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@ARTICLE{Fizazi:276405,
      author       = {K. Fizazi and K. Herrmann$^*$ and B. J. Krause and K.
                      Rahbar and K. N. Chi and M. J. Morris and O. Sartor and S.
                      T. Tagawa and A. T. Kendi and N. Vogelzang and J. Calais and
                      J. Nagarajah and X. X. Wei and V. S. Koshkin and J.-M.
                      Beauregard and B. Chang and R. Ghouse and M. DeSilvio and R.
                      A. Messmann and J. de Bono},
      title        = {{H}ealth-related quality of life and pain outcomes with
                      [177{L}u]{L}u-{PSMA}-617 plus standard of care versus
                      standard of care in patients with metastatic
                      castration-resistant prostate cancer ({VISION}): a
                      multicentre, open-label, randomised, phase 3 trial.},
      journal      = {The lancet / Oncology},
      volume       = {24},
      number       = {6},
      issn         = {1470-2045},
      address      = {London},
      publisher    = {The Lancet Publ. Group},
      reportid     = {DKFZ-2023-01089},
      pages        = {597 - 610},
      year         = {2023},
      abstract     = {In VISION, the prostate-specific membrane antigen
                      (PSMA)-targeted radioligand therapy lutetium-177
                      [177Lu]Lu-PSMA-617 (vipivotide tetraxetan) improved
                      radiographic progression-free survival and overall survival
                      when added to protocol-permitted standard of care in
                      patients with metastatic castration-resistant prostate
                      cancer. Here, we report additional health-related quality of
                      life (HRQOL), pain, and symptomatic skeletal event
                      results.This multicentre, open-label, randomised, phase 3
                      trial was conducted at 84 cancer centres in nine countries
                      in North America and Europe. Eligible patients were aged 18
                      years or older; had progressive PSMA-positive metastatic
                      castration-resistant prostate cancer; an Eastern Cooperative
                      Oncology Group (ECOG) performance status score of 0-2; and
                      had previously received of at least one androgen receptor
                      pathway inhibitor and one or two taxane-containing regimens.
                      Patients were randomly assigned (2:1) to receive either
                      [177Lu]Lu-PSMA-617 plus protocol-permitted standard of care
                      ([177Lu]Lu-PSMA-617 group) or standard of care alone
                      (control group) using permuted blocks. Randomisation was
                      stratified by baseline lactate dehydrogenase concentration,
                      liver metastases, ECOG performance status, and androgen
                      receptor pathway inhibitor inclusion in standard of care.
                      Patients in the [177Lu]Lu-PSMA-617 group received
                      intravenous infusions of 7·4 gigabecquerel (GBq; 200
                      millicurie [mCi]) [177Lu]Lu-PSMA-617 every 6 weeks for four
                      cycles plus two optional additional cycles. Standard of care
                      included approved hormonal treatments, bisphosphonates, and
                      radiotherapy. The alternate primary endpoints were
                      radiographic progression-free survival and overall survival,
                      which have been reported. Here we report the key secondary
                      endpoint of time to first symptomatic skeletal event, and
                      other secondary endpoints of HRQOL assessed with the
                      Functional Assessment of Cancer Therapy-Prostate (FACT-P)
                      and EQ-5D-5L, and pain assessed with the Brief Pain
                      Inventory-Short Form (BPI-SF). Patient-reported outcomes and
                      symptomatic skeletal events were analysed in all patients
                      who were randomly assigned after implementation of measures
                      designed to reduce the dropout rate in the control group (on
                      or after March 5, 2019), and safety was analysed according
                      to treatment received in all patients who received at least
                      one dose of treatment. This trial is registered with
                      ClinicalTrials.gov, NCT03511664, and is active but not
                      recruiting.Between June 4, 2018, and Oct 23, 2019, 831
                      patients were enrolled, of whom 581 were randomly assigned
                      to the [177Lu]Lu-PSMA-617 group (n=385) or control group
                      (n=196) on or after March 5, 2019, and were included in
                      analyses of HRQOL, pain, and time to first symptomatic
                      skeletal event. The median age of patients was 71 years (IQR
                      65-75) in the [177Lu]Lu-PSMA-617 group and 72·0 years
                      (66-76) in the control group. Median time to first
                      symptomatic skeletal event or death was 11·5 months $(95\%$
                      CI 10·3-13·2) in the [177Lu]Lu-PSMA-617 group and 6·8
                      months (5·2-8·5) in the control group (hazard ratio [HR]
                      0·50, $95\%$ CI 0·40-0·62). Time to worsening was delayed
                      in the [177Lu]Lu-PSMA-617 group versus the control group for
                      FACT-P score (HR 0·54, 0·45-0·66) and subdomains, BPI-SF
                      pain intensity score (0·52, 0·42-0·63), and EQ-5D-5L
                      utility score (0·65, 0·54-0·78). Grade 3 or 4
                      haematological adverse events included decreased haemoglobin
                      (80 $[15\%]$ of 529 assessable patients who received
                      [177Lu]Lu-PSMA-617 plus standard of care vs 13 $[6\%]$ of
                      205 who received standard of care only), lymphocyte
                      concentrations (269 $[51\%]$ vs 39 $[19\%]),$ and platelet
                      counts (49 $[9\%]$ vs five $[2\%]).$ Treatment-related
                      adverse events leading to death occurred in five $(1\%)$
                      patients who received [177Lu]Lu-PSMA-617 plus standard of
                      care (pancytopenia [n=2], bone marrow failure [n=1],
                      subdural haematoma [n=1], and intracranial haemorrhage
                      [n=1]) and no patients who received standard of care
                      only.[177Lu]Lu-PSMA-617 plus standard of care delayed time
                      to worsening in HRQOL and time to skeletal events compared
                      with standard of care alone. These findings support the use
                      of [177Lu]Lu-PSMA-617 in patients with metastatic
                      castration-resistant prostate cancer who received previous
                      androgen receptor pathway inhibitor and taxane
                      treatment.Advanced Accelerator Applications (Novartis).},
      keywords     = {Male / Humans / Aged / Quality of Life / Prostatic
                      Neoplasms, Castration-Resistant: drug therapy / Receptors,
                      Androgen / Standard of Care / Androgen Receptor Antagonists:
                      adverse effects / Pain: chemically induced / Taxoids /
                      Antineoplastic Combined Chemotherapy Protocols: adverse
                      effects / PSMA-617 (NLM Chemicals) / Receptors, Androgen
                      (NLM Chemicals) / Androgen Receptor Antagonists (NLM
                      Chemicals) / taxane (NLM Chemicals) / Taxoids (NLM
                      Chemicals)},
      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:37269841},
      doi          = {10.1016/S1470-2045(23)00158-4},
      url          = {https://inrepo02.dkfz.de/record/276405},
}