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Highlights from the 2023 American Society of Clinical Oncology Annual Meeting |
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| Assessing PSA Levels as Prognostic of Overall Survival in Men with mHSPC
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| Susan Halabi, Ph.D.
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| In this presentation, Susan Halabi discusses the assessment of PSA levels as a prognostic factor for overall survival in men with metastatic hormone-sensitive prostate cancer (mHSPC). Prior data have shown that PSA ≤ 0.2 ng/dL at 6-7 months with ADT with testosterone suppression alone is prognostic of OS. Dr. Halabi and colleagues hypothesized that a PSA ≤0.1 ng/dL at 7 months would be a stronger prognostic factor for OS in men with mHSPC treated with testosterone suppression alone.
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| Darolutamide and Time to Pain Progression by Disease Volume In ARASENS
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| Matthew R. Smith, MD, Ph.D. |
| In patients with mHSPC, the addition of darolutamide to ADT and docetaxel provided clinically meaningful benefit through delayed time to pain progression, notably in patients with high volume disease. Increased overall survival, a delay in time to pain progression, and a favorable safety profile set darolutamide + ADT + docetaxel as a new standard of care for patients with mHSPC. |
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| The Relationship Between a Priori Defined Prognostic Risk Groups and Overall Survival in Men with mHSPC |
| Susan Halabi, Ph.D. |
| Susan Halabi discusses the relationship between a priori defined prognostic risk groups and overall survival in men with mHSPC. Prior analyses have shown that men who present with high volume disease and de novo metastases have shorter OS compared with other mHSPC subgroups. This analysis aimed to determine the prognostic relationship between a-priori defined 4-prognostic groups and OS in men with mHSPC and in a subset of trials in patients treated with ADT + docetaxel. |
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| Treatment and Survival of De Novo mHSPC Among African American US Veterans
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| Rigoberto De Jesus Pizarro, MD |
| In an equal access health care system, African American veterans had similar survival to white veterans despite having double the PSA levels, reflecting higher risk disease. African Americans presented 3.5 years younger and are likely treated with doublet therapy. The differences in the age of onset and burden of disease highlight persistent differences in populations with mHSPC. Further investigations to understand environmental, social, and tumor factors are warranted to explain these disparities. |
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| PSMA PET Findings in an “EMBARK-like” Cohort of Patients with High-Risk Non-Metastatic Hormone-Sensitive Prostate Cancer: A Single Center Post-Hoc Retrospective Analysis |
| Wesley Armstrong |
| PSMA-PET detected M1 disease in 36%, 56%, 60%, and 46% of radical prostatectomy, definitive radiotherapy, salvage radiotherapy, and the overall cohort, respectively. Oligometastatic disease was detected in 34% and polymetastatic disease (>5 M1 lesions) in 8% of patients. Further studies are needed to assess its independent prognostic value and use for treatment guidance. |
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| DEAR: Comparative Real-World Evidence on Darolutamide, Enzalutamide, and Apalutamide for Patients with nmCRPC in the United States
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| Alicia K. Morgans, MD, MPH |
| Overall, a lower percentage of patients discontinued initial ARI treatment, progressed to metastasis, or had adverse events on darolutamide vs enzalutamide/apalutamide. In analyses adjusting for observed baseline factors, patients on darolutamide had considerably lower risk of discontinued initial ARI treatment and a percentage who progressed to metastasis vs enzalutamide/apalutamide. This study confirms darolutamide’s strong efficacy and favorable tolerability profile in a real-world setting. |
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| ARASEC: Open-Label Study of Darolutamide Plus ADT vs ADT in mHSPC Using an External Control Arm |
| Neal Shore, MD, FACS |
| In this presentation, Neal Shore discusses the ARASEC study, an open-label study of darolutamide plus ADT vs ADT in metastatic hormone-sensitive prostate cancer (mHSPC) using an external control arm. The primary endpoint analysis will take place after 161 PFS events have occurred and primary completion is anticipated in June 2024. |
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| Use of ctDNA to Complement Tumor Tissue Homologous Recombination Repair Gene Alteration Testing in TALAPRO-2, a Study of Talazoparib + Enzalutamide Vs Placebo + ENZA as First-Line Treatment for mCRPC
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| Arun Azad, PhD, MBBS, FRACP |
| Arun Azad presented the results of an exploratory analysis from TALAPRO-2, evaluating the use of circulating tumor DNA (ctDNA) as a complement to tumor tissue homologous recombination repair (HRR) gene alteration testing. there appears to be an almost perfect (96%) agreement between prospective tissue and ctDNA-based HRR mutational status testing using FoundationOne®, consistent with results reported in the literature.
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| PSMA Expression and Response to 177Lu-PSMA-617 in Men with vs. Without DNA Damage Repair Mutations
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| Ruben Raychaudhuri, MD
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| Ruben Raychaudhuri presents the results of a retrospective analysis evaluating PSMA expression and subsequent response to 177Lu-PSMA-617 in prostate cancer patients with and without DNA damage repair (DDR) mutations. Based on the data, the investigators concluded that mutations in DDR genes were associated with an improved PSA50 response rate following 177Lu-PSMA-617 compared to patients without a DDR mutation.
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| Early Changes of PSMA PET Signal After Initiation of Androgen Receptor Signaling Inhibitors in mCRPC: An International Multicenter Retrospective Study |
| Lena Unterrainer, MD
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| Lena Unterrainer presents the results of an international multicenter retrospective study evaluating early changes in PSMA-PET/CT signaling following initiation of androgen receptor signaling inhibitors (ARSIs) in mCRPC patients. PSMA-PET/CT performed early after ARSI initiation was associated with slight increases in whole-body PSMA-TV, but no significant changes in whole body PSMA SUVmean or SUVmax. |
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| Circulating Tumor Cells in Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC) Treated with Olaparib plus 177lutetium-Prostate Specific Membrane Antigen-617 (177Lu-PSMA-617) in the LuPARP Trial |
| Anis Hamid, MBBS
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| Anis Hamid presents an analysis from the LuPARP trial evaluating circulating tumor cells (CTCs) in patients with mCRPC treated with olaparib plus 177Lu-PSMA-617. The investigators observed high rates of total and PSMA+ CTCs in PSMA-expressing mCRPC. Total and PSMA+ CTCs declined with combined olaparib and 177Lu-PSMA-617 treatment. Early declines in total and PSMA+ CTCs including 12 week CTC clearance paralleled PSA responses. |
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| Enzalutamide, Docetaxel and Androgen Deprivation (ENZADA Trial) for Metastatic Castrate Sensitive Prostate Cancer |
| Earle Burgess, MD |
| Earle Burgess presents the results of ENZADA, a single arm phase II trial evaluating the triplet combination of enzalutamide, docetaxel, and ADT for patients with metastatic castrate sensitive prostate cancer (mCSPC). Dr. Burgess concluded that triplet therapy with ADT + docetaxel + enzalutamide improved one-year PSA CR rates compared to historical controls with ADT + docetaxel. |
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| Early Results from CASCARA: A Phase 2 Study of Cabazitaxel/Carboplatin plus Abiraterone in High-Volume Metastatic Castrate-Sensitive Prostate Cancer (mCSPC)
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| Charles Ryan, MD
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| Charles Ryan and colleagues found that quadruplet therapy with ADT + cabazitaxel/carboplatin + abiraterone was well tolerated. At one year, 77% of patients were free of PSA/radiographic progression. 61% of patients achieved a PSA ≤0.2 ng/mL by 7 months post-treatment initiation, which is higher than the historical rate of 45% observed in the CHAARTED-docetaxel arm. Dr. Ryan emphasized that further exploration of this quadruplet strategy in randomized phase III studies is warranted in the early results from the CASCARA study.
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| Prostate-Specific Antigen Value at 3 & 7 Months (PSA-3mo, PSA-7mo) and Overall Survival (OS) in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Treated with Androgen Deprivation (ADT) with or without Orteronel (SWOG S1216) |
| Mamta Parikh, MD, MS |
| Mamta Parikh presents an exploratory analysis of the SWOG S1216 trial evaluating the overall survival (OS) prognostic values of 3- and 7-months serum PSA levels in metastatic hormone sensitive prostate cancer (mHSPC) patients treated with ADT +/- orteronel. |
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