AUTHOR=Ye Hua , Pang Haowen , Shi Xiangxiang , Ren Peirong , Huang Shangke , Yu Hong , Wu Jingbo , Lin Sheng 

TITLE=Nivolumab and Hypofractionated Radiotherapy in Patients With Advanced Lung Cancer: ABSCOPAL-1 Clinical Trial

JOURNAL=Frontiers in Oncology

VOLUME=11

YEAR=2021

URL=https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2021.657024

DOI=10.3389/fonc.2021.657024

ISSN=2234-943X

ABSTRACT=<sec><title>Background</title><p>More clinical practice need to be performed to verify the toxicity of the hypofractionated radiotherapy (HFRT) combined with PD-1 blockade in lung cancer. This phase I study aimed to investigate the safety and efficacy of nivolumab combined with HFRT in patients with progressive advanced lung cancer following multiline treatment.</p></sec><sec><title>Methods</title><p>We enrolled 31 patients with advanced lung cancer pathologically confirmed to have progressive disease and treated with first-line or a higher therapy. Selected lesions were treated using HFRT, and nivolumab was administered within 7 days subsequently. Nivolumab was administered once a month following partial remission. Peripheral blood was collected before and after 1 month of treatment to evaluate relevant cytokines between nivolumab responders and non-responders.</p></sec><sec><title>Results</title><p>Overall, 23 patients who completed the treatment were evaluated. Of them, 9 and 14 patients underwent hypofractionated brachytherapy with 30 Gy in a single fraction <italic>via</italic> percutaneous interstitial implantation of (192)Ir and 40–50 Gy in 5 fractions <italic>via</italic> stereotactic body radiation therapy, respectively. The median follow-up period was 11 months. At the 1-year follow-up, no patient developed grade ≥ 3 pneumonitis. The overall objective response and complete remission rates were 39.13% and 13.04%, respectively. The 1-year overall survival and median progression-free survival were 60.9% and 6 months, respectively. The plasma levels of interleukin IL-6, IL-10, and IL-17A were significantly reduced after treatment in nivolumab responders.</p></sec><sec><title>Conclusions</title><p>HFRT could increase the responsivity to nivolumab and reduce its administration frequency. This combination treatment is well tolerated with acceptable toxicity and thus merits further trials to validate benefits.</p></sec><sec><title>Clinical Trial Registration</title><p><uri xlink:href="http://www.chictr.org.cn/index.aspx" xmlns:xlink="http://www.w3.org/1999/xlink">http://www.chictr.org.cn/index.aspx</uri>, identifier ChiCTR-1900027768.</p></sec>