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多西他赛联合顺铂对先前蒽环类药物治疗耐药的转移性乳腺癌患者有效:一项II期临床试验。

Docetaxel plus cisplatin is effective for patients with metastatic breast cancer resistant to previous anthracycline treatment: a phase II clinical trial.

作者信息

Park Se Hoon, Cho Eun Kyung, Bang Soo-Mee, Shin Dong Bok, Lee Jae Hoon, Lee Young Don

机构信息

Division of Hematology and Oncology, Internal Medicine, Gachon Medical School Gil Medical Center, Incheon 405-760, Korea.

出版信息

BMC Cancer. 2005 Feb 22;5:21. doi: 10.1186/1471-2407-5-21.

Abstract

BACKGROUND

Patients with metastatic breast cancer (MBC) are frequently exposed to high cumulative doses of anthracyclines and are at risk of resistance and cardiotoxicity. This phase II trial evaluated the efficacy and toxicity of docetaxel plus cisplatin, as salvage chemotherapy in patients with MBC resistant to prior anthracyclines.

METHODS

Patients with MBC that had progressed after at least one prior chemotherapy regimen containing anthracyclines received docetaxel 75 mg/m2 followed by cisplatin 60 mg/m2 every 3 weeks for a maximum of 6 cycles or until disease progression.

RESULTS

Between Jan 2000 and May 2002, 24 patients with tumors primary resistant and 15 with secondary resistant disease were accrued. All 39 patients were evaluable for safety and 36 for efficacy. The objective response rate was 31% (95% CI, 16-45%) with 3 complete responses. The median time to disease progression was 7 months, and the median overall survival was 23 months (median follow-up of 41 months). Neutropenia was the most frequently observed severe hematologic toxicity (39% of patients), whereas asthenia and nausea were the most common non-hematologic toxicities. No treatment-related death was observed.

CONCLUSION

In conclusion, we found docetaxel plus cisplatin to be an active and safe chemotherapy regimen for patients with MBC resistant to anthracyclines.

摘要

背景

转移性乳腺癌(MBC)患者经常接受高累积剂量的蒽环类药物治疗,存在耐药和心脏毒性风险。本II期试验评估了多西他赛联合顺铂作为挽救性化疗方案用于对既往蒽环类药物耐药的MBC患者的疗效和毒性。

方法

既往至少接受过一种含蒽环类药物化疗方案后病情进展的MBC患者,接受多西他赛75mg/m²,随后每3周给予顺铂60mg/m²,最多6个周期或直至疾病进展。

结果

2000年1月至2002年5月期间,纳入了24例原发性耐药肿瘤患者和15例继发性耐药疾病患者。所有39例患者均进行了安全性评估,36例进行了疗效评估。客观缓解率为31%(95%CI,16-45%),有3例完全缓解。疾病进展的中位时间为7个月,中位总生存期为23个月(中位随访41个月)。中性粒细胞减少是最常观察到的严重血液学毒性(39%的患者),而乏力和恶心是最常见的非血液学毒性。未观察到与治疗相关的死亡。

结论

总之,我们发现多西他赛联合顺铂对于对蒽环类药物耐药的MBC患者是一种有效且安全的化疗方案。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4da6/553982/7e9656fe87af/1471-2407-5-21-1.jpg

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