Neoadjuvant SABR for Renal Cell Carcinoma Inferior Vena Cava Tumor Thrombus—Safety Lead-in Results of a Phase 2 Trial
Autor: | Nirmish Singla, Aditya Bagrodia, Vitaly Margulis, James Brugarolas, Ivan Pedrosa, Solomon L. Woldu, Laurentiu M. Pop, Samantha Mannala, Jeffrey Gahan, Raquibul Hannan, Yuval Freifeld, Robert Timmerman, Subrata Manna, Alana Christie, Michael A. Wait, Payal Kapur, Osama Mohamad |
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Rok vydání: | 2021 |
Předmět: |
Male
Cancer Research Kidney Disease Vena Cava medicine.medical_treatment SABR volatility model 030218 nuclear medicine & medical imaging Metastasis 0302 clinical medicine Renal cell carcinoma Clinical endpoint Cancer Venous Thrombosis Radiation Middle Aged Kidney Neoplasms Neoadjuvant Therapy Nephrectomy Other Physical Sciences Oncology medicine.vein 030220 oncology & carcinogenesis Female Patient Safety Safety Inferior medicine.medical_specialty Clinical Sciences Oncology and Carcinogenesis Urology Vena Cava Inferior Radiosurgery Inferior vena cava Article 03 medical and health sciences medicine Humans Radiology Nuclear Medicine and imaging Oncology & Carcinogenesis Adverse effect Carcinoma Renal Cell Aged Retrospective Studies business.industry Carcinoma Renal Cell medicine.disease business Kidney cancer |
Zdroj: | Int J Radiat Oncol Biol Phys International journal of radiation oncology, biology, physics, vol 110, iss 4 |
ISSN: | 0360-3016 |
Popis: | Purpose To evaluate the feasibility, safety, oncologic outcomes, and immune effect of neoadjuvant stereotactic radiation (Neo-SAbR) followed by radical nephrectomy and thrombectomy (RN-IVCT). Methods and Materials These are results from the safety lead-in portion of a single-arm phase 1 and 2 trial. Patients with kidney cancer (renal cell carcinoma [RCC]) and inferior vena cava (IVC) tumor thrombus (TT) underwent Neo-SAbR (40 Gy in 5 fractions) to the IVC-TT followed by open RN-IVCT. Absence of grade 4 to 5 adverse events (AEs) within 90 days of RN-IVCT was the primary endpoint. Exploratory studies included pathologic and immunologic alterations attributable to SAbR. Results Six patients were included in the final analysis. No grade 4 to 5 AEs were observed. A total of 81 AEs were reported within 90 days of surgery: 73% (59/81) were grade 1, 23% (19/81) were grade 2, and 4% (3/81) were grade 3. After a median follow-up of 24 months, all patients are alive. One patient developed de novo metastatic disease. Of 3 patients with metastasis at diagnosis, 1 had a complete and another had a partial abscopal response without the concurrent use of systemic therapy. Neo-SABR led to decreased Ki-67 and increased PD-L1 expression in the IVC-TT. Inflammatory cytokines and autoantibody titers reflecting better host immune status were observed in patients with nonprogressive disease. Conclusions Neo-SAbR followed by RN-IVCT for RCC IVC-TT is feasible and safe. Favorable host immune environment correlated with abscopal response to SABR and RCC relapse-free survival, though direct causal relation to SABR has yet to be established. |
Databáze: | OpenAIRE |
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