Multicenter Evaluation of the Tolerability of Combined Treatment With PD-1 and CTLA-4 Immune Checkpoint Inhibitors and Palliative Radiation Therapy

International Journal of Radiation Oncology Biology Physics

Volumn 98, Issue 2, 2017, Pages 344-351

  Bang, Andrew ^a,d   Wilhite, Tyler J ^b   Pike, Luke R G ^a   Cagney, Daniel N ^a   Aizer, Ayal A ^a   Taylor, Allison ^a   Spektor, Alexander ^a   Krishnan, Monica ^a   Ott, Patrick A ^c   Balboni, Tracy A ^a   Hodi, F Stephen ^c   Schoenfeld, Jonathan D ^a  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b HARVARD MEDICAL SCHOOL   (United States)

^c DANA FARBER CANCER INSTITUTE   (United States)

^d UNIVERSITY OF OTTAWA   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

DISEASES; DRUG PRODUCTS; PATIENT MONITORING; RADIATION; RADIOTHERAPY;

CLINICAL PRACTICES; COMBINED TREATMENT; COMMON TERMINOLOGY CRITERIA; EQUIVALENT DOSE; METHODS AND MATERIALS; NON SMALL CELL LUNG CANCER; PALLIATIVE RADIATIONS; RENAL CELL CANCERS;

PATIENT TREATMENT;

ANTINEOPLASTIC AGENT; CYTOTOXIC T LYMPHOCYTE ANTIGEN 4 ANTIBODY; MONOCLONAL ANTIBODY; PROGRAMMED DEATH 1 RECEPTOR ANTIBODY; UNCLASSIFIED DRUG; CTLA4 PROTEIN, HUMAN; CYTOTOXIC T LYMPHOCYTE ANTIGEN 4; PDCD1 PROTEIN, HUMAN; PROGRAMMED DEATH 1 RECEPTOR;

ADULT; AGED; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER IMMUNOTHERAPY; CANCER PALLIATIVE THERAPY; CANCER PATIENT; CANCER RADIOTHERAPY; COLITIS; CONFORMAL RADIOTHERAPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DERMATITIS; DISEASE ASSOCIATION; DRUG TOLERABILITY; FEMALE; HUMAN; HYPERTHYROIDISM; HYPERTRANSAMINASEMIA; HYPOPHYSITIS; HYPOTHYROIDISM; INTENSITY MODULATED RADIATION THERAPY; KIDNEY CANCER; KIDNEY CARCINOMA; MAJOR CLINICAL STUDY; MALE; MEDICAL RECORD REVIEW; MELANOMA; MONOTHERAPY; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NON SMALL CELL LUNG CANCER; PNEUMONIA; PRIORITY JOURNAL; RADIATION DOSE FRACTIONATION; RADIOTHERAPY DOSAGE; RETROSPECTIVE STUDY; STEREOTACTIC RADIOSURGERY; TEMPORAL ARTERITIS; WHOLE BRAIN RADIOTHERAPY; ADVERSE EFFECTS; ANTAGONISTS AND INHIBITORS; CARCINOMA, NON-SMALL-CELL LUNG; CARCINOMA, RENAL CELL; CELL CYCLE CHECKPOINT; CLINICAL TRIAL; DRUG EFFECTS; IMMUNOLOGY; IMMUNOTHERAPY; KIDNEY NEOPLASMS; LUNG NEOPLASMS; MIDDLE AGED; MULTIMODALITY CANCER THERAPY; PALLIATIVE THERAPY; PATHOLOGY; PROCEDURES; SECONDARY; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; CARCINOMA, NON-SMALL-CELL LUNG; CARCINOMA, RENAL CELL; CELL CYCLE CHECKPOINTS; COLITIS; COMBINED MODALITY THERAPY; CTLA-4 ANTIGEN; DERMATITIS; FEMALE; HUMANS; IMMUNOTHERAPY; KIDNEY NEOPLASMS; LUNG NEOPLASMS; MALE; MELANOMA; MIDDLE AGED; PALLIATIVE CARE; PROGRAMMED CELL DEATH 1 RECEPTOR; RETROSPECTIVE STUDIES;

EID: 85018269954     PISSN: 03603016     EISSN: 1879355X     Source Type: Journal    
DOI: 10.1016/j.ijrobp.2017.02.003     Document Type: Article

References (43)

1. 1 Hodi, F.S., O'Day, S.J., McDermott, D.F., et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med 363 (2010), 711–723.
2. 2 Robert, C., Long, G.V., Brady, B., et al. Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med 372 (2015), 320–330.
3. 3 Postow, M.A., Chesney, J., Pavlick, A., et al. Nivolumab and ipilimumab versus ipilimumab in untreated melanoma. N Engl J Med 372 (2015), 2006–2017.
4. 4 Garon, E.B., Rizvi, N.A., Hui, R., et al. Pembrolizumab for the treatment of non-small-cell lung cancer. N Engl J Med 372 (2015), 2018–2028.
5. 5 Motzer, R.J., Escudier, B., McDermott, D.F., et al. Nivolumab versus everolimus in advanced renal cell carcinoma. N Engl J Med 373 (2015), 1803–1813.
6. 6 Rosenberg, J.E., Hoffman-Censits, J., van der Heijden, M.S., et al. Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: A single-arm, multicentre, phase 2 trial. Lancet 387 (2016), 1909–1920.
7. 7 Ansell, S.M., Lesokhin, A.M., Borrello, I., et al. PD-1 blockade with nivolumab in relapsed or refractory Hodgkin's lymphoma. N Engl J Med 372 (2015), 311–319.
8. 8 Cohen, E.E., Machiels, E.W., Harrington, K.J., et al. KEYNOTE-040: A phase III randomized trial of pembrolizumab (MK-3475) versus standard treatment in patients with recurrent or metastatic head and neck cancer. J Clin Oncol, 33(Suppl. 1), 2015, TPS6084.
9. 9 Larkin, J., Chiarion-Sileni, V., Gonzalez, R., et al. Combined nivolumab and ipilimumab or monotherapy in untreated melanoma. N Engl J Med 373 (2015), 23–34.
10. 10 Wolchok, J.D., Kluger, H., Callahan, M.K., Nivolumab plus ipilimumab in advanced melanoma. N Engl J Med 369 (2013), 122–133.
11. 11 Johnson, D.B., Balko, J.M., Compton, M.L., et al. Fulminant myocarditis with combination immune checkpoint blockade. N Engl J Med 375 (2016), 1749–1755.
12. 12 Naidoo, J., Page, D.B., Li, B.T., et al. Toxicities of the antiPD-1 and anti-PD-L1 immune checkpoint antibodies. Ann Oncol 26 (2015), 2375–2391.
13. 13 Horvat, T.Z., Adel, N.G., 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 33 (2015), 3193–3198.
14. 14 Weber, J.S., D'Angelo, S.P., Minor, D., et al. Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): A randomised, controlled, open-label, phase 3 trial. Lancet Oncol 16 (2015), 375–384.
15. 15 Rizvi, N.A., Mazières, J., Planchard, D., et al. Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): A phase 2, single-arm trial. Lancet Oncol 16 (2015), 257–265.
16. 16 Robert, C., Ribas, A., Wolchok, J.D., et al. Anti-programmed-deathreceptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: A randomised dose-comparison cohort of a phase 1 trial. Lancet 384 (2014), 1109–1117.
17. 17 Topalian, S.L., Sznol, M., McDermott, D.F., et al. Survival, durable tumor remission, and long-term safety in patients with advanced melanoma receiving nivolumab. J Clin Oncol 32 (2014), 1020–1030.
18. 18 Luke, J.J., Ott, P.A., PD-1 pathway inhibitors: The next generation of immunotherapy for advanced melanoma. Oncotarget 6 (2015), 3479–3492.
19. 19 Lutz, S.T., Jones, J., Chow, E., Role of radiation therapy in palliative care of the patient with cancer. J Clin Oncol 32 (2014), 2913–2919.
20. 20 Salama, J.K., Milano, M.T., Radical irradiation of extracranial metastases. J Clin Oncol 32 (2014), 2902–2912.
21. 21 Sridharan, V., Schoenfeld, J.D., Immune effects of targeted radiation therapy for cancer. Discov Med 19 (2015), 219–228.
22. 22 Qin, R., Olson, A., Singh, B., et al. Safety and efficacy of radiation therapy in advanced melanoma treated with ipilimumab. Int J Radiat Oncol Biol Phys 96 (2016), 72–77.
23. 23 Boyer, M.J., Gu, L., Wang, X., et al. Toxicity of definitive and post-operative radiation following ipilimumab in non-small cell lung cancer. Lung Cancer 98 (2016), 76–78.
24. 24 Gao, J., He, Q., Subudhi, S., et al. Review of immune-related adverse events in prostate cancer patients with ipilimumab: MD Anderson experience. Oncogene 34 (2015), 5411–5417.
25. 25 Ahmed, K.A., Stallworth, D.G., Kim, Y., et al. Clinical outcomes of melanoma brain metastases treated with stereotactic radiation and anti-PD-1 therapy. Ann Oncol 27 (2016), 434–441.
26. 26 Johnson, C.B., Jagsi, R., The promise of the abscopal effect and the future of trials combining immunotherapy and radiation therapy. Int J Radiat Oncol Biol Phys 95 (2016), 1254–1256.
27. 27 Bristol-Myers Squibb. Algorithm for suspected immune-related adverse events. Available at: www.nwcscnsenate.nhs.uk/files/5314/7394/1043/IPI_IRAEs_ALGORITHM.pdf. Accessed December 1, 2016.
28. 28 Merck Oncology. A guide to monitoring patients during the treatment with Keytruda. Available at: https://www.keytruda.com/static/pdf/guide-for-keytruda.pdf. Accessed December 1, 2016.
29. 29 Bristol-Myers Squibb. Immune-mediated adverse reactions management guide. Available at: www.opdivoyervoyhcp.com/servlet/servlet.FileDownload?file=00Pi000000SRPWfEAP. Accessed December 1, 2016.
30. 30 National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) v4.03. Available at: http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf. Accessed May 5, 2016.
31. 31 Kiess, A.P., Wolchok, J.D., Barker, C.A., Stereotactic radiosurgery for melanoma brain metastases in patients receiving ipilimumab: Safety profile and efficacy of combined treatment. Int J Radiat Oncol Biol Phys 92 (2015), 368–375.
32. 32 Silk, A.W., Bassetti, M.F., West, B.T., et al. Ipilimumab and radiation therapy for melanoma brain metastases. Cancer Med 2 (2013), 899–906.
33. 33 Knisely, J.P., Yu, J.B., Flanigan, J., et al. Radiosurgery for melanoma brain metastases in the ipilimumab era and the possibility of longer survival. J Neurosurg 117 (2012), 227–233.
34. 34 Mathew, M., Tam, M., Ott, P.A., et al. Ipilimumab in melanoma with limited brain metastases treated with stereotactic radiosurgery. Melanoma Res 23 (2013), 191–195.
35. 35 Barker, C.A., Postow, M.A., Khan, S.A., et al. Concurrent radiotherapy and ipilimumab immunotherapy for patients with melanoma. Cancer Immunol Res 1 (2013), 92–98.
36. 36 Hiniker, S.M., Reddy, S.A., Maeker, H.T., et al. A prospective clinical trial combining radiation therapy with systemic immunotherapy in metastatic melanoma. Int J Radiat Oncol Biol Phys 96 (2016), 578–588.
37. 37 Postow, M.A., Callahan, M.K., Barker, C.A., et al. Immunologic correlates of the abscopal effect in a patient with melanoma. N Engl J Med 366 (2012), 925–931.
38. 38 Stamell, E.F., Wolchok, J.D., Gnjatic, S., et al. The abscopal effect associated with a systemic anti-melanoma immune response. Int J Radiat Oncol Biol Phys 85 (2013), 293–295.
39. 39 Demaria, S., Kawashima, N., Yang, A.M., et al. Immune-mediated inhibition of metastases after treatment with local radiation and CTLA-4 blockade in a mouse model of breast cancer. Clin Cancer Res 11 (2005), 728–734.
40. 40 Dewan, M.Z., Galloway, A.E., Kawashima, N., et al. Fractionated but not single-dose radiotherapy induces an immune-mediated abscopal effect when combined with anti-CTLA-4 antibody. Clin Cancer Res 15 (2009), 5379–5388.
41. 41 Grimaldi, A.M., Simeone, E., Giannarelli, D., et al. Abscopal effects of radiotherapy on advanced melanoma patients who progressed after ipilimumab immunotherapy. Oncoimmunology, 3, 2014, e28780.
42. 42 Chandra, R.A., Wilhite, T.J., Balboni, T.A., et al. A systematic evaluation of abscopal responses following radiotherapy in patients with metastatic melanoma treated with ipilimumab. Oncoimmunology, 4, 2015, e1046028.
43. 43 Twyman-Saint, V.C., Rech, A.J., Maity, A., et al. Radiation and dual checkpoint blockade activate non-redundant immune mechanisms in cancer. Nature 520 (2015), 373–377.