SKYSCRAPER-02：未经治疗的广泛期小细胞肺癌中Tiragolumab与Atezolizumab加化疗的联合应用

SCI

3 December 2023

SKYSCRAPER-02: Tiragolumab in Combination With Atezolizumab Plus Chemotherapy in Untreated Extensive-Stage Small-Cell Lung Cancer

（Journal of clinical oncology；IF：45.3）

Rudin CM, Liu SV, Soo RA, Lu S, Hong MH, Lee JS, Bryl M, Dumoulin DW, Rittmeyer A, Chiu CH, Ozyilkan O, Johnson M, Navarro A, Novello S, Ozawa Y, Tam SH, Patil NS, Wen X, Huang M, Hoang T, Meng R, Reck M. SKYSCRAPER-02: Tiragolumab in Combination With Atezolizumab Plus Chemotherapy in Untreated Extensive-Stage Small-Cell Lung Cancer. J Clin Oncol. 2023 Nov 17:JCO2301363. doi: 10.1200/JCO.23.01363. Epub ahead of print. PMID: 37976444.

CORRESPONDING AUTHOR 

Charles M. Rudin, MD, PhD, Memorial Sloan Kettering Cancer Center, 125 York Ave, New York, NY 10065; e-mail: rudinc@mskcc.org.

Purpose 目的

The phase III SKYSCRAPER-02 study determined whether the benefits of atezolizumab plus carboplatin and etoposide (CE) could be enhanced by the addition of tiragolumab in untreated extensive-stage small-cell lung cancer (ES-SCLC). We report final progression-free survival (PFS) and overall survival (OS) analyses.

三期SKYSCRAPER-02研究确定了在未经治疗的广泛期小细胞肺癌（ES-SCLC）中，通过添加tiragolumab来增强atezolizumab加卡铂和依托泊苷（CE）的疗效。我们报告了最终的无进展生存期（PFS）和总生存期（OS）分析结果。

Methods 方法

Patients received tiragolumab 600 mg/placebo, plus atezolizumab 1,200 mg and CE (four cycles), then maintenance tiragolumab/placebo plus atezolizumab. Primary end points were investigator-assessed PFS and OS in patients without history/presence of brain metastases (primary analysis set [PAS]). Additional end points included PFS and OS in all patients regardless of brain metastases status (full analysis set [FAS]), response, and safety.

患者接受tiragolumab 600毫克/安慰剂，加上atezolizumab 1,200毫克和CE（四个周期），然后进行tiragolumab/安慰剂加atezolizumab的维持治疗。主要终点是由研究者评估的没有脑转移史/存在的患者的PFS和OS（主要分析集[PAS]）。其他终点包括所有患者的PFS和OS，不论脑转移状态（完整分析集[FAS]），其反应和安全性。

Results 结果

Four hundred ninety patients were randomly assigned (FAS): 243 to tiragolumab arm and 247 to control arm. At the cutoff date (February 6, 2022; median duration of follow-up, 14.3 months [PAS] and 13.9 months [FAS]), final analysis of PFS in the PAS (n = 397) did not reach statistical significance (stratified hazard ratio [HR], 1.11; P = .3504; median, 5.4 months tiragolumab v 5.6 months control). At the cutoff date (September 6, 2022; median duration of follow-up, 21.2 months [FAS]), median OS in the PAS at final OS analysis was 13.1 months in both arms (stratified HR, 1.14; P = .2859). Median PFS and OS in the FAS were consistent with the PAS. The proportion of patients with immune-mediated adverse events (AEs) in the tiragolumab and control arms was 54.4% and 49.2%, respectively (grade 3/4: 7.9% and 7.7%). AEs leading to treatment withdrawal occurred in 8.4% and 9.3% of tiragolumab- and control-treated patients, respectively.

共有490名患者随机分配（FAS）：243名进入tiragolumab组，247名进入对照组。截至截止日期（2022年2月6日；中位随访时间，14.3个月[PAS]和13.9个月[FAS]），在PAS中（n = 397）的PFS最终分析并未达到统计显著性（分层风险比[HR]，1.11；P = .3504；中位数，tiragolumab组5.4个月vs对照组5.6个月）。截至截止日期（2022年9月6日；中位随访时间，21.2个月[FAS]），在最终OS分析中，PAS中的中位OS在两组中均为13.1个月（分层HR，1.14；P = .2859）。完整分析集中的中位PFS和OS与PAS一致。在tiragolumab组和对照组中，患有免疫介导不良事件（AEs）的患者比例分别为54.4％和49.2％（3/4级：7.9％和7.7％）。由于AEs导致治疗中断的患者比例分别为tiragolumab组的8.4％和对照组的9.3％。

Conclusion 结论

Tiragolumab did not provide additional benefit over atezolizumab and CE in untreated ES-SCLC. The combination was well tolerated with no new safety signals.

在未经治疗的广泛期小细胞肺癌（ES-SCLC）中，Tiragolumab并没有比atezolizumab和CE提供额外的益处。这种组合治疗具有良好的耐受性，并且没有新的安全问题。

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