Mayo Clinic Rochester, Rochester, Minnesota 55905, USA.
Cancer. 2011 Apr 15;117(8):1704-10. doi: 10.1002/cncr.25659. Epub 2010 Nov 8.
There is increasing evidence that paclitaxel and carboplatin are clinically active in the treatment of metastatic melanoma (MM). ABI-007 is an albumin-bound formulation of paclitaxel that has demonstrated single-agent activity against metastatic melanoma.
A parallel phase II trial was conducted in patients with unresectable stage IV melanoma who were either chemotherapy naive (CN) or previously treated (PT). The treatment regimen consisted of ABI-007 (100 mg/m(2) ) and carboplatin area under the curve (AUC2) administered on days 1, 8, and 15 every 28 days. The primary aim of this study was objective response rate (RECIST).
Seventy-six patients (41 CN and 35 PT) were enrolled between November 2006 and July 2007. Three patients withdrew consent prior to starting treatment. The median number of treatment cycles was 4. There were 10 (25.6%) responses (1 complete response [CR] and 9 partial responses [PRs]) in the CN cohort (90% CI, 16.7%-42.3%) and 3 (8.8%) responses (3 PRs) in the PT cohort (90% CI, 2.5%-21.3%). Median progression-free survival was 4.5 months in the CN cohort and 4.1 months in the PT cohort. Median overall survival (OS) was 11.1 months in the CN group and 10.9 months in the PT group. Severe toxicities in both groups (Common Terminology Criteria for Adverse Effects v.3.0 ≥grade 3) included neutropenia, thrombocytopenia, neurosensory problems, fatigue, nausea, and vomiting.
The weekly combination of ABI-007 and carboplatin appears to be moderately well tolerated, with promising clinical activity as therapy in patients who are chemotherapy naive and with modest antitumor activity in those previously treated.
紫杉醇和卡铂在治疗转移性黑色素瘤（MM）方面具有显著的临床疗效，这一观点已得到越来越多的证据支持。ABI-007 是一种紫杉醇的白蛋白结合剂型，其在治疗转移性黑色素瘤方面具有单药活性。
本研究为一项平行的 II 期临床试验，入组了未经化疗（CN）或已接受化疗（PT）的不可切除的 IV 期黑色素瘤患者。治疗方案为 ABI-007（100mg/m²）联合卡铂曲线下面积（AUC2），第 1、8 和 15 天给药，每 28 天为一个周期。该研究的主要目的是客观缓解率（RECIST）。
2006 年 11 月至 2007 年 7 月共入组 76 例患者（CN 组 41 例，PT 组 35 例），其中 3 例患者在开始治疗前撤回了同意。中位治疗周期数为 4 个。CN 组中有 10 例（25.6%）患者（90%CI：16.7%-42.3%）获得缓解（1 例完全缓解[CR]，9 例部分缓解[PR]），PT 组中有 3 例（8.8%）患者（3 例 PR）获得缓解（90%CI：2.5%-21.3%）。CN 组和 PT 组的中位无进展生存期分别为 4.5 个月和 4.1 个月，中位总生存期（OS）分别为 11.1 个月和 10.9 个月。两组患者（不良事件通用术语标准 3.0 版≥3 级）的严重毒性包括中性粒细胞减少、血小板减少、神经感觉问题、疲劳、恶心和呕吐。
ABI-007 联合卡铂每周方案的耐受性较好，在化疗初治患者中具有良好的临床获益，在既往治疗患者中具有适度的抗肿瘤活性。
