Welles L, Saville M W, Lietzau J, Pluda J M, Wyvill K M, Feuerstein I, Figg W D, Lush R, Odom J, Wilson W H, Fajardo M T, Humphrey R W, Feigal E, Tuck D, Steinberg S M, Broder S, Yarchoan R
HIV and AIDS Malignancy Branch, National Cancer Institute; the Warren G. Magnuson Clinical Center, Bethesda, MD 20892-1906, USA.
J Clin Oncol. 1998 Mar;16(3):1112-21. doi: 10.1200/JCO.1998.16.3.1112.
To investigate the antitumor activity and safety of paclitaxel in patients with advanced human immunodeficiency virus (HIV)-associated Kaposi's sarcoma (KS).
Twenty-nine patients with advanced HIV-associated KS were enrolled. The patients were overall quite immunosuppressed (median CD4 count, 15 cells/microL). Paclitaxel was initially administered at 135 mg/m2 over 3 hours every 3 weeks without filgrastim support; the dose was increased as tolerated to a maximum of 175 mg/m2. Patients who failed to respond or progressed could then receive filgrastim support or paclitaxel administered over 96 hours.
Of 28 assessable patients, 20 had major responses (18 partial responses [PRs], one clinical complete response [CR], and one CR), for a major response rate of 71.4% (95% confidence interval [CI], 51.3% to 86.8%). Each of the five patients with pulmonary KS responded, as did all four assessable patients who had previously received anthracycline therapy for KS. Of six patients who went on to receive a 96-hour infusion of paclitaxel, five had major responses. Neutropenia was the most frequent dose-limiting toxicity; possible novel toxicities included late fevers, late rash, and eosinophilia. Two patients developed an elevated creatinine concentration and one cardiomyopathy.
Paclitaxel has substantial activity against advanced HIV-associated KS as a single agent, even in patients with pulmonary involvement or who had previously received anthracyclines. Further research is needed to define the optimal treatment schedule and its role vis-a-vis the other available therapies for this disease.
研究紫杉醇对晚期人类免疫缺陷病毒（HIV）相关卡波西肉瘤（KS）患者的抗肿瘤活性和安全性。
招募了29例晚期HIV相关KS患者。这些患者总体免疫抑制程度较高（中位CD4细胞计数为15个/微升）。紫杉醇最初每3周一次，在无非格司亭支持的情况下，于3小时内静脉滴注135mg/m²；剂量可根据耐受情况增加至最大175mg/m²。对无反应或病情进展的患者，随后可给予非格司亭支持或96小时持续静脉滴注紫杉醇。
在28例可评估患者中，20例有主要反应（18例部分缓解[PR]、1例临床完全缓解[CR]和1例CR），主要反应率为71.4%（95%置信区间[CI]，51.3%至86.8%）。5例肺部KS患者均有反应，所有4例之前接受过蒽环类药物治疗KS的可评估患者也有反应。在6例接受96小时紫杉醇静脉滴注的患者中，5例有主要反应。中性粒细胞减少是最常见的剂量限制性毒性；可能的新毒性包括迟发性发热、迟发性皮疹和嗜酸性粒细胞增多。2例患者肌酐浓度升高，1例发生心肌病。
紫杉醇作为单一药物对晚期HIV相关KS具有显著活性，即使是肺部受累或之前接受过蒽环类药物治疗的患者。需要进一步研究以确定最佳治疗方案及其相对于该疾病其他可用疗法的作用。
