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000303122 1001_ $$aBozorgmehr, Farastuk$$b0
000303122 245__ $$aReconsidering palliative radiotherapy in addition to PD-1 blockade for non-small cell lung cancer: results from the FORCE phase II trial (AIO/YMO-TRK-0415).
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000303122 520__ $$aIntroduction 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.
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000303122 650_7 $$2Other$$aImmunotherapy
000303122 650_7 $$2Other$$aNivolumab
000303122 650_7 $$2Other$$aNon-small cell lung cancer
000303122 650_7 $$2Other$$aPalliative radiotherapy
000303122 650_7 $$2Other$$aRadioimmunotherapy
000303122 650_7 $$2NLM Chemicals$$aImmune Checkpoint Inhibitors
000303122 650_7 $$031YO63LBSN$$2NLM Chemicals$$aNivolumab
000303122 650_7 $$2NLM Chemicals$$aProgrammed Cell Death 1 Receptor
000303122 650_7 $$2NLM Chemicals$$aPDCD1 protein, human
000303122 650_2 $$2MeSH$$aHumans
000303122 650_2 $$2MeSH$$aCarcinoma, Non-Small-Cell Lung: therapy
000303122 650_2 $$2MeSH$$aCarcinoma, Non-Small-Cell Lung: pathology
000303122 650_2 $$2MeSH$$aCarcinoma, Non-Small-Cell Lung: mortality
000303122 650_2 $$2MeSH$$aCarcinoma, Non-Small-Cell Lung: drug therapy
000303122 650_2 $$2MeSH$$aMale
000303122 650_2 $$2MeSH$$aFemale
000303122 650_2 $$2MeSH$$aLung Neoplasms: pathology
000303122 650_2 $$2MeSH$$aLung Neoplasms: therapy
000303122 650_2 $$2MeSH$$aLung Neoplasms: mortality
000303122 650_2 $$2MeSH$$aLung Neoplasms: drug therapy
000303122 650_2 $$2MeSH$$aAged
000303122 650_2 $$2MeSH$$aMiddle Aged
000303122 650_2 $$2MeSH$$aImmune Checkpoint Inhibitors: therapeutic use
000303122 650_2 $$2MeSH$$aPalliative Care: methods
000303122 650_2 $$2MeSH$$aNivolumab: therapeutic use
000303122 650_2 $$2MeSH$$aProgrammed Cell Death 1 Receptor: antagonists & inhibitors
000303122 650_2 $$2MeSH$$aAged, 80 and over
000303122 650_2 $$2MeSH$$aAdult
000303122 7001_ $$aChung, Inn$$b1
000303122 7001_ $$aFischer, Jürgen R$$b2
000303122 7001_ $$aBischof, Marc$$b3
000303122 7001_ $$aAtmaca, Akin$$b4
000303122 7001_ $$aWetzel, Sophie$$b5
000303122 7001_ $$aFaehling, Martin$$b6
000303122 7001_ $$aBottke, Dirk$$b7
000303122 7001_ $$0P:(DE-HGF)0$$aWermke, Martin$$b8
000303122 7001_ $$aTroost, Esther G C$$b9
000303122 7001_ $$aKropf-Sanchen, Cornelia$$b10
000303122 7001_ $$aWiegel, Thomas$$b11
000303122 7001_ $$aSchmidt, Bernd$$b12
000303122 7001_ $$aStupavsky, Andrej$$b13
000303122 7001_ $$aEngel-Riedel, Walburga$$b14
000303122 7001_ $$aHammer-Hellmig, Michaela$$b15
000303122 7001_ $$aReinmuth, Niels$$b16
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000303122 7001_ $$aKrempien, Robert$$b19
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000303122 7001_ $$aSterzing, Florian$$b21
000303122 7001_ $$aReck, Martin$$b22
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000303122 7001_ $$aFleckenstein, Jochen$$b24
000303122 7001_ $$aPetroff, Alev$$b25
000303122 7001_ $$aHenschke, Sven$$b26
000303122 7001_ $$aBehnisch, Rouven$$b27
000303122 7001_ $$aCvetkovic, Jelena$$b28
000303122 7001_ $$aBrückner, Lena$$b29
000303122 7001_ $$aSchwab, Constantin$$b30
000303122 7001_ $$aStenzinger, Albrecht$$b31
000303122 7001_ $$aGötze, Thorsten$$b32
000303122 7001_ $$aKopp, Christina$$b33
000303122 7001_ $$aSchröder, Helge$$b34
000303122 7001_ $$aDebus, Jürgen$$b35
000303122 7001_ $$aChristopoulos, Petros$$b36
000303122 7001_ $$aThomas, Michael$$b37
000303122 7001_ $$aRieken, Stefan$$b38
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