舒尼替尼二线治疗B3型胸腺瘤或胸腺癌患者的II期试验STYLE (NCT03449173)

SCI

26 May 2023

STYLE (NCT03449173) a phase II Trial of Sunitinib in patients with type B3 Thymoma or Thymic Carcinoma in second and further lines 

（Journal of Thoracic Oncology；IF: 20.121）

Proto C, Manglaviti S, Lo Russo G, Musca M, Galli G, Imbimbo M, Perrino M, Cordua N, Rulli E, Ballatore Z, Maso AD, Chella A, Sbrana A, Prelaj A, Ferrara R, Occhipinti M, Brambilla M, De Toma A, Mazzeo L, Beninato T, Signorelli D, Massa G, Greco FG, Calareso G, Miliziano D, Di Mauro RM, Mella G, Lucarelli A, Paggio A, Galli F, Torri V, de Braud FGM, Pasello G, Petrini I, Berardi R, Ganzinelli M, Garassino M, Zucali P 

CORRESPONDENCE TO: claudia.proto@istitutotumori.mi.it

Background 背景

Thymic malignancies are rare tumors with few therapeutic options. The STYLE trial was aimed to evaluate activity and safety of sunitinib in advanced/recurrent type B3 thymoma (T) and thymic carcinoma (TC).

胸腺恶性肿瘤是罕见的肿瘤，治疗方案很少。STYLE试验旨在评估舒尼替尼对晚期/复发性B3型胸腺瘤（T）和胸腺癌（TC）的有效性和安全性。

Methods 方法

In this multicenter Simon 2 stages phase II trial, patients with pretreated T/TC were enrolled in two cohorts and assessed separately. Sunitinib was administered 50mg daily for 4- weeks, followed by a 2-week rest period (schedule 4/2), until disease progression or unacceptable toxicity. The primary endpoint was objectives response rate (ORR). Progression free survival (PFS), overall survival (OS), disease control rate (DCR) and safety were secondary endpoints.

在这项多中心的Simon二阶段II期试验中，预处理的T/TC患者被纳入两个队列并分别评估。舒尼替尼连续4周每天50毫克，然后停药2周，直到疾病进展或出现不可接受的毒性。主要终点是目标反应率（ORR）。无进展生存期（PFS）、总生存期（OS）、疾病控制率（DCR）和安全性是次要终点。

Results 结果

From 03/2017 to 01/2022, 12 T and 32 TC patients were enrolled. At stage 1 ORR was 0% (90%CI 0.0-22.1) in T and 16.7% (90%CI 3.1-43.8) in TC, so T cohort was closed. At stage 2, the primary endpoint was met for TC with ORR of 21.7% (90%CI 9.0%-40.4%). In the ITT analysis DCR was 91.7% (95%CI 61.5%-99.8%) in Ts and 89.3% (95%CI 71.8%-97.7%) in TCs. mPFS was 7.7 months (95%CI 2.4-45.5) in Ts, 8.8 (95%CI 5.3-11.1) in TCs; mOS was 47.9 months (95%CI 4.5-not reached) in Ts, and 27.8 (95%CI 13.2-53.2) in TCs. Adverse events (AEs) occurred in 91.7% T and 93.5% TCs. Grade ≥3 treatment-related AEs were reported in 25.0% T and 51.6% TC.

从2017年3月至2022年1月，有12名T型和32名TC型患者入组。在第一阶段，T组的ORR为0%（90%CI 0.0-22.1），TC组为16.7%（90%CI 3.1-43.8），因此T队列结束。在第2阶段，TC的ORR为21.7%（90%CI 9.0%-40.4%），达到主要终点。在ITT分析中，T组的DCR为91.7%（95%CI 61.5%-99.8%），TC组的为89.3%（95%CI 71.8%-97.7%）；T组的mPFS为7.7个月（95%CI 2.4-45.5），TC组为8.8（95%CI 5.3-11.1）；T组的mOS为47.9个月（95%CI 4.5-not reached），TC组为27.8（95%CI 13.2-53.2）。不良事件（AEs）发生率为T组91.7%和TC组93.5%。25.0%的T组和51.6%的TC组报告了≥3级的治疗相关AEs。

Conclusions 结论

This trial confirms the activity of sunitinib in TC patients, supporting its use as second line treatment. 

这项试验证实了舒尼替尼在TC患者中的有效性，支持其作为二线治疗。

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