Low Total Pathologic Complete Response (tpCR) Rate to Preoperative Chemotherapy in Patients with Invasive Lobular Carcinoma of Breast (ILC): Analysis of Subgroup of Three Phase II Trials

P. K. Shahi
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Abstract

Background: Total pathologic complete response (tpCR; ypT0/is ypN0) after preoperative chemotherapy (PCT) is associated with better outcome in locally advanced breast cancers. However, the tpCR rate according to histology is not usually considered in trials. Patients and Methods: Patients with invasive lobular breast carcinoma (ILC), including in 3 phase II trials (AT, ATX and TXH), were eligible. Expression of markers and clinical phenotypes (CPh) were determined by immunohistochemistry. The primary end-point was tpCR rate in patients with ILC. Secondary end-points were breast conservation surgery rate (BCSR), event-free survival (EFS), and overall survival (OS). Results: In the subgroup of patients with ILC (n=16), median age was 50 years, 56.25% was premenopausal, median tumor size was 5 cm, and 68.75% had clinically node involvement. Six patients (37.5%) had clinical stage II and 10 (62.5%) had clinical stage III. Hormone receptor positive disease was present in 93.75% of the patients, and median Ki-67 was 25%. CPh were Luminal A-like in 37.5%, Luminal B-like in 50%, HER2-positive in 6.25% and triple negative in 6.25% of tumors. Only 1 patient (6.25%) had a tpCR, and another patient had a pCR only in the breast. With a median follow-up of 146 months, median EFS was 120 months (95% CI: 68-139), and median OS was not reached. Ten-year EFS and OS probability was 47% and 60%, respectively. BCSR
浸润性乳腺小叶癌(ILC)患者术前化疗的总病理完全缓解率(tpCR)低:三个II期试验的亚组分析
研究背景:病理完全缓解(tpCR;术前化疗(PCT)后ypT0/ ypN0与局部晚期乳腺癌预后较好相关。然而,根据组织学的tpCR率在试验中通常不被考虑。患者和方法:浸润性小叶性乳腺癌(ILC)患者,包括3个II期试验(AT, ATX和TXH)。免疫组织化学检测标记物表达和临床表型(CPh)。主要终点是ILC患者的tpCR率。次要终点为乳房保护手术率(BCSR)、无事件生存期(EFS)和总生存期(OS)。结果:在ILC亚组中(n=16),中位年龄为50岁,56.25%为绝经前,中位肿瘤大小为5 cm, 68.75%有临床淋巴结累及。临床II期6例(37.5%),临床III期10例(62.5%)。93.75%的患者存在激素受体阳性疾病,中位Ki-67为25%。37.5%的肿瘤呈腔a样,50%的肿瘤呈腔b样,6.25%的肿瘤呈her2阳性,6.25%的肿瘤呈三阴。只有1例患者(6.25%)有tpCR,另1例患者仅在乳房有pCR。中位随访146个月,中位EFS为120个月(95% CI: 68-139),中位OS未达到。10年EFS和OS概率分别为47%和60%。BCSR
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