。結(jié)論：本研究證明治療前貧血與乳腺癌新輔助化療后pCR呈負(fù)相關(guān),合并貧血是新輔助化療病理學(xué)療效的獨(dú)立預(yù)測因素,治療前貧血也與乳腺癌新輔助化療后遠(yuǎn)期生存顯著相關(guān),合并貧血是乳腺癌的不良預(yù)后因素�，F(xiàn)有的糾正貧血的治療措施不良反應(yīng)多,今后需進(jìn)一步優(yōu)化貧血干預(yù)措施,以期改善合并貧血的乳腺癌患者的臨床結(jié)局。背景及目的：新輔助化療是局部晚期乳腺癌的重要治療手段,近年來在早期可手術(shù)的浸潤性乳腺癌中的應(yīng)用也逐漸增多。通過新輔助化療獲得病理學(xué)完全緩解的患者其預(yù)后更好,化療后無緩解甚至是疾病進(jìn)展的患者生存狀況較差,因此亟需一種可以預(yù)測乳腺癌化療敏感性的生物標(biāo)記物來篩選可能會從新輔助化療中獲益的患者。循環(huán)微小RNA (microRNA, miRNA)是指存在于體液如血漿、血清中的miRNA,探討其作為腫瘤診斷、療效預(yù)測和監(jiān)測、預(yù)后指標(biāo)的研究日益增多。本研究擬在接受新輔助化療的乳腺癌患者中動態(tài)監(jiān)測其血漿miRNA的變化,并探討這種動態(tài)變化與療效的相關(guān)性,以期發(fā)現(xiàn)可早期預(yù)測乳腺癌新輔助化療敏感性的分子標(biāo)記物。方法：本研究基于一項(xiàng)對比不同亞型乳腺癌新輔助化療方案療效的前瞻性臨床試驗(yàn)進(jìn)行,共納入109名可手術(shù)或局部晚期乳腺癌患者,在我院接受4-6周期表阿霉素聯(lián)合紫杉醇(ET方案)新輔助化療。根據(jù)激素受體(hormone receptor, HR)和人類表皮生長因子受體2(human epidermal growth factor receptor 2, HER2)表達(dá)狀況將患者分成HR陽性/HER2陰性、HER2陽性和三陰性乳腺癌(triple-negative breast cancer, TNBC)組,在每個亞組中分別進(jìn)行研究。采集患者基線、2周期化療后(C2)和術(shù)前的外周血標(biāo)本并進(jìn)行血漿miRNA檢測。根據(jù)臨床療效將患者分為化療敏感(完全/部分緩解)和不敏感(疾病穩(wěn)定/進(jìn)展)者。先通過TaqMan miRNA芯片檢測篩選出其動態(tài)變化與化療敏感性可能相關(guān)的候選miRNA;在基線、C2和術(shù)前標(biāo)本中用實(shí)時定量PCR法檢測待驗(yàn)證的miRNA,并通過logistic回歸分析評價基線/C2miRNA表達(dá)水平是否可預(yù)測化療敏感性。結(jié)果：化療不敏感者占31.2%(34/109)。通過miRNA芯片檢測發(fā)現(xiàn)兩種血漿miRNA波動趨勢可能與療效相關(guān)：1、基線時在敏感組和不敏感組之間表達(dá)明顯差異,術(shù)前血漿中這種差異進(jìn)一步擴(kuò)大；2、基線時兩組間表達(dá)相近,化療后呈相反的變化趨勢。在HR+/HER2-亞型(n=51)中選擇了4個血漿miRNA (miR222、miR-20a、 miR-451、miR-9)進(jìn)一步驗(yàn)證：與敏感組基線相比,不敏感組基線miR-222表達(dá)顯著升高(2.065倍,p=0.047),化療2周期后繼續(xù)升高(4.870倍,p0.001),而在敏感組中未觀察到上述化療誘導(dǎo)的波動趨勢(C2 vs.基線,0.977倍,p=0.826)；基線時miR-20a在敏感和不敏感組間表達(dá)無明顯差異(p=0.218),化療后不敏感組miR-20a表達(dá)上調(diào)(C2 vs.基線,2.637倍,p=0.008),敏感組血漿miR-20a表達(dá)無明顯改變(C2 vs.基線,0.986倍,p=0.882)；血漿miR-451波動趨勢與miR-20a大致相反(基線vs.基線,p=0.673；不敏感組C2 vs.基線,0.762倍,p=0.014；敏感組C2 vs.基線,1.194倍,p=0.060)。在3個亞型中均發(fā)現(xiàn)血漿miR-34a的動態(tài)變化與化療敏感性相關(guān)：基線時血漿miR-34a在兩組間表達(dá)相近,不敏感者化療后miR-34a水平下降�；�miR-222 (OR=6.422,p=0.049)、C2 miR-20a (OR=0.144, p=0.021)、 C2 miR-451 (OR=8.213,p=0.012)水平是HR陽性/HER2陰性乳腺癌新輔助化療臨床療效的預(yù)測因素。結(jié)論：本研究通過在接受ET方案新輔助化療的乳腺癌患者中動態(tài)監(jiān)測血漿miRNA的變化趨勢,發(fā)現(xiàn)基線miR-222高表達(dá)、2周期化療后miR-20a表達(dá)上調(diào)和miR-451表達(dá)下降是HR陽性/HER2陰性乳腺癌化療敏感性的預(yù)測因素。此外,2周期化療后血漿miR-34a表達(dá)下降與化療不敏感相關(guān),提示miR-34a是一種潛在的早期療效預(yù)測標(biāo)記物。背景及目的：既往關(guān)于乳腺癌新輔助化療療效預(yù)測因素的研究結(jié)果多不一致,提示單一因素預(yù)測療效的能力不足,將多種潛在的療效相關(guān)因素組合起來建立模型或可提高預(yù)測的準(zhǔn)確度。除了常見的臨床病理特征外,治療前貧血也是乳腺癌新輔助化療療效的預(yù)測因素；生物學(xué)因素如血漿miRNA的動態(tài)變化是潛在的療效預(yù)測分子標(biāo)記物,其中血漿miR-34a化療后表達(dá)下調(diào)與臨床療效不佳相關(guān)。列線圖是一種用來估算個體發(fā)生特定臨床結(jié)局事件的可能性或風(fēng)險的統(tǒng)計(jì)學(xué)工具。本研究擬在接受新輔助化療的乳腺癌患者中探究療效相關(guān)的臨床和生物學(xué)因素,并建立可早期預(yù)測新輔助化療療效的列線圖,用來估計(jì)乳腺癌患者從新輔助化療中獲益的可能性。方法：本研究共納入149名患者,其中109人來自一項(xiàng)對比不同亞型乳腺癌新輔助化療方案療效的前瞻性臨床試驗(yàn),接受4-6周期表阿霉素聯(lián)合紫杉醇(ET方案)新輔助化療,該群體定義為訓(xùn)練集；另有40名患者于我院接受ET方案新輔助化療,但未參加上述臨床試驗(yàn),該群體定義為驗(yàn)證集。根據(jù)臨床療效將患者定義為化療敏感(完全／部分緩解)或不敏感(疾病穩(wěn)定／進(jìn)展)。在訓(xùn)練集(n=109)中收集患者的臨床病理信息以及C2血漿miR-34a相對表達(dá)量,篩選與臨床療效(化療不敏感)相關(guān)的預(yù)測因子并建模,通過列線圖的方式展示所建立的預(yù)測模型；在上述訓(xùn)練集中對預(yù)測模型的區(qū)分度(用曲線下面積(area under curve, AUC)衡量)和校正進(jìn)行考核,也就是內(nèi)部驗(yàn)證；在驗(yàn)證集(n=40)中對建立的預(yù)測模型進(jìn)行外部驗(yàn)證,評價其區(qū)分度和校正情況。結(jié)果：在訓(xùn)練集中,結(jié)合logistic回歸結(jié)果和臨床實(shí)際意義確定基線Ki-67、治療前貧血、C2 miR-34a表達(dá)、HER2表達(dá)狀況和臨床N分期為潛在的乳腺癌新輔助化療療效預(yù)測因素,基于這5個因素建立預(yù)測模型并描繪列線圖。在訓(xùn)練集中從區(qū)分度和校正情況兩方面評價模型的預(yù)測能力,模型的AUC為0.765,通過bootstrap法進(jìn)行內(nèi)部驗(yàn)證,校正后的AUC為0.726；模型的校正情況良好,預(yù)測概率與實(shí)際發(fā)生率之間無明顯差異(Hosmer-Lemeshow檢驗(yàn)p=0.835)。在驗(yàn)證集中預(yù)測模型的AUC為0.751,說明模型的區(qū)分度較好；模型預(yù)測概率與實(shí)際觀察到的發(fā)生率較為一致,無明顯差異,說明校正情況良好(U統(tǒng)計(jì)量對應(yīng)的p值0.99)。結(jié)論：本研究基于臨床生物學(xué)因素提出了一種可早期預(yù)測乳腺癌新輔助化療療效的模型,并用列線圖進(jìn)行展示,通過列線圖可以快速估算個體從ET方案新輔助化療中獲益的概率,但是該模型的預(yù)測能力仍有待在大樣本、多中心研究中進(jìn)一步驗(yàn)證,今后可進(jìn)一步優(yōu)化該模型,擴(kuò)大其適用范圍。
[Abstract]:Background and purpose: anemia is a common malignant tumor complication. Previous studies suggest that anemia may be a predictor of adverse outcomes after chemotherapy for breast cancer. However, most studies focus on the relationship between anemia and postoperative adjuvant chemotherapy outcomes. In this case, it is often difficult to evaluate the curative effect intuitively, and it is difficult to accurately evaluate anemia and chemotherapy. Correlation. Neoadjuvant chemotherapy, also known as preoperative chemotherapy, is an important treatment for breast cancer, which provides direct evidence for the effect of tumor chemotherapy in vivo. In the new adjuvant chemotherapy, it can better explore the true influence of anemia on the therapeutic effect of chemotherapy. Pre treatment anemia as a clinical factor on the pathological effect and long-term survival of neoadjuvant chemotherapy for breast cancer, that is, to determine whether anemia is a predictive factor and prognostic factor for neoadjuvant chemotherapy for breast cancer before treatment. Methods: This study included 655 patients with surgical or locally advanced breast cancer (stage II a- III C), all of which were 199 A new adjuvant chemotherapy with anthracycline combined paclitaxel regimen was accepted in our hospital from January to December 2011 9. The patients were divided into anemia group (Hb12.0g/dL) and non anemia group (Hb > 12.0g/dL) according to the pre treatment hemoglobin (hemoglobin, Hb) level. The main end point was complete pathological remission (pathological complete remission, pCR), and secondary end point. The study endpoint was relapse-free survival RFS, tumor specific survival (cancer-specific survival, CSS) and total survival (overall survival, OS). Compare the pCR rates of the anemia and non anemia groups, RFS, CSS, and other factors, and to determine whether various clinical factors including anemia were new adjuvant to breast cancer by multiple regression analysis. Prognostic factors and prognostic factors. Results: 166 people (25.3%) combined with anemia before treatment. The pCR rate in anemia group was significantly lower than non anemia group (5.4% vs.11.7%; p=0.024); pre treatment anemia was an independent predictor of pCR and was negatively correlated with pCR (OR 0.428,95% C10.198-0.927, p=0.031); baseline Hb level as a continuous variable and a new auxiliary There was no significant correlation between the curative effects of chemotherapy and chemotherapy (OR 1.007,95% CI 0.990-1.024, p=0.452); age (OR 4.805,95% CI 1.845-12.515, p=0.001) and ER expression were also independent predictors. Compared with the non anemia group, the 10 years of anemia group (59.1%, 66%, 90.9%) 001) and CSS (82.4% vs 94.4%, p0.001) decreased significantly. Multivariate analysis suggested that pre treatment anemia was an independent prognostic factor of RFS (HR 1.453,95% CI 1.077-1.962, p=0.015), OS (HR 2.873,95%, 2.961, 95%). It was found that CSS (HR 0.979,95% CI 0.961-0.997, p=0.021) and OS (HR 0.977,95% CI 0.962-0.992) were superior to those with low levels. The baseline level was also a prognostic factor for breast cancer. Conclusion: This study showed that anemia before treatment was negatively correlated with breast cancer neoadjuvant chemotherapy and anemia was a new supplement. The independent predictors for the therapeutic effect of chemotherapy, anemia before treatment are also significantly related to the long-term survival of breast cancer after neoadjuvant chemotherapy. Anemia is a bad prognostic factor for breast cancer. There are many adverse reactions to the treatment of anemia, and further optimization of anemia intervention should be made in the future in order to improve the incidence of anemia associated with breast cancer. Background and objective: neoadjuvant chemotherapy is an important treatment for local advanced breast cancer. In recent years, the application in early operable invasive breast cancer is increasing. The prognosis of patients with complete pathologic remission through neoadjuvant chemotherapy is better, and the patients who have no remission or even the progression of the disease after chemotherapy are born. Poor survival, so there is a need for a biomarker that can predict chemosensitivity to breast cancer to screen patients who may benefit from neoadjuvant chemotherapy. Circulating minute RNA (microRNA, miRNA) refers to the presence of miRNA in body fluids such as plasma and serum, to explore the diagnosis, prognosis, and monitoring of the tumor as a swelling tumor, and the study day of prognostic indicators. This study intends to dynamically monitor changes in plasma miRNA in breast cancer patients receiving neoadjuvant chemotherapy and explore the correlation between this dynamic change and efficacy in order to find molecular markers for early prediction of breast cancer sensitivity to neoadjuvant chemotherapy. Method: This study was based on a new contrast of different subtypes of breast cancer. A prospective clinical trial of chemotherapeutic regimens was carried out in 109 patients with surgical or locally advanced breast cancer, with 4-6 cycles of epirubicin combined with paclitaxel (ET) neoadjuvant chemotherapy in our hospital. According to the hormone receptor (hormone receptor, HR) and human epidermal growth factor receptor 2 (human epidermal growth factor receptor 2, H) ER2) was divided into HR positive /HER2 negative, HER2 positive and three negative breast cancer (triple-negative breast cancer, TNBC) groups in each subgroup. The patients were studied in each subgroup. The patient baseline, 2 cycles of chemotherapy (C2) and preoperative peripheral blood specimens and plasma miRNA tests were carried out. The patients were divided into chemotherapeutic sensitivity according to the clinical effect. Complete / partial remission) and insensitivity (disease stability / progression). First, TaqMan miRNA chip detection was used to screen candidate miRNA for possible dynamic changes associated with chemosensitivity; miRNA was detected by real-time quantitative PCR in baseline, C2 and preoperative specimens, and the baseline /C2miRNA expression level was evaluated by logistic regression analysis. Results: chemosensitivity was predicted. Results: 31.2% (34/109) was not sensitive to chemotherapy. The miRNA chip detection showed that the trend of miRNA fluctuation in two plasma may be related to the curative effect: 1, the difference between the sensitive group and the insensitive group at baseline was significantly different, and the difference of plasma in the preoperative plasma was increased step by step; 2, the expression of the two groups was similar in the baseline. 4 plasma miRNA (miR222, miR-20a, miR-451, miR-9) were selected in the HR+/HER2- subtype (n=51) to further verify that the baseline miR-222 expression in the insensitive group was significantly increased (2.065 times, p=0.047) compared with the sensitive group baseline, and continued to increase (4.870 times, p0.001) after 2 weeks of chemotherapy, but not in the sensitive group. The trend of chemotherapy induced fluctuation (C2 vs. baseline, 0.977 times, p=0.826), and no significant difference (p=0.218) between sensitive and insensitive groups at baseline (p=0.218), the expression of miR-20a in the non sensitive group after chemotherapy was up (C2 vs. baseline, 2.637 times, p=0.008), and there was no significant change in the expression of miR-20a in the sensitive group (C2 vs. baseline, 0.986 times,); 1 the fluctuation trend was roughly the opposite of miR-20a (baseline vs. baseline, p=0.673; insensitive group C2 vs. baseline, 0.762 times, p=0.014; sensitive group C2 vs. baseline, 1.194 times, p=0.060). In the 3 subtypes, the dynamic changes of plasma miR-34a were found to be related to chemosensitivity: the plasma miR-34a in the baseline was similar between the two groups, and the insensitive patients after chemotherapy miR-3 4A level decreased. Baseline miR-222 (OR=6.422, p=0.049), C2 miR-20a (OR=0.144, p=0.021), C2 miR-451 (OR=8.213, p=0.012) were predictors of the clinical efficacy of neoadjuvant chemotherapy for positive negative breast cancer. Conclusion: This study monitored the changes of plasma levels dynamically in breast cancer patients receiving neoadjuvant chemotherapy. Trend, the high expression of baseline miR-222, up regulation of miR-20a expression and decrease of miR-451 expression after 2 cycles of chemotherapy are predictors for chemosensitivity of HR positive /HER2 negative breast cancer. In addition, the decrease of miR-34a expression after 2 cycles of chemotherapy is associated with chemotherapy insensitivity, suggesting that miR-34a is a potential prognostic marker for early efficacy. The results of previous studies on the predictive factors of neoadjuvant chemotherapy for breast cancer are often inconsistent, suggesting that the single factor is not able to predict the curative effect, combining various potential therapeutic factors together to establish a model or to improve the accuracy of the prediction. Prognostic factors for adjuvant chemotherapy; biological factors such as dynamic changes in plasma miRNA are potential prognostic molecular markers, in which the down-regulation of plasma miR-34a after chemotherapy is associated with poor clinical efficacy. A column map is a statistical tool used to estimate the possibility or risk of individual occurrence of a specific clinical outcome. To explore the clinical and biological factors related to the effectiveness of the breast cancer patients receiving neoadjuvant chemotherapy and to establish a line map that can predict the efficacy of neoadjuvant chemotherapy early to estimate the possibility of breast cancer patients benefiting from the neoadjuvant chemotherapy. Methods: This study included 149 patients, of which 109 were from a different contrast. A prospective clinical trial of neoadjuvant chemotherapy for subtype breast cancer received 4-6 cycles of epirubicin combined with paclitaxel (ET) neoadjuvant chemotherapy. The group was defined as a training set; another 40 patients received neoadjuvant chemotherapy in our hospital, but the group was not involved in the clinical trials. The group was defined as a validation set. According to clinical efficacy, the group was defined as a test set. The patient is defined as chemotherapy sensitive (complete / partial remission) or insensitivity (disease stability / progression). In the training set (n=109), the clinicopathological information of the patient and the relative expression of the C2 plasma miR-34a are collected, and the predictive factors associated with the clinical efficacy (insensitivity to chemotherapy) are screened and modeled, and the prediction of the prediction is presented through the line diagram. Model; in the above training center, the area indexing of the prediction model (area under curve, AUC) is measured and the correction is examined, that is, internal verification. In the verification set (n=40), the established prediction model is verified externally, and the degree and correction of the area are evaluated. Results: in the training concentration, combined with the logistic regression knot. Determine baseline Ki-67, pre treatment anemia, C2 miR-34a expression, HER2 expression, and clinical N staging as potential prognostic factors for neoadjuvant chemotherapy for breast cancer. Based on these 5 factors, a predictive model is established and a line map is depicted. The predictive ability of the model is evaluated in the two aspects of the training centralization and correction. The AUC of the model is 0.765, the internal verification by bootstrap method and the corrected AUC are 0.726. The correction of the model is good, there is no obvious difference between the prediction probability and the actual occurrence rate (Hosmer-Lemeshow test p=0.835). In the verification of the centralized prediction model, the AUC is 0.751, indicating the good distinction of the model; the model prediction probability and the actual view. The rate of detection was consistent and no significant difference was found, indicating that the correction was good (the corresponding p value of U statistics 0.99). Conclusion: Based on the clinical biological factors, a new model for predicting the efficacy of new adjuvant chemotherapy for breast cancer was proposed in this study, and a column diagram was used to predict the new individual from the ET scheme. The probability of benefiting in adjuvant chemotherapy, but the prediction ability of the model still needs to be further verified in the large sample and multi center research. In the future, the model can be further optimized and its scope of application can be expanded.
【學(xué)位授予單位】：北京協(xié)和醫(yī)學(xué)院
【學(xué)位級別】：博士
【學(xué)位授予年份】：2016
【分類號】：R737.9

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