Accelerated Middle Half Body Radiotherapy in Bone Metastases from Prostate Cancer: A Phase I Study (SHARON Project)

Alice Zamagni; Milly Buwenge; Gabriella Macchia; Giambattista Siepe; Savino Cilla; Francesco Cellini; Alessandra Arcelli; Eleonora Farina; Francesco Deodato; Silvia Cammelli; Alessio G Morganti

doi:10.21873/anticanres.13699

Accelerated Middle Half Body Radiotherapy in Bone Metastases from Prostate Cancer: A Phase I Study (SHARON Project)

Alice Zamagni, Milly Buwenge, Gabriella Macchia, Giambattista Siepe, Savino Cilla, Francesco Cellini, Alessandra Arcelli, Eleonora Farina, Francesco Deodato, Silvia Cammelli, Alessio G Morganti

IRCCS Fondazione Policlinico Universitario A. Gemelli

Research output: Contribution to journal › Article › peer-review

Abstract

BACKGROUND/AIM: The primary endpoint of this phase I study was the maximum tolerated dose (MTD) of middle half body (MHB) accelerated radiotherapy (RT) in multiple bone metastatic (BM) prostate cancer (PCa) patients.

PATIENTS AND METHODS: Three step dose escalation [13 Gy (3.25 Gy/fraction), 14 Gy (3.5 Gy/fraction), and 15 Gy (3.75 Gy/fraction)] in three consecutive patient cohorts were planned. RT was delivered in two consecutive days and two daily fractions. Six patients were enrolled in the first two cohorts and 12 in the third cohort. Grade ≥3 toxicity was considered as a dose-limiting toxicity (DLT).

RESULTS: Twenty-five patients (median age=71 years, median follow-up=7.4 months) were enrolled. Defined MTD dose was 15 Gy. Overall pain response rate was 76%: 9 patients (36%) showed complete and 10 patients (40%) reported partial response of pain.

CONCLUSION: MHB accelerated RT (total dose: 15 Gy) delivered in two consecutive days and two daily fractions is well tolerated.

Original language	English
Pages (from-to)	5065-5069
Number of pages	5
Journal	Anticancer Research
Volume	39
Issue number	9
DOIs	https://doi.org/10.21873/anticanres.13699
Publication status	Published - Sept 2019

Keywords

Aged
Bone Neoplasms/radiotherapy
Combined Modality Therapy
Follow-Up Studies
Humans
Male
Maximum Tolerated Dose
Middle Aged
Prostatic Neoplasms/pathology
Quality of Life
Radiotherapy/adverse effects
Radiotherapy Dosage
Treatment Outcome

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10.21873/anticanres.13699

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title = "Accelerated Middle Half Body Radiotherapy in Bone Metastases from Prostate Cancer: A Phase I Study (SHARON Project)",

abstract = "BACKGROUND/AIM: The primary endpoint of this phase I study was the maximum tolerated dose (MTD) of middle half body (MHB) accelerated radiotherapy (RT) in multiple bone metastatic (BM) prostate cancer (PCa) patients.PATIENTS AND METHODS: Three step dose escalation [13 Gy (3.25 Gy/fraction), 14 Gy (3.5 Gy/fraction), and 15 Gy (3.75 Gy/fraction)] in three consecutive patient cohorts were planned. RT was delivered in two consecutive days and two daily fractions. Six patients were enrolled in the first two cohorts and 12 in the third cohort. Grade ≥3 toxicity was considered as a dose-limiting toxicity (DLT).RESULTS: Twenty-five patients (median age=71 years, median follow-up=7.4 months) were enrolled. Defined MTD dose was 15 Gy. Overall pain response rate was 76%: 9 patients (36%) showed complete and 10 patients (40%) reported partial response of pain.CONCLUSION: MHB accelerated RT (total dose: 15 Gy) delivered in two consecutive days and two daily fractions is well tolerated.",

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author = "Alice Zamagni and Milly Buwenge and Gabriella Macchia and Giambattista Siepe and Savino Cilla and Francesco Cellini and Alessandra Arcelli and Eleonora Farina and Francesco Deodato and Silvia Cammelli and Morganti, {Alessio G}",

year = "2019",

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doi = "10.21873/anticanres.13699",

language = "English",

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T1 - Accelerated Middle Half Body Radiotherapy in Bone Metastases from Prostate Cancer

T2 - A Phase I Study (SHARON Project)

AU - Zamagni, Alice

AU - Buwenge, Milly

AU - Macchia, Gabriella

AU - Siepe, Giambattista

AU - Cilla, Savino

AU - Cellini, Francesco

AU - Arcelli, Alessandra

AU - Farina, Eleonora

AU - Deodato, Francesco

AU - Cammelli, Silvia

AU - Morganti, Alessio G

PY - 2019/9

Y1 - 2019/9

N2 - BACKGROUND/AIM: The primary endpoint of this phase I study was the maximum tolerated dose (MTD) of middle half body (MHB) accelerated radiotherapy (RT) in multiple bone metastatic (BM) prostate cancer (PCa) patients.PATIENTS AND METHODS: Three step dose escalation [13 Gy (3.25 Gy/fraction), 14 Gy (3.5 Gy/fraction), and 15 Gy (3.75 Gy/fraction)] in three consecutive patient cohorts were planned. RT was delivered in two consecutive days and two daily fractions. Six patients were enrolled in the first two cohorts and 12 in the third cohort. Grade ≥3 toxicity was considered as a dose-limiting toxicity (DLT).RESULTS: Twenty-five patients (median age=71 years, median follow-up=7.4 months) were enrolled. Defined MTD dose was 15 Gy. Overall pain response rate was 76%: 9 patients (36%) showed complete and 10 patients (40%) reported partial response of pain.CONCLUSION: MHB accelerated RT (total dose: 15 Gy) delivered in two consecutive days and two daily fractions is well tolerated.

AB - BACKGROUND/AIM: The primary endpoint of this phase I study was the maximum tolerated dose (MTD) of middle half body (MHB) accelerated radiotherapy (RT) in multiple bone metastatic (BM) prostate cancer (PCa) patients.PATIENTS AND METHODS: Three step dose escalation [13 Gy (3.25 Gy/fraction), 14 Gy (3.5 Gy/fraction), and 15 Gy (3.75 Gy/fraction)] in three consecutive patient cohorts were planned. RT was delivered in two consecutive days and two daily fractions. Six patients were enrolled in the first two cohorts and 12 in the third cohort. Grade ≥3 toxicity was considered as a dose-limiting toxicity (DLT).RESULTS: Twenty-five patients (median age=71 years, median follow-up=7.4 months) were enrolled. Defined MTD dose was 15 Gy. Overall pain response rate was 76%: 9 patients (36%) showed complete and 10 patients (40%) reported partial response of pain.CONCLUSION: MHB accelerated RT (total dose: 15 Gy) delivered in two consecutive days and two daily fractions is well tolerated.

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KW - Combined Modality Therapy

KW - Follow-Up Studies

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KW - Male

KW - Maximum Tolerated Dose

KW - Middle Aged

KW - Prostatic Neoplasms/pathology

KW - Quality of Life

KW - Radiotherapy/adverse effects

KW - Radiotherapy Dosage

KW - Treatment Outcome

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ER -

Accelerated Middle Half Body Radiotherapy in Bone Metastases from Prostate Cancer: A Phase I Study (SHARON Project)

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