External beam radiotherapy with dose escalation in 1080 prostate cancer patients: Definitive outcome and dose impact

Elisabetta Garibaldi, Domenico Gabriele, Angelo Maggio, Elena Delmastro, Monica Garibaldi, Sara Bresciani, Cinzia Ortega, Michele Stasi, Pietro Gabriele

Research output: Contribution to journalArticle

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Abstract

BACKGROUND: The aim of this paper was to report definitive outcome of prostate cancer patients treated with dose escalation during a period of 12.5 years. METHODS: From October 1999 to march 2012 we treated 1080 patients affected by prostate cancer, using external Beam radiotherapy (EBRT). The mean age was 69.2 years. most of the patients (69%) were staged as cT2, Gleason Score (GS)<7; the mean iPSA 18 ng/ mL; the rate of clinical positive nodes was 1%. Our intention to treat was the following: For low risk patients 72 Gy; for intermediate risk patients 75.6 Gy and for high-very high risk patients 79.2 Gy in 1.8 Gy/day fractions. From 2008 we changed the fractionation scheme and the doses were the following: For low risk patients 74 Gy and for intermediate and high-very high risk patients 78 Gy in 2.0 Gy/day fractions. Whole pelvis irradiation was performed in high-very high risk patients with 43.2-50.4 Gy in 1.8 Gy per day. The mean follow-up was 81 months. RESULTS: For the whole population at 5 and 10 years, the prostate cancer specific overall survival (CSOS) was 96.7% and 92.2% respectively; the clinical disease free survival (CDFS) 88% and 77%; the biochemical disease free survival (BDFS) 75% and 58.5%. The 5 and 10 years CSOS was 98% and 96% respectively for low risk, 96% and 92% for intermediate risk and 89% and 82% for high-very high risk patients. in intermediate and high-very high risk groups at 5 and 10 years the CSOS was 95.2% and 89.2% respectively, the CDFS 84.5% and 70% and the BDFS 70% and 51% respectively. in high-very high risk patients at 5 and 10 years the CSOS were respectively 89% and 82% the CDFS was 78% and 61% and BDFS was 61% and 34%. in whole patient population the BDFS was related with the dose level (P=0.006) as well as the CDFS (P=0.003) with a cut off of 75.6 Gy. in the subgroup of intermediate plus high-very high risk patients the BDFS and the CDFS were dose-related with a cut off of 75.6 Gy (P=0.007 and P=0.0018 respectively). Finally, in the subgroup of high-very high risk patients we found that the CSOS, the BDFS and the CDFS were related to the dose level with a cut-off of 77.7 Gy (P=0.017; P=0.006 and P=0.038, respectively). Overall gastrointestinal (Gi) acute and late G2 toxicities were respectively 5 % and 3.8%; Gi acute and late >G3 toxicities were respectively 0.5% and 0.9%; acute and late >G2 genitourinary (GU) toxicities were respectively 10.5% and 2.6%; finally GU acute and late >G3 toxicities were respectively 0.6% and 0.5%. CONCLUSIONS: The dose escalation is not relevant for the outcome in low risk patients that can benefit from relatively moderate doses (72-74 Gy). For intermediate and high-very high risk patients the dose becomes significant to levels above 75.6 Gy; particularly in high-very high risk doses >77.7 Gy correlate with an improved outcome. Patients receiving dose >77.7 Gy presented a higher rate of overall Gi and GU toxicity, but the number of grade >2 remains low. Our results, consolidated by a long follow-up, corroborate the literature data, confirming that 3D-CRT can allow a safe dose escalation without significantly increasing the severe toxicity.

Original languageEnglish
Pages (from-to)121-129
Number of pages9
JournalPanminerva Medica
Volume58
Issue number2
Publication statusPublished - Jun 1 2016

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Prostatic Neoplasms
Radiotherapy
Neoplasm Grading

Keywords

  • Outcome assessment (health care)
  • Prostate neoplasms
  • Radiotherapy

ASJC Scopus subject areas

  • Medicine(all)

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External beam radiotherapy with dose escalation in 1080 prostate cancer patients : Definitive outcome and dose impact. / Garibaldi, Elisabetta; Gabriele, Domenico; Maggio, Angelo; Delmastro, Elena; Garibaldi, Monica; Bresciani, Sara; Ortega, Cinzia; Stasi, Michele; Gabriele, Pietro.

In: Panminerva Medica, Vol. 58, No. 2, 01.06.2016, p. 121-129.

Research output: Contribution to journalArticle

@article{dce03f603b15436e9d133fe07d8ab339,
title = "External beam radiotherapy with dose escalation in 1080 prostate cancer patients: Definitive outcome and dose impact",
abstract = "BACKGROUND: The aim of this paper was to report definitive outcome of prostate cancer patients treated with dose escalation during a period of 12.5 years. METHODS: From October 1999 to march 2012 we treated 1080 patients affected by prostate cancer, using external Beam radiotherapy (EBRT). The mean age was 69.2 years. most of the patients (69{\%}) were staged as cT2, Gleason Score (GS)<7; the mean iPSA 18 ng/ mL; the rate of clinical positive nodes was 1{\%}. Our intention to treat was the following: For low risk patients 72 Gy; for intermediate risk patients 75.6 Gy and for high-very high risk patients 79.2 Gy in 1.8 Gy/day fractions. From 2008 we changed the fractionation scheme and the doses were the following: For low risk patients 74 Gy and for intermediate and high-very high risk patients 78 Gy in 2.0 Gy/day fractions. Whole pelvis irradiation was performed in high-very high risk patients with 43.2-50.4 Gy in 1.8 Gy per day. The mean follow-up was 81 months. RESULTS: For the whole population at 5 and 10 years, the prostate cancer specific overall survival (CSOS) was 96.7{\%} and 92.2{\%} respectively; the clinical disease free survival (CDFS) 88{\%} and 77{\%}; the biochemical disease free survival (BDFS) 75{\%} and 58.5{\%}. The 5 and 10 years CSOS was 98{\%} and 96{\%} respectively for low risk, 96{\%} and 92{\%} for intermediate risk and 89{\%} and 82{\%} for high-very high risk patients. in intermediate and high-very high risk groups at 5 and 10 years the CSOS was 95.2{\%} and 89.2{\%} respectively, the CDFS 84.5{\%} and 70{\%} and the BDFS 70{\%} and 51{\%} respectively. in high-very high risk patients at 5 and 10 years the CSOS were respectively 89{\%} and 82{\%} the CDFS was 78{\%} and 61{\%} and BDFS was 61{\%} and 34{\%}. in whole patient population the BDFS was related with the dose level (P=0.006) as well as the CDFS (P=0.003) with a cut off of 75.6 Gy. in the subgroup of intermediate plus high-very high risk patients the BDFS and the CDFS were dose-related with a cut off of 75.6 Gy (P=0.007 and P=0.0018 respectively). Finally, in the subgroup of high-very high risk patients we found that the CSOS, the BDFS and the CDFS were related to the dose level with a cut-off of 77.7 Gy (P=0.017; P=0.006 and P=0.038, respectively). Overall gastrointestinal (Gi) acute and late G2 toxicities were respectively 5 {\%} and 3.8{\%}; Gi acute and late >G3 toxicities were respectively 0.5{\%} and 0.9{\%}; acute and late >G2 genitourinary (GU) toxicities were respectively 10.5{\%} and 2.6{\%}; finally GU acute and late >G3 toxicities were respectively 0.6{\%} and 0.5{\%}. CONCLUSIONS: The dose escalation is not relevant for the outcome in low risk patients that can benefit from relatively moderate doses (72-74 Gy). For intermediate and high-very high risk patients the dose becomes significant to levels above 75.6 Gy; particularly in high-very high risk doses >77.7 Gy correlate with an improved outcome. Patients receiving dose >77.7 Gy presented a higher rate of overall Gi and GU toxicity, but the number of grade >2 remains low. Our results, consolidated by a long follow-up, corroborate the literature data, confirming that 3D-CRT can allow a safe dose escalation without significantly increasing the severe toxicity.",
keywords = "Outcome assessment (health care), Prostate neoplasms, Radiotherapy",
author = "Elisabetta Garibaldi and Domenico Gabriele and Angelo Maggio and Elena Delmastro and Monica Garibaldi and Sara Bresciani and Cinzia Ortega and Michele Stasi and Pietro Gabriele",
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T1 - External beam radiotherapy with dose escalation in 1080 prostate cancer patients

T2 - Definitive outcome and dose impact

AU - Garibaldi, Elisabetta

AU - Gabriele, Domenico

AU - Maggio, Angelo

AU - Delmastro, Elena

AU - Garibaldi, Monica

AU - Bresciani, Sara

AU - Ortega, Cinzia

AU - Stasi, Michele

AU - Gabriele, Pietro

PY - 2016/6/1

Y1 - 2016/6/1

N2 - BACKGROUND: The aim of this paper was to report definitive outcome of prostate cancer patients treated with dose escalation during a period of 12.5 years. METHODS: From October 1999 to march 2012 we treated 1080 patients affected by prostate cancer, using external Beam radiotherapy (EBRT). The mean age was 69.2 years. most of the patients (69%) were staged as cT2, Gleason Score (GS)<7; the mean iPSA 18 ng/ mL; the rate of clinical positive nodes was 1%. Our intention to treat was the following: For low risk patients 72 Gy; for intermediate risk patients 75.6 Gy and for high-very high risk patients 79.2 Gy in 1.8 Gy/day fractions. From 2008 we changed the fractionation scheme and the doses were the following: For low risk patients 74 Gy and for intermediate and high-very high risk patients 78 Gy in 2.0 Gy/day fractions. Whole pelvis irradiation was performed in high-very high risk patients with 43.2-50.4 Gy in 1.8 Gy per day. The mean follow-up was 81 months. RESULTS: For the whole population at 5 and 10 years, the prostate cancer specific overall survival (CSOS) was 96.7% and 92.2% respectively; the clinical disease free survival (CDFS) 88% and 77%; the biochemical disease free survival (BDFS) 75% and 58.5%. The 5 and 10 years CSOS was 98% and 96% respectively for low risk, 96% and 92% for intermediate risk and 89% and 82% for high-very high risk patients. in intermediate and high-very high risk groups at 5 and 10 years the CSOS was 95.2% and 89.2% respectively, the CDFS 84.5% and 70% and the BDFS 70% and 51% respectively. in high-very high risk patients at 5 and 10 years the CSOS were respectively 89% and 82% the CDFS was 78% and 61% and BDFS was 61% and 34%. in whole patient population the BDFS was related with the dose level (P=0.006) as well as the CDFS (P=0.003) with a cut off of 75.6 Gy. in the subgroup of intermediate plus high-very high risk patients the BDFS and the CDFS were dose-related with a cut off of 75.6 Gy (P=0.007 and P=0.0018 respectively). Finally, in the subgroup of high-very high risk patients we found that the CSOS, the BDFS and the CDFS were related to the dose level with a cut-off of 77.7 Gy (P=0.017; P=0.006 and P=0.038, respectively). Overall gastrointestinal (Gi) acute and late G2 toxicities were respectively 5 % and 3.8%; Gi acute and late >G3 toxicities were respectively 0.5% and 0.9%; acute and late >G2 genitourinary (GU) toxicities were respectively 10.5% and 2.6%; finally GU acute and late >G3 toxicities were respectively 0.6% and 0.5%. CONCLUSIONS: The dose escalation is not relevant for the outcome in low risk patients that can benefit from relatively moderate doses (72-74 Gy). For intermediate and high-very high risk patients the dose becomes significant to levels above 75.6 Gy; particularly in high-very high risk doses >77.7 Gy correlate with an improved outcome. Patients receiving dose >77.7 Gy presented a higher rate of overall Gi and GU toxicity, but the number of grade >2 remains low. Our results, consolidated by a long follow-up, corroborate the literature data, confirming that 3D-CRT can allow a safe dose escalation without significantly increasing the severe toxicity.

AB - BACKGROUND: The aim of this paper was to report definitive outcome of prostate cancer patients treated with dose escalation during a period of 12.5 years. METHODS: From October 1999 to march 2012 we treated 1080 patients affected by prostate cancer, using external Beam radiotherapy (EBRT). The mean age was 69.2 years. most of the patients (69%) were staged as cT2, Gleason Score (GS)<7; the mean iPSA 18 ng/ mL; the rate of clinical positive nodes was 1%. Our intention to treat was the following: For low risk patients 72 Gy; for intermediate risk patients 75.6 Gy and for high-very high risk patients 79.2 Gy in 1.8 Gy/day fractions. From 2008 we changed the fractionation scheme and the doses were the following: For low risk patients 74 Gy and for intermediate and high-very high risk patients 78 Gy in 2.0 Gy/day fractions. Whole pelvis irradiation was performed in high-very high risk patients with 43.2-50.4 Gy in 1.8 Gy per day. The mean follow-up was 81 months. RESULTS: For the whole population at 5 and 10 years, the prostate cancer specific overall survival (CSOS) was 96.7% and 92.2% respectively; the clinical disease free survival (CDFS) 88% and 77%; the biochemical disease free survival (BDFS) 75% and 58.5%. The 5 and 10 years CSOS was 98% and 96% respectively for low risk, 96% and 92% for intermediate risk and 89% and 82% for high-very high risk patients. in intermediate and high-very high risk groups at 5 and 10 years the CSOS was 95.2% and 89.2% respectively, the CDFS 84.5% and 70% and the BDFS 70% and 51% respectively. in high-very high risk patients at 5 and 10 years the CSOS were respectively 89% and 82% the CDFS was 78% and 61% and BDFS was 61% and 34%. in whole patient population the BDFS was related with the dose level (P=0.006) as well as the CDFS (P=0.003) with a cut off of 75.6 Gy. in the subgroup of intermediate plus high-very high risk patients the BDFS and the CDFS were dose-related with a cut off of 75.6 Gy (P=0.007 and P=0.0018 respectively). Finally, in the subgroup of high-very high risk patients we found that the CSOS, the BDFS and the CDFS were related to the dose level with a cut-off of 77.7 Gy (P=0.017; P=0.006 and P=0.038, respectively). Overall gastrointestinal (Gi) acute and late G2 toxicities were respectively 5 % and 3.8%; Gi acute and late >G3 toxicities were respectively 0.5% and 0.9%; acute and late >G2 genitourinary (GU) toxicities were respectively 10.5% and 2.6%; finally GU acute and late >G3 toxicities were respectively 0.6% and 0.5%. CONCLUSIONS: The dose escalation is not relevant for the outcome in low risk patients that can benefit from relatively moderate doses (72-74 Gy). For intermediate and high-very high risk patients the dose becomes significant to levels above 75.6 Gy; particularly in high-very high risk doses >77.7 Gy correlate with an improved outcome. Patients receiving dose >77.7 Gy presented a higher rate of overall Gi and GU toxicity, but the number of grade >2 remains low. Our results, consolidated by a long follow-up, corroborate the literature data, confirming that 3D-CRT can allow a safe dose escalation without significantly increasing the severe toxicity.

KW - Outcome assessment (health care)

KW - Prostate neoplasms

KW - Radiotherapy

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