Hainsworth J D
Department of Medicine, Vanderbilt University, Nashville, TN.
Ann Oncol. 1993;4 Suppl 2:37-40. doi: 10.1093/annonc/4.suppl_2.s37.
Metastatic breast cancer remains an incurable disease; therefore, both the efficacy and the toxicity of palliative chemotherapy are important considerations. Mitoxantrone and 5-fluorouracil (5-FU) with high dose leucovorin are active drugs in the treatment of breast cancer, and both can be given with relatively few side effects. We evaluated the efficacy and toxicity of these agents in a combination regimen for the treatment of metastatic breast cancer.
In a phase II study, we treated 35 women with metastatic breast cancer with the following regimen: mitoxantrone 12 mg/m2 i.v. day 1; leucovorin 300 mg i.v. over 1 hour followed by 5-FU 350 mg/m2 i.v. push on days 1, 2 and 3; courses repeated every 21 days. Responding patients received a total of 6-8 courses. Most patients were receiving second-line chemotherapy for metastatic breast cancer, but some were receiving first-line therapy following failure of adjuvant chemotherapy.
Twenty of 31 assessable patients (65%) had objective responses; in addition, 2 of 4 patients with bone-only metastases had sustained symptomatic responses. Toxicity was mild and the regimen was well tolerated. The activity of this drug combination has been verified in several other phase II studies.
The combination of mitoxantrone, 5-FU and high-dose leucovorin provides an attractive option for second-line chemotherapy of metastatic breast cancer. The efficacy of this combination in first-line therapy is currently being compared to cyclophosphamide, methotrexate and 5-FU (CMF) in a randomized trial.
转移性乳腺癌仍然是一种无法治愈的疾病；因此，姑息化疗的疗效和毒性都是重要的考虑因素。米托蒽醌和高剂量亚叶酸的5-氟尿嘧啶（5-FU）是治疗乳腺癌的活性药物，且两者给药时副作用相对较少。我们评估了这些药物联合方案治疗转移性乳腺癌的疗效和毒性。
在一项II期研究中，我们用以下方案治疗了35例转移性乳腺癌女性患者：第1天静脉注射米托蒽醌12 mg/m²；第1、2和3天，先静脉滴注1小时亚叶酸300 mg，随后静脉推注5-FU 350 mg/m²；每21天重复一个疗程。有反应的患者共接受6 - 8个疗程。大多数患者接受转移性乳腺癌的二线化疗，但有些患者在辅助化疗失败后接受一线治疗。
31例可评估患者中有20例（65%）出现客观反应；此外，4例仅骨转移患者中有2例有持续的症状缓解。毒性轻微，该方案耐受性良好。这种药物联合的活性已在其他几项II期研究中得到验证。
米托蒽醌、5-FU和高剂量亚叶酸的联合方案为转移性乳腺癌的二线化疗提供了一个有吸引力的选择。目前正在一项随机试验中将该联合方案在一线治疗中的疗效与环磷酰胺、甲氨蝶呤和5-FU（CMF）进行比较。
