Association of baseline systemic corticosteroid use with overall survival and time to next treatment in patients receiving immune checkpoint inhibitor therapy in real-world US oncology practice for advanced non-small cell lung cancer, melanoma, or urothelial carcinoma

References

• Larkin J, Chiarion-Sileni V, Gonzalez R, Grob J-J, Rutkowski P, Lao CD, Cowey CL, Schadendorf D, Wagstaff J, Dummer R, et al. Five-year survival with combined nivolumab and ipilimumab in advanced melanoma. N Engl J Med. 2019;381(16):1535–9. doi:10.1056/NEJMoa1910836.
   PubMed Web of Science ®Google Scholar
• Hodi FS, O’Day SJ, McDermott DF, Weber RW, Sosman JA, Haanen JB, Gonzalez R, Robert C, Schadendorf D, Hassel JC, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010;363(8):711–723. doi:10.1056/NEJMoa1003466.
   PubMed Web of Science ®Google Scholar
• Hamid O, Robert C, Daud A, Hodi FS, Hwu W-J, Kefford R, Wolchok JD, Hersey P, Joseph RW, Weber JS, et al. Safety and tumor responses with lambrolizumab (anti-PD-1) in melanoma. N Engl J Med. 2013;369(2):134–144. doi:10.1056/NEJMoa1305133.
   PubMed Web of Science ®Google Scholar
• Wolchok JD, Kluger H, Callahan MK, Postow MA, Rizvi NA, Lesokhin AM, Segal NH, Ariyan CE, Gordon R-A, Reed K, et al. Nivolumab plus ipilimumab in advanced melanoma. N Engl J Med. 2013;369(2):122–133. doi:10.1056/NEJMoa1302369.
   PubMed Web of Science ®Google Scholar
• Robert C, Long GV, Brady B, Dutriaux C, Maio M, Mortier L, Hassel JC, Rutkowski P, McNeil C, Kalinka-Warzocha E, et al. Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med. 2015;372(4):320–330. doi:10.1056/NEJMoa1412082.
   PubMed Web of Science ®Google Scholar
• Bellmunt J, de Wit R, Vaughn DJ, Fradet Y, Lee J-L, Fong L, Vogelzang NJ, Climent MA, Petrylak DP, Choueiri TK, et al. Pembrolizumab as second-line therapy for advanced urothelial carcinoma. N Engl J Med. 2017;376(11):1015–1026. doi:10.1056/NEJMoa1613683.
   PubMed Web of Science ®Google Scholar
• Powles T, Durán I, van der Heijden MS, Loriot Y, Vogelzang NJ, De Giorgi U, Oudard S, Retz MM, Castellano D, Bamias A, et al. Atezolizumab versus chemotherapy in patients with platinum-treated locally advanced or metastatic urothelial carcinoma (IMvigor211): a multicenter, open-label, phase 3 randomized controlled trial. Lancet. 2018;391(10122):748–757. doi:10.1016/S0140-6736(17)33297-X.
   PubMed Web of Science ®Google Scholar
• Galsky MD, Arranz Arija JA, Aristotelis Bamias A, Davis ID, De Santis M, Kikuchi E, Garcia-Del-Muro X, De Giorgi U, Mencinger M, Izumi K, et al. Atezolizumab with or without chemotherapy in metastatic urothelial cancer (IMvigor130): a multicentre, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395(10236):1547–1557. doi:10.1016/S0140-6736(20)30230-0.
   Google Scholar
• Rittmeyer A, Barlesi F, Waterkamp D, Park K, Ciardiello F, von Pawel J, Gadgeel SM, Hida T, Kowalski DM, Dols MC, et al. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Lancet. 2017;389(10066):255–265. doi:10.1016/S0140-6736(16)32517-X.
   PubMed Web of Science ®Google Scholar
• Fehrenbacher L, Spira A, Ballinger M, Kowanetz M, Vansteenkiste J, Mazieres J, Park K, Smith D, Artal-Cortes A, Lewanski C, et al. Atezolizumab versus docetaxel for patients with previously treated non-small-cell lung cancer (POPLAR): a multicentre, open-label, phase 2 randomised controlled trial. Lancet. 2016;387(10030):1837–1846. doi:10.1016/S0140-6736(16)00587-0.
   PubMed Web of Science ®Google Scholar
• Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE, Chow LQ, Vokes EE, Felip E, Holgado E, et al. Nivolumab versus docetaxel in advanced nonsquamous non–small-cell lung cancer. N Engl J Med. 2015;373(17):1627–1639. doi:10.1056/NEJMoa1507643.
   PubMed Web of Science ®Google Scholar
• Brahmer J, Reckamp KL, Baas P, Crinò L, Eberhardt WEE, Poddubskaya E, Antonia S, Pluzanski A, Vokes EE, Holgado E, et al. Nivolumab versus docetaxel in advanced squamous-cell non–small-cell lung cancer. N Engl J Med. 2015;373(2):123–135. doi:10.1056/NEJMoa1504627.
   PubMed Web of Science ®Google Scholar
• Herbst RS, Baas P, Kim D-W, Felip E, Pérez-Gracia JL, Han J-Y, Molina J, Kim J-H, Arvis CD, Ahn M-J, 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. doi:10.1016/S0140-6736(15)01281-7.
   PubMed Web of Science ®Google Scholar
• Beaulieu E, Ngo D, Santos L, Yang YH, Smith M, Jorgensen C, Escriou V, Scherman D, Courties G, Apparailly F, et al. Glucocorticoid-induced leucine zipper is an endogenous anti-inflammatory mediator in arthritis. Arth Rheum. 2010;62:2651–2661. doi:10.1002/art.27566.
   PubMedGoogle Scholar
• Davis TE, Kis-Toth K, Szanto A, Tsokos GC. Glucocorticoids suppress T cell function by upregulating microRNA-98. Arth Rheum. 2013;65:1882–1890. doi:10.1002/art.37966.
   PubMedGoogle Scholar
• National Comprehensive Cancer Network. Antiemesis. Version 1.2020. [ Accessed 2020 Mar 31] https://www.nccn.org/professionals/physician_gls/pdf/antiemesis.pdf.
   Google Scholar
• National Comprehensive Cancer Network. Management of immunotherapy-related toxicities. Version 1.2020. [ Accessed 2020 Mar 31] https://www.nccn.org/professionals/physician_gls/pdf/immunotherapy.pdf
   Google Scholar
• Schadendorf D, Wolchok JD, Hodi FS, Chiarion-Sileni V, Gonzalez R, Rutkowski P, Grob -J-J, Cowey CL, Lao CD, Chesney J. Efficacy and safety outcomes in patients with advanced melanoma who discontinued treatment with nivolumab and ipilimumab because of adverse events: a pooled analysis of randomized phase II and III trials. J Clin Oncol. 2017;35(34):3807–3814. doi:10.1200/JCO.2017.73.2289.
   PubMed Web of Science ®Google Scholar
• Pardoll DM. The blockade of immune checkpoints in cancer immunotherapy. Nat Rev Cancer. 2012;12:252–264. doi:10.1038/nrc3239.
   PubMed Web of Science ®Google Scholar
• Fuca G, Galli G, Poggi M, Lo Russo G, Proto C, Imbimbo M, Ferrara R, Zilembo N, Ganzinelli M, Sica A, et al. Modulation of peripheral blood immune cells by early use of steroids and its association with clinical outcomes in patients with metastatic non-small cell lung cancer treated with immune checkpoint inhibitors. ESMO Open. 2019;4(1):e000457. doi:10.1136/esmoopen-2018-000457.
   PubMed Web of Science ®Google Scholar
• Arbour KC, Mezquita L, Long N, Rizvi H, Auclin E, Ni A, Martínez-Bernal G, Ferrara R, Lai WV, Hendriks LEL, et al. Impact of baseline steroids on efficacy of programmed cell death-1 and programmed death-ligand 1 blockade in patients with non–small-cell lung cancer. J Clin Oncol. 2018;36(28):2872–2878. doi:10.1200/JCO.2018.79.0006.
   PubMed Web of Science ®Google Scholar
• Spakowicz D, Hoyd R, Muniak M, Husain M, Bassett JS, Wang L, Tinoco G, Patel SH, Burkart J, Miah A, et al. Inferring the role of the microbiome on survival in patients treated with immune checkpoint inhibitors: causal modeling, timing, and classes of concomitant medications. BMC Cancer. 2020;20(1):383. doi:10.1186/s12885-020-06882-6.
   PubMed Web of Science ®Google Scholar
• Eggermont AMM, Kicinski M, Blank CU, Mandala M, Long GV, Atkinson V, Dalle S, Haydon A, Khattak A, Carlino MS, et al. Association between immune-related adverse events and recurrence-free survival among patients with stage III melanoma randomized to receive pembrolizumab or placebo: a secondary analysis of a randomized clinical trial. JAMA Oncol. 2020;6(4):519–527. doi:10.1001/jamaoncol.2019.5570.
   PubMed Web of Science ®Google Scholar
• De Giglio A, Mezquita L, Auclin E, Blanc-Durand F, El-Amarti L, Caramella C, Bernal GM, Hendriks L, Ferrara R, Naltet C, et al. Impact of early introduction of steroid on immune-checkpoint inhibitors (ICI) in patients with advanced non-small cell lung cancer treated. Ann Oncol. 2019;30(suppl 11):xi16–xi32. doi:10.1093/annonc/mdz449.
   Google Scholar
• Leighl N, Gandhi L, Hellmann MD. Pembrolizumab for NSCLC: immune-mediated adverse events and corticosteroid use. J Thorac Oncol. 2015;10:S233.
   Web of Science ®Google Scholar
• Scott SC, Pennell NA. Early use of corticosteroids in patients with advanced NSCLC treated with nivolumab. J Thorac Oncol. 2018;13:1771–1775. doi:10.1016/j.jtho.2018.06.004.
   PubMed Web of Science ®Google Scholar
• Pan EY, Merl MY, Lin K. The impact of corticosteroid use during anti-PD1 treatment. J Oncol Pharm Pract. Sep 2019;7. doi:10.1177/1078155219872786.
   Web of Science ®Google Scholar
• Mehra N, Sharp A, Lorente D, Dolling D, Sumanasuriya S, Johnson B, Dearnaley D, Parker C, de Bono J. Neutrophil to lymphocyte ratio in castration-resistant prostate cancer patients treated with daily oral corticosteroids. Clin Genitourin Cancer. 2017;15(6):678–684. doi:10.1016/j.clgc.2017.05.012.
   PubMed Web of Science ®Google Scholar
• Garant A, Guilbault C, Ekmekjian T, Greenwald Z, Murgoi P, Vuong T. Concomitant use of corticosteroids and immune checkpoint inhibitors in patients with hematologic or solid neoplasms: a systematic review. Crit Rev Oncol Hematol. 2017;120:86–92. doi:10.1016/j.critrevonc.2017.10.009.
   PubMed Web of Science ®Google Scholar
• Riudavets M, Mosquera J, Garcia Compelo R, Serra J, Anguera G, Gallardo P, Sullivan IG, Barba A, Majem M. Impact of corticosteroids and antibiotics on efficacy of immune-checkpoint inhibitors in patients with advanced non-small cell lung cancer. J Thoracic Oncol. 2019;14(10):S728. doi:10.1016/j.jtho.2019.08.1557.
   Google Scholar
• Mager DE, Lin SX, Blum RA, Lates CD, Jusko WJ. Dose equivalency evaluation of major corticosteroids: pharmacokinetics and cell trafficking and cortisol dynamics. J Clin Pharmacol. 2003;43(11):1216–1227. doi:10.1177/0091270003258651.
   PubMed Web of Science ®Google Scholar
• Webb R, Singer M. Oxford handbook of critical care. New York (NY): Oxford University Press; 2005.
   Google Scholar
• Curtis MD, Griffith SD, Tucker M. Development and validation of a high-quality composite real-world mortality endpoint. Health Serv Res. 2018;53(6):4460–4476. doi:10.1111/1475-6773.12872.
   PubMed Web of Science ®Google Scholar
• Zhang Q, Gossai A, Monroe S, Nussbaum NC, Parrinello CM. Validation analysis of a composite real-world mortality endpoint for US cancer patients [abstract]. In: Proceedings of the Annual Meeting of the American Association for Cancer Research 2020; 2020 Apr 27-28 and Jun 22-24. Philadelphia (PA): AACR; Cancer Res 2020; 80(16Suppl):Abstract nr 5772.
   Google Scholar
• Griffith SD, Miksad RA, Calkins G, You P, Lipitz NG, Bourla AB, Williams E, George DJ, Schrag D, Khozin S, et al. Characterizing the feasibility and performance of real-world tumor progression end points and their association with overall survival in a large advanced non-small-cell lung cancer data set. JCO Clin Cancer Inform. 2019;3:1–13. doi:10.1200/CCI.19.00013.
   Google Scholar
• Quan H, Li B, Couris CM, Fushimi K, Graham P, Hider P, Januel J-M, Sundararajan V. Updating and validating the charlson comorbidity index and score for risk adjustment in hospital discharge abstracts using data from 6 countries. Am J Epidemiol. 2011;173(6):676–682. doi:10.1093/aje/kwq433.
   PubMed Web of Science ®Google Scholar
• Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373–383. doi:10.1016/0021-9681(87)90171-8.
   PubMedGoogle Scholar
• Ricciuti B, Dahlberg SE, Adeni A, Sholl LM, Nishino M, Awad MM. Immune checkpoint inhibitor outcomes for patients with non–small-cell lung cancer receiving baseline corticosteroids for palliative versus nonpalliative indications. J Clin Oncol. 2019;37(22):1927–1934. doi:10.1200/JCO.19.00189.
   PubMed Web of Science ®Google Scholar
• Martínez Bernal G, Mezquita L, Auclin E, Ferrara R, Planchard D, Remon Masip J, Lahmar J, Boucher M-E, Caramella C, Adam J, et al. Baseline corticosteroids (CS) could be associated with absence of benefit to immune checkpoint inhibitors (ICI) in advanced non-small cell lung cancer  (NSCLC) patients. Ann Oncol. 2017;28(suppl 5):v460–v496. doi:10.1093/annonc/mdx380.025.
   Google Scholar
• Okoye IS, Xu L, Walker J, Elahi S. The glucocorticoids prednisone and dexamethasone differentially modulate T cell function in response to anti-PD-1 and anti-CTLA-4 immune checkpoint blockade. Cancer Immunol Immunother. 2020;69(8):1423–1436. doi:10.1007/s00262-020-02555-2.
   PubMed Web of Science ®Google Scholar
• Svaton M, Zemanova M, Zemanova P, Kultan J, Fischer O, Skrickova J, Jakubikova L, cernovska M, Hrnciarik M, Jirousek M, et al. Impact of concomitant medication administered at the time of initation of nivolumab therapy on outcome in non-small cell lung cancer. Anticancer Res. 2020;40:2209–2217. doi:10.21873/anticanres.14182.
   PubMed Web of Science ®Google Scholar
• Rier HN, Levin MD, van Rosmalen J, Bos MMEM, Drooger JC, de Jong P, Portielje JEA, Elsten EMP, Ten Tije A-J, Sleijfer S, et al. First-line palliative HER2-targeted therapy in HER2-positive metastatic breast cancer is less effective after previous adjuvant trastuzumab-based therapy. Oncologist. 2017a;22(8):901–909. doi:10.1634/theoncologist.2016-0448.
   PubMed Web of Science ®Google Scholar
• Rier HN, Jager A, Sleijfer S, van Rosmalen J, Kock MCJM, Levin M-D. Low muscle attenuation is a prognostic factor for survival in metastatic breast cancer patients treated with first line palliative chemotherapy. Breast. 2017b;31:9–15. doi:10.1016/j.breast.2016.10.014.
   PubMed Web of Science ®Google Scholar
• Liang C, Li L, Fraser CD, Ko A, Corzo D, Enger C, Patt D. The treatment patterns, efficacy, and safety of nab-paclitaxel for the treatment of metastatic breast cancer in the United States: results from health insurance claims analysis. BMC Cancer. 2015;15:1019. doi:10.1186/s12885-015-2027-x.
   PubMed Web of Science ®Google Scholar