Northfelt D W, Dezube B J, Thommes J A, Miller B J, Fischl M A, Friedman-Kien A, Kaplan L D, Du Mond C, Mamelok R D, Henry D H
University of California, San Francisco, USA.
J Clin Oncol. 1998 Jul;16(7):2445-51. doi: 10.1200/JCO.1998.16.7.2445.
Kaposi's sarcoma (KS), the most common neoplasm in patients with AIDS, is a significant clinical problem for which current therapies are frequently unsatisfactory. We conducted a randomized phase III clinical trial to compare the efficacy and toxicities of a new form of therapy, pegylated-liposomal doxorubicin, with standard combination chemotherapy in patients with advanced AIDS-related KS (AIDS-KS).
Two hundred fifty-eight patients with advanced AIDS-KS were randomly assigned to receive either pegylated-liposomal doxorubicin (20 mg/m2) or the combination of doxorubicin (20 mg/m2), bleomycin (10 mg/m2) and vincristine (1 mg) (ABV) every 14 days for six cycles. Standard response criteria, toxicity criteria, and predefined indicators of clinical benefit were examined to evaluate outcomes.
Among 133 patients randomized to receive pegylated-liposomal doxorubicin, one achieved a complete clinical response and 60 achieved a partial response for an overall response rate of 45.9% (95% confidence interval [CI], 37% to 54%). Among 125 patients randomized to receive ABV, 31 achieved a partial response (24.8%; 95% confidence interval [CI], 17% to 32%). This difference was statistically significant (P < .001). In addition to objective responses, prospectively defined clinical benefits and toxicity outcomes also favored pegylated-liposomal doxorubicin.
Pegylated-liposomal doxorubicin is more effective and less toxic than the standard combination chemotherapy regimen ABV for treatment of AIDS-KS.
卡波西肉瘤（KS）是艾滋病患者中最常见的肿瘤，是一个重大的临床问题，目前的治疗方法常常不能令人满意。我们进行了一项随机III期临床试验，比较一种新的治疗形式——聚乙二醇化脂质体阿霉素与标准联合化疗对晚期艾滋病相关卡波西肉瘤（AIDS-KS）患者的疗效和毒性。
258例晚期AIDS-KS患者被随机分配，每14天接受一次聚乙二醇化脂质体阿霉素（20mg/m²）或阿霉素（20mg/m²）、博来霉素（10mg/m²）和长春新碱（1mg）的联合用药（ABV），共六个周期。采用标准反应标准、毒性标准和预先定义的临床获益指标来评估结果。
在133例随机接受聚乙二醇化脂质体阿霉素治疗的患者中，1例获得完全临床缓解，60例获得部分缓解，总缓解率为45.9%（95%置信区间[CI]，37%至54%）。在125例随机接受ABV治疗的患者中，31例获得部分缓解（24.8%；95%置信区间[CI]，17%至32%）。这种差异具有统计学意义（P<.001）。除了客观反应外，预先定义的临床获益和毒性结果也有利于聚乙二醇化脂质体阿霉素。
对于治疗AIDS-KS，聚乙二醇化脂质体阿霉素比标准联合化疗方案ABV更有效且毒性更小。
