ASCO 2021: Aanbevolen abstracten voor prostaatkanker en nierkanker

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13 juni 2021: ASCO 2021:

Hier een aantal aanbevolen abstracten over prostaatkanker door artsen die zelf voor ASCO werken. Deze aanbevelingen doet Alan H. Bryce MD. Medical Director of the Genomic Oncology Clinic at Mayo Clinic.

Klik op de nummers voor de abstracten.

Poster Discussion Session: Genitourinary Cancer—Prostate, Testicular, and Penile
Available Starting on Friday, June 4, 2021; 9:00 EDT

5040 Differential responses to taxanes and PARP inhibitors (PARPi) in ATM- versus BRCA2-mutated metastatic castrate-resistant prostate cancer (mCRPC) patients (pts). CT Su, E Nizialek, JE Berchuck, et al

Take-Home Message

This retrospective study evaluated the activity of taxanes and PARP inhibitors in patients with metastatic castrate-resistant prostate cancer with specific DNA repair alterations. ATM- and BRCA2-mutated patients received either a taxane only, a taxane prior to a PARP inhibitor, a PARP inhibitor only, or a PARP inhibitor prior to a taxane.
Improved overall survival and time to treatment discontinuation trended toward improvement in ATM-mutated patients when taxanes were delivered before PARP inhibitor therapy; in BRCA2-mutated patients, time to treatment discontinuation was improved when a PARP inhibitor was administered before taxane treatment.

5058 Differences in the tumor genomic landscape between African Americans (AA) and Caucasians (CA) advanced prostate cancer (aPC) patients (pts) by comprehensive genomic profiling (CGP) of cell-free DNA (cfDNA). PC Barata, R Reisinger, MA Bilen, et al

Take-Home Message

Comprehensive genomic profiling of cfDNA was used to identify potential differences in genomic alterations between White and Black patients with advanced prostate cancer. Many mutations were enriched in Black patients compared with White patients; the CDK12 mutation, in particular, was enriched significantly (9.4% vs 1.9%; P = .006).
Differences in genetic mutations within specific patient populations may account for some outcome disparities. The identification of specific molecular drivers of tumor progression within Black advanced prostate cancer patient populations may allow the development of tailored treatment regimens.

5063 Association of ATM mutations in metastatic prostate cancer with differential genomic alteration profiles from homologous recombination deficient and proficient tumors. CJ Ryan, JE McGrath, J Xiu, et al

Take-Home Message

As PARP inhibitors have failed to live up to their preclinical promise in ataxia-telangiectasia–mutant (ATM) prostate cancer, this study attempted to identify potential co-occurring genomic alterations that may contribute to therapy resistance in patients with metastatic disease and ATM mutations.
ATM-mutated tumors were determined to express different genomic mutation profiles compared with BRACA2-mutated tumors, and homologous recombination–deficient and –proficient metastatic prostate cancer tumors. Among these changes, the FGF- and PTPN11-related pathways were identified as potentially targetable.

5069 Association of androgen receptor signature and RB1, PTEN, TP53 gene expression with clinical outcome in metastatic hormone-sensitive prostate cancer treated with docetaxel and androgen deprivation therapy. L Ferrer-Mileo, N Jiménez, O Reig, et al

Take-Home Message

In this multicenter retrospective biomarker study, androgen receptor gene expression levels were assessed in correlation with castration-resistant prostate cancer–free survival (CRPC-FS) and overall survival in patients with metastatic hormone-sensitive prostate cancer (mHSPC) treated with ADT plus docetaxel.
CRPC-FS outcomes were associated with specific androgen receptor gene expression (ie, high androgen receptor expression: longer CRPC-FS; ARV7 expression: shorter CRPC-FS), and aggressive clinical evolution was correlated with low tumor suppressor gene expression (ie, RB1, PTEN, and TP53).

5072 Real-world first-line (1L) treatment patterns in patients (pts) with metastatic castration-sensitive prostate cancer (mCSPC) in a U.S. health insurance database. U Swami, A Hong, NN El-Chaar, et al

Take-Home Message

In this retrospective study, health insurance claims data were evaluated to determine the real-world utilization of effective first-line treatment combination therapies in patients with metastatic castration-sensitive prostate cancer from January 2014 to June 2019.
Despite the improved survival reported for intensified treatment (ie, androgen-deprivation therapy plus docetaxel or plus novel hormone therapies), insurance records indicated that the majority of commercially insured and Medicare Advantage patients in the US with metastatic castration-sensitive prostate cancer did not receive optimal, life-prolonging therapies.

5074 Real-world treatment patterns among patients diagnosed with metastatic castration-sensitive prostate cancer (mCSPC) in community oncology settings. DJ George, N Agarwal, JR Rider, et al

Take-Home Message

In this study, electronic medical record data were used to evaluate real-world first-line treatment selection for patients with metastatic castration-sensitive prostate cancer.
Although intensified treatment use increased over the 5-year retrospective study period, analysis revealed that over half of even recently diagnosed (2019) patients with metastatic castration-sensitive prostate cancer did not receive optimal, life-prolonging therapy. Patients who did receive intensified treatment did not receive the full regimen as recommended by registrational trials.

5078 Diagnostic performance of Gallium-68 prostate-specific membrane antigen (PSMA) PET/CT imaging in early-relapsed prostate cancer: Phase 3, prospective, multicenter study (IAEA-PSMA study). JJ Cerci, S Fanti, IAEA Prostate Working Group

Take-Home Message

In this phase III, prospective, multicenter study, biochemical recurrence (BCR) was monitored by PET and PSMA measurement in patients with prostate cancer who had undergone primary definitive treatment and who exhibited rising PSA levels. Correlations were determined between 68Ga PSMA PET/CT positivity and Gleason score and between lesion identification and PSA value.
The largest multicenter trial of its kind (>1000 participants), this study confirmed the reliability of 68Ga PSMA PET/CT in BCR auditing. More, PSMA results impacted treatment approaches in the majority (56.8%) of patients.

5080 A phase II randomized controlled trial of exercise on biochemical progression in men with prostate cancer on active surveillance. D-W Kang, AS Fairey, NG Boulé, et al

Take-Home Message

In this phase II trial, prostate cancer patients undergoing active surveillance were randomized to supervised high-intensity interval training (HIIT) three times per week for 12 weeks or to usual care. In the HIIT group, peak cardiorespiratory fitness was significantly increased (P = .014), and PSA (P = .043), PSA velocity (P = .04), and LNCaP cell growth (P = .024) were significantly decreased.
This is the first randomized, controlled study to demonstrate a correlation between HIIT, improved physical fitness, and inhibited biochemical progression in prostate cancer patients on active surveillance. Further study is warranted to determine if these improvements can be translated into long-term clinical outcomes.

Plenary Session
Sunday, June 6, 2021; 1:00 PM–4:00 PM EDT

LBA4 Phase III study of lutetium-177-PSMA-617 in patients with metastatic castration-resistant prostate cancer (VISION). MJ Morris, JS De Bono, KN Chi, et al

Oral Abstract Session: Genitourinary Cancer—Prostate, Testicular, and Penile
Tuesday, June 8, 2021; 8:00 AM–11:00 AM EDT

5000 A phase 3 trial with a 2x2 factorial design of abiraterone acetate plus prednisone and/or local radiotherapy in men with de novo metastatic castration-sensitive prostate cancer (mCSPC): First results of PEACE-1. K Fizazi, X Maldonado, S Foulon, et al

Take-Home Message

In this phase III study, the effects of standard of care (SOC; androgen deprivation therapy from 2013–2015, ADT or ADT + docetaxel from 2015–2017, or ADT + docetaxel from 2017–2018), SOC + abiraterone acetate-prednisone (abiraterone), SOC + radiotherapy to the primary tumor (RXT), or SOC + abiraterone + RXT treatment were evaluated in de novo metastatic castration-sensitive prostate cancer patients. The addition of abiraterone did not significantly impact grade 3/4 adverse event incidence (<20% of patients in both SOC and abiraterone cohorts). Abiraterone improved radiologic PFS (overall population: 2.2 years; ADT + docetaxel population: 2.0 years; abiraterone: 4.5 years) and PFS including PSA progression as an event (overall population: 1.5; SOC: 1.5 years; abiraterone: 3.2.–3.8 years). RXT did not impact outcomes, so abiraterone arm data were pooled.

The addition of abiraterone to ADT + docetaxel SOC significantly improved outcomes in de novo metastatic castration-sensitive prostate cancer patients with minimal added short-term toxicity.

5002 Decreased fracture rate by mandating bone protecting agents in the EORTC 1333/PEACEIII trial combining Ra223 with enzalutamide versus enzalutamide alone: An updated safety analysis. S Gillessen, A Choudhury, A Rodriguez-Vida, et al

Take-Home Message

This updated safety analysis of the EORTC 1333/PEACEIII trial evaluated the ability of bone-protecting agents (zoledronic acid or denosumab) to mitigate fracture risk in mCRPC patients while undergoing systemic treatment (enzalutamide or enzalutamide plus radium-223) for advanced disease.

The addition of radium-223 increased the risk of fracture in prostate cancer patients compared with the risk of fracture observed in patients treated with enzalutamide alone. Continuous, prophylactic administration of bone-protecting agents almost completely eliminated this risk in both treatment groups.

Clinical Science Symposium—Novel Initiatives to Address Disparities in Cancer
Monday, June 7, 2021; 11:30 AM–12:45 PM EDT

100 Accrual of Black participants to cancer clinical trials following a five-year prospective initiative of community outreach and engagement. CE Guerra, V Sallee, W-T Hwang, et al

Take-Home Message

The Abramson Cancer Center at the University of Pennsylvania initiated a 5-year program to engage Black cancer patients in clinical trials in an attempt to address the historical failure to accrue these participants. Over 10,000 Black cancer patients were reached, increasing the percentage of Black cancer patients seen at the Abramson Cancer Center to that of the percentage of Black cancer patients within the center’s catchment area (11% to 16.2%). The percentages of Black cancer patients enrolled into non-therapeutic interventional, non-interventional, and treatment trials increased from nearly two- to fourfold.

These findings validate the use of a multipronged approach for closing the minority trial participation gap and suggest that disparities in cancer center access are key to clinical trial access.

Abstracten aanbevolen door Jun Gond MD:

Poster Discussion Session: Genitourinary Cancer—Kidney and Bladder
Available Starting on Friday, June 4, 2021; 9:00 EDT

4510 Phase II study of nivolumab and salvage nivolumab + ipilimumab in treatment-naïve patients (pts) with advanced non-clear cell renal cell carcinoma (nccRCC) (HCRN GU16-260-Cohort B). MB Atkins, O Jegede, NB Haas, et al

Take-Home Message

In this phase II follow-up to the HCRN GU16-260 trial, patients with advanced non–clear cell RCC with progressive disease before or stable disease at 48 weeks of nivolumab treatment who met eligibility requirements received salvage nivolumab 3 mg/kg plus ipilimumab 1 mg/kg every 3 weeks for 12 weeks followed by nivolumab maintenance every 4 weeks for up to 48 weeks. RECIST-defined ORR was 14.3%; immune-related ORR was 22.9%. Median PFS was 4.0 months and, as of this reporting, no responders had progressed or died. Partial response was demonstrated in 1 patient. No new adverse events were reported.

Both nivolumab and nivolumab plus ipilimumab salvage therapy have limited activity in patients with advanced non–clear cell RCC.

4511 Clinical activity of durvalumab and savolitinib in MET-driven, metastatic papillary renal cancer. CS Rodriguez, J Larkin, PM Patel, et al

Take-Home Message

In this phase I/II study, patients with MET-driven metastatic papillary renal cancer were treated with 4 weeks of savolitinib 600 mg OD followed by durvalumab 150 mg every 4 weeks plus savolitinib 600 mg OD. The confirmed response rate was 57%; median PFS was 10.5 months and OS 27.4 was months. No new adverse events were reported.

As clinical activity was observed with the combination of durvalumab plus savolitinib, a phase III analysis will follow.

Poster Discussion Session: Genitourinary Cancer—Prostate, Testicular, and Penile
Available Starting on Friday, June 4, 2021; 9:00 EDT

5014 COMBAT-CRPC: Concurrent administration of bipolar androgen therapy (BAT) and nivolumab in men with metastatic castration-resistant prostate cancer (mCRPC). MC Markowski, M-E Taplin, RR Aggarwal, et al

Take-Home Message

In this prospective phase II study, patients with metastatic castration-resistant prostate cancer were treated with testosterone cypionate 400 mg IM (bipolar androgen therapy ) for 12 weeks followed by BAT plus nivolumab (NIVO) 480 mg IV every 28 days; both stages of treatment were performed under LHRH cover. Most adverse events and immune-related adverse events were grade <2; only two grade 3 immune-related adverse events were reported. Patients who received BAT plus NIVO demonstrated a radiographic PFS of 5.7 months, with an ORR of 23.8% and a PSA50 response rate of 40%. A subset of patients (n = 5/45) maintained a radiographic PFS response for ≥11 months, with 1 patient remaining completely radiographic progression free for >13 months.

The treatment met the primary endpoint (PSA50 >25%) and was well-tolerated; a subset of patients achieved a durable response. Studies are currently underway to identify prognostic biomarkers.

Plenary Session
Sunday, June 6, 2021; 1:00 PM–4:00 PM EDT

LBA4 Phase III study of lutetium-177-PSMA-617 in patients with metastatic castration-resistant prostate cancer (VISION). MJ Morris, JS De Bono, KN Chi, et al

LBA5 Pembrolizumab versus placebo as post-nephrectomy adjuvant therapy for patients with renal cell carcinoma: Randomized, double-blind, phase III KEYNOTE-564 study. TK Choueiri, P Tomczak, SH Park, et al

Oral Abstract Session: Genitourinary Cancer—Kidney and Bladder
Monday, June 7, 2021; 8:00 AM–11:00 AM EDT

4505 Phase II trial of durvalumab plus tremelimumab with concurrent radiotherapy (RT) in patients (pts) with localized muscle invasive bladder cancer (MIBC) treated with a selective bladder preservation approach: IMMUNOPRESERVE-SOGUG trial. XG del Muro, BP Valderrama, A Medina, et al

Take-Home Message

In this phase II trial, after transurethral tumor resection, patients with muscle-invasive bladder cancer were treated with durvalumab (a PD-L1 blocking antibody) 1500 mg IV plus tremelimumab (an anti–CDLA-4 antibody) 75 mg IV every 4 weeks for 12 weeks. At 2 weeks after immunotherapy completion, patients received normofractionated external-beam radiotherapy (46 Gy to the minor pelvis and 64–66 Gy to the bladder). Grade 3/4 adverse events were reported in 31% of patients. At 6 months, the disease-free survival with bladder intact was 76%; disease-free survival overall was 80%, and overall survival was 93%.

This well-tolerated and effective combination immuno- and radiotherapy approach permits bladder preservation in a high number (30/32) of patients; further study will determine the feasibility of the treatment as an alternative to cystectomy.

Oral Abstract Session: Genitourinary Cancer—Prostate, Testicular, and Penile
Tuesday, June 8, 2021; 8:00 AM–11:00 AM EDT

Take-Home Message

In this phase III study, the effects of standard of care (SOC; androgen deprivation therapy from 2013–2015, ADT or ADT + docetaxel from 2015–2017, or ADT + docetaxel from 2017–2018), SOC + abiraterone acetate-prednisone (abiraterone), SOC + radiotherapy to the primary tumor (RXT), or SOC + abiraterone + RXT treatment were evaluated in de novo metastatic castration-sensitive prostate cancer patients. The addition of abiraterone did not significantly impact grade 3/4 adverse event incidence (<20% of patients in both SOC and abiraterone cohorts). Abiraterone improved radiologic PFS (overall population: 2.2 years; ADT + docetaxel population: 2.0 years; abiraterone: 4.5 years) and PFS including PSA progression as an event (overall population: 1.5; SOC: 1.5 years; abiraterone: 3.2.–3.8 years). RXT did not impact outcomes, so abiraterone arm data were pooled.

The addition of abiraterone to ADT + docetaxel SOC significantly improved outcomes in de novo metastatic castration-sensitive prostate cancer patients with minimal added short-term toxicity.

5001 SWOG S1216: A phase III randomized trial comparing androgen deprivation therapy (ADT) plus TAK-700 with ADT plus bicalutamide in patients (pts) with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC) (NCT01809691). N Agarwal, C Tangen, MHA Hussain, et al

Take-Home Message

In this phase III trial, the effects of androgen deprivation therapy (ADT) plus TAK-700 (Tak; an oral selective nonsteroidal 17, 20-lyase inhibitor) 300 mg twice daily were compared with the effects of ADT plus bicalutamide (Bic; an antiandrogen) 50 mg/day in newly diagnosed patients with metastatic hormone-sensitive prostate cancer. Tak improved PFS (47.6 vs 23.0) and PSA (58.3% vs 44.0%) over Bic. No significant improvement in OS was observed, and more grade 3/4 adverse events were reported in Tak-treated patients compared with patients who received Bic combination therapy (43% vs 14%).

Although prespecified criteria for statistical OS significance were not met, the median control arm (standard ADT) OS was higher than estimated compared with similar phase III trial settings, and PFS and PSA measures were clinically significant in Tak-treated patients.

5003 Ancestral characterization of the genomic landscape, comprehensive genomic profiling utilization, and treatment patterns may inform disparities in advanced prostate cancer: A large-scale analysis. S Sivakumar, JK Lee, JA Moore, et al

Take-Home Message

In this study, the gene alterations patterns, comprehensive genomic profiling (CGP) utilization, and treatment regimens in advanced prostate cancer were evaluated in a large, diverse patient cohort to evaluate the effects of race and ethnicity on prostate cancer incidence, mortality, and outcomes. Similar rates of genomic alterations were observed across ancestry, but patients of African ancestry received CGP later in treatment (two lines of therapy before CGP for African-descended men vs one line for men of European descent) and were three times less likely to receive a clinical study drug than patients of European descent (11% vs 30%), regardless of actionable alteration status (1% vs 6%).

This is the largest known comparison of patient data from men of European and African descent undertaken to determine the therapeutic implications of CGP across ancestry in prostate cancer outcomes. Results suggest that disparities between patient treatment regimens correlate with patient ancestry and that these correlations may impact patient outcomes.

ASCO 2021, prostaatkanker, parpremmers, immuuntherapie, anti-PD medicijnen, enzalutamide, abiraterone, apalutamide