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晚期乳腺癌化疗剂量强化:一项可行性II期研究。

Dose intensification of chemotherapy in advanced breast cancer: a feasibility phase II study.

作者信息

Pedrazzoli P, Zamagni C, Martoni A, Capotorto A M, Da Prada G A, Pavesi L, Preti P, Lelli G, Pannuti F, Robustelli della Cuna G

机构信息

Division of Medical Oncology, Clinica del Lavoro Foundation, IRCCS, Pavia, Italy.

出版信息

Tumori. 1994 Aug 31;80(4):273-5. doi: 10.1177/030089169408000405.

DOI:10.1177/030089169408000405
PMID:7526508
Abstract

AIMS AND BACKGROUND

Dose intensification of chemotherapy is associated with increased response rates in advanced breast cancer. Achievement of dose incrementation is usually limited by drug-dependent bone marrow toxicity. The recent availability of recombinant human colony-stimulating factors (CSFs) have made it possible to evaluate their potential in ameliorating chemotherapy-induced myelosuppression. The aim of this study was to evaluate tolerability and effectiveness of an intensified mitoxantrone, methotrexate and mitomycin-C (3M) regimen, given with G-CSF support in patients with advanced breast cancer (ABC).

STUDY DESIGN

Twenty-eight eligible patients with advanced breast cancer were treated with mitomycin -C (7 mg/sqm i.v. every 4 weeks), methotrexate (35 mg/sqm i.v.) and mitoxantrone (7 mg/sqm i.v. every 2 weeks) for 6 cycles. Recombinant human granulocyte colony-stimulating factor (r-HuG-CSF, Filgrastim) (5 micrograms/kg/day) was given subcutaneously from day 2 to day 12 after each chemotherapy administration to prevent leukopenia.

RESULTS

Of the 27 evaluable patients, 4 had complete response and 14 achieved partial response; the overall response rate was 63% (95% CI; 46.8%-82.2%). The median duration of response was 8 months (range, 4-13+). Chemotherapy-related toxicity was mild: only 3 out of 163 courses had to be postponed due to myelotoxicity.

CONCLUSIONS

The 3M regimen given at 2- week intervals is a feasible, active and well toleratel treatment in patients not previously treated for metastatic breast cancer.

摘要

目的与背景

在晚期乳腺癌中,化疗剂量强化与缓解率增加相关。剂量增加通常受药物依赖性骨髓毒性限制。重组人集落刺激因子(CSF)的近期可得性使得评估其在改善化疗引起的骨髓抑制方面的潜力成为可能。本研究的目的是评估在粒细胞集落刺激因子(G-CSF)支持下,强化的米托蒽醌、甲氨蝶呤和丝裂霉素-C(3M)方案对晚期乳腺癌(ABC)患者的耐受性和有效性。

研究设计

28例符合条件的晚期乳腺癌患者接受丝裂霉素-C(每4周静脉注射7mg/m²)、甲氨蝶呤(静脉注射35mg/m²)和米托蒽醌(每2周静脉注射7mg/m²)治疗6个周期。每次化疗给药后第2天至第12天皮下注射重组人粒细胞集落刺激因子(r-HuG-CSF,非格司亭)(5μg/kg/天)以预防白细胞减少。

结果

27例可评估患者中,4例完全缓解,14例部分缓解;总缓解率为63%(95%CI:46.8%-82.2%)。缓解的中位持续时间为8个月(范围4-13+)。化疗相关毒性较轻:163个疗程中仅3个因骨髓毒性而不得不推迟。

结论

对于既往未接受转移性乳腺癌治疗的患者,每2周给药的3M方案是一种可行、有效且耐受性良好的治疗方法。

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