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

Abstract

BackgroundMore 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.MethodsWe 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.ResultsOverall, 23 patients who completed the treatment were evaluated. Of them, 9 and 14 patients underwent hypofractionated brachytherapy with 30 Gy in a single fraction via percutaneous interstitial implantation of (192)Ir and 40–50 Gy in 5 fractions via 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.ConclusionsHFRT 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.Clinical Trial Registrationhttp://www.chictr.org.cn/index.aspx, identifier ChiCTR-1900027768.

Predictive value of 18F-FDG PET/CT for evaluating the response to hypofractionated radiotherapy combined with PD-1 blockade in non-small cell lung cancer

“…The overall objective response and complete remission rates were 39.13% and 13.04%, respectively. The 1-year OS and median progression-free survival were 60.9% and 6 months, respectively ( 27 ).…”

Tracking Peripheral Memory T Cell Subsets in Advanced Nonsmall Cell Lung Cancer Treated with Hypofractionated Radiotherapy and PD-1 Blockade

“…In our previous study, the overall objective response and complete remission rate were 39.13% and 13.04%, respectively [17]. CR patients maintained continuous remission for a 2yearfollow-up period.…”

“…Clinical response was assessed using computed tomography (CT) scans according to the Response Evaluation Criteria for Solid Tumors (RECIST V1.1) and classifed as partial response (PR), stable disease (SD), or progressive disease (PD). Further details are provided in our previous report [17]. Interpretation of response from positron emission tomography (PET) scans was based on the European Organization for Research and Treatment of Cancer 1999 standard [19].…”

Immunotherapy Alone or in Combination with Stereotactic Body Radiotherapy in Advanced Lung Cancer: A Pooled Analysis of Randomized Clinical Trials

“…Exclusion criteria were ( 1 ) single-arm studies, ( 2 ) reviews/comments/letters, ( 3 ) meeting abstracts, ( 4 ) IT plus SBRT versus SBRT studies, ( 5 ) study protocols, ( 6 ) case reports, and ( 7 ) retrospective studies. Any disagreements were resolved by discussion.…”

“…In a phase 1 trial reported by Bestvina, IT combined with SBRT showed a 46% objective response rate (ORR) with a median progression-free survival (PFS) of 5.8 months in widely metastatic NSCLC patients ( 5 ). In another phase 1 trial reported by Ye, the ORR was 39% and the median PFS was six months when advanced lung cancer patients were treated with IT plus SBRT ( 6 ). Moreover, several case studies indicated that some advanced patients achieved long-term survival after IT and SBRT ( 7 , 8 ).…”