Gastrointestinal and genitourinary toxicity profiles of metformin versus placebo in men with prostate cancer receiving prostate radiotherapy: interim toxicity results of a double-blinded, multicenter, phase II randomized controlled trial

Abstract Androgen deprivation therapy (ADT) used for prostate cancer (PCa) management is associated with metabolic and anthropometric toxicity. Metformin given concurrent to ADT is hypothesized to counteract these changes. This planned interim analysis reports the gastrointestinal and genitourinary...

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Autores principales:	Julian O. Kim, Megan O. McDonald, Aldrich Ong, Rashmi Koul, Arbind Dubey, William Hunter, Shahida Ahmed, Harvey Quon, Don Yee, Matthew Parliament, Gokulan Sivananthan, Brita Danielson, Lindsay Rowe, Sunita Ghosh, Nawaid Usmani
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Metformin Prostate cancer Gastrointestinal toxicity Genitourinary toxicity Medical physics. Medical radiology. Nuclear medicine R895-920 Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
Acceso en línea:	https://doaj.org/article/8e04f6c57db3446ca965c661d060cba7
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spelling	oai:doaj.org-article:8e04f6c57db3446ca965c661d060cba72021-11-08T10:44:58ZGastrointestinal and genitourinary toxicity profiles of metformin versus placebo in men with prostate cancer receiving prostate radiotherapy: interim toxicity results of a double-blinded, multicenter, phase II randomized controlled trial10.1186/s13014-021-01935-x1748-717Xhttps://doaj.org/article/8e04f6c57db3446ca965c661d060cba72021-11-01T00:00:00Zhttps://doi.org/10.1186/s13014-021-01935-xhttps://doaj.org/toc/1748-717XAbstract Androgen deprivation therapy (ADT) used for prostate cancer (PCa) management is associated with metabolic and anthropometric toxicity. Metformin given concurrent to ADT is hypothesized to counteract these changes. This planned interim analysis reports the gastrointestinal and genitourinary toxicity profiles of PCa patients receiving ADT and prostate/pelvic radiotherapy plus metformin versus placebo as part of a phase 2 randomized controlled trial. Men with intermediate or high-risk PCa were randomized 1:1 to metformin versus placebo. Both groups were given ADT for 18–36 months with minimum 2-month neoadjuvant phase prior to radiotherapy. Acute gastrointestinal and genitourinary toxicities were quantified using CTCAE v4.0. Differences in ≥ grade 2 toxicities by treatment were assessed by chi-squared test. 83 patients were enrolled with 44 patients randomized to placebo and 39 randomized to metformin. There were no significant differences at any time point in ≥ grade 2 gastrointestinal toxicities or overall gastrointestinal toxicity. Overall ≥ grade 2 gastrointestinal toxicity was low prior to radiotherapy (7.9% (placebo) vs. 3.1% (metformin), p = 0.39) and at the end of radiotherapy (2.8% (placebo) vs 3.1% (metformin), p = 0.64). There were no differences in overall ≥ grade 2 genitourinary toxicity between treatment arms (19.0% (placebo) vs. 9.4% (metformin), p = 0.30). Metformin added to radiotherapy and ADT did not increase rates of ≥ grade 2 gastrointestinal or genitourinary toxicity and is generally safe and well-tolerated.Julian O. KimMegan O. McDonaldAldrich OngRashmi KoulArbind DubeyWilliam HunterShahida AhmedHarvey QuonDon YeeMatthew ParliamentGokulan SivananthanBrita DanielsonLindsay RoweSunita GhoshNawaid UsmaniBMCarticleMetforminProstate cancerGastrointestinal toxicityGenitourinary toxicityMedical physics. Medical radiology. Nuclear medicineR895-920Neoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENRadiation Oncology, Vol 16, Iss 1, Pp 1-6 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Metformin Prostate cancer Gastrointestinal toxicity Genitourinary toxicity Medical physics. Medical radiology. Nuclear medicine R895-920 Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
spellingShingle	Metformin Prostate cancer Gastrointestinal toxicity Genitourinary toxicity Medical physics. Medical radiology. Nuclear medicine R895-920 Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 Julian O. Kim Megan O. McDonald Aldrich Ong Rashmi Koul Arbind Dubey William Hunter Shahida Ahmed Harvey Quon Don Yee Matthew Parliament Gokulan Sivananthan Brita Danielson Lindsay Rowe Sunita Ghosh Nawaid Usmani Gastrointestinal and genitourinary toxicity profiles of metformin versus placebo in men with prostate cancer receiving prostate radiotherapy: interim toxicity results of a double-blinded, multicenter, phase II randomized controlled trial
description	Abstract Androgen deprivation therapy (ADT) used for prostate cancer (PCa) management is associated with metabolic and anthropometric toxicity. Metformin given concurrent to ADT is hypothesized to counteract these changes. This planned interim analysis reports the gastrointestinal and genitourinary toxicity profiles of PCa patients receiving ADT and prostate/pelvic radiotherapy plus metformin versus placebo as part of a phase 2 randomized controlled trial. Men with intermediate or high-risk PCa were randomized 1:1 to metformin versus placebo. Both groups were given ADT for 18–36 months with minimum 2-month neoadjuvant phase prior to radiotherapy. Acute gastrointestinal and genitourinary toxicities were quantified using CTCAE v4.0. Differences in ≥ grade 2 toxicities by treatment were assessed by chi-squared test. 83 patients were enrolled with 44 patients randomized to placebo and 39 randomized to metformin. There were no significant differences at any time point in ≥ grade 2 gastrointestinal toxicities or overall gastrointestinal toxicity. Overall ≥ grade 2 gastrointestinal toxicity was low prior to radiotherapy (7.9% (placebo) vs. 3.1% (metformin), p = 0.39) and at the end of radiotherapy (2.8% (placebo) vs 3.1% (metformin), p = 0.64). There were no differences in overall ≥ grade 2 genitourinary toxicity between treatment arms (19.0% (placebo) vs. 9.4% (metformin), p = 0.30). Metformin added to radiotherapy and ADT did not increase rates of ≥ grade 2 gastrointestinal or genitourinary toxicity and is generally safe and well-tolerated.
format	article
author	Julian O. Kim Megan O. McDonald Aldrich Ong Rashmi Koul Arbind Dubey William Hunter Shahida Ahmed Harvey Quon Don Yee Matthew Parliament Gokulan Sivananthan Brita Danielson Lindsay Rowe Sunita Ghosh Nawaid Usmani
author_facet	Julian O. Kim Megan O. McDonald Aldrich Ong Rashmi Koul Arbind Dubey William Hunter Shahida Ahmed Harvey Quon Don Yee Matthew Parliament Gokulan Sivananthan Brita Danielson Lindsay Rowe Sunita Ghosh Nawaid Usmani
author_sort	Julian O. Kim
title	Gastrointestinal and genitourinary toxicity profiles of metformin versus placebo in men with prostate cancer receiving prostate radiotherapy: interim toxicity results of a double-blinded, multicenter, phase II randomized controlled trial
title_short	Gastrointestinal and genitourinary toxicity profiles of metformin versus placebo in men with prostate cancer receiving prostate radiotherapy: interim toxicity results of a double-blinded, multicenter, phase II randomized controlled trial
title_full	Gastrointestinal and genitourinary toxicity profiles of metformin versus placebo in men with prostate cancer receiving prostate radiotherapy: interim toxicity results of a double-blinded, multicenter, phase II randomized controlled trial
title_fullStr	Gastrointestinal and genitourinary toxicity profiles of metformin versus placebo in men with prostate cancer receiving prostate radiotherapy: interim toxicity results of a double-blinded, multicenter, phase II randomized controlled trial
title_full_unstemmed	Gastrointestinal and genitourinary toxicity profiles of metformin versus placebo in men with prostate cancer receiving prostate radiotherapy: interim toxicity results of a double-blinded, multicenter, phase II randomized controlled trial
title_sort	gastrointestinal and genitourinary toxicity profiles of metformin versus placebo in men with prostate cancer receiving prostate radiotherapy: interim toxicity results of a double-blinded, multicenter, phase ii randomized controlled trial
publisher	BMC
publishDate	2021
url	https://doaj.org/article/8e04f6c57db3446ca965c661d060cba7
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Gastrointestinal and genitourinary toxicity profiles of metformin versus placebo in men with prostate cancer receiving prostate radiotherapy: interim toxicity results of a double-blinded, multicenter, phase II randomized controlled trial

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