Département d'Oncologie Médicale, Gustave Roussy, 114 Rue Edouard Vaillant, 94805 Villejuif Cedex, Villejuif, France.
Sarcoma Center, West German Cancer Center, University of Duisburg-Essen, Hufelandstraße 55, 45147, Essen, Germany.
BMC Cancer. 2019 Aug 13;19(1):794. doi: 10.1186/s12885-019-5988-3.
PALETTE is a phase 3 trial that demonstrated single-agent activity of pazopanib in advanced soft tissue sarcomas (aSTS). We performed retrospective subgroup analyses to explore potential relationships between patient characteristics, prior lines of therapy, dose intensity, and dose modifications on safety and efficacy of pazopanib in aSTS.
PALETTE compared pazopanib with placebo in patients with aSTS (age ≥ 18 years) whose disease had progressed during or following prior chemotherapy. In these subgroup analyses, median progression-free survival (mPFS) among patients receiving pazopanib was the efficacy outcome of interest. Adverse events (AEs) were also compared within subgroups. All analyses were descriptive and exploratory.
A total of 246 patients received pazopanib in the PALETTE study. The mPFS was longer in patients who had only 1 prior line versus 2+ prior lines of therapy (24.7 vs 18.9 weeks, respectively); AE rates were similar regardless of number of prior lines of therapy. The mPFS was similar in patients aged < 65 and ≥ 65 y (20.0 and 20.1 weeks, respectively). Although AEs leading to study discontinuation were higher in older patients (≥65 y, 30%; < 65 y, 17%), rates of dose reductions, dose interruptions, and serious AEs were similar between the 2 age groups. No reduction in mPFS was noted in patients requiring dose reductions or dose interruptions to manage toxicities.
Longer mPFS was observed in patients receiving pazopanib following only 1 line of therapy. Additionally, mPFS with pazopanib was maintained regardless of patient age or dose modifications used to manage toxicity.
NCT00753688 , first posted September 16, 2008 (registered prospectively).
PALETTE 是一项 3 期临床试验，证明了帕唑帕尼在晚期软组织肉瘤（aSTS）中的单药活性。我们进行了回顾性亚组分析，以探讨患者特征、先前治疗线数、剂量强度以及剂量调整与 aSTS 中帕唑帕尼安全性和疗效之间的潜在关系。
PALETTE 将帕唑帕尼与安慰剂在疾病进展或在先前化疗期间进展的 aSTS 患者（年龄≥18 岁）中进行了比较。在这些亚组分析中，接受帕唑帕尼治疗的患者的中位无进展生存期（mPFS）是疗效的研究终点。还比较了亚组内的不良事件（AE）。所有分析均为描述性和探索性的。
共有 246 名患者在 PALETTE 研究中接受了帕唑帕尼治疗。与接受 2+线治疗的患者相比，仅接受 1 线治疗的患者的 mPFS 更长（分别为 24.7 周和 18.9 周）；AE 发生率与先前治疗线数无关。年龄<65 岁和≥65 岁的患者的 mPFS 相似（分别为 20.0 周和 20.1 周）。尽管年龄较大的患者（≥65 岁，30%；<65 岁，17%）因 AE 而导致研究中止的比例较高，但两组之间的剂量减少、剂量中断和严重 AE 的发生率相似。在需要减少剂量或中断剂量以控制毒性的患者中，mPFS 没有降低。
接受帕唑帕尼治疗的患者仅接受 1 线治疗后，mPFS 更长。此外，无论患者年龄或用于控制毒性的剂量调整如何，帕唑帕尼的 mPFS 均保持不变。
NCT00753688，首次于 2008 年 9 月 16 日发布（前瞻性注册）。
