de Vries E G, Rodenhuis S, Schouten H C, Hupperets P S, Dolsma W V, Lebesque J V, Blijham G H, Bontenbal M, Mulder N H
Dutch Working Party on ABMT in Solid Tumors, Department of Medical Oncology, University Hospital Groningen, The Netherlands.
Breast Cancer Res Treat. 1996;39(3):307-13. doi: 10.1007/BF01806158.
This trial studied the disease-free survival after high-dose chemotherapy in patients in complete remission of metastatic breast cancer.
Thirty women, mean age 42.2 years (range 33-55) with metastatic breast cancer, received high-dose chemotherapy in a phase II study. Patients were eligible if they were < or = 55 years of age, had achieved complete remission within 6 months of the initiation of chemotherapy, and had a WHO performance scale of 0 or 1. The high-dose regimen consisted of melphalan 180 mg/m2 and mitoxantrone 60 mg/m2 both divided over 3 days. On day 7 bone marrow and/or peripheral stem cells were infused. After bone marrow recovery, external beam radiation was administered to sites of previous metastatic disease in 15 patients.
Apart from leuko- and thrombocytopenia, mucositis was the major side effect. One patient died during the bone marrow transplant period due to an aspergillus infection. The median follow-up since high-dose chemotherapy is 25 months (range 13 to 56 months). The median disease-free survival since high-dose chemotherapy is 27 months and the disease free survival is still 43% with an overall survival of 53% at 3 years. In two patients tumor relapse occurred only in the brain; in one patient the only relapse sign was a meningeal carcinosis. At the moment 17 patients are disease-free (13(+)-56+) months after high-dose chemotherapy.
Until now this high-dose regimen in selected patients with complete remission after induction chemotherapy for metastatic breast cancer has a promising disease free survival.
本试验研究了转移性乳腺癌完全缓解患者接受大剂量化疗后的无病生存期。
30名转移性乳腺癌女性患者，平均年龄42.2岁（范围33 - 55岁），在一项II期研究中接受了大剂量化疗。符合条件的患者年龄≤55岁，在化疗开始后6个月内实现完全缓解，且世界卫生组织体能状态评分为0或1。大剂量方案包括美法仑180mg/m²和米托蒽醌60mg/m²，均分3天给药。在第7天输注骨髓和/或外周血干细胞。骨髓恢复后，15名患者接受了针对先前转移病灶部位的外照射放疗。
除白细胞减少和血小板减少外，粘膜炎是主要副作用。1名患者在骨髓移植期间因曲霉菌感染死亡。自大剂量化疗后的中位随访时间为25个月（范围13至56个月）。自大剂量化疗后的中位无病生存期为27个月，3年时无病生存率仍为43%，总生存率为53%。2名患者仅脑部出现肿瘤复发；1名患者唯一的复发迹象是脑膜癌。目前，17名患者在大剂量化疗后（13(+) - 56(+)）个月无疾病。
迄今为止，对于转移性乳腺癌诱导化疗后完全缓解的选定患者，这种大剂量方案具有有前景的无病生存期。
