Clinical features affecting efficacy of immune checkpoint inhibitors in pretreated patients with advanced NSCLC: a Danish nationwide real-world study

References

• Siegel RL, Miller KD, Fuchs HE, et al. Cancer statistics, 2021. CA A Cancer J Clin. 2021;71(1):7–33.
   PubMed Web of Science ®Google Scholar
• NORDCAN. March 26, 2019. https://www-dep.iarc.fr/nordcan/dk/StatsFact.asp?cancer=180&country=0. [accessed September 2021].
   Google Scholar
• Brahmer J, Reckamp KL, Baas P, et al. Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer. N Engl J Med. 2015;373(2):123–135.
   PubMed Web of Science ®Google Scholar
• Borghaei H, Paz-Ares L, Horn L, et al. Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer. N Engl J Med. 2015;373(17):1627–1639.
   PubMed Web of Science ®Google Scholar
• Herbst RS, Baas P, Kim DW, et al. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. Lancet. 2016;387(10027):1540–1550.
   PubMed Web of Science ®Google Scholar
• Reck M, Rodríguez-Abreu D, Robinson AG, et al. Pembrolizumab versus chemotherapy for PD-L1-positive non-small-cell lung cancer. N Engl J Med. 2016;375(19):1823–1833.
   PubMed Web of Science ®Google Scholar
• Gandhi L, Rodríguez-Abreu D, Gadgeel S, et al. Pembrolizumab plus chemotherapy in metastatic non-small-cell lung cancer. N Engl J Med. 2018;378(22):2078–2092.
   PubMed Web of Science ®Google Scholar
• Paz-Ares L, Luft A, Vicente D, et al. Pembrolizumab plus chemotherapy for squamous non-small-cell lung cancer. N Engl J Med. 2018;379(21):2040–2051.
   PubMed Web of Science ®Google Scholar
• Medicinrådet. Pembrolizumab (Keytruda) i kombination med kemoterapi (genvurdering). October 21, 2020. https://medicinraadet.dk/anbefalinger-og-vejledninger/laegemidler-og-indikationsudvidelser/m-p/pembrolizumab-keytruda-ikke-planocellulaer-ikke-smacellet-lungekraeft-genvurdering. [accessed September 2021]
   Google Scholar
• Medicinrådet. Pembrolizumab (Keytruda) i kombination med platinbaseret kemoterapi (genvurdering). January 27, 2021. https://medicinraadet.dk/media/hbqdv2rt/medicinr%C3%A5dets_anbefaling_vedr-_pembrolizumab_i_komb-_m-_kemoterapi_til_nsclc-vers-_1-0_adlegacy.pdf. [accessed September 2021]
   Google Scholar
• DOLG. DOLG referenceprogram. 2018. http://dolg.dk/referenceprogram/referenceprogram-kapitel-7/. [accessed September 2021]
   Google Scholar
• La J, Cheng D, Brophy MT, et al. Real-world outcomes for patients treated with immune checkpoint inhibitors in the veterans affairs system. JCO Clin Cancer Inform. 2020;4:918–928.
   PubMed Web of Science ®Google Scholar
• Conforti F, Pala L, Bagnardi V, et al. Cancer immunotherapy efficacy and patients' sex: a systematic review and meta-analysis. Lancet Oncol. 2018;19(6):737–746.
   PubMed Web of Science ®Google Scholar
• Conforti F, Pala L, Bagnardi V, et al. Sex-based heterogeneity in response to lung cancer immunotherapy: a systematic review and meta-analysis. J Natl Cancer Inst. 2019;111(8):772–781.
   PubMedGoogle Scholar
• Sacher AG, Le LW, Leighl NB, et al. Elderly patients with advanced NSCLC in phase III clinical trials: Are the elderly excluded from practice-changing trials in advanced NSCLC? J Thorac Oncol. 2013;8(3):366–368.
   PubMed Web of Science ®Google Scholar
• Ekman S, Horvat P, Rosenlund M, et al. Epidemiology and survival outcomes for patients with NSCLC in scandinavia in the preimmunotherapy era: a SCAN-LEAF retrospective analysis from the I-O optimise initiative. JTO Clin Res Rep. 2021;2(5):100165
   PubMedGoogle Scholar
• Landre T, Des Guetz G, Chouahnia K, et al. Immune checkpoint inhibitors for patients aged ≥ 75 years with advanced cancer in first- and second-line settings: a Meta-analysis. Drugs Aging. 2020;37(10):747–754.
   PubMed Web of Science ®Google Scholar
• Lilenbaum RC, Cashy J, Hensing TA, et al. Prevalence of poor performance status in lung cancer patients: Implications for research. J Thorac Oncol. 2008;3(2):125–129.
   PubMed Web of Science ®Google Scholar
• Campos-Balea B, de Castro Carpeño J, Massutí B, et al. Prognostic factors for survival in patients with metastatic lung adenocarcinoma: an analysis of the SEER database. Thorac Cancer. 2020;11(11):3357–3364.
   PubMed Web of Science ®Google Scholar
• Gouliaev A, Hilberg O, Christensen NL, et al. Comorbidity among danish lung cancer patients before and after initial cancer diagnosis. Eur Clin Respir J. 2020;8:1861579.
   PubMed Web of Science ®Google Scholar
• von Itzstein MS, Gonugunta AS, Mayo HG, et al. Immunotherapy use in patients with lung cancer and comorbidities. Cancer J. 2020;26(6):525–536.
   PubMed Web of Science ®Google Scholar
• Sculier JP, Botta I, Bucalau AM, et al. Medical anticancer treatment of lung cancer associated with comorbidities: a review. Lung Cancer. 2015;87(3):241–248.
   PubMed Web of Science ®Google Scholar
• Freshwater T, Kondic A, Ahamadi M, et al. Evaluation of dosing strategy for pembrolizumab for oncology indications. J Immunother Cancer. 2017;5:43.
   PubMed Web of Science ®Google Scholar
• Schemper M, Wakounig S, Heinze G. The estimation of average hazard ratios by weighted cox regression. Statist Med. 2009;28(19):2473–2489.
   PubMed Web of Science ®Google Scholar
• Charlson ME, Pompei P, Ales KL, et al. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373–383.
   PubMedGoogle Scholar
• Team RC. R: A language and environment for statistical computing. https://www.R-project.org/. [accessed September 2021]
   Google Scholar
• Danish Lung Cancer Group. National Clinical Guidelines for the treatment of Lung cancer. https://www.lungecancer.dk/referenceprogram/. [accessed September 2021.
   Google Scholar
• Felip E, Ardizzoni A, Ciuleanu T, et al. CheckMate 171: a phase 2 trial of nivolumab in patients with previously treated advanced squamous non-small cell lung cancer, including ECOG PS 2 and elderly populations. Eur J Cancer. 2020;127:160–172.
   PubMed Web of Science ®Google Scholar
• Spigel DR, McCleod M, Jotte RM, et al. Safety, efficacy, and patient-reported health-related quality of life and symptom burden with nivolumab in patients with advanced non-small cell lung cancer, including patients aged 70 Years or Older or with Poor Performance Status (CheckMate 153). J Thorac Oncol. 2019;14(9):1628–1639.
   PubMed Web of Science ®Google Scholar
• Cook MB, McGlynn KA, Devesa SS, et al. Sex disparities in cancer mortality and survival. Cancer Epidemiol Biomarkers Prev. 2011;20(8):1629–1637.
   PubMed Web of Science ®Google Scholar
• Cook MB, Dawsey SM, Freedman ND, et al. Sex disparities in cancer incidence by period and age. Cancer Epidemiol Biomarkers Prev. 2009;18(4):1174–1182.
   PubMed Web of Science ®Google Scholar
• Luciani A, Marra A, Toschi L, et al. Efficacy and safety of anti-PD-1 immunotherapy in patients aged≥ 75 years with non-small-cell lung cancer (NSCLC): an Italian, multicenter, retrospective study. Clin Lung Cancer. 2020;21(6):e567–e571.
   PubMed Web of Science ®Google Scholar
• Elkrief A, Richard C, Malo J, et al. Efficacy of immune checkpoint inhibitors in older patients with non-small cell lung cancer: Real-world data from multicentric cohorts in Canada and France. J Geriatr Oncol. 2020;11(5):802–806.
   PubMed Web of Science ®Google Scholar
• Dall'Olio FG, Maggio I, Massucci M, et al. ECOG performance status ≥2 as a prognostic factor in patients with advanced non small cell lung cancer treated with immune checkpoint inhibitors-A systematic review and meta-analysis of real world data. Lung Cancer. 2020;145:95–104.
   PubMed Web of Science ®Google Scholar
• Middleton G, Brock K, Savage J, et al. Pembrolizumab in patients with non-small-cell lung cancer of performance status 2 (PePS2): a single arm, phase 2 trial. Lancet Respir Med. 2020;8(9):895–904.
   PubMed Web of Science ®Google Scholar
• Mok TSK, Wu YL, Kudaba I, KEYNOTE-042 Investigators, et al. Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial. Lancet. 2019;393(10183):1819–1830.
   PubMed Web of Science ®Google Scholar
• Passaro A, Attili I, Morganti S, et al. Clinical features affecting survival in metastatic NSCLC treated with immunotherapy: a critical review of published data. Cancer Treat Rev. 2020;89:102085.
   PubMed Web of Science ®Google Scholar
• Mencoboni M, Ceppi M, Bruzzone M, et al. Effectiveness and safety of immune checkpoint inhibitors for patients with advanced non small-cell lung cancer in real-world: review and meta-analysis. Cancers (Basel). 2021;13(6):1388.
   PubMed Web of Science ®Google Scholar
• Yang K, Li J, Bai C, et al. Efficacy of immune checkpoint inhibitors in non-small-cell lung cancer patients with different metastatic sites: a systematic review and meta-analysis. Front Oncol. 2020;10:1098.
   PubMed Web of Science ®Google Scholar
• Botticelli A, Cirillo A, Scagnoli S, et al. The agnostic role of site of metastasis in predicting outcomes in cancer patients treated with immunotherapy. Vaccines (Basel). 2020;8(2):203.
   Web of Science ®Google Scholar
• Landi L, D'Incà F, Gelibter A, et al. Bone metastases and immunotherapy in patients with advanced non-small-cell lung cancer. J Immunother Cancer. 2019;7(1):316.
   PubMed Web of Science ®Google Scholar
• Bjørnhart B, Hansen KH, Jørgensen TL, et al. Efficacy and safety of immune checkpoint inhibitors in a danish real life non-small cell lung cancer population: a retrospective cohort study. Acta Oncol. 2019;58(7):953–961.
   PubMed Web of Science ®Google Scholar
• Hsiehchen D, Watters MK, Lu R, et al. Variation in the assessment of immune-related adverse event occurrence, grade, and timing in patients receiving immune checkpoint inhibitors. JAMA Netw Open. 2019;2(9):e1911519
   PubMed Web of Science ®Google Scholar
• De Giglio A, Mezquita L, Auclin E, et al. Impact of intercurrent introduction of steroids on clinical outcomes in advanced non-small-cell lung cancer (NSCLC) patients under immune-checkpoint inhibitors (ICI). Cancers (Basel). 2020;12(10):2827.
   Web of Science ®Google Scholar
• Derosa L, Hellmann MD, Spaziano M, et al. Negative association of antibiotics on clinical activity of immune checkpoint inhibitors in patients with advanced renal cell and non-small-cell lung cancer. Ann Oncol. 2018;29(6):1437–1444.
   PubMed Web of Science ®Google Scholar
• Cortellini A, Ricciuti B, Tiseo M, et al. Baseline BMI and BMI variation during first line pembrolizumab in NSCLC patients with a PD-L1 expression ≥ 50%: a multicenter study with external validation. J Immunother Cancer. 2020;8(2):e001403.
   PubMed Web of Science ®Google Scholar