7 juni 2021: ASCO 2021

Dr. Sumanta Pal, hoofdredacteur van het PracticeUpdate Center of Excellence niercelcarcinoom, beveelt de volgende abstracten aan die specifiek gerelateerd zijn aan nierkanker die zijn gepresenteerd op het ASCO 2021.

Klik op de nummers voor de abstracten:

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

4509 Nivolumab plus cabozantinib in patients with non-clear cell renal cell carcinoma: Results of a phase 2 trial. C-H Lee, MH Voss, MI Carlo, et al

Take-Home Message

  • In this phase II trial, patients with papillary-, unclassified-, or translocation-associated RCC (cohort 1) or chromophobe RCC (cohort 2) were treated with cabozantinib 40 mg/day plus nivolumab 240 mg every 2 weeks or 480 mg every 4 weeks. Patients in cohort 1 demonstrated an ORR of 48%, a median PFS of 12.5 months, and a median OS of 28 months. No new grade 3/4 adverse events were reported. Cohort 2 was closed early due to lack of efficacy.
  • Cabozantinib plus nivolumab was tolerated and effective in papillary-, unclassified-, or translocation-associated RCC patients; limited activity was observed in chromophobe RCC patients.

4513 First results of a randomized phase IB study comparing nivolumab/ ipilimumab with or without CBM-588 in patients with metastatic renal cell carcinoma. LA Meza, N Dizman, PG Bergerot, et al

Take-Home Message

  • In this first report from a phase Ib study, confirmed clear cell and/or sarcomatoid metastatic RCC patients were treated with nivolumab plus ipilimumab with or without the probiotic CBM-588. Metagenomic sequencing of paired stool specimens revealed an eightfold increase in B. bifidum and a sixfold increase in B. adolescentis in both treatment groups from baseline to week 12. C. butyricum was detected in patients treated with CBM-588 only; pathogenic species were detected in nivolumab plus ipilimumab–treated patients only. The addition of CBM-588 improved the response rate (59% vs 11%) and median progression-free survival PFS (NR vs 11 weeks); CBM-588 did not impact toxicity.
  • This prospective study marks the first report of enhancement of immune checkpoint inhibitor activity using a live bacterial product.

4515 Safety and efficacy outcomes with nivolumab plus ipilimumab in patients with advanced renal cell carcinoma and brain metastases: results from the CheckMate 920 trial. H Emamekhoo, MR Olsen, BC Carthon, et al

Take-Home Message

  • In this phase IIIb/IV follow-up of the CheckMate 920 study, nivolumab plus ipilimumab continued to be well-tolerated by previously untreated patients with advanced/metastatic RCC with asymptomatic brain metastases. The objective response rate was 32%, with 8 patients achieving partial response and 10 achieving stable disease; median progression-free survival was 9 months. Overall survival was not reached at the time of this reporting.
  • Long-term follow-up reveals good tolerance for and efficacy of this treatment in previously untreated patients with advanced/metastatic advanced RCC.

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

4546 TIVO-3: Durability of response and updated overall survival of tivozanib versus sorafenib in metastatic renal cell carcinoma (mRCC). E Verzoni, B Escudier, TE Hutson, et al

Take-Home Message

  • In the phase III TIVO-3 study, investigators compared the survival benefit associated with tivozanib versus sorafenib among 350 patients with metastatic renal cell carcinoma (mRCC) who had failed two or three prior systemic regimens. The objective treatment response rate was higher for patients treated with tivozanib than for patients treated with sorafenib (23% vs 11%), and the duration of response was longer with tivozanib than with sorafenib (median duration in months, 20.3 vs 9.0). However, overall survival did not differ significantly between the patient groups.
  • In a setting of third- and fourth-line treatment for mRCC, tivozanib resulted in better progression-free survival, a higher objective response rate, and more durable responses compared with sorafenib, but not in improved overall survival.

4552 The impact of antibiotic (Ab) exposure on clinical outcomes in patients with metastatic renal cell carcinoma (mRCC) treated with immune checkpoint inhibitors (ICI) or VEGF targeted therapy (VEGF-TT). MS Ernst, SA Alaiwi, N Dizman, et al

Take-Home Message

  • The study authors evaluated the effect of recent antibiotic use on clinical outcomes in patients receiving immune checkpoint inhibitors (ICI) or VEGF targeted therapy (VEGF-TT) for treatment of metastatic renal cell carcinoma (mRCC). Recent exposure to antibiotics was defined as use within 60 days before initiation of systemic therapy. In the ICI subgroup, exposed patients had significantly poorer IMDC disease risk compared with unexposed patients (favorable, 14% vs 18%; intermediate, 47% vs 62%; poor, 39% vs 21%; P = .03). A similar trend was observed in the VEGF-TT subgroup. However, on multivariate analysis overall survival did not vary significantly by antibiotic exposure status in either treatment subgroup.
  • Among patients receiving ICI or VEGF-TT for mRCC, recent antibiotic use was significantly associated with a poorer IMDC risk category on univariate analysis but was not associated with overall survival after adjustment for confounding factors.

4553 Nivolumab plus cabozantinib (N+C) versus sunitinib (S) for advanced renal cell carcinoma (aRCC): Outcomes by baseline disease characteristics in the phase 3 CheckMate 9ER trial. AB Apolo, T Powles, M Burotto, et al

Take-Home Message

  • In the phase III CheckMate 9ER trial, patients were randomly assigned to receive nivolumab plus cabozantinib or sunitinib for treatment of advanced renal cell carcinoma. Outcomes were assessed within patient subgroups defined by several factors, including risk level. A clinical benefit of nivolumab plus cabozantinib for complete response and overall survival was observed in most patient subgroups. Objective response rates were higher for nivolumab plus cabozantinib (38%–66%) than for sunitinib (10%–44%) across most patient subgroups.
  • Study findings support the clinical benefit of nivolumab plus cabozantinib over sunitinib for first-line treatment of advanced RCC in most patient subgroups.

4554 Outcomes of first-line (1L) ipilimumab and nivolumab (IPI-NIVO) and subsequent therapy in metastatic renal cell carcinoma (mRCC): Results from the International mRCC Database Consortium (IMDC). CL Gan, JC Wells, AL Schmidt, et al

Take-Home Message

  • Using data from the IMDC, these authors evaluated clinical outcomes among 706 patients with metastatic renal cell carcinoma (mRCC; mean age, 61 years) on first-line treatment with ipilimumab and nivolumab. Patients categorized by the IMDC criteria as having favorable risk had better 12-month overall survival rates (92%) than patients categorized as intermediate (79%) or poor risk (56%; P < .01). A similar trend was observed for 24-month overall survival. Overall, 66% of patients discontinued first-line treatment; most of these patients (55%) started second-line therapy with sunitinib, cabozantinib, pazopanib, or axitinib.
  • In a real-world setting, IMDC risk criteria are predictive of clinical outcomes in patients receiving first-line ipilimumab and nivolumab for treatment of mRCC.

4555 Phase 2 study of belzutifan (MK-6482), an oral hypoxia-inducible factor 2α (HIF-2α) inhibitor, for Von Hippel-Lindau (VHL) disease-associated clear cell renal cell carcinoma (ccRCC). R Srinivasan, F Donskov, O Iliopoulos, et al

Take-Home Message

  • In the phase II MK-6482 trial, 61 adults with measurable and localized/nonmetastatic clear-cell renal cell carcinoma (ccRCC) associated with germline von Hippel–Lindau (VHL) alterations were treated with belzutifan. After a median follow-up of 69 weeks, 22 patients (36%) had an objective response; the median time to response was 31 weeks, and the median duration of response was not reached. At week 52 of follow-up, the progression-free survival rate was 98%. Treatment-related adverse events were reported in 98% of patients, and 13% of patients had a grade 3 event. Outcomes in patients with non-RCC tumors were also evaluated. The objective response rate was 80% in patients with pancreatic neuroendocrine tumors and 32% in patients with CNS hemangioblastomas.
  • Belzutifan provided a clinical benefit alongside a good safety profile for patients with VHL-associated ccRCC tumors, pancreatic neuroendocrine tumors, and hemangioblastomas.

4557 Treatment outcomes in renal cell carcinoma patients with metastases to the pancreas and other sites. C Duarte, B Beuselinck, N Weise, et al

Take-Home Message

  • Study authors retrospectively evaluated clinical outcomes in 229 patients with metastatic renal cell carcinoma (mRCC) involving the pancreas. After a median follow-up of 51.5 months, the median overall survival after diagnosis of metastatic disease was 7.7 years. In unadjusted analysis, survival was significantly longer for patients who received first-line immunotherapy (median OS not reached) compared with patients who received first-line VEGF inhibitors (median OS, 7.6 years).
  • The study findings support previous reports of longer survival among mRCC patients with involvement of the pancreas compared with other mRCC populations. First-line immunotherapy may enhance survival compared with other treatment options.

4560 Analysis of the CLEAR study in patients (pts) with advanced renal cell carcinoma (RCC): Depth of response and efficacy for selected subgroups in the lenvatinib (LEN) + pembrolizumab (PEMBRO) and sunitinib (SUN) treatment arms. V Grünwald, T Powles, E Kopyltsov, et al

Take-Home Message

  • Study investigators used data from the phase III CLEAR study to evaluate outcomes in patients with advanced renal cell carcinoma (RCC). Patients were randomly assigned to receive lenvatinib plus pembrolizumab (LEN + PEMBRO; n = 355) or sunitinib (SUN; n = 357). Among patients categorized as intermediate- or poor-risk (per IMDC criteria), progression-free survival was significantly better in those who received LEN + PEMBRO compared with those who received SUN (median PFS, 22.1 vs 5.9 months; HR, 0.36). Similar trends were observed for progression-free survival among patients in the IMDC favorable-risk subgroup, for overall survival in all IMDC risk subgroups, and for ORR in all IMDC risk subgroups. The clinical benefit of LEN+PEMBRO was also observed in patients with target kidney lesions.
  • Compared with SUN, LEN+PEMBRO improved survival among patients with advanced RCC, including patients with target kidney lesions.

4567 Temporal characteristics of treatment-emergent adverse events and dose modifications with tivozanib and sorafenib in the phase 3 TIVO-3 study of relapsed or refractory mRCC. SK Pal, DF McDermott, B Escudier, et al

Take-Home Message

  • This is a temporal analysis of safety outcomes in TIVO-3, a phase III study that randomly assigned patients with relapsed/refractory mRCC to tivozanib (TIVO; n = 173) or sorafenib (SOR; n = 170). Compared with SOR, TIVO was associated with fewer treatment-emergent adverse events (TEAEs) of grade >3 for diarrhea, rash, and PPE, and more TEAEs of grade >3 for hypertension; however, time to onset and duration of these TEAEs was similar across the treatments. Overall, compared with SOR, TIVO was associated with fewer dose reductions, interruptions, and discontinuations, as well as a longer time to onset of first dose reduction (45 vs 85 days), interruption (50 vs 81 days), and discontinuation (49 vs 114 days).
  • In a setting of treatment for mRCC, the time to onset and duration of TEAEs were similar for TIVO and SOR, but dose modifications were less frequent and occurred after a longer interval for TIVO. 

4578 Efficacy outcomes of nivolumab + cabozantinib versus pembrolizumab + axitinib in patients with advanced renal cell carcinoma (aRCC): Matching-adjusted indirect comparison (MAIC). BA McGregor, DM Geynisman, M Burotto, et al

Take-Home Message

  • Using data from several trials, study authors compared nivolumab plus cabozantinib (N+C) with pembrolizumab plus axitinib (P+A) for first-line treatment of advanced renal cell carcinoma (aRCC). Matching of patient data was conducted using demographic and clinicopathologic factors, including IMDC risk score. In matched analysis, progression-free survival was longer in patients who received N+C compared with those who received P+A (median months, 19.3 vs 15.7). Compared with P+A, N+C was associated with a reduced risk of progression or death (HR, 0.70; P = .02), a higher ORR (difference, 8.4%; P = .11), and a longer duration of response (HR, 0.70; P = 0.36).
  • Findings of this analysis, which adjusted for between-trial differences, suggest that N+C has a survival benefit compared with P+A for first-line treatment of aRCC.

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

4500 Pembrolizumab (pembro) plus axitinib (axi) versus sunitinib as first-line therapy for advanced clear cell renal cell carcinoma (ccRCC): Results from 42-month follow-up of KEYNOTE-426. BI Rini, ER Plimack, V Stus, et al

Take-Home Message

  • In this phase III trial, follow-up from KEYNOTE-426, treatment-naïve patients with advanced clear cell RCC who received pembrolizumab plus axitinib continued to demonstrate improved overall survival (45.7 vs 40.1 months), progression-free survival (15.7 vs 11.1 months), and ORR (60.4% vs 39.5%) compared with patients on sunitinib monotherapy.
  • At 42.8-months, the longest follow-up reported for anti–PD-1/L1 plus VEGF/VEGFR inhibitor combination therapy for first-line RCC, these study data continue to support the superior efficacy of pembrolizumab plus axitinib over sunitinib.

4501 CANTATA: Primary analysis of a global, randomized, placebo (Pbo)-controlled, double-blind trial of telaglenastat (CB-839) + cabozantinib versus Pbo + cabozantinib in advanced/metastatic renal cell carcinoma (mRCC) patients (pts) who progressed on immune checkpoint inhibitor (ICI) or anti-angiogenic therapies. NM Tannir, N Agarwal, C Porta, et al

Take-Home Message

  • The phase II CANTANA study compared telaglenastat plus cabozantinib (Tela+Cabo) with placebo plus Cabo (Pbo+Cabo) among 444 patients with advanced/metastatic renal cell carcinoma (mRCC) who had previously received one to two lines of systemic therapy. After a median follow-up of 11.7 months, the Tela+Cabo and Pbo+Cabo arms were similar with regard to progression-free survival (median months, 9.2 vs 9.3) and ORR (31% vs 28%). Among patients with prior ICI treatment, Tela+Cabo was associated with longer progression-free survival than Pbo+Cabo (median months, 11.1 vs 9.2), but this trend was not significant. The treatment arms had similar rates of adverse events.
  • Among patients with mRCC previously treated with systemic therapy, the addition of Tela to Cabo did not lead to improved patient outcomes.

4502 Health-related quality-of-life (HRQoL) analysis from the phase 3 CLEAR trial of lenvatinib (LEN) plus pembrolizumab (PEMBRO) or everolimus (EVE) versus sunitinib (SUN) for patients (pts) with advanced renal cell carcinoma (aRCC). RJ. Motzer, C Porta, B Alekseev, et al

Take-Home Message

  • In this phase III secondary objective report from the CLEAR trial, the health-related quality of life of advanced RCC patients treated with lenvatinib plus pembrolizumab or lenvatinib plus everolimus was compared with that of those patients treated with sunitinib.
  • In regard to patient-reported physical function, fatigue, dyspnea, pain, appetite loss, and diarrhea, adverse events in patients treated with lenvatinib plus pembrolizumab were similar or improved compared with those experiences by sunitinib-treated patients.

4507 A randomized phase II study comparing cisplatin and gemcitabine with or without berzosertib in patients with advanced urothelial carcinoma. SK Pal, A Mortazavi, MI Milowsky, et al

Take-Home Message

  • In this phase II study, patients with advanced urothelial carcinoma were randomly assigned to receive cisplatin with gemcitabine (CG; n = 41) or CG plus berzosertib (CG + berzosertib; n = 46). Patients in the CG arm and those in the CG + berzosertib arm had similar response rates (54% vs 63%; P = .66) and progression-free survival (median months, 8.0 in both arms). Overall survival was longer in the CG arm compared with the CG + berzosertib arm (median months, 19.8 vs 14.4), but this finding was not significant. The CG + berzosertib arm had a higher proportion of patients with toxicity-related discontinuation compared with the CG arm (24% vs 15%). 
  • The addition of berzosertib did not improve the efficacy of CG for treatment of advanced urothelial carcinoma. Rather, it was associated with a nonsignificant trend toward worse survival and more drug toxicity.
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 

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.

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.



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