Vredenburgh J J, Madan B, Coniglio D, Ross M, Broadwater G, Niedzwiecki D, Edwards J, Marks L, Vandemark R, McDonald C, Affronti M L, Peters W P
Division of Medical Oncology/Transplantation, Duke University Medical Center, Durham, NC 27710, USA.
Bone Marrow Transplant. 2006 Jun;37(11):1009-15. doi: 10.1038/sj.bmt.1705367.
The prognosis for patients with metastatic breast cancer remains poor. Metastatic breast cancer confined to the bones may have a better prognosis, especially hormone receptor-positive disease. We performed a prospective, randomized clinical trial to compare immediate consolidation with high-dose chemotherapy and hematopoietic support versus observation with high-dose consolidation at the time of disease progression in women with metastatic breast cancer and only bone metastases. The patients received chemotherapy with doxorubicin, 5-fluorouracil and methotrexate before randomization. In all, 85 patients were enrolled and 69 were randomized. The median follow-up is 8.1 years from randomization. The median event-free survival (EFS) for the immediate transplant arm is 12 months and for the observation arm is 4.3 months (P<0.0001). The median overall survival for the immediate transplant arm is 2.97 years and for the observation arm 1.81 years, a difference that is not statistically significant. Immediate high-dose chemotherapy and radiation therapy as consolidation offers a clinically and statistically significant improvement in EFS compared with radiation therapy alone following induction chemotherapy for women with metastatic breast cancer confined to the bones.
转移性乳腺癌患者的预后仍然很差。局限于骨骼的转移性乳腺癌可能预后较好，尤其是激素受体阳性的疾病。我们进行了一项前瞻性随机临床试验，以比较转移性乳腺癌且仅有骨转移的女性患者立即进行大剂量化疗和造血支持巩固治疗与疾病进展时进行大剂量巩固治疗观察的效果。患者在随机分组前接受了阿霉素、5-氟尿嘧啶和甲氨蝶呤化疗。总共招募了85名患者，69名被随机分组。自随机分组起，中位随访时间为8.1年。立即移植组的中位无事件生存期（EFS）为12个月，观察组为4.3个月（P<0.0001）。立即移植组的中位总生存期为2.97年，观察组为1.81年，差异无统计学意义。对于局限于骨骼的转移性乳腺癌女性患者，与诱导化疗后单纯放疗相比，立即进行大剂量化疗和放疗作为巩固治疗可使EFS在临床和统计学上有显著改善。
