Medical Oncology, IRCCS Foundation, San Matteo Hospital, Pavia, Italy.
Medical Oncology, European Institute of Oncology, Milan, Italy.
Biol Blood Marrow Transplant. 2014 Apr;20(4):501-6. doi: 10.1016/j.bbmt.2013.12.569. Epub 2013 Dec 27.
The efficacy of high-dose chemotherapy (HDC) and autologous hemopoietic progenitor cell transplantation (AHPCT) for breast cancer (BC) patients has been an area of intense controversy among the medical oncology community. The aim of this study was to assess toxicity and efficacy of this procedure in a large cohort of high-risk primary BC patients who underwent AHPCT in Italy. A total of 1183 patients receiving HDC for high-risk BC (HRBC) (>3 positive nodes) were identified in the Italian registry. The median age was 46 years, 62% of patients were premenopausal at treatment, 60.1% had endocrine-responsive tumors, and 20.7% had a human epidermal growth factor receptor 2 (HER2)-positive tumor. The median number of positive lymph nodes (LN) at surgery was 15, with 71.5% of patients having ≥ 10 positive nodes. Seventy-three percent received an alkylating agent-based HDC as a single procedure, whereas 27% received epirubicin or mitoxantrone-containing HDC, usually within a multitransplantation program. The source of stem cells was peripheral blood in the vast majority of patients. Transplantation-related mortality was .8%, whereas late cardiac and secondary tumor-related mortality were around 1%, overall. With a median follow-up of 79 months, median disease-free and overall survival (OS) in the entire population were 101 and 134 months, respectively. Subgroup analysis demonstrated that OS was significantly better in patients with endocrine-responsive tumors and in patients receiving multiple transplantation procedures. HER2 status did not affect survival probability. The size of the primary tumor and number of involved LN negatively affected OS. Adjuvant HDC with AHPCT has a low mortality rate and provides impressive long-term survival rates in patients with high-risk primary BC. Our results suggest that this treatment modality should be proposed in selected HRBC patients and further investigated in clinical trials.
高剂量化疗（HDC）和自体造血祖细胞移植（AHPCT）治疗乳腺癌（BC）患者的疗效一直是肿瘤内科领域争议的焦点。本研究旨在评估意大利高危原发性 BC 患者接受 AHPCT 后该治疗方案的毒性和疗效。在意大利登记处确定了 1183 名接受 HDC 治疗高危 BC（HRBC）（>3 个阳性淋巴结）的患者。中位年龄为 46 岁，治疗时 62%的患者处于绝经前，60.1%的患者肿瘤对内分泌治疗有反应，20.7%的患者人表皮生长因子受体 2（HER2）阳性。手术时的阳性淋巴结（LN）中位数为 15 个，71.5%的患者有≥10 个阳性淋巴结。73%的患者接受了基于烷化剂的 HDC 作为单一方案，而 27%的患者接受了含有表柔比星或米托蒽醌的 HDC，通常在多移植方案中。绝大多数患者的干细胞来源为外周血。移植相关死亡率为 0.8%，而晚期心脏和继发性肿瘤相关死亡率约为 1%，总体而言。中位随访 79 个月，整个队列的中位无病生存和总生存（OS）分别为 101 和 134 个月。亚组分析表明，内分泌治疗有反应的患者和接受多次移植的患者 OS 显著改善。HER2 状态对生存概率没有影响。原发肿瘤大小和受累 LN 数量对 OS 有负面影响。辅助 HDC 联合 AHPCT 的死亡率较低，可为高危原发性 BC 患者提供令人印象深刻的长期生存率。我们的研究结果表明，这种治疗方式应在选择的 HRBC 患者中提出，并在临床试验中进一步研究。
