Dataset Information

Hypofractionated Low-Dose Radiotherapy Combined with Immune Checkpoint Inhibition in Metastatic Solid Tumors.

ABSTRACT:

Background

The combination of radiotherapy and immunotherapy can bring benefits to patients, especially advanced patients. However, conventional radiotherapy brings about great adverse reactions. How about the hypofractionated low-dose radiotherapy?

Materials and methods

In this retrospective cohort study, we included 32 patients with metastatic solid tumors treated with hypofractionated radiotherapy combined with an immune checkpoint inhibitor. Patients underwent radiotherapy of 4Gy/Fx on day 1, 3, and 5, and received single-drug immunotherapy of PD-1 inhibitor on day 2. We evaluated the following outcomes: objective response rate (ORR), disease control rate (DCR), change of nonirradiated and irradiated lesions, quality of life, and symptom improvement.

Results

Among the 32 patients, the ORR was 9.4% (3/32) and the DCR was 56.25% (18/32). Hypofractionated radiotherapy combined with immunotherapy showed a remarkable efficacy of local control on metastatic tumor patients. Local masses irradiated in two patients (6.25%) were complete remission, partial response rate was 37.5% (12 patients), and 56.25% was stability (18 patients). Out of those 18 patients, 15 patients had the local masses shrank more or less. The ORR of local control reached 43.75%, and its DCR was 100%. In addition, the intratumor necrosis rate was 44.4% in the SD patients. Median progression-free survival was 3.8 months (95%Cl: 2.2-5.4). By treating the local mass, the symptoms of most patients were alleviated, and the quality of life was improved.

Conclusion

Our retrospective analysis revealed that hypofractionated radiotherapy combined with immunotherapy was effective in local control, it also relieved clinical symptoms and improved quality of life. The adverse effect rate was low. However, the incidence of abscopal effects was low either. This mode was suitable for the palliative treatment and expected to improve survival for patients with metastatic tumors.

SUBMITTER: Li D

PROVIDER: S-EPMC7869699 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

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Publications

Hypofractionated Low-Dose Radiotherapy Combined with Immune Checkpoint Inhibition in Metastatic Solid Tumors.

Li Dongqing D Zhu Wenyu W Zhou Juying J Peng Mingya M Geng Qian Q Pu Xiaolin X Wang Mengjie M Jiang Hua H

OncoTargets and therapy 20210204

<h4>Background</h4>The combination of radiotherapy and immunotherapy can bring benefits to patients, especially advanced patients. However, conventional radiotherapy brings about great adverse reactions. How about the hypofractionated low-dose radiotherapy?<h4>Materials and methods</h4>In this retrospective cohort study, we included 32 patients with metastatic solid tumors treated with hypofractionated radiotherapy combined with an immune checkpoint inhibitor. Patients underwent radiotherapy of ...[more]

PMID: 33568917

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Project description:Preclinical and clinical studies have shown that intestinal low dose radiotherapy (ILDR) can enhance antitumor immunity and response to immune checkpoint blockade (ICB) by regulating intestinal flora. Therefore, the investigators design a phase II trial to validate the clinical value of combining ILDR and programmed cell death-1 (PD-1) inhibitors in patients with metastatic malignant solid tumors who have failed immunotherapy. The primary endpoints of this analysis are disease control rate (DCR), progression free survival while receiving second-line therapy (PFS2), and objective response rate (ORR). The secondary endpoints are the incidence of adverse events (AEs) and the overall response rate. This study is a researcher-initiated, prospective clinical study. The target population is patients with advanced metastatic malignant solid tumors who have progressed after immunotherapy. Thirty participants will be enrolled in this study. The primary objective of the study is to evaluate the efficacy and safety of ILDR combined with PD-1 inhibitors in immune-resistant metastatic malignant solid tumors, and the effect of ILDR combined with PD-1 inhibitors on the intestinal flora. Treatment will be given to patients who meet the eligibility criteria after obtaining their written informed consent. Subjects will be allocated into 3 groups. The jejunum and ileum will be selected and performed with low dose radiation of 1Gy/F, 1F/W, 1Gy-3Gy. The immunotherapy regimen is determined by the doctor in charge based on the patient’s clinical status, original immunotherapy regimen, radiological findings, and pathological results. Immunotherapy is administered in combination with radiotherapy, with a treatment frequency of once every 3 weeks until progression. Assess the occurrence rates of DCR, PFS2, ORR, and AEs in accordance with the guidelines for response criteria for use in trials testing immunotherapeutics (iRECIST) to determine the extent of benefit for patients participating in this trial. At least one accessible and measurable lesion should be selected as the target lesion for observation. Furthermore, tissue samples, stool samples, and peripheral blood samples will be collected to assess the effect of this treatment on immune status and intestinal flora.

Dataset Information

Hypofractionated Low-Dose Radiotherapy Combined with Immune Checkpoint Inhibition in Metastatic Solid Tumors.

Background

Materials and methods

Results

Conclusion

Publications

Hypofractionated Low-Dose Radiotherapy Combined with Immune Checkpoint Inhibition in Metastatic Solid Tumors.

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