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III期非小细胞肺癌放化疗后度伐利尤单抗巩固治疗的真实世界数据。

Real world data of durvalumab consolidation after chemoradiotherapy in stage III non-small-cell lung cancer.

作者信息

Jung Hyun Ae, Noh Jae Myoung, Sun Jong-Mu, Lee Se-Hoon, Ahn Jin Seok, Ahn Myung-Ju, Pyo Hongryull, Ahn Yong Chan, Park Keunchil

机构信息

Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.

Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.

出版信息

Lung Cancer. 2020 Aug;146:23-29. doi: 10.1016/j.lungcan.2020.05.035. Epub 2020 May 31.

Abstract

OBJECTIVES

The PACIFIC study demonstrated the benefits of durvalumab consolidation on progression-free survival (PFS) and overall survival (OS) among patients with unresectable locally advanced non-small-cell lung cancer (LA-NSCLC). However, in real-world practice, patients with unresectable LA-NSCLC are heterogeneous with diverse tumor burdens and clinical factors; thus, it is important to examine the effectiveness and side effects of durvalumab when used in real clinical practice.

MATERIALS AND METHODS

We investigated the efficacy of durvalumab consolidation and the incidence of radiation pneumonitis in patients who received concurrent chemo-radiotherapy (CCRT) for unresectable LA-NSCLC in a single institute.

RESULTS

Overall, 55.3 % of patients did not meet the criteria of the PACIFIC study; however, they still received consolidation durvalumab in real-world practice. Durvalumab consolidation was associated with favorable PFS in the total population as well as in the subgroup of patients who did not meet the criteria of the PACIFIC study. However, radiation pneumonitis occurred more frequently in the durvalumab group, especially within 3-6 months after CCRT. The incidence of grade 3 radiation pneumonitis was 14.3 % in the durvalumab group versus 2.5 % in the observation group.

CONCLUSIONS

Durvalumab consolidation was associated with favorable PFS in patients with LA-NSCLC in clinical practice. However, careful selection of candidates for durvalumab treatment and active surveillance and appropriate management for radiation pneumonitis are needed.

摘要

目的

PACIFIC研究证明了度伐利尤单抗巩固治疗对不可切除的局部晚期非小细胞肺癌(LA-NSCLC)患者的无进展生存期(PFS)和总生存期(OS)的益处。然而,在实际临床实践中,不可切除的LA-NSCLC患者具有异质性,肿瘤负荷和临床因素各不相同;因此,研究度伐利尤单抗在实际临床应用中的有效性和副作用很重要。

材料与方法

我们在一家单一机构中调查了度伐利尤单抗巩固治疗对接受同步放化疗(CCRT)的不可切除LA-NSCLC患者的疗效以及放射性肺炎的发生率。

结果

总体而言,55.3%的患者不符合PACIFIC研究的标准;然而,他们在实际临床实践中仍接受了度伐利尤单抗巩固治疗。度伐利尤单抗巩固治疗在总人群以及不符合PACIFIC研究标准的患者亚组中均与良好的PFS相关。然而,度伐利尤单抗组放射性肺炎的发生频率更高,尤其是在CCRT后3至6个月内。度伐利尤单抗组3级放射性肺炎的发生率为14.3%,而观察组为2.5%。

结论

在临床实践中,度伐利尤单抗巩固治疗与LA-NSCLC患者良好的PFS相关。然而,需要仔细选择度伐利尤单抗治疗的候选者,并对放射性肺炎进行积极监测和适当管理。

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