Ontology highlight
ABSTRACT: Background
Although immune checkpoint inhibitors (ICI) targeting for PD-1 axis is a promising approach for advanced gastric cancer (GC) patients, the response rate is still limited. Induction of synergistic effect of irradiation with ICI targeting for the PD-1 axis can be an attractive strategy. The aim of this study was to assess the effect of the combination of irradiation with anti-PD-1 therapy for advanced GC.Methods
We conducted a single-arm, phase I/II trial in GC patients treated with a combination of nivolumab and oligo-fractionated irradiation (22.5 Gy/5 fractions/5 days) (NCT03453164). Eligible patients (n = 40) had unresectable advanced or recurrent GC which progressed after primary and secondary chemotherapy with more than one lesion. The primary endpoint is the disease control rate (DCR) of non-irradiated target lesions and the secondary endpoints are the median survival time (MST), safety, and DCR of irradiated lesions.Results
We observe that the DCR for the non-irradiated target as the abscopal effect is 22.5% (90% confidence interval (CI), 12.3-36.0), and the DCR for the irradiated lesion is 40.0% (90% CI, 26.9-54.2). The median survival time is 230 days (95% CI, 157-330), and grade 3 and higher adverse events (AEs) are observed in 16 patients (39 %) with no obvious additional AEs when adding irradiation.Conclusions
The present study suggests that the combination of nivolumab with oligo-fractionated irradiation has the potential to induce a promising anti-tumor effect for advanced GC.
SUBMITTER: Mimura K
PROVIDER: S-EPMC10427681 | biostudies-literature | 2023 Aug
REPOSITORIES: biostudies-literature
Mimura Kosaku K Ogata Takashi T Yoshimoto Yuya Y Yoshida Daisaku D Nakajima Shotaro S Sato Hisashi H Machida Nozomu N Yamada Takanobu T Watanabe Yohei Y Tamaki Tomoaki T Fujikawa Hirohito H Inokuchi Yasuhiro Y Hayase Suguru S Hanayama Hiroyuki H Saze Zenichiro Z Katoh Hiroyuki H Takahashi Fumiaki F Oshima Takashi T Suzuki Yoshiyuki Y Kono Koji K
Communications medicine 20230815 1
<h4>Background</h4>Although immune checkpoint inhibitors (ICI) targeting for PD-1 axis is a promising approach for advanced gastric cancer (GC) patients, the response rate is still limited. Induction of synergistic effect of irradiation with ICI targeting for the PD-1 axis can be an attractive strategy. The aim of this study was to assess the effect of the combination of irradiation with anti-PD-1 therapy for advanced GC.<h4>Methods</h4>We conducted a single-arm, phase I/II trial in GC patients ...[more]