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Positive Interaction between Prophylactic Cranial Irradiation and Maintenance Sunitinib for Untreated Extensive-Stage Small Cell Lung Cancer Patients After Standard Chemotherapy: A Secondary Analysis of CALGB 30504 (ALLIANCE)

机译:预防性颅脑照射与维持舒尼替尼治疗标准化疗后未治疗的广泛期小细胞肺癌患者的正相互作用:CaLGB 30504(aLLIaNCE)的二次分析

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摘要

BACKGROUND:Prophylactic cranial irradiation (PCI) has become a standard option for patients with extensive-stage small cell lung cancer (ES-SCLC). The Cancer and Leukemia Group B 30504 trial was a randomized phase II study of the effect of sunitinib versus placebo in ES-SCLC patients responding to platinum-based systemic therapy. The study required preenrollment brain imaging. PCI was provided at the discretion of treating physicians. We performed a secondary analysis of the Cancer and Leukemia Group B trial to determine the impact of PCI on patients with ES-SCLC.METHODS:Fisher's exact test and the Wilcoxon rank-sum test were conducted to identify the differences between patients receiving PCI and patients not receiving PCI. Kaplan-Meier analyses described progression-free survival (PFS) and overall survival (OS) for patients in the PCI and non-PCI groups.RESULTS:A total of 85 patients received maintenance therapy (41 received placebo and 44 received sunitinib). Patient characteristics were balanced between the PCI and non-PCI groups. The patients receiving PCI plus sunitinib had a nonsignificant 2.7-month improvement in PFS (5.0 months versus 2.3 months, p = 0.14, hazard risk [HR] = 0.62, 95% confidence interval [CI]: 0.33-1.18) trending toward improved OS (8.9 months versus 5.4 months, p = 0.053, HR = 0.47, 95% CI: 0.22-1.03). PCI was associated with a trend toward improved median PFS (2.9 months versus 2.2 months, p = 0.096, HR = 0.69, 95% CI: 0.45-1.07) but not median OS (8.3 months in the PCI group versus 8.7 months in the non-PCI group, p = 0.76, HR = 1.07, 95% CI: 0.67-1.71). The patients receiving placebo had no improvement in PFS or OS with PCI.CONCLUSIONS:Trends toward improved PFS and OS were seen in patients receiving PCI and sunitinib, thus supporting the need for further prospective research evaluating the integration of maintenance systemic therapy and PCI for patients with ES-SCLC. Improved outcomes for patients with ES-SCLC after induction chemotherapy may require PCI, thoracic radiotherapy, and maintenance systemic therapy to achieve control of both intracranial and extracranial disease.
机译:背景:预防性颅脑照射(PCI)已成为广泛期小细胞肺癌(ES-SCLC)患者的标准选择。癌症和白血病B 30504组试验是舒尼替尼与安慰剂对铂类全身治疗有反应的ES-SCLC患者疗效的随机II期研究。该研究需要入组前脑成像。 PCI由治疗医师酌情决定。我们对癌症和白血病B组试验进行了二级分析,以确定PCI对ES-SCLC患者的影响。方法:进行了Fisher精确检验和Wilcoxon秩和检验以鉴定接受PCI的患者与患者之间的差异没有收到PCI。 Kaplan-Meier分析描述了PCI和非PCI组患者的无进展生存期(PFS)和总生存期(OS)。结果:共有85例患者接受了维持治疗(41例接受了安慰剂,44例接受了舒尼替尼)。 PCI和非PCI组之间的​​患者特征保持平衡。接受PCI加舒尼替尼的患者的PFS改善无显着2.7个月改善(5.0个月对2.3个月,p = 0.14,危险风险[HR] = 0.62,95%置信区间[CI]:0.33-1.18),倾向于改善OS (8.9个月对5.4个月,p = 0.053,HR = 0.47,95%CI:0.22-1.03)。 PCI与中位PFS改善趋势相关(2.9个月对2.2个月,p = 0.096,HR = 0.69,95%CI:0.45-1.07),但与OS无关(PCI组为8.3个月,非OS为8.7个月) -PCI组,p = 0.76,HR = 1.07,95%CI:0.67-1.71)。结论:接受PCI和舒尼替尼治疗的患者观察到PFS和OS有改善的趋势,因此,有必要进行进一步的前瞻性研究,以评估维持系统治疗与PCI的结合与ES-SCLC。诱导化疗后ES-SCLC患者改善的结局可能需要PCI,胸腔放疗和维持性全身治疗,以实现对颅内和颅外疾病的控制。

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