Bone metabolism biomarkers (BMB) and progression-free survival (PFS) in men with metastatic hormone-sensitive prostate cancer (HSPC): SWOG S1216, a phase III trial of androgen deprivation therapy (ADT) with or without orteronel.

Media type: E-Article

Title: Bone metabolism biomarkers (BMB) and progression-free survival (PFS) in men with metastatic hormone-sensitive prostate cancer (HSPC): SWOG S1216, a phase III trial of androgen deprivation therapy (ADT) with or without orteronel

Contributor: Lara, Primo; Mayerson, Edward; Gertz, Erik; Tangen, Catherine; Goldkorn, Amir; Van Loan, Marta; Hussain, Maha H. A.; Gupta, Shilpa; Zhang, Jingsong; Twardowski, Przemyslaw; Quinn, David I.; Vogelzang, Nicholas J.; Thompson, Ian Murchie; Agarwal, Neeraj

imprint: American Society of Clinical Oncology (ASCO), 2020

Language: English

DOI: 10.1200/jco.2020.38.15_suppl.5523

ISSN: 1527-7755; 0732-183X

Keywords: Cancer Research ; Oncology

Origination:

Footnote:

Description: 5523 Background: We previously reported that baseline BMB are independently prognostic for overall survival (OS) in men with castration resistant prostate cancer. We correlated BMB with outcomes in mHSPC as part of S1216, a phase III trial of ADT +/- the novel CYP17 inhibitor orteronel. Methods: Blood was obtained at study entry for bone resorption [C-telopeptide(CTx) & Pyridinoline(PYD)] & formation markers [C-terminal collagen propeptide(CICP) & bone alkaline phosphatase(BAP)]. With prior DSMC approval, patients were sampled to mask potential treatment effect. Logistic regression was used to assess if BMB elevation above median was prognostic for a PFS event w/in 2 years across pooled study treatment arms, adjusting for baseline variables (including disease extent, PSA, age, pre-randomization ADT, & presence of bone mets). An additional interaction term between BMB elevation & presence of bone mets was included; if significant, separate models were developed for men +/- bone mets. Results: Of 1,313 men, 656 were included in this analysis. All 4 BMB levels were higher in men with a PFS event w/in 2 years vs. those with no PFS event. The odds ratio (OR) for a PFS event was significantly higher in men w/ elevated baseline BMB (see table). For BAP, a significant interaction between marker elevation and bone mets was seen (p = 0.003); men w/ bone mets and BAP elevation had an OR of 1.83 for a PFS event in 2 years. Conclusions: In men with newly diagnosed HSPC, elevated baseline levels of BMB were significantly associated with PFS, with about a two-fold increased risk of a progression event w/in 2 years. For CICP, CTx, & PYD, this association was independent of the presence of bone metastases. Baseline BMB levels have strong prognostic value in the mHSPC context. Correlative analysis of BMB & OS is planned. Clinical trial information: NCT01809691 . [Table: see text]

Access State: Open Access

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