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
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
Externí odkaz: