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@ARTICLE{Bozorgmehr:303122,
      author       = {F. Bozorgmehr and I. Chung and J. R. Fischer and M. Bischof
                      and A. Atmaca and S. Wetzel and M. Faehling and D. Bottke
                      and M. Wermke$^*$ and E. G. C. Troost and C. Kropf-Sanchen
                      and T. Wiegel and B. Schmidt and A. Stupavsky and W.
                      Engel-Riedel and M. Hammer-Hellmig and N. Reinmuth and F.
                      Manapov and C. Grohe and R. Krempien and C. Schumann and F.
                      Sterzing and M. Reck and F. Würschmidt and J. Fleckenstein
                      and A. Petroff and S. Henschke and R. Behnisch and J.
                      Cvetkovic and L. Brückner and C. Schwab and A. Stenzinger
                      and T. Götze and C. Kopp and H. Schröder and J. Debus and
                      P. Christopoulos and M. Thomas and S. Rieken},
      title        = {{R}econsidering palliative radiotherapy in addition to
                      {PD}-1 blockade for non-small cell lung cancer: results from
                      the {FORCE} phase {II} trial ({AIO}/{YMO}-{TRK}-0415).},
      journal      = {Clinical $\&$ experimental metastasis},
      volume       = {42},
      number       = {5},
      issn         = {0262-0898},
      address      = {Dordrecht},
      publisher    = {Springer Science + Business Media B.V.},
      reportid     = {DKFZ-2025-01541},
      pages        = {42},
      year         = {2025},
      abstract     = {Introduction of immune checkpoint inhibitors (ICI) has
                      improved overall survival (OS) for advanced non-small cell
                      lung cancer (NSCLC). However, responses differ greatly
                      amongst patients. Additional radiotherapy (RT) may promote
                      tumor-specific immunity and synergize with ICI to improve
                      tumor control. The multicenter phase II FORCE trial
                      evaluated safety and efficacy of nivolumab with additional
                      palliative radiotherapy (5 × 4 Gy) as clinically indicated
                      in pre-treated metastatic non-squamous NSCLC (group A, n =
                      41), including pretreated patients without an indication for
                      radiotherapy in a parallel cohort as real-world controls
                      (group B, n = 60). With an objective response rate (ORR) of
                      $8.3\%$ in group A (n = 41), the primary endpoint was not
                      met (p = 0.991). ORR in group B (n = 60) was $23.8\%.$
                      Patient characteristics indicated a significantly poorer
                      baseline clinical condition for group A compared to B,
                      including worse Eastern Cooperative Oncology Group (ECOG)
                      performance status (PS, p = 0.020) and more metastatic sites
                      (p = 0.009). Consequently, group A had shorter
                      progression-free survival (median PFS, 1.9 versus 3.7
                      months, hazard ratio [HR] 1.69 $[95\%$ CI (1.10, 2.58)]) and
                      OS (median 6.0 versus 12.6 months, HR 1.75 $[95\%$ CI (1.07,
                      2.84)]). In multivariable analyses for the
                      intention-to-treat (ITT) population, ORR, PFS and OS were
                      inversely associated with the patients' ECOG PS (ORR odds
                      ratio [OR] 0.126, p = 0.004) and correlated positively with
                      tumor PD-L1 expression (ORR OR 12.8, p = 0.022), but not
                      with radiotherapy administration (p = 0.169-0.854). Adverse
                      events were distributed equally in both groups. Addition of
                      palliative radiotherapy to nivolumab was safe and feasible,
                      but not associated with improved efficacy. Patients with an
                      indication for palliative radiotherapy have an inherently
                      worse prognosis which cannot be overcome by
                      radiation-induced immunostimulation. Clinical features and
                      PD-L1 expression influence clinical outcomes more than
                      radiotherapy administration and should be considered when
                      evaluating the effectiveness of immuno-/radiotherapy
                      combinations.ClinicalTrials.gov identifier: NCT03044626.},
      keywords     = {Humans / Carcinoma, Non-Small-Cell Lung: therapy /
                      Carcinoma, Non-Small-Cell Lung: pathology / Carcinoma,
                      Non-Small-Cell Lung: mortality / Carcinoma, Non-Small-Cell
                      Lung: drug therapy / Male / Female / Lung Neoplasms:
                      pathology / Lung Neoplasms: therapy / Lung Neoplasms:
                      mortality / Lung Neoplasms: drug therapy / Aged / Middle
                      Aged / Immune Checkpoint Inhibitors: therapeutic use /
                      Palliative Care: methods / Nivolumab: therapeutic use /
                      Programmed Cell Death 1 Receptor: antagonists $\&$
                      inhibitors / Aged, 80 and over / Adult / Immunotherapy
                      (Other) / Nivolumab (Other) / Non-small cell lung cancer
                      (Other) / Palliative radiotherapy (Other) /
                      Radioimmunotherapy (Other) / Immune Checkpoint Inhibitors
                      (NLM Chemicals) / Nivolumab (NLM Chemicals) / Programmed
                      Cell Death 1 Receptor (NLM Chemicals) / PDCD1 protein, human
                      (NLM Chemicals)},
      cin          = {DD01},
      ddc          = {610},
      cid          = {I:(DE-He78)DD01-20160331},
      pnm          = {899 - ohne Topic (POF4-899)},
      pid          = {G:(DE-HGF)POF4-899},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:40702361},
      pmc          = {pmc:PMC12287132},
      doi          = {10.1007/s10585-025-10358-x},
      url          = {https://inrepo02.dkfz.de/record/303122},
}