Phase i dose-escalation study of stereotactic body radiotherapy (SBRT) for poor surgical candidates with localized renal cell carcinoma

Lee Ponsky, Simon S. Lo, Yuxia Zhang, Mark Schluchter, Yiying Liu, Ravi Patel, Robert Abouassaly, Scott Welford, Vikas Gulani, John Robert Haaga, Mitchell Machtay, Rodney J. Ellis

Research output: Contribution to journalArticle

32 Citations (Scopus)

Abstract

Purpose To evaluate the tolerability of escalating doses of stereotactic body radiotherapy (SBRT) for primary treatment of localized renal cell carcinoma (RCC) in poor surgical candidates. Patients and methods Eligible patients included those with clinically staged radiographic and or pathologically confirmed RCC who had not undergone previous abdominal or pelvic radiotherapy. All patients had comorbid medical conditions which precluded surgery. Median (range) patient age was 77.6 years (range 59-89) years and all patients had Karnofsky Performance Status of ≥60. Median tumor volume was 57.9 cm3 (range 13.8-174.7 cm3). Dose-limiting toxicity (DLT) was defined as grade 3 or worse gastrointestinal/genitourinary toxicity by Common Terminology Criteria of Adverse Events (version 4). Tumor response was assessed by imaging results using Response Evaluation Criteria In Solid Tumors (RECIST) measurement and percutaneous biopsy. Results A total of 19 patients (13 men and 6 women) were treated on protocol from June 2006 through August 2011. Groups of 3-6 patients received 24, 32, 40, and 48 Gy in 4 fractions. Median (range) follow-up was 13. 7 months (5.9-34.7 months). For possibly treatment-related acute toxicities, one patient developed grade 2 fatigue and one developed grade 4 duodenal ulcer. For possibly treatment-related late toxicities, 2 patients experienced grade 3 renal toxicity (worsening chronic kidney disease), one reported grade 2 urinary incontinence and one developed grade 4 duodenal ulcer. Among the 15 patients with evaluable response, 3 and 12 had partial response and stable disease, respectively, utilizing RECIST criteria. Among the 11 patients who had post-SBRT biopsy, only one (9%) was negative on first biopsy and an additional one (9%) turned negative without further therapy on second biopsy. Conclusions Dose escalation to 48 Gy in 4 fractions has been achieved successfully without dose-limiting toxicities. A planned extension of this phase I trial is currently underway treating patients to 60 Gy in 3 fractions to further evaluate this experimental therapy.

Original languageEnglish (US)
Pages (from-to)183-187
Number of pages5
JournalRadiotherapy and Oncology
Volume117
Issue number1
DOIs
StatePublished - Oct 1 2015
Externally publishedYes

Fingerprint

Radiosurgery
Renal Cell Carcinoma
Biopsy
Duodenal Ulcer
Karnofsky Performance Status
Investigational Therapies
Urinary Incontinence
Therapeutics
Tumor Burden
Chronic Renal Insufficiency
Terminology
Fatigue
Radiotherapy

Keywords

  • Renal cell carcinoma
  • Stereotactic body radiation therapy

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Radiology Nuclear Medicine and imaging

Cite this

Phase i dose-escalation study of stereotactic body radiotherapy (SBRT) for poor surgical candidates with localized renal cell carcinoma. / Ponsky, Lee; Lo, Simon S.; Zhang, Yuxia; Schluchter, Mark; Liu, Yiying; Patel, Ravi; Abouassaly, Robert; Welford, Scott; Gulani, Vikas; Haaga, John Robert; Machtay, Mitchell; Ellis, Rodney J.

In: Radiotherapy and Oncology, Vol. 117, No. 1, 01.10.2015, p. 183-187.

Research output: Contribution to journalArticle

Ponsky, L, Lo, SS, Zhang, Y, Schluchter, M, Liu, Y, Patel, R, Abouassaly, R, Welford, S, Gulani, V, Haaga, JR, Machtay, M & Ellis, RJ 2015, 'Phase i dose-escalation study of stereotactic body radiotherapy (SBRT) for poor surgical candidates with localized renal cell carcinoma', Radiotherapy and Oncology, vol. 117, no. 1, pp. 183-187. https://doi.org/10.1016/j.radonc.2015.08.030
Ponsky, Lee ; Lo, Simon S. ; Zhang, Yuxia ; Schluchter, Mark ; Liu, Yiying ; Patel, Ravi ; Abouassaly, Robert ; Welford, Scott ; Gulani, Vikas ; Haaga, John Robert ; Machtay, Mitchell ; Ellis, Rodney J. / Phase i dose-escalation study of stereotactic body radiotherapy (SBRT) for poor surgical candidates with localized renal cell carcinoma. In: Radiotherapy and Oncology. 2015 ; Vol. 117, No. 1. pp. 183-187.
@article{6113f6b1204a43fdba965566958a1b64,
title = "Phase i dose-escalation study of stereotactic body radiotherapy (SBRT) for poor surgical candidates with localized renal cell carcinoma",
abstract = "Purpose To evaluate the tolerability of escalating doses of stereotactic body radiotherapy (SBRT) for primary treatment of localized renal cell carcinoma (RCC) in poor surgical candidates. Patients and methods Eligible patients included those with clinically staged radiographic and or pathologically confirmed RCC who had not undergone previous abdominal or pelvic radiotherapy. All patients had comorbid medical conditions which precluded surgery. Median (range) patient age was 77.6 years (range 59-89) years and all patients had Karnofsky Performance Status of ≥60. Median tumor volume was 57.9 cm3 (range 13.8-174.7 cm3). Dose-limiting toxicity (DLT) was defined as grade 3 or worse gastrointestinal/genitourinary toxicity by Common Terminology Criteria of Adverse Events (version 4). Tumor response was assessed by imaging results using Response Evaluation Criteria In Solid Tumors (RECIST) measurement and percutaneous biopsy. Results A total of 19 patients (13 men and 6 women) were treated on protocol from June 2006 through August 2011. Groups of 3-6 patients received 24, 32, 40, and 48 Gy in 4 fractions. Median (range) follow-up was 13. 7 months (5.9-34.7 months). For possibly treatment-related acute toxicities, one patient developed grade 2 fatigue and one developed grade 4 duodenal ulcer. For possibly treatment-related late toxicities, 2 patients experienced grade 3 renal toxicity (worsening chronic kidney disease), one reported grade 2 urinary incontinence and one developed grade 4 duodenal ulcer. Among the 15 patients with evaluable response, 3 and 12 had partial response and stable disease, respectively, utilizing RECIST criteria. Among the 11 patients who had post-SBRT biopsy, only one (9{\%}) was negative on first biopsy and an additional one (9{\%}) turned negative without further therapy on second biopsy. Conclusions Dose escalation to 48 Gy in 4 fractions has been achieved successfully without dose-limiting toxicities. A planned extension of this phase I trial is currently underway treating patients to 60 Gy in 3 fractions to further evaluate this experimental therapy.",
keywords = "Renal cell carcinoma, Stereotactic body radiation therapy",
author = "Lee Ponsky and Lo, {Simon S.} and Yuxia Zhang and Mark Schluchter and Yiying Liu and Ravi Patel and Robert Abouassaly and Scott Welford and Vikas Gulani and Haaga, {John Robert} and Mitchell Machtay and Ellis, {Rodney J.}",
year = "2015",
month = "10",
day = "1",
doi = "10.1016/j.radonc.2015.08.030",
language = "English (US)",
volume = "117",
pages = "183--187",
journal = "Radiotherapy and Oncology",
issn = "0167-8140",
publisher = "Elsevier Ireland Ltd",
number = "1",

}

TY - JOUR

T1 - Phase i dose-escalation study of stereotactic body radiotherapy (SBRT) for poor surgical candidates with localized renal cell carcinoma

AU - Ponsky, Lee

AU - Lo, Simon S.

AU - Zhang, Yuxia

AU - Schluchter, Mark

AU - Liu, Yiying

AU - Patel, Ravi

AU - Abouassaly, Robert

AU - Welford, Scott

AU - Gulani, Vikas

AU - Haaga, John Robert

AU - Machtay, Mitchell

AU - Ellis, Rodney J.

PY - 2015/10/1

Y1 - 2015/10/1

N2 - Purpose To evaluate the tolerability of escalating doses of stereotactic body radiotherapy (SBRT) for primary treatment of localized renal cell carcinoma (RCC) in poor surgical candidates. Patients and methods Eligible patients included those with clinically staged radiographic and or pathologically confirmed RCC who had not undergone previous abdominal or pelvic radiotherapy. All patients had comorbid medical conditions which precluded surgery. Median (range) patient age was 77.6 years (range 59-89) years and all patients had Karnofsky Performance Status of ≥60. Median tumor volume was 57.9 cm3 (range 13.8-174.7 cm3). Dose-limiting toxicity (DLT) was defined as grade 3 or worse gastrointestinal/genitourinary toxicity by Common Terminology Criteria of Adverse Events (version 4). Tumor response was assessed by imaging results using Response Evaluation Criteria In Solid Tumors (RECIST) measurement and percutaneous biopsy. Results A total of 19 patients (13 men and 6 women) were treated on protocol from June 2006 through August 2011. Groups of 3-6 patients received 24, 32, 40, and 48 Gy in 4 fractions. Median (range) follow-up was 13. 7 months (5.9-34.7 months). For possibly treatment-related acute toxicities, one patient developed grade 2 fatigue and one developed grade 4 duodenal ulcer. For possibly treatment-related late toxicities, 2 patients experienced grade 3 renal toxicity (worsening chronic kidney disease), one reported grade 2 urinary incontinence and one developed grade 4 duodenal ulcer. Among the 15 patients with evaluable response, 3 and 12 had partial response and stable disease, respectively, utilizing RECIST criteria. Among the 11 patients who had post-SBRT biopsy, only one (9%) was negative on first biopsy and an additional one (9%) turned negative without further therapy on second biopsy. Conclusions Dose escalation to 48 Gy in 4 fractions has been achieved successfully without dose-limiting toxicities. A planned extension of this phase I trial is currently underway treating patients to 60 Gy in 3 fractions to further evaluate this experimental therapy.

AB - Purpose To evaluate the tolerability of escalating doses of stereotactic body radiotherapy (SBRT) for primary treatment of localized renal cell carcinoma (RCC) in poor surgical candidates. Patients and methods Eligible patients included those with clinically staged radiographic and or pathologically confirmed RCC who had not undergone previous abdominal or pelvic radiotherapy. All patients had comorbid medical conditions which precluded surgery. Median (range) patient age was 77.6 years (range 59-89) years and all patients had Karnofsky Performance Status of ≥60. Median tumor volume was 57.9 cm3 (range 13.8-174.7 cm3). Dose-limiting toxicity (DLT) was defined as grade 3 or worse gastrointestinal/genitourinary toxicity by Common Terminology Criteria of Adverse Events (version 4). Tumor response was assessed by imaging results using Response Evaluation Criteria In Solid Tumors (RECIST) measurement and percutaneous biopsy. Results A total of 19 patients (13 men and 6 women) were treated on protocol from June 2006 through August 2011. Groups of 3-6 patients received 24, 32, 40, and 48 Gy in 4 fractions. Median (range) follow-up was 13. 7 months (5.9-34.7 months). For possibly treatment-related acute toxicities, one patient developed grade 2 fatigue and one developed grade 4 duodenal ulcer. For possibly treatment-related late toxicities, 2 patients experienced grade 3 renal toxicity (worsening chronic kidney disease), one reported grade 2 urinary incontinence and one developed grade 4 duodenal ulcer. Among the 15 patients with evaluable response, 3 and 12 had partial response and stable disease, respectively, utilizing RECIST criteria. Among the 11 patients who had post-SBRT biopsy, only one (9%) was negative on first biopsy and an additional one (9%) turned negative without further therapy on second biopsy. Conclusions Dose escalation to 48 Gy in 4 fractions has been achieved successfully without dose-limiting toxicities. A planned extension of this phase I trial is currently underway treating patients to 60 Gy in 3 fractions to further evaluate this experimental therapy.

KW - Renal cell carcinoma

KW - Stereotactic body radiation therapy

UR - http://www.scopus.com/inward/record.url?scp=84946485522&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84946485522&partnerID=8YFLogxK

U2 - 10.1016/j.radonc.2015.08.030

DO - 10.1016/j.radonc.2015.08.030

M3 - Article

VL - 117

SP - 183

EP - 187

JO - Radiotherapy and Oncology

JF - Radiotherapy and Oncology

SN - 0167-8140

IS - 1

ER -