国产多西他赛单药治疗晚期乳腺癌的疗效及安全性

doi:10.6040/j.issn.1671-7554.0.2017.1025

摘要/Abstract

摘要： 目的观察国产多西他赛单药在晚期乳腺癌治疗中的疗效及安全性。方法收集141例采用单药多西他赛治疗的晚期乳腺癌患者,每2周期进行疗效评价,回顾性分析单药多西他赛的客观反应率(ORR)、至疾病进展时间(TTP)、至治疗失败时间(TTF)以及安全性,并观察减少地塞米松剂量对患者安全性的影响。结果 141例均为可评价病例。完成中位6周期(1~14周期)单药多西他赛化疗后,疗效评价为完全缓解(CR)0例、部分缓解(PR)62例、疾病稳定(SD)61例、疾病进展(PD)18例;多西他赛单药治疗ORR为43.0 %(62/141);临床获益率(CBR)为51.8 %(73/141),疾病控制率(DCR)为87.2%(123/141); TTP为6.5个月(5.8~7.2个月), TTF为4.0个月(3.9~4.1个月);3~4级不良反应主要为中性粒细胞减少(72.3%),腹痛腹泻(2.8%)、口腔黏膜炎(4.3%),给予对症处理后均有所改善。同时发现给予地塞米松减量后未增加不良反应。结论单药国产多西他赛治疗晚期乳腺癌疗效肯定,耐受性良好,且易于执行,适合晚期乳腺癌的解救治疗。对于不能耐受糖皮质激素不良反应的患者可考虑给予减少地塞米松的使用剂量。

关键词: 国产多西他赛, 晚期乳腺癌, 疗效, 安全性, 化疗

Abstract: Objective To observe the efficacy and toxicities of domestic docetaxel single-agent chemotherapy in the treatment of advanced breast cancer. Methods A total of 141 patients with advanced breast cancer treated with domestic docetaxel were reviewed every 2 cycles of treatment. The objective response rate(ORR), time to progress(TTP), time to treatment failure(TTF), toxicity and adverse responses were evaluated. The effects of dexamethasone dosage on the safety of chemotherapy were observed. Results The median number of treatment was 6(1~14)cycles. Of all 141 cases, none were complete remission(CR), 62 were partial remission(PR), 61 were stable disease(SD), and 18 were progression disease(PD). The ORR was 43.0%(62/141), clinical benefit rate(CBR)was 51.8 %(73/141), disease control rate(DCR)was 87.2%(123/141), TTP was 6.5(5.8~7.2)months, and TTF was 4.0(3.9~4.1)months. The grade 3~4 adverse reactions included neutropenia(72.3%), abdominal pain and diarrhea(2.8%)and oral mucositis(4.3%), which were relieved after symptomatic treatment. Reducing the dosage of dexamethasone did not increase adverse reactions. Conclusion Single-agent domestic docetaxel showed good efficacy and safety for patients with advanced breast cancer. The dosage of dexamethasone can be reduced for those who could not tolerate adverse reactions caused by corticosteroid.

Key words: Domestic docetaxel, Advanced breast cancer, Efficacy, Safety, Chemotherapy

中图分类号:

R737.9

律慧敏,张梦玮,牛李敏,曾惠爱,闫敏. 国产多西他赛单药治疗晚期乳腺癌的疗效及安全性[J]. 山东大学学报 (医学版), 2018, 56(1): 45-49.

LÜ Huimin, ZHANG Mengwei, NIU Limin, ZENG Huiai, YAN Min. Efficacy and safety of single-agent domestic docetaxel in the treatment of advanced breast cancer[J]. Journal of Shandong University (Health Sciences), 2018, 56(1): 45-49.

参考文献

[1] Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016[J]. CA Cancer J Clin, 2016, 66(1): 7-30.
[2] Early Breast Cancer Trialists Collaborative Group(EBCTCG): Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomized trials[J]. Lancet, 2005, 365(9472): 1687-1717.
[3] Cardoso F, Costa A, Senkus E, et al. 3rd ESMO International Consensus Guidelines for Advanced Breast Cancer(ABC 3)[J]. Ann Oncol, 2017, 28(1): 16-33.
[4] Carrick S, Parker S, Thornton CE, et al. Single agent versus combination chemotherapy for metastatic breast cancer[J]. Cochrane Database Syst Rev, 2009, 2(2). Doi:10.1002/14651858.CD-003372 pub3.
[5] Seidman AD, Tiersten A, Hudis C, et al. Phase Ⅱ trial of paclitaxel by 3- hour infusion as initial and salvage chemotherapy for metastatic breast cancer[J]. J Clin Oncol, 1995, 13(10): 2575-2581.
[6] Perez EA, Vogel CL, Irwin DH, et al. Multicenter phase II trial of weekly paclitaxel in women with metastatic breast cancer[J]. J Clin Oncol, 2001, 19(22): 4216-4223.
[7] Rd BH. Single-agent docetaxel(Taxotere)in randomized phase III trials[J]. Semin Oncol, 1999, 26(9): 1-6.
[8] Eisenhauer EA,Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline(version 1.1)[J]. Eur J Cancer, 2009, 45(2): 228-247.
[9] National Cancer Institute. Common Terminology Criteria for Adverse Events v.4.0(CTCAE). Available at: http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm. Accessed June 14, 2011.
[10] Nabholtz JM, Tonkin K, Smylie M, et al. Chemotherapy of breast cancer: are the taxanes going to change the natural history of breast cancer?[J]. Expert Opin Pharmaco, 2000, 1(2): 187-206.
[11] Kelland LR, Abel G. Comparative in vitro cytotoxicity of taxol and Taxotere against cisplatin-sensitive and -resistant human ovarian carcinoma cell lines[J]. Cancer Chemother Pharmacol, 1992, 30(6): 444-450.
[12] Harvey V, Mouridsen H, Semiglazov V, et al. Phase Ⅲ trial comparing three doses of docetaxel for second-1ine treatment of advanced breast cancer[J]. J Clin Oncol, 2006, 24(31): 4963-4970.
[13] Figgitt DP, Wiseman LR. Docetaxel: an update of its use in advanced breast cancer[J]. Drugs, 2000, 59(3): 621-651.
[14] 王子平, 孙燕, 张湘茹, 等. 多西他赛治疗晚期乳腺癌的临床研究[J]. 中华肿瘤杂志, 2006, 28(6): 468-470. WANG Ziping, SUN Yan, ZHANG Xiangru, et al. Docetaxel in the treatment of advanced breast cancer[J]. Chinese Journal of Oncology, 2006, 28(6): 468-470.
[15] Marty M, Cognetti F, Maraninchi D, et al. Randomized phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as first-line treatment: the M77001 study group[J]. J Clin Oncol, 2005, 23(19): 4265-4274.
[16] Jones SE, Erban J, Overmoyer B, et al. Randomized phase III study of docetaxel compared with paclitaxel in metastatic breast cancer[J]. J Clin Oncol, 2005, 23(24): 5542-5551.
[17] Nabholtz JM, Senn HJ, Bezwoda WR, et al. Prospective randomized trial of docetaxel versus mitomycin plus vinblastine in patients with metastatic breast cancer progressing despite previous anthracycline-containing chemotherapy[J]. J Clin Oncol, 1999, 17(5): 1413-1424.
[18] Bonneterre J, Roche H, Monnier A, et al. Docetaxel vs 5-fluorouracil plus vinorelbine in metastatic breast cancer after anthracycline therapy failure[J]. Br J Cancer, 2002, 87(11): 1210-1215.
[19] Sjöström J, Blomqvist C, Mouridsen H, et al. Docetaxel compared with sequential methotrexate and 5-fluorouracil in patients with advanced breast cancer after anthracycline failure: a randomised phase III study with crossover on progression by the Scandinavian Breast Group[J]. Eur J Cancer, 1999, 35(8): 1194-1201.
[20] Brodowicz T, Koestler WJ, Tomek S, et al. Monotherapy with docetaxel in second- or third-line treatment of anthracycline-resistant metastatic breast cancer[J]. Anti-Cancer Drugs, 2000, 11(3): 149-153.
[21] Bergh M, Magnusson K, Nilsson JL, et al. Contact allergenic activity of Tween 80 before and after air exposure[J]. Contact Dermatitis,1997, 37: 9-18.
[22] Semb KA, Aamdal S, Oian P. Capillary protein leak syndrome appears to explain fluid retention in cancer patients who receive docetaxel treatment[J]. J Clin Oncol, 1998, 16(10): 3426-3432.
[23] Schwartz JR. Dexamethasone premedication for prophylaxis of taxane toxicities: can the doses be reduced when paclitaxel or docetaxel are given weekly?[J]. J Oncol Pharm Practice, 2012, 18(2): 250-256.
[24] Chouhan JD, Herrington JD. Single premedication dose of dexamethasone 20 mg IV before docetaxel administration[J]. J Oncol Pharm Practice, 2010, 17(3): 155-159.
[25] 李海志, 徐沁甜, 宋毕清. 单次剂量地塞米松10 mg静注预防多西他赛副反应的安全性与可行性研究[J]. 中国现代医药杂志, 2016, 18(8): 63-64.

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