Gill P S, Tulpule A, Espina B M, Cabriales S, Bresnahan J, Ilaw M, Louie S, Gustafson N F, Brown M A, Orcutt C, Winograd B, Scadden D T
Departments of Medicine and Pharmacy, University of Southern California, Kenneth Norris Cancer Hospital and Research Institute, Los Angeles, CA, USA.
J Clin Oncol. 1999 Jun;17(6):1876-83. doi: 10.1200/JCO.1999.17.6.1876.
Liposomal anthracyclines are the present standard treatment for advanced AIDS-related Kaposi's sarcoma (KS). No effective therapies have been defined for use after treatment failure of these agents. A phase II trial was thus conducted with paclitaxel in patients with advanced KS to assess safety and antitumor activity.
A regimen of paclitaxel at a dose of 100 mg/m(2) was given every 2 weeks to patients with advanced AIDS-related KS. Patients were treated until complete remission, disease progression, or unacceptable toxicity occurred.
Fifty-six patients with advanced AIDS-related KS were accrued. Tumor-associated edema was present in 70% of patients and visceral involvement in 45%. Forty patients (71%) had received prior systemic therapy; 31 of these were resistant to an anthracycline. The median entry CD4(+) lymphocyte count was 20 cells/mm(3) (range, 0 to 358). A median of 10 cycles (range, 1 to 54+) of paclitaxel was administered. Fifty-nine percent of patients showed complete (n = 1) or partial response (n = 32) to paclitaxel. The median duration of response was 10.4 months (range, 2.8 to 26.7+ months) and the median survival was 15.4 months. The main side effects of therapy were grade 3 or 4 neutropenia in 61% of patients and mild-to-moderate alopecia in 87%.
Paclitaxel at 100 mg/m(2) given every 2 weeks is active and well tolerated in the treatment of advanced and previously treated AIDS-related KS. The median duration of response is among the longest observed for any regimen or single agent reported for AIDS-related KS. Paclitaxel at this dosage and schedule is a treatment option for patients with advanced AIDS-related KS, including those who have experienced treatment failure of prior systemic therapy.
脂质体蒽环类药物是目前治疗晚期艾滋病相关卡波西肉瘤（KS）的标准疗法。对于这些药物治疗失败后的情况，尚未确定有效的治疗方法。因此，开展了一项针对晚期KS患者的紫杉醇II期试验，以评估安全性和抗肿瘤活性。
对晚期艾滋病相关KS患者每2周给予一次剂量为100mg/m²的紫杉醇治疗方案。患者持续接受治疗，直至完全缓解、疾病进展或出现不可接受的毒性反应。
共纳入56例晚期艾滋病相关KS患者。70%的患者存在肿瘤相关水肿，45%的患者有内脏受累。40例患者（71%）曾接受过全身治疗；其中31例对蒽环类药物耐药。入组时CD4⁺淋巴细胞计数中位数为20个细胞/mm³（范围为0至358）。紫杉醇的给药周期中位数为10个周期（范围为1至54个以上周期）。59%的患者对紫杉醇显示出完全缓解（n = 1）或部分缓解（n = 32）。缓解持续时间中位数为10.4个月（范围为2.8至26.7个以上月），中位生存期为15.4个月。治疗的主要副作用为61%的患者出现3级或4级中性粒细胞减少，87%的患者出现轻度至中度脱发。
每2周给予100mg/m²的紫杉醇在治疗晚期且先前接受过治疗的艾滋病相关KS中具有活性且耐受性良好。缓解持续时间中位数是报道的治疗艾滋病相关KS的任何方案或单一药物中观察到的最长时间之一。这种剂量和给药方案的紫杉醇是晚期艾滋病相关KS患者的一种治疗选择，包括那些先前全身治疗失败的患者。
Zotero 插件