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1 juni 2020: ASCO 2020

Hier een aantal aanbevolen abstracten specifiek voor gevorderde prostaatkanker van ASCO 2020. Aanbevolen door verschillende artsen / oncologen uit de praktijk en vaak ook werkend voor ASCO zelf. Klik op de nummers voor de studiepublicaties en presentaties.

Aanbevolen door: Jonathan Silberstein MD, MBA

Session: Genitourinary Cancer—Prostate, Testicular, and Penile

5500 TheraP: A randomised phase II trial of 177Lu-PSMA-617 (LuPSMA) theranostic versus cabazitaxel in metastatic castration resistant prostate cancer (mCRPC) progressing after docetaxel: Initial results (ANZUP protocol 1603). MS Hofman, L Emmett, S Kaur, et al

Take-Home Message

  • This study evaluated the efficacy of LuPSMA (a radiolabeled small molecule that delivers therapeutic beta radiation to PSMA-expressing tumors) compared with cabazitaxel in patients with metastatic castration-resistant prostate cancer (mCRPC) who progressed after docetaxel. mCRPC patients with high PSMA expression (n=200) were randomly assigned 1:1 to LuPSMA or cabazitaxel. A PSA response rate of a >50% reduction (PSA50-RR) was seen in 66% of patients in the LuPSMA group versus 37% in the cabazitaxel group. PSA progression-free survival was significantly improved in the LuPSMA group. There were relatively fewer grade 3/4 adverse events in the LuPSMA group.
  • LuPSMA achieved a higher PSA50-RR and more favorable PSA progression-free survival with fewer grade 3/4 adverse events than cabazitaxel in patients with mCRPC.

5504 Neoadjuvant apalutamide (APA) plus leuprolide (LHRHa) with or without abiraterone (AA) in localized high-risk prostate cancer (LHRPC). E Efstathiou, MA Boukovala, N Spetsieris, et al

Take-Home Message

  • This study evaluated the efficacy of neoadjuvant apalutamide (APA) and leuprolide (LHRHa) with or without abiraterone (AA) in localized high-risk prostate cancer (LHRPC), and examined molecular markers that may be associated with the response to treatment. Of the 65 patients who were enrolled, 63 had radical prostatectomy. In the APA+LHRHa group, organ-confined disease was seen in 41% of patients compared with 39% in the APA+AA+LHRHa group. Pathologic complete remission was seen in 3% of patients and minimal residual disease was seen in 10% of patients in the APA+AA+LHRHa group. Heterogeneity in measures of tumor viability was seen, and organ-confined disease was associated with a prespecified molecular signature, PTEN expression, and the absence of cribriform/ intraductal spread. The prespecified biopsy signature was associated with clinical outcome.
  • APA+LHRHa was well-tolerated and resulted in tumor regression in a subset of LHRPC patients; however, the addition of AA did not further improve the outcome. A specific molecular signature was associated with the clinical response to treatment. Tumor heterogeneity and clinical implications should be considered for improved outcomes.

5517 TRANSFORMER: Bipolar androgen therapy (BAT) versus enzalutamide (E) for castration-resistant metastatic prostate cancer (mCRPC). SR Denmeade, H Wang, H Cao, et al

Take-Home Message

  • This study compared bipolar androgen therapy (BAT) and enzalutamide in patients with castration-resistant metastatic prostate cancer (mCRPC) who progressed on abiraterone. Patients received either testosterone cypionate 400 mg IM (BAT) once every 28 days or daily oral enzalutamide 160 mg and were allowed to crossover at progression. The PSA response and median PFS were similar between primary treatments, whereas objective response and OS were more favorable in the BAT group. For patients who received BAT and then crossed over to enzalutamide, the PSA50 response was higher and time to PSA progression was longer than in patients who did not receive BAT before enzalutamide. The treatment sequence significantly affected outcome, with more favorable outcomes seen with BAT followed by enzalutamide treatment in terms of PFS2 and OS.
  • BAT was well-tolerated in mCRPC patients and showed similar PFS to enzalutamide; however, PSA50 response, OS, and PFS2 after crossover were significantly improved in patients who received BAT→enzalutamide versus enzalutamide→BAT.

Aanbevolen door Brian D. Lewis MD

Session: Genitourinary Cancer—Prostate, Testicular, and Penile

5501 Impact of PSMA-targeted imaging with 18F-DCFPyL-PET/CT on clinical management of patients (pts) with biochemically recurrent (BCR) prostate cancer (PCa): Results from a phase III, prospective, multicenter study (CONDOR). MJ Morris, PR Carroll, L Saperstein, et al

Take-Home Message

  • This study evaluated the utility of 18F-DCFPyL (PyL), a novel PET imaging agent that binds selectively and with high affinity to PSMA, in the detection of occult disease in men with biochemical recurrence of prostate cancer (BCR PCa). A single dose of PyL was injected, followed by PET/CT after 1 to 2 hours, in men aged 18 years or older with rising PSA levels after definitive therapy who had negative or ambiguous imaging results (n=208). Of the 131 patients who had a change in intended management after PyL-PET/CT, 78.6% had changes attributable to positive PyL findings. PyL was well-tolerated; the most common adverse effect was headache.
  • PSMA-targeted PyL-PET/CT detected and localized occult disease in most men with BCR PCa, which led to changed management plans in the majority, indicating the usefulness of this method in detecting recurrent or suspected metastatic disease.

5602 HERO phase III trial: Results comparing relugolix, an oral GnRH receptor antagonist, versus leuprolide acetate for advanced prostate cancer. ND Shore, DJ George, F Saad, et al

Take-Home Message

  • This study compared the safety and efficacy of relugolix (the first oral GnRH receptor antagonist that rapidly suppresses testosterone levels) with leuprolide acetate in patients with advanced prostate cancer. The 934 patients were randomized 2:1 to receive relugolix 120 mg orally once daily or leuprolide acetate via 3-month depot injection. Of the patients on relugolix, 96.7% achieved and maintained castration-level testosterone suppression through 48 weeks compared with 88.8% on leuprolide. These results demonstrated the noninferiority of relugolix to leuprolide and the superiority of relugolix to leuprolide (P < .0001). Additionally, all key secondary efficacy endpoints tested demonstrated superiority of relugolix over leuprolide (P < .0001). Safety and tolerability profiles were comparable between the treatments, except for major adverse cardiovascular events, which were lower in the relugolix group.
  • Relugolix demonstrated superiority over leuprolide in suppression of testosterone levels up to 48 weeks and in all secondary efficacy endpoints tested. Relugolix may become a standard therapy for patients with advanced prostate cancer.

5514 Overall survival (OS) results of phase III ARAMIS study of darolutamide (DARO) added to androgen deprivation therapy (ADT) for nonmetastatic castration-resistant prostate cancer (nmCRPC). K Fizazi, ND Shore, T Tammela, et al

Take-Home Message

  • This study evaluated the overall survival (OS) and safety of darolutamide (DARO) when added to androgen deprivation therapy (ADT) for nonmetastatic castration-resistant prostate cancer (nmCRPC). Patients with nmCRPC were randomized 2:1 to DARO 600 mg twice daily (n=955) or placebo (n=554) while continuing ADT. After the primary analysis, 170 patients crossed over from placebo to DARO. Final OS analysis was conducted after 254 deaths were observed (15.5% of DARO and 19.1% of placebo patients). DARO showed a statistically significant OS benefit corresponding to a 31% reduction in the risk of death compared with placebo. All other secondary endpoints were significantly prolonged by DARO. Adverse effects were comparable between the DARO and placebo groups.
  • DARO showed a significant benefit in OS in patients with nmCRPC, delayed the onset of cancer-related symptoms and subsequent chemotherapy, and demonstrated favorable safety and tolerability.

5515 Final overall survival (OS) from PROSPER: A phase III, randomized, double-blind, placebo (PBO)-controlled study of enzalutamide (ENZA) in men with nonmetastatic castration-resistant prostate cancer (nmCRPC). CN Sternberg, K Fizazi, F Saad, et al

Take-Home Message

  • This study evaluated the overall survival (OS) in nonmetastatic castration-resistant prostate cancer (nmCRPC) patients with rapidly rising prostate-specific antigen (PSA) who received enzalutamide (ENZA, 160 mg) in addition to androgen deprivation therapy (ADT). ENZA significantly prolonged OS compared with placebo (HR, 0.73; P = .0011): median OS was 67.0 months in the ENZA arm compared with 56.3 months in the placebo arm. A smaller proportion of patients in the ENZA group initiated other antineoplastic therapy after treatment discontinuation compared with the placebo arm. Grade ≥3 adverse events were reported by 48% of patients in the ENZA group versus 27% in the PBO group.
  • Treatment with ENZA significantly reduced the risk of death in nmCRPC patients with rapidly rising PSA levels, and these study results support the use of ENZA plus ADT in this group of patients.

5516 Final survival results from SPARTAN, a phase III study of apalutamide (APA) versus placebo (PBO) in patients (pts) with nonmetastatic castration-resistant prostate cancer (nmCRPC). EJ Small, F Saad, S Chowdhury, et al

Take-Home Message

  • This study evaluated the final overall survival (OS) of nonmetastatic castration-resistant prostate cancer (nmCRPC) patients with rapidly rising PSA levels treated with apalutamide (APA) versus placebo while on androgen deprivation therapy (ADT). nmCRPC patients on ADT were randomized 2:1 to APA (240 mg once daily) or placebo. After the primary efficacy endpoint of metastasis-free survival was met, 19% of placebo patients crossed over to APA. Median OS in the APA group was 73.9 months and was 59.9 months in the placebo group. APA treatment lengthened the time to cytotoxic chemotherapy, and discontinuation rates due to disease progression were lower in the APA group.
  • APA treatment in addition to ADT significantly improved OS in patients with nmCRPC, with a median OS longer than 6 years and a 14 month improvement over placebo.

5553 Primary analysis of a phase II study of metastasis-directed ablative therapy to PSMA (18F-DCFPyL) PET-MR/CT defined oligorecurrent prostate cancer. R Glicksman, U Metser, D Vines, et al

Take-Home Message

  • This study evaluated metastasis-directed therapy directed to PSMA PET-MR/CT–positive foci in prostate cancer patients with rising PSA after maximal local therapies. After PSMA PET-MR and PET-CT, patients underwent metastasis-directed therapy (either stereotactic ablative radiotherapy or lymph node dissection); no ADT was used in these patients. After a median of 11 months post metastasis-directed therapy, 22% of patients had a complete response and 38% had a partial response.
  • PSMA PET-MR/CT has a high detection rate of PSMA-positive foci, and favorable results were seen with metastasis-directed therapy to these foci in patients with metachronous PSMA-unveiled oligometastatic prostate cancer.

5563 Results of the randomized phase II study of sipuleucel-T (Sip-T) +/- Radium-223 (Ra-223) in men with bone-metastatic castration resistant prostate cancer. CH Marshall, JC Park, W Fu, et al

Take-Home Message

  • This study compared the immune response and outcome in metastatic castration-resistant prostate cancer (mCRPC) patients treated with sipuleucel-T (Sip-T) with or without radium-223 (Ra-223) cotreatment. Patients with asymptomatic, bone-predominant mCRPC, were randomized 1:1 (n=16 per group) to SipT alone or SipT with six doses of Ra-223, where patients in the SipT+Ra-223 arm started SipT between the second and third dose of Ra-223. Median radiographic progression-free survival was longer in the SipT+Ra-223 arm (9.3 months in SipT+Ra-223 arm vs 3.2 months in SipT-alone arm; HR, 0.26; P=.007). There were no significant differences in antigen spread or humoral responses, and PSA and ALP responses were better in the SipT+Ra-223 arm.
  • The combination of SipT and Ra-223 was associated with improved clinical response and higher PSA response compared with SipT alone, suggesting a synergistic effect of the two treatments.

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