Paciucci Paolo Alberto, Raptis George, Bleiweiss Ira, Weltz Christina, Lehrer Deborah, Gurry Rita
Division of Medical Oncology, The Mount Sinai School of Medicine, New York, NY 10029, USA.
Anticancer Drugs. 2002 Sep;13(8):791-5. doi: 10.1097/00001813-200209000-00002.
Neo-adjuvant, dose-dense docetaxel, 100 mg/m(2) every 2 weeks x 4 cycles, was administered to 12 patients with locally advance breast cancer (LABC) (10 stage IIIa and three stage IIIb). Eligibility requirements included a PS 0-2, normal hepatic and renal function, and radiologic absence of metastatic disease. Filgrastim [granulocyte colony stimulating factor (G-CSF)] was started 1 day after chemotherapy and was given for 6 days. Complete blood counts were determined weekly. Surgery was planned upon recovery from the last dose of docetaxel and followed by 4 cycles of adjuvant doxorubicin plus cyclophosphamide (AC) and radiotherapy. Patients with ER status received tamoxifen. The median age was 45 (range 34-73) and pre-treatment pathology revealed poorly differentiated infiltrating duct carcinoma in 11 and infiltrating lobular cancer in one, with positive ER/PR status in five. Twelve patients were treated, and all are evaluable for response and toxicity. Nine patients had a major clinical tumor response with five PR and four pathologic complete responses (pCR rate of 33%). Three patients (of whom two with stage IIIb) had progressive disease and went on to receive neo-adjuvant therapy with AC. There was one instance of grade 3 hematologic toxicity (neutropenic fever in one G-CSF non-compliant patient). There were two instances of grade 3 extra-hematologic toxicity: one patient had severe pain and one had treatment-related fatigue. After a median follow-up of 20 months (range 7-49 months) all patients are alive and eight of nine responders remain progression-free. Despite the small size of our study, we believe that dose-dense neo-adjuvant docetaxel is well tolerated and its activity warrants confirmation in a larger number of patients.
对12例局部晚期乳腺癌（LABC）患者（10例Ⅲa期和2例Ⅲb期）给予新辅助剂量密集多西他赛治疗，剂量为100mg/m²，每2周1次，共4个周期。入选标准包括体能状态（PS）0 - 2、肝肾功能正常以及影像学检查无转移病灶。化疗后第1天开始使用非格司亭[粒细胞集落刺激因子（G - CSF）]，持续给药6天。每周进行全血细胞计数。计划在最后一剂多西他赛恢复后进行手术，随后进行4个周期的辅助阿霉素加环磷酰胺（AC）治疗及放疗。雌激素受体（ER）阳性患者接受他莫昔芬治疗。患者中位年龄为45岁（范围34 - 73岁），治疗前病理显示11例为低分化浸润性导管癌，1例为浸润性小叶癌，5例ER/孕激素受体（PR）状态阳性。12例患者接受了治疗，所有患者均可评估疗效和毒性。9例患者有主要临床肿瘤反应，其中5例部分缓解（PR），4例病理完全缓解（pCR率为33%）。3例患者（其中2例为Ⅲb期）病情进展，随后接受AC新辅助治疗。有1例3级血液学毒性（1例未遵医嘱使用G - CSF的患者发生中性粒细胞减少性发热）。有2例3级血液外毒性：1例患者有严重疼痛，1例患者有治疗相关疲劳。中位随访20个月（范围7 - 49个月）后，所有患者均存活，9例缓解者中有8例无疾病进展。尽管我们的研究规模较小，但我们认为剂量密集新辅助多西他赛耐受性良好，其活性值得在更多患者中得到证实。
