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Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

5516 - Durvalumab in frail and elder patients with stage four NSCLC- the DURATION trial

Date

20 Oct 2018

Session

Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

Topics

Immunotherapy;  Cancer in Older Adults

Tumour Site

Presenters

Jonas Kuon

Citation

Annals of Oncology (2018) 29 (suppl_8): viii493-viii547. 10.1093/annonc/mdy292

Authors

J. Kuon1, F. Bozorgmehr2, M.A. Schneider3, J. Krisam4, F. Lasitschka5, M. Serke6, W. Schuette7, N. Moosmann8, W. Gleiber9, M. Faehling10, M. Wermke11, P. Schuett12, M. Boesche13, V. van Laak14, L. Fischer von Weikersthal15, M. Ulmer16, C. Meyer zum Büschenfelde17, J.R. Fischer18, M. Thomas19

Author affiliations

  • 1 Thoracic Oncology, Thoraxklinik Heidelberg, 69126 - Heidelberg/DE
  • 2 Thoracic Oncology, University Hospital Heidelberg, 69126 - Heidelberg/DE
  • 3 Translational Research Unit, Thoraxklinik At Heidelberg University Hospital, Thoraxklinik Heidelberg, 69126 - Heidelberg/DE
  • 4 Institute Of Medical Biometry And Informatics, University of Heidelberg, 69120 - Heidelberg/DE
  • 5 Institute Of Pathology, Heidelberg University Hospital, 69120 - Heidelberg/DE
  • 6 Thorakale Onkologie, Lungenklinik Hemer des Deutschen Gemeinschafts-Diakonieverbandes GmbH, 58675 - Hemer/DE
  • 7 Oncology, Hospital Martha-Maria Halle-Doelau, 6120 - Halle/DE
  • 8 Department Of Oncology And Hematology, Hospital Barmherzige Brüder, 93049 - Regensburg/DE
  • 9 Medizinische Klinik I, 9University Hospital Frankfurt, 60590 - Frankfurt/DE
  • 10 Klinik Für Kardiologie Und Pneumologie, Klinikum Esslingen, 73730 - Esslingen/DE
  • 11 University Hospital Carl-gustav-carus, University Hospital Carl-Gustav-Carus, 01307 - Dresden/DE
  • 12 Oncology, Onkologische Schwerpunktpraxis, 33332 - Gütersloh/DE
  • 13 Oncology, University of Greifswald, 17475 - Greifswald/DE
  • 14 Department Of Pulmonary Medicine, DRK-Klinikum Berlin-Mitte, Berlin/DE
  • 15 Oncology, 15Hospital St. Marien Amberg, 92224 - Amberg/DE
  • 16 Oncology, Hospital Ludwigsburg, 71640 - ludwigsburg/DE
  • 17 Clinic For Hematology, Oncology, St. Vincentius Hospital Karlsruhe, 76137 - Karlsruhe/DE
  • 18 Oncology, Klinik Loewenstein GmbH Med Klinik II Onkologie, 74245 - Loewenstein/DE
  • 19 Thoraxoncology, Thoraxklinik Heidelberg, 69126 - Heidelberg/DE

Resources

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Abstract 5516

Background

Elderly patients represent a major population of non-small cell lung cancer (NSCLC) patients in routine clinical practice, yet are underrepresented in clinical trials. In particular, data regarding efficacy and safety in frail or elderly patients with respect to immunotherapy is lacking. Importantly, immunosenescence in elderly patients can result in altered activities of immune-modulating drugs such as PD-1/PD-L1 inhibitors. Thus, there is an urgent need to assess safety and efficiency of such inhibitors in this group.

Trial design

In this prospective, open label, treatment stratified, and randomized phase II study, 200 patients with stage IV NSCLC, >70 years old and/or “frail” (Charlson Comorbidity Index >1) or restricted performance score (ECOG >1), who are amenable for at least chemotherapy with gemcitabine or vinorelbine, will be included. Patients are stratified after a modified CARG Score (a predicting chemotherapy toxicity score): ”Fit” patients are treated with doublet chemotherapy (carboplatin/nab-paclitaxel), while “unfit” patients receive monochemotherapy (gemcitabine or vinorelbine). Patients are then 1:1 randomized and receive either 4 cycles of chemotherapy + follow-up every 8 weeks (Arm A/D) or 2 cycles of chemotherapy followed by 2 cycles of durvalumab and subsequent maintenance durvalumab every 4 weeks (Arm B/C). The primary endpoint is the rate of treatment related grade III/IV adverse events (CTCAE V4.03). As secondary endpoints progression-free survival according to RECIST 1.1, overall survival, descriptive subgroup analyses according to PD-L1 expression, and quality of life will be addressed. Geriatric screening assessments and functional tests will be performed to complete the description of a potential “frail” and “elderly” patient cohort (G8-questionnaire, Timed up & go test, 6MWT). Further, a biomarker profiling program will analyse immune-related effects and potentially identify novel response predictors. The DURATION trial will prospectively investigate the safety and tolerability of PD-L1 treatment with durvalumab after chemotherapy in elderly and frail patients and thereby provide new insights into the effect of PD-L1 blockade and the impact of immunosenescence in this important cohort.

Clinical trial identification

EudraCT: 2016-003963-20.

Legal entity responsible for the study

AIO-Studien-gGmbH.

Funding

AstraZeneca, Celgene.

Editorial Acknowledgement

Disclosure

J. Kuon: Honoraria: AstraZeneca, Pfizer. M. Serke: Honoraria: BMS, Celgene, Lilly, Roche. AD boards: AstraZeneca; BMS, Boehringer, Celgene, Hexal, Lilly, Merck, MSD, Pfizer, Roche, Teva, Abbvie, AIO. M. Faehling: Honoraria: AstraZeneca, BMS, MSD, Roche. M. Wermke: Honoraria: BMS, Novartis, Roche, Bayer, Glenmark, AstraZeneca; Travel cost reimbursements: AstraZeneca, BMS, MSC, Novartis, Glenmark; Research funding: Novartis, Pfizer. M. Thomas: Speaker honoraria: Lilly; BMS, MSD, Roche, Pfizer, AstraZeneca; Advisory boards: Lilly, BMS, MSD, Roche, Pfizer, AstraZeneca, Celgene; Mediolanum Scientific projects: AstraZeneca, BMS, Celgene. All other authors have declared no conflict of interest.

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