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@ARTICLE{Fizazi:303005,
      author       = {K. Fizazi and K. N. Chi and N. D. Shore and V. Herrmann$^*$
                      and J. S. de Bono and D. Castellano and J. M. Piulats and A.
                      Fléchon and X. X. Wei and H. Mahammedi and G. Roubaud and
                      M. Fleming and T. Haas and S. Ghebremariam and T. N. Kreisl
                      and S. Rajagopalan and O. Sartor and M. J. Morris},
      collaboration = {P. Investigators},
      title        = {{F}inal overall survival and safety analyses of the phase 3
                      {PSMA}fore trial of [177{L}u]{L}u-{PSMA}-617 versus change
                      of androgen receptor pathway inhibitor in taxane-naive
                      patients with metastatic castration-resistant prostate
                      cancer.},
      journal      = {Annals of oncology},
      volume       = {nn},
      issn         = {0923-7534},
      address      = {Amsterdam [u.a.]},
      publisher    = {Elsevier},
      reportid     = {DKFZ-2025-01452},
      pages        = {nn},
      year         = {2025},
      note         = {epub},
      abstract     = {In PSMAfore, [177Lu]Lu-PSMA-617 (177Lu-PSMA-617) prolonged
                      radiographic progression-free survival (rPFS) in
                      taxane-naive patients with metastatic castration-resistant
                      prostate cancer (mCRPC), with a favourable safety profile,
                      versus a change in androgen receptor pathway inhibitor
                      (ARPI). We report the final overall survival (OS) analysis
                      and updated safety data.PSMAfore (NCT04689828) was an
                      open-label, international, phase 3 trial. Patients with
                      prostate-specific membrane antigen (PSMA)-positive mCRPC who
                      had experienced disease progression once on a previous ARPI
                      and were candidates for ARPI change were randomized 1:1 to
                      177Lu-PSMA-617 or ARPI change to abiraterone or
                      enzalutamide. Crossover from ARPI change to 177Lu-PSMA-617
                      was allowed after centrally confirmed radiographic
                      progression. Endpoints included rPFS (primary), OS (key
                      secondary), and safety (secondary).Patients were randomized
                      to 177Lu-PSMA-617 or ARPI change (n = 234 each): 141/234
                      participants $(60.3\%)$ randomized to ARPI change crossed
                      over $(75.4\%$ of those with centrally confirmed
                      radiographic progression). The median OS was 24.48 months
                      $(95\%$ CI 19.55-28.94) with 177Lu-PSMA-617 versus 23.13
                      (19.61-25.53) with ARPI change (hazard ratio [HR] 0.91
                      $[95\%$ CI 0.72-1.14]; p = 0.20) based on the
                      intention-to-treat (ITT) principle; the crossover-adjusted
                      OS HR by inverse probability of censoring weighting
                      modelling was 0.59 $(95\%$ CI 0.38-0.91). For 177Lu-PSMA-617
                      versus ARPI change, exposure-adjusted incidences of grade
                      ≥ 3 and serious treatment-emergent adverse events were
                      60.8 versus 85.1 and 32.5 versus 49.9 per 100
                      patient-treatment years, respectively. Dry mouth occurred in
                      135/227 participants $(59.5\%;$ 2/227 grade ≥ 3) and
                      anaemia in 62/227 $(27.3\%;$ 14/227 grade ≥ 3) in the
                      177Lu-PSMA-617 arm.OS analyses did not show a statistically
                      significant difference between the 177Lu-PSMA-617 and ARPI
                      arms based on the ITT principle; results were likely
                      confounded by the high rate of crossover. The safety profile
                      of 177Lu-PSMA-617 was favourable with no new safety signals
                      identified.},
      keywords     = {(177)Lu-PSMA-617 (Other) / Metastatic castration-resistant
                      prostate cancer (Other) / overall survival (Other) /
                      radioligand therapy (Other) / safety (Other) / taxane-naive
                      (Other)},
      cin          = {ED01},
      ddc          = {610},
      cid          = {I:(DE-He78)ED01-20160331},
      pnm          = {899 - ohne Topic (POF4-899)},
      pid          = {G:(DE-HGF)POF4-899},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:40680993},
      doi          = {10.1016/j.annonc.2025.07.003},
      url          = {https://inrepo02.dkfz.de/record/303005},
}