Final results of a dose escalation protocol of stereotactic body radiotherapy for poor surgical candidates with localized renal cell carcinoma.


Journal

Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology
ISSN: 1879-0887
Titre abrégé: Radiother Oncol
Pays: Ireland
ID NLM: 8407192

Informations de publication

Date de publication:
02 2021
Historique:
received: 16 08 2020
revised: 19 10 2020
accepted: 20 10 2020
pubmed: 21 11 2020
medline: 24 4 2021
entrez: 20 11 2020
Statut: ppublish

Résumé

We previously demonstrated the safety of doses up to 48 Gy in 4 fractions with stereotactic body radiotherapy (SBRT) in poor surgical candidates with localized renal cell carcinoma (RCC). In an additional expansion cohort, we aimed to assess the safety of further dose escalation to 48-60 Gy in 3 fractions. Patients were required to have localized RCC and be poor surgical candidates due to medical comorbidities. Dose-limiting toxicity (DLT) was defined as acute (<180 days) grade ≥3 gastrointestinal/genitourinary toxicity by CTCAEv4. Tumor response was assessed using RECIST 1.1 criteria measurements every 6 months for 3 years and optional percutaneous biopsy. Groups of 4, 4, and 3 patients received 48, 54, and 60 Gy in 3 fractions, respectively from 2012 to 2016. Median follow-up was 34.3 months. Zero DLTs were observed. Acute toxicities were limited to grade 1 fatigue and nausea in 45.5% and 18.1%. Late grade 2+ and grade 3+ possibly treatment-related events occurred in 18.1% and 9.1%, respectively. Three-year local control was 90% by RECIST 1.1 criteria. Five of 5 post-treatment biopsies in the expansion cohort were positive by Hematoxylin and Eosin staining. Three of the 5 patients with positive biopsies have been observed for 1.2-3.9 years without evidence of progression. Dose escalation to 60 Gy in 3 fractions was achieved without DLTs. Favorable local control rates were observed, and the interpretation of post-SBRT biopsies remains uncertain. Further studies comparing SBRT to percutaneous ablation for poor surgical candidates with RCC are warranted.

Sections du résumé

BACKGROUND AND PURPOSE
We previously demonstrated the safety of doses up to 48 Gy in 4 fractions with stereotactic body radiotherapy (SBRT) in poor surgical candidates with localized renal cell carcinoma (RCC). In an additional expansion cohort, we aimed to assess the safety of further dose escalation to 48-60 Gy in 3 fractions.
MATERIAL AND METHODS
Patients were required to have localized RCC and be poor surgical candidates due to medical comorbidities. Dose-limiting toxicity (DLT) was defined as acute (<180 days) grade ≥3 gastrointestinal/genitourinary toxicity by CTCAEv4. Tumor response was assessed using RECIST 1.1 criteria measurements every 6 months for 3 years and optional percutaneous biopsy.
RESULTS
Groups of 4, 4, and 3 patients received 48, 54, and 60 Gy in 3 fractions, respectively from 2012 to 2016. Median follow-up was 34.3 months. Zero DLTs were observed. Acute toxicities were limited to grade 1 fatigue and nausea in 45.5% and 18.1%. Late grade 2+ and grade 3+ possibly treatment-related events occurred in 18.1% and 9.1%, respectively. Three-year local control was 90% by RECIST 1.1 criteria. Five of 5 post-treatment biopsies in the expansion cohort were positive by Hematoxylin and Eosin staining. Three of the 5 patients with positive biopsies have been observed for 1.2-3.9 years without evidence of progression.
CONCLUSION
Dose escalation to 60 Gy in 3 fractions was achieved without DLTs. Favorable local control rates were observed, and the interpretation of post-SBRT biopsies remains uncertain. Further studies comparing SBRT to percutaneous ablation for poor surgical candidates with RCC are warranted.

Identifiants

pubmed: 33214131
pii: S0167-8140(20)30878-1
doi: 10.1016/j.radonc.2020.10.031
pii:
doi:

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

138-143

Informations de copyright

Copyright © 2020 Elsevier B.V. All rights reserved.

Auteurs

William R Grubb (WR)

Department of Radiation Oncology, Augusta University Medical Center, USA. Electronic address: wigrubb@augusta.edu.

Lee Ponsky (L)

Department of Urology, University Hospitals Cleveland Medical Center, USA.

Simon S Lo (SS)

Department of Radiation Oncology, University of Washington School of Medicine, Seattle, USA.

Michael Kharouta (M)

Department of Radiation Oncology, University Hospital Seidman Cancer Center, Cleveland, USA.

Bryan Traughber (B)

Department of Radiation Oncology, University Hospital Seidman Cancer Center, Cleveland, USA.

Kate Sandstrom (K)

Department of Radiation Oncology, University Hospital Seidman Cancer Center, Cleveland, USA.

Gregory T MacLennan (GT)

Department of Pathology, University Hospitals Cleveland Medical Center, USA.

Eswar Shankar (E)

Department of Urology, Case Western Reserve University School of Medicine, Cleveland, USA.

Sanjay Gupta (S)

Department of Urology, Case Western Reserve University School of Medicine, Cleveland, USA.

Mitchell Machtay (M)

Department of Radiation Oncology, University Hospital Seidman Cancer Center, Cleveland, USA.

Rodney J Ellis (RJ)

Department of Radiation Oncology, Penn State Cancer Institute, USA.

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Classifications MeSH