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Review

Releasing the brake: safety profile of immune check-point inhibitors in non-small cell lung cancer

, , , , , & show all
Pages 573-585 | Received 01 Feb 2017, Accepted 27 Mar 2017, Published online: 19 Apr 2017

References

  • Rijavec E, Genova C, Alama A, et al. Role of immunotherapy in the treatment of advanced non-small-cell lung cancer. Future Oncol. 2014;10(1):79–90.
  • Schvartsman G, Ferrarotto R, Massarelli E. Check-point inhibitors in lung cancer: latest developments and clinical potential. Ther Adv Med Oncol. 2016;8(6):460–473.
  • Pardoll DM. The blockade of immune check-points in cancer immunotherapy. Nat Rev Cancer. 2012;12(4):252–264.
  • Intlekofer AM, Thompson CB. At the bench: preclinical rationale for CTLA-4 and PD-1 blockade as cancer immunotherapy. J Leukoc Biol. 2013;94(1):25–39.
  • Buchbinder EI, Desai A. CTLA-4 and PD-1 pathways: similarities, differences, and implications of their inhibition. J Clin Oncol. 2016;39(1):98–106.
  • Helissey C, Champiat S, Soria JC. Immune check-point inhibitors in advanced nonsmall cell lung cancer. Curr Opin Oncol. 2015;27(2):108–117.
  • Nakamura Y, Tanaka R, Asami Y, et al. Correlation between vitiligo occurrence and clinical benefit in advanced melanoma patients treated with nivolumab: a multi-institutional retrospective study. J Dermatol. 2016 Aug 11. [Epub ahead of print] DOI:10.1111/1346-8138.13520
  • Lo JA, Fisher DE, Flaherty KT. Prognostic significance of cutaneous adverse events associated with pembrolizumab therapy. JAMA Oncol. 2015 Dec;1(9):1340–1341.
  • Michot JM, Bigenwald C, Champiat S, et al. Immune-related adverse events with immune check-point blockade: a comprehensive review. Eur J Cancer. 2016;54:139–148.
  • Hasan Ali O, Diem S, Markert E, et al. Characterization of nivolumab-associated skin reactions in patients with metastatic non-small cell lung cancer. Oncoimmunology. 2016;5(11):e1231292.
  • Weber JS, Dummer R, de Pril V, et al. Patterns of onset and resolution of immune-related adverse events of special interest with ipilimumab: detailed safety analysis from a phase 3 trial in patients with advanced melanoma. Cancer. 2013;119(9):1675–1682.
  • Davies M. New modalities of cancer treatment for NSCLC: focus on immunotherapy. Cancer Manag Res. 2014;6:63–75.
  • Rizvi NA, Mazières J, Planchard D, et al. Activity and safety of nivolumab, an anti-PD-1 immune check-point inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): a phase 2, single-arm trial. Lancet Oncol. 2015;16(3):257–265.
  • 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.
  • 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.
  • Gettinger S, Rizvi NA, Chow LQ, et al. Nivolumab monotherapy for first-line treatment of advanced non-small-cell lung cancer. J Clin Oncol. 2016;34(25):2980–2987.
  • 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.
  • 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.
  • Garon EB, Rizvi NA, Hui R, et al. Pembrolizumab for the treatment of non-small-cell lung cancer. N Engl J Med. 2015;372(21):2018–2028.
  • Besse B, Johnson M, Janne PA, et al. 16LBA phase II, single-arm trial (BIRCH) of atezolizumab as first-line or subsequent therapy for locally advanced or metastatic PD-L1-selected non-small cell lung cancer (NSCLC). Eur J Cancer. 2015;51(3):S717–8.
  • Fehrenbacher L, Spira A, Ballinger M, 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.
  • Rittmeyer A, Barlesi F, Waterkamp D, 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. 2016 Dec 12; pii: S0140-6736(16)32517-X. [Epub ahead of print]. DOI:10.1016/S0140-6736(16)32517-X
  • Hellmann MD, Rizvi NA, Goldman JW, et al. Nivolumab plus ipilimumab as first-line treatment for advanced non-small-cell lung cancer (CheckMate 012): results of an open-label, phase 1, multicohort study. Lancet Oncol. 2017;18(1):31–41.
  • Antonia S, Goldberg SB, Balmanoukian A, et al. Safety and antitumour activity of durvalumab plus tremelimumab in non-small cell lung cancer: a multicentre, phase 1b study. Lancet Oncol. 2016;17(3):299–308.
  • Rizvi NA, Hellmann MD, Brahmer JR, et al. Nivolumab in combination with platinum-based doublet chemotherapy for first-line treatment of advanced non-small-cell lung cancer. J Clin Oncol. 2016;34(25):2969–2979.
  • Rizvi NA, Quan Man Chow L, Borghaei H, et al. Safety and response with nivolumab (anti-PD-1; BMS-936558, ONO-4538) plus erlotinib in patients (pts) with epidermal growth factor receptor mutant (EGFR MT) advanced NSCLC. J Clin Oncol. 2014;32(suppl; abstr 8022):5s.
  • Gadgeel SM, Stevenson J, Langer CJ, et al. Pembrolizumab (pembro) plus chemotherapy as front-line therapy for advanced NSCLC: KEYNOTE-021 cohorts A-C. J Clin Oncol. 2016;34(suppl; abstr 9016).
  • Kroeze SG, Fritz C, Hoyer M, et al. Toxicity of concurrent stereotactic radiotherapy and targeted therapy or immunotherapy: A systematic review. Cancer Treat Rev. 2016;53:25–37.
  • Sundar R, Cho B-C, Brahmer JR, et al. Nivolumab in NSCLC: latest evidence and clinical potential. Ther Adv Med Oncol. 2015;7(2):85–96.
  • Opdivo prescribing information (Food and Drug Administration). [cited 2017 Jul 01]. Available from: http://www.access data.fda.gov/drugsatfda_docs/label/2015/125554s005lbl.pdf
  • Keytruda prescribing information (Food and Drug Administration). [cited 2017 Jul 01]. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125514s012lbl.pdf
  • Bristol-Myers Squibb – Opdivo (Nivolumab) immune-mediated adverse reactions management guide. [cited 2017 Jul 01]. Availabel from: http://www.opdivoyervoyhcp.com/servlet/servlet.FileDownload?file=00Pi000000SRPWfEAP
  • Merck Oncology - A guide to monitoring patients during treatment with keytruda. [cited 2017 Jul 01]. Available from: https://www.keytruda.com/static/pdf/Guide-to-Monitoring-Patients-During-Treatment-With-KEYTRUDA.pdf
  • Horvat TZ, Adel NG, Dang T-O, et al. Immune-related adverse events, need for systemic immunosuppression, and effects on survival and time to treatment failure in patients with melanoma treated with ipilimumab at memorial sloan kettering cancer center. J Clin Oncol. 2015;33(28):3193–3198.
  • Harmankaya K, Erasim C, Koelblinger C, et al. Continuous systemic corticosteroids do not affect the ongoing regression of metastatic melanoma for more than two years following ipilimumab therapy. Med Oncol. 2011;28(4):1140–1144.
  • Villadolid J, Amin A. Immune check-point inhibitors in clinical practice: update on management of immune-related toxicities. Transl Lung Cancer Res. 2015;4(5):560–575.
  • Remicade prescribing information (Food and Drug Administration). [cited 2017 Aug 01]. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103772s5359lbl.pdf
  • Del Castillo Garcia M, Redelman-Sidi G. Opportunistic infections in patients receiving immunotherapy with CTLA-4, PD-1 and PD-L1 blockers for treatment of metastatic melanoma. Open Forum Infect Dis. 2015;2(suppl 1). DOI:10.1093/ofid/ofv133.926
  • Kyi C, Hellmann MD, Wolchok JD, et al. Opportunistic infections in patients treated with immunotherapy for cancer. J Immunother Cancer. 2014;2:19.
  • Arriola E, Wheater M, Krishnan R, et al. Immunosuppression for ipilimumab-related toxicity can cause pneumocystis pneumonia but spare antitumor immune control. Oncoimmunology. 2015;4(10):e1040218.
  • Abdel-Rahman O, Helbling D, Schmidt J, et al. Treatment-associated fatigue in cancer patients treated with immune check-point inhibitors; a systematic review and meta-analysis. Clin Oncol (R Coll Radiol). 2016;28(10):e127–38.
  • Dev R, Wong A, Hui D, et al. The evolving approach to management of cancer cachexia. Oncology (Williston Park). 2017;31(1).
  • Naidoo J, Page DB, Li BT, et al. Toxicities of the anti-PD-1 and anti-PD-L1 immune check-point antibodies. Ann Oncol. 2016;27(7):1362.
  • Lacouture ME, Wolchok JD, Yosipovitch G, et al. Ipilimumab in patients with cancer and the management of dermatologic adverse events. J Am Acad Dermatol. 2014;71(1):161–169.
  • Pintova S, Sidhu H, Friedlander PA, et al. Sweet’s syndrome in a patient with metastatic melanoma after ipilimumab therapy. Melanoma Res. 2013;23(6):498–501.
  • Topalian SL, Sznol M, McDermott DF, et al. Survival, durable tumor remission, and long-term safety in patients with advanced melanoma receiving nivolumab. J Clin Oncol. 2014;32(10):1020–1030.
  • Weber JS, Yang JC, Atkins MB, et al. Toxicities of immunotherapy for the practitioner. J Clin Oncol. 2015;33(18):2092–2099.
  • American Dietetic Association - Crohn’s Disease and Ulcerative Colitis Nutrition Therapy. [cited 2017 Oct 01]. Available from: http://www.uccs.edu/Documents/peakfood/hlthTopics/Crohns%20Disease%20Nutrition.pdf
  • Edsbäcker S, Bengtsson B, Larsson P, et al. A pharmacoscintigraphic evaluation of oral budesonide given as controlled-release (Entocort) capsules. Aliment Pharmacol Ther. 2003;17(4):525–536.
  • Weber J, Thompson JA, Hamid O, et al. A randomized, double-blind, placebo-controlled, phase II study comparing the tolerability and efficacy of ipilimumab administered with or without prophylactic budesonide in patients with unresectable stage III or IV melanoma. Clin Cancer Res. 2009;15(17):5591–5598.
  • Pagès C, Gornet JM, Monsel G, et al. Ipilimumab-induced acute severe colitis treated by infliximab. Melanoma Res. 2013;23(3):227–230.
  • Gonzalez RS, Salaria SN, Bohannon CD, et al. PD-1 inhibitor gastroenterocolitis: case series and appraisal of ‘immunomodulatory gastroenterocolitis’. Histopathology. 2016 Nov 7. [Epub ahead of print]. DOI:10.1111/his.13118
  • Spain L, Diem S, Larkin J. Management of toxicities of immune check-point inhibitors. Cancer Treat Rev. 2016;44:51–60.
  • Kleiner DE, Berman D. Pathologic changes in ipilimumab-related hepatitis in patients with metastatic melanoma. Dig Dis Sci. 2012;57(8):2233–2240.
  • Gelsomino F, Vitale G, D’Errico A, et al. Nivolumab-induced cholangitic liver disease: a novel form of serious liver injury. Ann Oncol. 2016 Dec 19;pii: mdw649. [Epub ahead of print]
  • Parekh R, Kaur N. Liver injury secondary to anti-TNF-alpha therapy in inflammatory bowel disease: a case series and review of the literature. Case Rep Gastrointest Med. 2014;2014:956463.
  • Abdel-Rahman O, Fouad M. Risk of pneumonitis in cancer patients treated with immune check-point inhibitors: a meta-analysis. Ther Adv Respir Dis. 2016;10(3):183–193.
  • Nishino M, Giobbie-Hurder A, Hatabu H, et al. Incidence of programmed cell death 1 inhibitor-related pneumonitis in patients with advanced cancer: a systematic review and meta-analysis. JAMA Oncol. 2016;2(12):1607–1616.
  • Nishino M, Ramaiya NH, Awad MM, et al. PD-1 inhibitor-related pneumonitis in advanced cancer patients: radiographic patterns and clinical course. Clin Cancer Res. 2016;22(24):6051–6060.
  • Gounant V, Brosseau S, Naltet C, et al. Nivolumab-induced organizing pneumonitis in a patient with lung sarcomatoid carcinoma. Lung Cancer. 2016;99:162–165.
  • Watanabe S, Kimura H, Takato H, et al. Severe pneumonitis after nivolumab treatment in a patient with melanoma. Allergol Int. 2016;65(4):487–489.
  • Nishino M, Chambers ES, Chong CR, et al. Anti-PD-1 inhibitor-related pneumonitis in non-small cell lung cancer. Cancer Immunol Res. 2016;4(4):289–293.
  • Martin-Liberal J, Furness AJ, Joshi K, et al. Anti-programmed cell death-1 therapy and insulin-dependent diabetes: a case report. Cancer Immunol Immunother. 2015;64(6):765–767.
  • Rossi G, Albertelli M, Nazzari E, et al. Endocrinological side-effects of nivolumab in advanced non-small cell lung cancer. 17th world conference on lung cancer. 4-7 december 2016, Vienna, Austria. J Torac Oncol. 2017;12(S1):S681 (P3.02C-039).
  • Abdel-Rahman O, ElHalawani H, Fouad M. Risk of endocrine complications in cancer patients treated with immune check point inhibitors: a meta-analysis. Future Oncol. 2016;12(3):413–425.
  • Torino F, Corsello SM, Salvatori R. Endocrinological side-effects of immune check-point inhibitors. Curr Opin Oncol. 2016;28(4):278–287.
  • Rossi E, Sgambato A, De Chiara G, et al. Endocrinopathies induced by immune-check-point inhibitors in advanced non-small cell lung cancer. Expert Rev Clin Pharmacol. 2016;9(3):419–428.
  • Okano Y, Satoh T, Horiguchi K, et al. Nivolumab-induced hypophysitis in a patient with advanced malignant melanoma. Endocr J. 2016;63(10):905–912.
  • Tanaka R, Fujisawa Y, Maruyama H, et al. Nivolumab-induced thyroid dysfunction. Jpn J Clin Oncol. 2016;46(6):575–579.
  • Orlov S, Salari F, Kashat L, et al. Induction of painless thyroiditis in patients receiving programmed death 1 receptor immunotherapy for metastatic malignancies. J Clin Endocrinol Metab. 2015;100(5):1738–1741.
  • Verma I, Modi A, Tripathi H, et al. Nivolumab causing painless thyroiditis in a patient with adenocarcinoma of the lung. BMJ Case Rep. 2016;2016:pii: bcr2015213692.
  • Corsello SM, Barnabei A, Marchetti P, et al. Endocrine side effects induced by immune check-point inhibitors. J Clin Endocrinol Metab. 2013;98(4):1361–1375.
  • Trainer H, Hulse P, Higham CE, et al. Hyponatraemia secondary to nivolumab-induced primary adrenal failure. Endocrinol Diabetes Metab Case Rep. 2016;2016:pii: 16-0108. Epub 2016 Nov 1
  • Cappelli LC, Gutierrez AK, Bingham CO 3rd, et al. Rheumatic and musculoskeletal immune-related adverse events due to immune check-point inhibitors: A systematic review of the literature. Arthritis Care Res (Hoboken). 2016 Dec 20. [Epub ahead of print]. DOI:10.1002/acr.23177
  • Law-Ping-Man S, Martin A, Briens E, et al. Psoriasis and psoriatic arthritis induced by nivolumab in a patient with advanced lung cancer. Rheumatology (Oxford). 2016;55(11):2087–2089.
  • Syrigos K, Tsagouli S, Grapsa D. Nivolumab-induced recurrence of rheumatoid arthritis in a patient with advanced non-small cell lung cancer: a case report. Ann Intern Med. 2016;165(12):894–895.
  • Salmon JH, Lambrecht I, Brochot P, et al. A case of arthritis under pembrolizumab. Joint Bone Spine. 2016 Apr 22:pii: S1297-319X(16)30017-3. [Epub ahead of print]. DOI:10.1016/j.jbspin.2016.03.003
  • Chan MM, Kefford RF, Carlino M, et al. Arthritis and tenosynovitis associated with the anti-PD1 antibody pembrolizumab in metastatic melanoma. J Immunother. 2015;38(1):37–39.
  • Cappelli LC, Gutierrez AK, Baer AN, et al. Inflammatory arthritis and sicca syndrome induced by nivolumab and ipilimumab. Ann Rheum Dis. 2017;76(1):43–50.
  • Roberts P, Fishman GA, Joshi K, et al. Chorioretinal lesions in a case of melanoma-associated retinopathy treated with pembrolizumab. JAMA Ophthalmol. 2016;134(10):1184–1188.
  • Abu Samra K, Valdes-Navarro M, Lee S, et al. A case of bilateral uveitis and papillitis in a patient treated with pembrolizumab. Eur J Ophthalmol. 2016;26(3):e46–8.
  • Aaberg MT, Aaberg TM Jr. Pembrolizumab administration associated with posterior uveitis. Retin Cases Brief Rep. 2016 Aug 2. Epub ahead of print
  • Antoun J, Titah C, Cochereau I. Ocular and orbital side-effects of check-point inhibitors: a review article. Curr Opin Oncol. 2016;28(4):288–294.
  • Le Fournis S, Gohier P, Urban T, et al. Corneal graft rejection in a patient treated with nivolumab for primary lung cancer. Lung Cancer. 2016;102:28–29.
  • Hottinger AF. Neurologic complications of immune check-point inhibitors. Curr Opin Neurol. 2016;29(6):806–812.
  • Wilson MA, Guld K, Galetta S, et al. Acute visual loss after ipilimumab treatment for metastatic melanoma. J Immunother Cancer. 2016;4:66.
  • Abe J, Sato T, Tanaka R, et al. Nivolumab-induced severe akathisia in an advanced lung cancer patient. Am J Case Rep. 2016;17:880–882.
  • Jung K, Zeng X, Bilusic M. Nivolumab-associated acute glomerulonephritis: a case report and literature review. BMC Nephrol. 2016;17(1):188.
  • Belliere J, Meyer N, Mazieres J, et al. Acute interstitial nephritis related to immune check-point inhibitors. Br J Cancer. 2016;115(12):1457–1461.
  • Wanchoo R, Karam S, Uppal NN, et al. Adverse renal effects of immune check-point inhibitors: a narrative review. Am J Nephrol. 2017 Jan 12;45(2): 160–169. [Epub ahead of print] DOI:10.1159/000455014
  • Nair R, Gheith S, Nair SG. Immunotherapy-associated hemolytic anemia with pure red-cell aplasia. N Engl J Med. 2016;374(11):1096–1097.
  • Kong BY, Micklethwaite KP, Swaminathan S, et al. Autoimmune hemolytic anemia induced by anti-PD-1 therapy in metastatic melanoma. Melanoma Res. 2016;26(2):202–204.
  • Simeone E, Grimaldi AM, Esposito A, et al. Serious haematological toxicity during and after ipilimumab treatment: a case series. J Med Case Rep. 2014;8:240.
  • Du Rusquec P, Saint-Jean M, Brocard A, et al. Ipilimumab-induced autoimmune pancytopenia in a case of metastatic melanoma. J Immunother. 2014;37(6):348–350.
  • Ikeuchi K, Okuma Y, Tabata T. Immune-related pancreatitis secondary to nivolumab in a patient with recurrent lung adenocarcinoma: A case report. Lung Cancer. 2016;99:148–150.
  • Alabed YZ, Aghayev A, Sakellis C, et al. Pancreatitis secondary to anti-programmed death receptor 1 immunotherapy diagnosed by FDG PET/CT. Clin Nucl Med. 2015;40(11):e528–9.
  • Kushnir I, Wolf I. Nivolumab-induced pericardial tamponade: a case report and discussion. Cardiology. 2017;136(1):49–51.
  • Semper H, Muehlberg F, Schulz-Menger J, et al. Drug-induced myocarditis after nivolumab treatment in a patient with PDL1- negative squamous cell carcinoma of the lung. Lung Cancer. 2016;99:117–119.
  • Johnson DB, Balko JM, Compton ML, et al. Fulminant myocarditis with combination immune checkpoint blockade. N Engl J Med. 2016;375(18):1749–1755.
  • Rijavec E, Genova C, Sarocchi M, et al. Cardiac troponin-I elevation in patients with non-small cell lung cancer during PD1/PDL1 inhibition with nivolumab. 17th world conference on lung cancer. 4-7 december 2016, Vienna, Austria. J Torac Oncol. 2017;12(S1):S695(P3.02C-077).
  • Ben Amar J, Zaibi H, Bouzid K, et al. Role of procalcitonin and c-reactive protein levels: a diagnostic tool in lower respiratory tract infections. Tunis Med. 2016;94(3):176–180.
  • [cited 2017 Jan 24]. Available from: https://www.clinicaltrials.gov/ct2/show/NCT02039674?term=pembrolizumab+chemotherapy&rank=23
  • Lee CS, Thomas CM, Ng KE. An Overview of the changing landscape of treatment for advanced melanoma. Pharmacotherapy. 2017 Jan;4. [Epub ahead of print]. DOI:10.1002/phar.1895
  • Kanz BA, Mh P 1st, Johnpulle R, et al. Safety and efficacy of anti-PD-1 in patients with baseline cardiac, renal, or hepatic dysfunction. J Immunother Cancer. 2016;4:60.
  • Menzies AM, Johnson DB, Ramanujam S, et al. Anti-PD-1 therapy in patients with advanced melanoma and preexisting autoimmune disorders or major toxicity with ipilimumab. Ann Oncol. 2016 Sep 29; pii: mdw443. [Epub ahead of print] DOI:10.1093/annonc/mdw443. .
  • Davar D, Wilson M, Pruckner C, et al. PD-1 Blockade in advanced melanoma in patients with hepatitis C and/or HIV. Case Rep Oncol Med. 2015;2015:737389.
  • Elias R, Morales J, Rehman Y, et al. Immune checkpoint inhibitors in older adults. Curr Oncol Rep. 2016;18(8):47.

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