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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dc.contributor.authorKim, Julian O.
dc.contributor.authorMcDonald, Megan O.
dc.contributor.authorOng, Aldrich
dc.contributor.authorKoul, Rashmi
dc.contributor.authorDubey, Arbind
dc.contributor.authorHunter, William
dc.contributor.authorAhmed, Shahida
dc.contributor.authorQuon, Harvey
dc.contributor.authorYee, Don
dc.contributor.authorParliament, Matthew
dc.contributor.authorSivananthan, Gokulan
dc.contributor.authorDanielson, Brita
dc.contributor.authorRowe, Lindsay
dc.contributor.authorGhosh, Sunita
dc.contributor.authorUsmani, Nawaid
dc.date.accessioned2021-11-07T01:02:30Z
dc.date.available2021-11-07T01:02:30Z
dc.date.issued2021-11-04
dc.date.updated2021-11-07T01:02:29Z
dc.description.abstractAbstract 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.
dc.identifier.citationRadiation Oncology. 2021 Nov 04;16(1):212
dc.identifier.doihttps://doi.org/10.1186/s13014-021-01935-x
dc.identifier.urihttp://hdl.handle.net/1880/114098
dc.identifier.urihttps://doi.org/10.11575/PRISM/45631
dc.language.rfc3066en
dc.rights.holderThe Author(s)
dc.titleGastrointestinal 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
dc.typeJournal Article
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