Linac based SBRT for prostate cancer in 5 fractions with VMAT and flattening filter free beams: Preliminary report of a phase II study

Filippo Alongi, Luca Cozzi, Stefano Arcangeli, Cristina Iftode, Tiziana Comito, Elisa Villa, Francesca Lobefalo, Pierina Navarria, Giacomo Reggiori, Pietro Mancosu, Elena Clerici, Antonella Fogliata, Stefano Tomatis, Gianluigi Taverna, Pierpaolo Graziotti, Marta Scorsetti

Research output: Contribution to journalArticle

Abstract

Background: To evaluate the feasibility and early side effects of a short course hypo-fractionated SBRT programme with Volumetric Modulated Arc Therapy (VMAT) and Flattening Filter Free (FFF) beams.Methods: A prospective phase I-II study, started on February 2012. Inclusion criteria were: age ≤ 80 years, WHO-PS ≤ 2, PSA ≤ 20 ng/ml, histologically proven prostate adenocarcinoma, T1-T2 stage, no distant metastases, no previous surgery other than TURP, no malignant tumours in the previous 5 years, IPSS 0-7. The schedule was 35 Gy in 5 alternative days. SBRT was delivered with RapidArc VMAT, with 10MV FFF photons. Toxicity assessment was performed according to CTCAE v4.0 scale. EPIC questionnaires assessed Quality-of-Life. Neo-adjuvant/concomitant hormonal-therapy was prescribed according to risk classification. SpaceOAR™ gel was optionally implanted to increase the separation space between the prostate and the rectal wall.Results: Median follow-up was 11 months (range: 5-16); 40 patients were recruited in the protocol and treated. According to NCCN criteria, 26/40 patients were low-risk and 14/40 were intermediate risk. Median age was 70 years (56-80), median initial PSA was 6.25 ng/ml (0.50-13.43 ng/ml). Median Gleason score was 6 (6-7). All patients completed the treatment as programmed (median 11.8 days (9-22). Acute Toxicities were as follow: Rectum G0: 30/40 cases (75%); G1: 6/40 (15%); G2: 4/40 (10%). Genito-urinary: G0: 16/40 (40%); G1: 8/40 (20%); G2: 16/34 (40%). In two G2 urinary retention cases, intermittent catheter was needed. No acute G3 or greater toxicity was found. Median treatment time was 126 sec (120-136). SpaceOAR™ was implanted in 8 patients. PSA reduction from the pre-treatment value of the marker was documented in all patients.Conclusions: Early findings suggest that SBRT with RapidArc and FFF beams for prostate cancer in 5 fractions is feasible and tolerated in acute setting. Longer follow-up is needed for assessment of late toxicity and outcome.

Original languageEnglish
Article number171
JournalRadiation Oncology
Volume8
Issue number1
DOIs
Publication statusPublished - Jul 8 2013

Fingerprint

Intensity-Modulated Radiotherapy
Prostatic Neoplasms
Prostate
Transurethral Resection of Prostate
Urinary Retention
Neoplasm Grading
Therapeutics
Photons
Rectum
Appointments and Schedules
Adenocarcinoma
Catheters
Gels
Quality of Life
Neoplasm Metastasis
Neoplasms

Keywords

  • Prostate
  • RapidArc
  • Stereotactic body radiation therapy

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Medicine(all)

Cite this

@article{774b20af32f2466a8a91f377eff87920,
title = "Linac based SBRT for prostate cancer in 5 fractions with VMAT and flattening filter free beams: Preliminary report of a phase II study",
abstract = "Background: To evaluate the feasibility and early side effects of a short course hypo-fractionated SBRT programme with Volumetric Modulated Arc Therapy (VMAT) and Flattening Filter Free (FFF) beams.Methods: A prospective phase I-II study, started on February 2012. Inclusion criteria were: age ≤ 80 years, WHO-PS ≤ 2, PSA ≤ 20 ng/ml, histologically proven prostate adenocarcinoma, T1-T2 stage, no distant metastases, no previous surgery other than TURP, no malignant tumours in the previous 5 years, IPSS 0-7. The schedule was 35 Gy in 5 alternative days. SBRT was delivered with RapidArc VMAT, with 10MV FFF photons. Toxicity assessment was performed according to CTCAE v4.0 scale. EPIC questionnaires assessed Quality-of-Life. Neo-adjuvant/concomitant hormonal-therapy was prescribed according to risk classification. SpaceOAR™ gel was optionally implanted to increase the separation space between the prostate and the rectal wall.Results: Median follow-up was 11 months (range: 5-16); 40 patients were recruited in the protocol and treated. According to NCCN criteria, 26/40 patients were low-risk and 14/40 were intermediate risk. Median age was 70 years (56-80), median initial PSA was 6.25 ng/ml (0.50-13.43 ng/ml). Median Gleason score was 6 (6-7). All patients completed the treatment as programmed (median 11.8 days (9-22). Acute Toxicities were as follow: Rectum G0: 30/40 cases (75{\%}); G1: 6/40 (15{\%}); G2: 4/40 (10{\%}). Genito-urinary: G0: 16/40 (40{\%}); G1: 8/40 (20{\%}); G2: 16/34 (40{\%}). In two G2 urinary retention cases, intermittent catheter was needed. No acute G3 or greater toxicity was found. Median treatment time was 126 sec (120-136). SpaceOAR™ was implanted in 8 patients. PSA reduction from the pre-treatment value of the marker was documented in all patients.Conclusions: Early findings suggest that SBRT with RapidArc and FFF beams for prostate cancer in 5 fractions is feasible and tolerated in acute setting. Longer follow-up is needed for assessment of late toxicity and outcome.",
keywords = "Prostate, RapidArc, Stereotactic body radiation therapy",
author = "Filippo Alongi and Luca Cozzi and Stefano Arcangeli and Cristina Iftode and Tiziana Comito and Elisa Villa and Francesca Lobefalo and Pierina Navarria and Giacomo Reggiori and Pietro Mancosu and Elena Clerici and Antonella Fogliata and Stefano Tomatis and Gianluigi Taverna and Pierpaolo Graziotti and Marta Scorsetti",
year = "2013",
month = "7",
day = "8",
doi = "10.1186/1748-717X-8-171",
language = "English",
volume = "8",
journal = "Radiation Oncology",
issn = "1748-717X",
publisher = "BioMed Central",
number = "1",

}

TY - JOUR

T1 - Linac based SBRT for prostate cancer in 5 fractions with VMAT and flattening filter free beams

T2 - Preliminary report of a phase II study

AU - Alongi, Filippo

AU - Cozzi, Luca

AU - Arcangeli, Stefano

AU - Iftode, Cristina

AU - Comito, Tiziana

AU - Villa, Elisa

AU - Lobefalo, Francesca

AU - Navarria, Pierina

AU - Reggiori, Giacomo

AU - Mancosu, Pietro

AU - Clerici, Elena

AU - Fogliata, Antonella

AU - Tomatis, Stefano

AU - Taverna, Gianluigi

AU - Graziotti, Pierpaolo

AU - Scorsetti, Marta

PY - 2013/7/8

Y1 - 2013/7/8

N2 - Background: To evaluate the feasibility and early side effects of a short course hypo-fractionated SBRT programme with Volumetric Modulated Arc Therapy (VMAT) and Flattening Filter Free (FFF) beams.Methods: A prospective phase I-II study, started on February 2012. Inclusion criteria were: age ≤ 80 years, WHO-PS ≤ 2, PSA ≤ 20 ng/ml, histologically proven prostate adenocarcinoma, T1-T2 stage, no distant metastases, no previous surgery other than TURP, no malignant tumours in the previous 5 years, IPSS 0-7. The schedule was 35 Gy in 5 alternative days. SBRT was delivered with RapidArc VMAT, with 10MV FFF photons. Toxicity assessment was performed according to CTCAE v4.0 scale. EPIC questionnaires assessed Quality-of-Life. Neo-adjuvant/concomitant hormonal-therapy was prescribed according to risk classification. SpaceOAR™ gel was optionally implanted to increase the separation space between the prostate and the rectal wall.Results: Median follow-up was 11 months (range: 5-16); 40 patients were recruited in the protocol and treated. According to NCCN criteria, 26/40 patients were low-risk and 14/40 were intermediate risk. Median age was 70 years (56-80), median initial PSA was 6.25 ng/ml (0.50-13.43 ng/ml). Median Gleason score was 6 (6-7). All patients completed the treatment as programmed (median 11.8 days (9-22). Acute Toxicities were as follow: Rectum G0: 30/40 cases (75%); G1: 6/40 (15%); G2: 4/40 (10%). Genito-urinary: G0: 16/40 (40%); G1: 8/40 (20%); G2: 16/34 (40%). In two G2 urinary retention cases, intermittent catheter was needed. No acute G3 or greater toxicity was found. Median treatment time was 126 sec (120-136). SpaceOAR™ was implanted in 8 patients. PSA reduction from the pre-treatment value of the marker was documented in all patients.Conclusions: Early findings suggest that SBRT with RapidArc and FFF beams for prostate cancer in 5 fractions is feasible and tolerated in acute setting. Longer follow-up is needed for assessment of late toxicity and outcome.

AB - Background: To evaluate the feasibility and early side effects of a short course hypo-fractionated SBRT programme with Volumetric Modulated Arc Therapy (VMAT) and Flattening Filter Free (FFF) beams.Methods: A prospective phase I-II study, started on February 2012. Inclusion criteria were: age ≤ 80 years, WHO-PS ≤ 2, PSA ≤ 20 ng/ml, histologically proven prostate adenocarcinoma, T1-T2 stage, no distant metastases, no previous surgery other than TURP, no malignant tumours in the previous 5 years, IPSS 0-7. The schedule was 35 Gy in 5 alternative days. SBRT was delivered with RapidArc VMAT, with 10MV FFF photons. Toxicity assessment was performed according to CTCAE v4.0 scale. EPIC questionnaires assessed Quality-of-Life. Neo-adjuvant/concomitant hormonal-therapy was prescribed according to risk classification. SpaceOAR™ gel was optionally implanted to increase the separation space between the prostate and the rectal wall.Results: Median follow-up was 11 months (range: 5-16); 40 patients were recruited in the protocol and treated. According to NCCN criteria, 26/40 patients were low-risk and 14/40 were intermediate risk. Median age was 70 years (56-80), median initial PSA was 6.25 ng/ml (0.50-13.43 ng/ml). Median Gleason score was 6 (6-7). All patients completed the treatment as programmed (median 11.8 days (9-22). Acute Toxicities were as follow: Rectum G0: 30/40 cases (75%); G1: 6/40 (15%); G2: 4/40 (10%). Genito-urinary: G0: 16/40 (40%); G1: 8/40 (20%); G2: 16/34 (40%). In two G2 urinary retention cases, intermittent catheter was needed. No acute G3 or greater toxicity was found. Median treatment time was 126 sec (120-136). SpaceOAR™ was implanted in 8 patients. PSA reduction from the pre-treatment value of the marker was documented in all patients.Conclusions: Early findings suggest that SBRT with RapidArc and FFF beams for prostate cancer in 5 fractions is feasible and tolerated in acute setting. Longer follow-up is needed for assessment of late toxicity and outcome.

KW - Prostate

KW - RapidArc

KW - Stereotactic body radiation therapy

UR - http://www.scopus.com/inward/record.url?scp=84879818128&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84879818128&partnerID=8YFLogxK

U2 - 10.1186/1748-717X-8-171

DO - 10.1186/1748-717X-8-171

M3 - Article

C2 - 23835141

AN - SCOPUS:84879818128

VL - 8

JO - Radiation Oncology

JF - Radiation Oncology

SN - 1748-717X

IS - 1

M1 - 171

ER -