DOSE INTENSE CHEMOTHERAPY & STEM CELL RESCUE IN INFLAMMATORY BREAST CANCER

这项研究的目的是评估一种包括化疗和手术切除肿瘤，然后附加化疗，然后两个治疗周期的非常高剂量的治疗与回输患者自己的骨髓来源的细胞。2)概述炎症性乳腺癌，在常规治疗时，复发的可能性很高。大剂量的联合化疗可能会改善患者的结果，目前正在研究一种新的药物和剂量组合。为了减少与大剂量化疗相关的潜在副作用，干细胞拯救(患者自己的骨髓来源细胞被重新注入其中的过程)将随之而来。3)谁有可能符合条件？：年龄约18-65岁；被诊断为IIIB期乳腺癌；必须在确诊后6个月内至少有以下临床特征之一：炎症、红斑、疼痛或过敏、水肿症(橙色)、皮肤增厚。病人必须在其他方面身体状况良好。4)治疗说明：如果患者之前接受过不超过一次的化疗，并且没有接受过手术切除肿瘤，他们将开始使用一种名为阿霉素的药物进行化疗。然后，患者将接受第二种药物紫杉醇，然后手术切除他们的乳腺癌。所有患者都将在96小时内通过静脉导管接受紫杉醇治疗。将使用粒细胞集落刺激因子(G-CSF)来增加血液循环中的循环骨髓细胞数量。接下来，患者将接受PBSC(外周血干细胞)采集。这一过程包括通过一台机器循环血液，机器将血液分离成组分，并将除白细胞外的所有东西都返回给患者。患者将被送往医院接受第一个周期的高剂量联合化疗，包括静脉输注阿霉素和环磷酰胺，第二天再输注紫杉醇。之后，患者将接受之前储存的PBSC的部分回输。在不超过7周的时间后，患者将重新入院接受第二个周期的大剂量化疗，包括两种药物马法兰和顺铂。从治疗开始的一周起，患者将接受另一剂量的马法兰和顺铂，随后，部分重新输注以前收集的PBSC。患者从大剂量化疗恢复后将接受胸壁和淋巴结区的放射治疗，如果肿瘤激素受体呈阳性，还将开始服用药物他莫昔芬，为期5年。在接受治疗后，患者将受到密切监测。

The purpose of this study is to evaluate a treatment consisting of chemotherapy and surgical removal of cancer followed by additional chemotherapy and then two treatment cycles of very high-dose therapy with reinfusion of patient's own bone marrow derived cells. 2) Overview Inflammatory breast cancer, when treated conventionally, carries a high likelihood of relapse. High doses of combination chemotherapy may improve this outcome for patients and a new combination of drugs and doses is being investigated. To reduce the potential side effects associated with high dose chemotherapy, stem cell rescue (a process in which the patient's own bone marrow derived cells are reinfused back to them) will follow. 3) Who Is Potentially Eligible?: Age approximately 18-65 years; Diagnosed with stage IIIB breast cancer; Must have at least one of the following clinical features within six months from time of diagnosis: inflammation, erythema, pain or hypersensitivity, edema (peau d'orange), thickening of skin. Patient must be in otherwise generally good health. 4) Description of Treatment: If the patient has received no more than one prior cycle chemotherapy treatment and has not had surgical removal of their tumor, they will begin chemotherapy with a drug called doxorubicin. Then, the patient will receive a second drug, Taxol, followed by surgical removal of their breast cancer. All patients will receive Taxol through an intravenous catheter over a period of 96 hours. Granulocyte colony stimulating factor (G-CSF) will be administered to increase the number of circulating bone marrow cells in their blood circulation. Next, the patient will undergo PBSC (peripheral blood stem cell) collection. The procedure involves circulating blood through a machine that separates the blood into components and returns everything but the white blood cells back to the patient.The patient will be admitted to the hospital to receive their first cycle of high-dose combination chemotherapy, consisting of intravenous infusions of doxorubicin and cyclophosphamide, and the next day, an infusion of Taxol. Following this, the patient will receive partial reinfusions of their previously stored PBSC. After no more then a 7-week period, the patient will be readmitted to receive a second cycle of high-dose chemotherapy, consisting of the two drugs melphalan and cisplatin. One week from the beginning of their therapy the patient will receive another dose of melphalan and cisplatin, and following that, partial reinfusions of previously collected PBSC. The patient will receive radiation therapy to the chest wall and lymph node areas following recovery from high-dose chemotherapy, and if the tumor was hormone-receptor positive, will also start taking a drug, tamoxifen, for a period of 5 years. Following treatment, the patient will be closely monitored.