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@ARTICLE{Taugner:167866,
      author       = {J. Taugner and L. Käsmann$^*$ and C. Eze and A. Rühle$^*$
                      and A. Tufman and N. Reinmuth and T. Duell and C. Belka$^*$
                      and F. Manapov$^*$},
      title        = {{R}eal-world prospective analysis of treatment patterns in
                      durvalumab maintenance after chemoradiotherapy in
                      unresectable, locally advanced {NSCLC} patients.},
      journal      = {Investigational new drugs},
      volume       = {39},
      number       = {4},
      issn         = {1573-0646},
      address      = {Dordrecht [u.a.]},
      publisher    = {Springer Science + Business Media B.V},
      reportid     = {DKFZ-2021-00600},
      pages        = {1189-1196},
      year         = {2021},
      note         = {2021 Aug;39(4):1189-1196},
      abstract     = {The aim of this prospective study is to evaluate the
                      clinical use and real-world efficacy of durvalumab
                      maintenance treatment after chemoradiotherapy (CRT) in
                      unresectable stage, locally advanced non-small cell lung
                      cancer (NSCLC). All consecutive patients with unresectable,
                      locally advanced NSCLC and PD-L1 expression $(≥1\%)$
                      treated after October 2018 were included. Regular follow up,
                      including physical examination, PET/CT and/or
                      contrast-enhanced CT-Thorax/Abdomen were performed every
                      three months after CRT. Descriptive treatment pattern
                      analyses, including reasons of discontinuation and salvage
                      treatment, were undertaken. Statistics were calculated from
                      the last day of thoracic irradiation (TRT). Twenty-six
                      patients were included. Median follow up achieved
                      20.6 months (range: 1.9-30.6). Durvalumab was initiated
                      after a median of 25 (range: 13-103) days after completion
                      of CRT. In median 14 (range: 2-24) cycles of durvalumab were
                      applied within 6.4 (range 1-12.7) months. Six patients
                      $(23\%)$ are still in treatment and seven $(27\%)$ have
                      completed treatment with 24 cycles. Maintenance treatment
                      was discontinued in 13 $(50\%)$ patients: 4 $(15\%)$
                      patients developed grade 3 pneumonitis according to CTCAE v5
                      after a median of 3.9 (range: 0.5-11.6) months and 7 (range:
                      2-17) cycles of durvalumab. Four $(15\%)$ patients developed
                      grade 2 skin toxicity. One $(4\%)$ patient has discontinued
                      treatment due to incompliance. Six and 12- month
                      progression-free survival (PFS) rates were $82\%$ and
                      $62\%,$ median PFS was not reached. No case of
                      hyperprogression was documented. Eight $(31\%)$ patients
                      have relapsed during maintenance treatment after a median of
                      4.8 (range: 2.2-11.3) months and 11 (range: 6-17) durvalumab
                      cycles. Two patients $(9\%)$ developed a local-regional
                      recurrence after 14 and 17 cycles of durvalumab.
                      Extracranial distant metastases and brain metastases as
                      first site of failure were detected in 4 $(15\%)$ and 2
                      $(8\%)$ patients, respectively. Three $(13\%)$ patients
                      presented with symptomatic relapse. Our prospective study
                      confirmed a favourable safety profile of durvalumab
                      maintenance treatment after completion of CRT in
                      unresectable stage, locally advanced NSCLC in a real-world
                      setting. In a median follow-up time of 20.6 months,
                      durvalumab was discontinued in $27\%$ of all patients due to
                      progressive disease. All patients with progressive disease
                      were eligible for second-line treatment.},
      keywords     = {Checkpoint inhibition (Other) / Chemoradiotherapy (Other) /
                      Non-small cell lung cancer (Other) / PD-L1 inhibitor (Other)
                      / Treatment pattern (Other)},
      cin          = {MU01 / FR01 / E055},
      ddc          = {610},
      cid          = {I:(DE-He78)MU01-20160331 / I:(DE-He78)FR01-20160331 /
                      I:(DE-He78)E055-20160331},
      pnm          = {315 - Bildgebung und Radioonkologie (POF4-315)},
      pid          = {G:(DE-HGF)POF4-315},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:33704621},
      doi          = {10.1007/s10637-021-01091-9},
      url          = {https://inrepo02.dkfz.de/record/167866},
}