Durvalumab with chemoradiotherapy for limited-stage small-cell lung cancer

杜瓦卢马布 医学 放化疗 传统PCI 危险系数 内科学 预防性头颅照射 化学免疫疗法 肺癌 放射治疗 肿瘤科 外科 化疗 置信区间 癌症 无容量 环磷酰胺 免疫疗法 心肌梗塞
作者
Sehhoon Park,Jae Myoung Noh,Yoon‐La Choi,Sang Ah,Kyunga Kim,Hyun Ae Jung,Se‐Hoon Lee,Jin Seok Ahn,Myung‐Ju Ahn,Jong‐Mu Sun
出处
期刊:European Journal of Cancer [Elsevier BV]
卷期号:169: 42-53 被引量:24
标识
DOI:10.1016/j.ejca.2022.03.034
摘要

The current standard treatment for limited-stage small-cell lung cancer (LS-SCLC) is chemotherapy with concurrent chemoradiotherapy (CCRT).In this single-arm phase II study, patients with LS-SCLC received four cycles of etoposide, cisplatin, and durvalumab every 3 weeks. Thoracic radiotherapy of 52.5 Gy in 25 once-daily fractions was started with the third cycle of chemoimmunotherapy. After CCRT plus durvalumab, patients received durvalumab consolidation therapy every 4 weeks for a maximum of 2 years after study enrolment. Prophylactic cranial irradiation (PCI) was recommended.Fifty-one patients were enrolled, and 50 were included in the full analysis set. With the median follow-up duration of 26.6 months, the median PFS was 14.4 months (95% confidence interval: 10.3-NA), and the 24-month PFS rate was 42.0%. The median overall survival was not reached with a 24-month overall survival rate of 67.8%. The positive PD-L1 group (n = 22) was not associated with longer PFS (hazard ratio, 0.70; 0.31-1.58) and overall survival (0.64; 0.22-1.84) compared with the negative PD-L1 group (n = 20). Among the 43 patients who were candidates for PCI treatment, the PCI group (n = 22) had significantly fewer events of brain metastasis as the first failure sites compared to the no PCI group (n = 21) (13.6% vs. 42.9%, P = 0.033). There were several grade 3 or 4 adverse events which were well managed with appropriate supportive care.Durvalumab with CCRT for LS-SCLC exhibited promising clinical efficacy with a tolerable safety profile, prompting its validation in a randomized study.NCT03585998.
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