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ASCO GU 2021

ASCO GU 2021: SURE: An Open Label, Sequential-Arm, Phase II Study of Neoadjuvant Sacituzumab Govitecan, and Sacituzumab Govitecan plus Pembro Before Radical Cystectomy, for Patients with MIBC Who Cannot Receive or Refuse Cisplatin-Based Chemotherapy

(UroToday.com) Muscle-invasive bladder cancer is a systemic disease as >40% of patients ultimately develop recurrence after radical cystectomy. For patients who cannot receive or refuse cisplatin-based chemotherapy, there is no standard-of-care neoadjuvant therapy. Single-agent pembrolizumab, given in the neoadjuvant setting in patients with T2-4N0M0 muscle-invasive bladder cancer, documented a 42% pathologic complete response-rate (ypT0N0) in the previously published PURE-01 trial.1 However, there is a huge proportion of patients who do not benefit from single-agent immune-checkpoint inhibitors. Sacituzumab govitecan is an antibody-drug conjugate composed of a humanized anti-Trop-2 antibody, SN-38 payload (a parent compound of irinotecan), and a hydrolysable linker for SN-38 release. Based on preliminary data from the TROPHY-U-01 trial, sacituzumab govitecan got fast-track designation for urothelial carcinoma by the US FDA. At the 2021 GU ASCO annual meeting, Dr. Andrea Necchi presented the trial design for the SURE trial, aiming to evaluate the efficacy of neoadjuvant sacituzumab govitecan either as a single-agent (SURE-01) or combined with pembrolizumab (SURE-02) before radical cystectomy.

ASCO GU 2021: The Landscape of Genetic Alterations Using ctDNA-based Comprehensive Genomic Profiling in Patients with Advanced Prostate Cancer

(UroToday.com) Genomics, both of the tumor (somatic) and germline, are increasingly being incorporated into clinical oncologic care, both with regard to specific targeted therapy selections (e.g. PARP inhibitors) and therapy intensity (e.g. aggressive variants, e.g. genomic alterations inRB1, TP53).  Often re-biopsy can impose an additional barrier for a patient, or is limited by site of metastasis, such as bone.  These realities are justifications for the herald of the non-invasive evaluation of tumor genomics from the circulating (blood) compartment via circulating tumor DNA (ctDNA).  Herein, Dr. Tukachinsky and colleagues endeavored to evaluate via hybrid-capture-based targeted gene panel next generation sequencing (NGS) the landscape of genomic alterations (GA) found in the plasma of patients with metastatic castration-resistant prostate cancer (mCRPC), and, in a subset, evaluate concordance with tissue-based NGS assessments.

ASCO GU 2021: Rucaparib plus Enzalutamide in Patients with Metastatic Castration-Resistant Prostate Cancer: Pharmacokinetics and Safety Data from the Phase Ib RAMP Study

(UroToday.com) Rucaparib is an inhibitor of poly (ADP-ribose) polymerase – PARP – that is approved for the treatment of BRCA1 and BRCA2 mutated metastatic castration-resistant prostate cancer (mCRPC) based on the recently published TRITON2 study. Enzalutamide is an androgen receptor antagonist that is approved for the treatment of mCRPC as well as metastatic castration sensitive prostate cancer (mHSPC). Preclinical studies have demonstrated potential synthetic lethality between androgen receptor signaling inhibition and PARP inhibition, which led to the investigation of these two drugs in combination. As enzalutamide strongly induces CYP3A4, which may contribute to the processing of rucaparib into its oxidative metabolite, the phase 1 RAMP study (NCT04179396) was designed to investigate potential drug-drug interactions and pharmacokinetics in genomically unselected patients as well as safety with the combination of enzalutamide and rucaparib. In this abstract, Arpit Rao presented pharmacokinetic, safety, and preliminary efficacy data for this drug combination in eight patients.

ASCO GU 2021: Updated Outcomes of POUT: A Phase III Randomized Trial of Peri-Operative Chemotherapy Versus Surveillance in Upper Tract Urothelial Cancer

(UroToday.com) The POUT trial (CRUK/11/027; NCT01993979) previously reported that adjuvant chemotherapy improves disease free survival (HR 0.45, 95% CI 0.30-0.68) for patients with histologically confirmed pT2-T4 N0-3 M0 upper tract urothelial carcinoma over a median follow-up of 30.3 months.1

ASCO GU 2021: Alignment and Discordances in Perceptions and Experiences of Shared Decision Making Among Bladder Cancer Patients and Their Care Team

(UroToday.com) Shared decision-making regarding cancer treatment is critical. In previous PRIME educational programs involving patients with bladder cancer and their care teams, effective shared decision-making was found to be integral to the development of treatment plans that reflected patient preferences and treatment goals. However, oncology care teams face complex barriers that impede their ability to personalize bladder cancer therapy for each patient. PRIME conducted a Collaborative Learning Program in five US healthcare systems to support communication and shared decision-making between patients with bladder cancer and their urology/medical oncology teams to improve outcomes and quality of life for these patients. At the 2021 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium, Dr. Karim Chamie and colleagues presented results of their study assessing alignment and discordances on aspects of shared decision-making among bladder cancer patients and their urology and oncology teams.

ASCO GU 2021: Final Results From a Phase I Trial and Expansion Cohorts of Cabozantinib and Nivolumab Alone or With Ipilimumab For Metastatic Genitourinary Tumors

(UroToday.com) Cabozantinib, nivolumab, and ipilimumab have been increasingly utilized for a number of genitourinary malignancies, most prominently in renal cell carcinoma. In a dose-escalation study, combinations of cabozantinib and nivolumab (CaboNivo) and cabozantinib, nivolumab, and ipilimumab (CaboNivoIpi) demonstrated promising efficacy and safety in a dose-escalation phase I study. In a plenary abstract presentation in the Rapid Abstract Session: Urothelial Carcinoma and Rare Tumors session at the 2021 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), Dr. Apolo presented results from a pooled analysis of the phase I dose-finding and 7 subsequent expansion cohorts among patients with metastatic genitourinary (mGU) tumors.

ASCO GU 2021: Association of Reductions in PSA Screening Across States with Increased Metastatic Prostate Cancer in the United States

(UroToday.com) Prostate cancer screening using prostate-specific antigen (PSA) testing has been controversial since shortly after its introduction in large part due to concerns of over-diagnosis and over-treatment, with the associated morbidity. Thus, despite improvements in prostate cancer-related metastasis and mortality demonstrated in the European Randomized Study of Screening for Prostate Cancer (ERSPC) randomized trial from Europe, PSA screening has remained contentious. In both 2008 and 2012, the US Preventive Services Task Force (USPSTF) did not recommend PSA screening. Some have attributed increased rates of metastatic prostate cancer in the US to reductions in PSA screening as a result of these recommendations from the USPSTF. To test this hypothesis, in the Poster Highlights: Prostate Cancer - Localized Disease Session at the 2021 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium, Dr. Vidit Sharma and colleagues assessed longitudinal variations in PSA screening across individual states with the incidence of de novo metastatic prostate cancer.

ASCO GU 2021: Timing of High-Dose Rate Brachytherapy with External Beam Radiotherapy in Intermediate and High-Risk Localized Prostate Cancer (THEPCA) Patients and Its Effects on Toxicity and Quality of Life: Results of a Randomized Feasibility Trial

(UroToday.com) There have been significant advances in the delivery of prostate radiotherapy in the past decade, particularly with the use of image guidance. However, in spite of this acute and late genitourinary (GU) and gastrointestinal (GI) toxicities remain a significant issue. For patients undergoing combined high-dose rate (HDR) brachytherapy and external beam radiotherapy (EBRT), there is no consensus on the timing of these treatments with significant variation between institutions. Thus, in the Poster Highlights: Prostate Cancer - Localized Disease Session at the 2021 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium, Dr. Imtiaz Ahmed and colleagues assessed the incidence of GI and GU toxicities in patients receiving HDR brachytherapy before and after EBRT.

ASCO GU 2021: Dose-Intensified Versus Conventional Dose-Salvage Radiotherapy for Biochemically Recurrent Prostate Cancer After Prostatectomy: Six-Year Outcomes of the SAKK 09/10 Randomized Phase III Trial

(UroToday.com) Radical prostatectomy (RP) is a standard treatment for patients with localized prostate cancer. A proportion of patients will experience biochemical recurrence following surgery. In these cases, salvage radiotherapy (ideally, early salvage radiotherapy) is indicated. During the plenary abstract presentation in the Prostate Cancer - Advanced Disease Poster Session at the 2021 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium, Dr. Pirus Ghadjar and colleagues report the results of the European SAKK 09/10 randomized Phase III trial comparing the effectiveness and tolerability of conventional vs. dose-intensified salvage radiation therapy (RT).

ASCO GU 2021: Best of Journals: Prostate Cancer - Surgery

(UroToday.com) The 2021 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium included a prostate cancer session 'Best of Journals' with Dr. Keyan Salari providing the surgical perspective. Dr. Salari selected two studies assessing active surveillance in Black men with low-risk prostate cancer, and one study assessing the timing of radiation therapy after radical prostatectomy.
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