Is first-line single-agent mitoxantrone in the treatment of high-risk metastatic breast cancer patients as effective as combination chemotherapy?: No difference in survival but higher quality of life were found in a multicenter randomized trial
Is first-line single-agent mitoxantrone in the treatment of high-risk metastatic breast cancer patients as effective as combination chemotherapy?: No difference in survival but higher quality of life were found in a multicenter randomized trial
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DOI：
10.1093/annonc/mdf306
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发表时间：
2002-01-01
影响因子：
50.5
通讯作者：
Kaufmann, M
中科院分区：
文献类型：
--
作者：
Heidemann, E;Stoeger, H;Kaufmann, M
背景资料：确定高危转移性乳腺癌患者是否从一线联合化疗中获益。患者和方法：共有260名患有可测量的转移性乳腺癌的女性符合高风险标准，以前未接受过转移性疾病的化疗，随机接受米托蒽醌12 mg/m2或氟尿嘧啶500 mg/m2，表阿霉素50 mg/m2和环磷酰胺500 mg/m2（FEC），每3周一次。治疗持续至完全缓解加两个周期，或直至疾病进展。在部分缓解或疾病稳定的情况下，在12个周期后停止治疗。二线治疗为长春地辛、丝裂霉素和泼尼松龙。使用改良的Brunner评分（包括至进展时间、患者对治疗获益的评分、脱发、呕吐和体能状态）评估治疗获益。经过1992年至1997年的招募和1997年至1999年的观察，最后的评估显示，在反应、客观缓解率、缓解持续时间、反应时间、最佳反应时间至进展时间或总生存期。然而，有一个显着的差异，从治疗中使用修改后的Brunner评分有利于单药治疗arm. There是没有证据表明，任何亚组将更好地与联合treatment.Conclusions治疗米托蒽醌作为一个单一的代理和低剂量FEC的组合在反应或生存方面的治疗之间没有显着差异检测;因此，对于高危转移性乳腺癌患者，一线联合化疗的必要性的迫切性可能受到质疑。由于毒性和生活质量评分有利于单药米托蒽醌治疗组，因此该治疗可提供给更喜欢生活质量而不是潜在的生存期小幅延长的患者。
Background: To determine whether patients with high-risk metastatic breast cancer draw benefit from combination chemotherapy as first-line treatment.Patients and methods: A total of 260 women with measurable metastatic breast cancer fulfilling high-risk criteria, previously untreated with chemotherapy for their metastatic disease, were randomized to receive either mitoxantrone 12 mg/m(2) or the combination of fluorouracil 500 mg/m(2), epirubicin 50 mg/m(2) and cyclophosphamide 500 mg/m(2) (FEC) every 3 weeks. Treatment was continued until complete remission plus two cycles, or until disease progression. In the case of partial remission or stable disease, treatment was stopped after 12 cycles. Second-line treatment was vindesine, mitomycin and prednisolone. Gain from treatment was estimated using a modified Brunner's score composed of time to progression, patients' rating of the treatment benefit, alopecia, vomiting and performance status.Results: After recruitment from 1992 to 1997 and observation from 1997 to 1999, the final evaluation showed that single-agent treatment with mitoxantrone does not differ significantly from combination treatment with FEC in terms of response, objective remission rate, remission duration, time to response, time to best response, time to progression or overall survival. There was, however, a significant difference in gain from treatment using a modified Brunner's score favoring the single-agent treatment arm. There was no evidence that any subgroup would fare better with combination treatment.Conclusions: No significant difference was detected between the treatment with mitoxantrone as a single agent and the combination of low-dose FEC in terms of response or survival; therefore, the imperative of the necessity of first-line combination chemotherapy for patients with high-risk metastatic breast cancer may be questioned. Since toxicity and quality of life score favored the single-agent mitoxantrone treatment arm, this treatment may be offered to patients preferring quality of life to a potential small prolongation of survival.