PDF(Pubmed)
Abstract：
UNASSIGNED: Brain metastases commonly occur in patients with non-small cell lung cancer (NSCLC). Standard first-line treatment for NSCLC, without an EGFR, ALK or ROS1 mutation, is either chemoimmunotherapy or anti-PD-1 monotherapy. Traditionally, patients with symptomatic or untreated brain metastases were excluded from the pivotal clinical trials that established first-line treatment recommendations. The intracranial effectiveness of these treatment protocols has only recently been elucidated in small-scale prospective trials.
UNASSIGNED: Patients with NSCLC and brain metastases, treated with first-line chemoimmunotherapy or anti-PD-1 monotherapy were selected from the Australian Registry and biObank of thoracic cancers (AURORA) clinical database covering seven institutions. The primary outcome was a composite time-to-event (TTE) outcome, including extracranial and intracranial progression, death, or need for local intracranial therapy, which served as a surrogate for disease progression. The secondary outcome included overall survival (OS), intracranial objective response rate (iORR) and objective response rate (ORR).
UNASSIGNED: 116 patients were included. 63% received combination chemoimmunotherapy and 37% received anti-PD-1 monotherapy. 69% of patients received upfront local therapy either with surgery, radiotherapy or both. The median TTE was 7.1 months (95% CI 5 - 9) with extracranial progression being the most common progression event. Neither type of systemic therapy or upfront local therapy were predictive of TTE in a multivariate analysis. The median OS was 17 months (95% CI 13-27). Treatment with chemoimmunotherapy was predictive of longer OS in multivariate analysis (HR 0.35; 95% CI 0.14 - 0.86; p=0.01). The iORR was 46.6%. The iORR was higher in patients treated with chemoimmunotherapy compared to immunotherapy (58% versus 31%, p=0.01). The use of chemoimmunotherapy being predictive of iORR in a multivariate analysis (OR 2.88; 95% CI 1.68 - 9.98; p=0.04).
UNASSIGNED: The results of this study of real-world data demonstrate the promising intracranial efficacy of chemoimmunotherapy in the first-line setting, potentially surpassing that of immunotherapy alone. No demonstrable difference in survival or TTE was seen between receipt of upfront local therapy. Prospective studies are required to assist clinical decision making regarding optimal sequencing of local and systemic therapies.
UNASSIGNED: Patients with NSCLC and brain metastases, treated with first-line chemoimmunotherapy or anti-PD-1 monotherapy were selected from the Australian Registry and biObank of thoracic cancers (AURORA) clinical database covering seven institutions. The primary outcome was a composite time-to-event (TTE) outcome, including extracranial and intracranial progression, death, or need for local intracranial therapy, which served as a surrogate for disease progression. The secondary outcome included overall survival (OS), intracranial objective response rate (iORR) and objective response rate (ORR).
UNASSIGNED: 116 patients were included. 63% received combination chemoimmunotherapy and 37% received anti-PD-1 monotherapy. 69% of patients received upfront local therapy either with surgery, radiotherapy or both. The median TTE was 7.1 months (95% CI 5 - 9) with extracranial progression being the most common progression event. Neither type of systemic therapy or upfront local therapy were predictive of TTE in a multivariate analysis. The median OS was 17 months (95% CI 13-27). Treatment with chemoimmunotherapy was predictive of longer OS in multivariate analysis (HR 0.35; 95% CI 0.14 - 0.86; p=0.01). The iORR was 46.6%. The iORR was higher in patients treated with chemoimmunotherapy compared to immunotherapy (58% versus 31%, p=0.01). The use of chemoimmunotherapy being predictive of iORR in a multivariate analysis (OR 2.88; 95% CI 1.68 - 9.98; p=0.04).
UNASSIGNED: The results of this study of real-world data demonstrate the promising intracranial efficacy of chemoimmunotherapy in the first-line setting, potentially surpassing that of immunotherapy alone. No demonstrable difference in survival or TTE was seen between receipt of upfront local therapy. Prospective studies are required to assist clinical decision making regarding optimal sequencing of local and systemic therapies.
摘要：
■脑转移通常发生在非小细胞肺癌（NSCLC）患者中。非小细胞肺癌的标准一线治疗，没有EGFR,ALK或ROS1突变，是化学免疫疗法或抗PD-1单一疗法。传统上,有症状或未经治疗的脑转移患者被排除在确立一线治疗建议的关键临床试验之外.这些治疗方案的颅内有效性直到最近才在小规模前瞻性试验中得到阐明。
■非小细胞肺癌和脑转移患者，我们从涵盖7个机构的澳大利亚注册和biObank胸癌(AURORA)临床数据库中选择一线化学免疫治疗或抗PD-1单药治疗.主要结局是复合事件发生时间（TTE）结局，包括颅外和颅内进展，死亡,或者需要局部颅内治疗，作为疾病进展的替代品。次要结局包括总生存期（OS），颅内客观缓解率(iORR)和客观缓解率(ORR)。
■116例患者被纳入。63%接受联合化学免疫疗法，37%接受抗PD-1单一疗法。69%的患者接受了手术前的局部治疗，放疗或两者兼而有之。中位TTE为7.1个月（95%CI5-9），颅外进展是最常见的进展事件。在多变量分析中，两种类型的全身治疗或前期局部治疗均不能预测TTE。中位OS为17个月(95%CI13-27)。在多变量分析中，化学免疫疗法治疗可预测更长的OS（HR0.35；95％CI0.14-0.86；p=0.01）。iORR为46.6%。与免疫疗法相比，接受化学免疫疗法治疗的患者的iORR更高（58％对31％，p=0.01)。在多变量分析中，使用化学免疫疗法可预测iORR(OR2.88;95%CI1.68-9.98;p=0.04)。
■这项现实世界数据研究的结果表明，在一线环境下，化学免疫疗法的颅内功效很有希望，可能超过单独的免疫疗法。在接受前期局部治疗之间，没有明显的生存率或TTE差异。需要前瞻性研究来协助有关局部和全身疗法的最佳排序的临床决策。
■非小细胞肺癌和脑转移患者，我们从涵盖7个机构的澳大利亚注册和biObank胸癌(AURORA)临床数据库中选择一线化学免疫治疗或抗PD-1单药治疗.主要结局是复合事件发生时间（TTE）结局，包括颅外和颅内进展，死亡,或者需要局部颅内治疗，作为疾病进展的替代品。次要结局包括总生存期（OS），颅内客观缓解率(iORR)和客观缓解率(ORR)。
■116例患者被纳入。63%接受联合化学免疫疗法，37%接受抗PD-1单一疗法。69%的患者接受了手术前的局部治疗，放疗或两者兼而有之。中位TTE为7.1个月（95%CI5-9），颅外进展是最常见的进展事件。在多变量分析中，两种类型的全身治疗或前期局部治疗均不能预测TTE。中位OS为17个月(95%CI13-27)。在多变量分析中，化学免疫疗法治疗可预测更长的OS（HR0.35；95％CI0.14-0.86；p=0.01）。iORR为46.6%。与免疫疗法相比，接受化学免疫疗法治疗的患者的iORR更高（58％对31％，p=0.01)。在多变量分析中，使用化学免疫疗法可预测iORR(OR2.88;95%CI1.68-9.98;p=0.04)。
■这项现实世界数据研究的结果表明，在一线环境下，化学免疫疗法的颅内功效很有希望，可能超过单独的免疫疗法。在接受前期局部治疗之间，没有明显的生存率或TTE差异。需要前瞻性研究来协助有关局部和全身疗法的最佳排序的临床决策。
