Phase 1 Study of Ipilimumab Combined With Whole Brain Radiation Therapy or Radiosurgery for Melanoma Patients With Brain Metastases

International Journal of Radiation Oncology Biology Physics

Volumn 99, Issue 1, 2017, Pages 22-30

  Williams, Noelle L ^a   Wuthrick, Evan J ^d   Kim, Hyun ^a   Palmer, Joshua D ^d   Garg, Shivank ^a   Eldredge Hindy, Harriet ^c   Daskalakis, Constantine ^b   Feeney, Kendra J ^a   Mastrangelo, Michael J ^a   Kim, Lyndon J ^a   Sato, Takami ^a   Kendra, Kari L ^d   Olencki, Thomas ^d   Liebner, David A ^d   Farrell, Christopher J ^a   Evans, James J ^a   Judy, Kevin D ^a   Andrews, David W ^a   Dicker, Adam P ^a   Werner Wasik, Maria ^a   Shi, Wenyin ^a   more..

^a THOMAS JEFFERSON UNIVERSITY   (United States)

^b THOMAS JEFFERSON UNIVERSITY   (United States)

^c BAYSTATE MEDICAL CENTER   (United States)

^d OHIO STATE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BRAIN; DERMATOLOGY; ONCOLOGY; PATHOLOGY; RADIOTHERAPY; TOXICITY;

DOSE LIMITING TOXICITY; GASTROINTESTINAL TOXICITIES; METHODS AND MATERIALS; NEUROTOXIC EFFECTS; PROGRESSION FREE SURVIVAL; REGISTRATION NUMBER; STEREOTACTIC RADIOSURGERY; WHOLE BRAIN RADIATION THERAPIES;

PATIENT TREATMENT;

IPILIMUMAB; MONOCLONAL ANTIBODY;

ADVERSE EFFECTS; BRAIN NEOPLASMS; CLINICAL TRIAL; DISEASE FREE SURVIVAL; DRUG ADMINISTRATION; FEMALE; FOLLOW UP; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; MALE; MAXIMUM TOLERATED DOSE; MELANOMA; MIDDLE AGED; MORTALITY; MULTICENTER STUDY; PHASE 1 CLINICAL TRIAL; PROCEDURES; PROSPECTIVE STUDY; RADIATION DOSE FRACTIONATION; RADIOSURGERY; SECONDARY; SKULL IRRADIATION; STATISTICS AND NUMERICAL DATA; TIME FACTOR;

ANTIBODIES, MONOCLONAL; BRAIN NEOPLASMS; CRANIAL IRRADIATION; DISEASE-FREE SURVIVAL; DOSE FRACTIONATION; DRUG ADMINISTRATION SCHEDULE; FEMALE; FOLLOW-UP STUDIES; HUMANS; INFUSIONS, INTRAVENOUS; MALE; MAXIMUM TOLERATED DOSE; MELANOMA; MIDDLE AGED; PROSPECTIVE STUDIES; RADIOSURGERY; TIME FACTORS;

EID: 85027692650     PISSN: 03603016     EISSN: 1879355X     Source Type: Journal    
DOI: 10.1016/j.ijrobp.2017.05.028     Document Type: Conference Paper

References (43)

1. Bafaloukos, D., Gogas, H., The treatment of brain metastases in melanoma patients. Cancer Treat Rev 30 (2004), 515–520.
2. Sampson, J.H., Carter, J.H., Friedman, A.H., et al. Demographics, prognosis, and therapy in 702 patients with brain metastases from malignant melanoma. J Neurosurg 88 (1998), 11–20.
3. Davies, M.A., Liu, P., McIntyre, S., et al. Prognostic factors for survival in melanoma patients with brain metastases. Cancer 117 (2011), 1687–1696.
4. Patchell, R.A., Tibbs, P.A., Regine, W.F., et al. Postoperative radiotherapy in the treatment of single metastases to the brain: A randomized trial. JAMA 280 (1998), 1485–1489.
5. Patchell, R.A., Tibbs, P.A., Walsh, J.W., et al. A randomized trial of surgery in the treatment of single metastases to the brain. N Engl J Med 322 (1990), 494–500.
6. Andrews, D.W., Current neurosurgical management of brain metastases. Semin Oncol 35 (2008), 100–107.
7. Thomas, S.S., Dunbar, E.M., Modern multidisciplinary management of brain metastases. Curr Oncol Rep 12 (2010), 34–40.
8. Qian, J.M., Yu, J.B., Kluger, H.M., et al. Timing and type of immune checkpoint therapy affect the early radiographic response of melanoma brain metastases to stereotactic radiosurgery. Cancer 122 (2016), 3051–3058.
9. Nagorsen, D., Scheibenbogen, C., Marincola, F.M., et al. Natural T cell immunity against cancer. Clin Cancer Res 9 (2003), 4296–4303.
10. Clemente, C.G., Mihm, M.C. Jr., Bufalino, R., et al. Prognostic value of tumor infiltrating lymphocytes in the vertical growth phase of primary cutaneous melanoma. Cancer 77 (1996), 1303–1310.
11. Hakansson, A., Gustafsson, B., Krysander, L., et al. Tumour-infiltrating lymphocytes in metastatic malignant melanoma and response to interferon alpha treatment. Br J Cancer 74 (1996), 670–676.
12. Mihm, M.C. Jr., Clemente, C.G., Cascinelli, N., Tumor infiltrating lymphocytes in lymph node melanoma metastases: A histopathologic prognostic indicator and an expression of local immune response. Lab Invest 74 (1996), 43–47.
13. Moschos, S.J., Edington, H.D., Land, S.R., et al. Neoadjuvant treatment of regional stage IIIB melanoma with high-dose interferon alfa-2b induces objective tumor regression in association with modulation of tumor infiltrating host cellular immune responses. J Clin Oncol 24 (2006), 3164–3171.
14. Peggs, K.S., Quezada, S.A., Korman, A.J., et al. Principles and use of anti-CTLA4 antibody in human cancer immunotherapy. Curr Opin Immunol 18 (2006), 206–213.
15. Robert, C., Ghiringhelli, F., What is the role of cytotoxic T lymphocyte-associated antigen 4 blockade in patients with metastatic melanoma?. Oncologist 14 (2009), 848–861.
16. Kaehler, K.C., Piel, S., Livingstone, E., et al. Update on immunologic therapy with anti-CTLA-4 antibodies in melanoma: Identification of clinical and biological response patterns, immune-related adverse events, and their management. Semin Oncol 37 (2010), 485–498.
17. Morse, M.A., Technology evaluation: Ipilimumab, Medarex/Bristol-Myers Squibb. Curr Opin Mol Ther 7 (2005), 588–597.
18. 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.
19. Weber, J.S., O'Day, S., Urba, W., et al. Phase I/II study of ipilimumab for patients with metastatic melanoma. J Clin Oncol 26 (2008), 5950–5956.
20. Theurich, S., Rothschild, S.I., Hoffmann, M., et al. Local tumor treatment in combination with systemic ipilimumab immunotherapy prolongs overall survival in patients with advanced malignant melanoma. Cancer Immunol Res 4 (2016), 744–754.
21. Dewey, D.L., The radiosensitivity of melanoma cells in culture. Br J Radiol 44 (1971), 816–817.
22. Barranco, S.C., Romsdahl, M.M., Humphrey, R.M., The radiation response of human malignant melanoma cells grown in vitro. Cancer Res 31 (1971), 830–833.
23. Bernier, J., Immuno-oncology: Allying forces of radio- and immuno-therapy to enhance cancer cell killing. Crit Rev Oncol Hematol 108 (2016), 97–108.
24. Popp, I., Grosu, A.L., Niedermann, G., et al. Immune modulation by hypofractionated stereotactic radiation therapy: Therapeutic implications. Radiother Oncol 120 (2016), 185–194.
25. Shaw, E., Scott, C., Souhami, L., et al. Single dose radiosurgical treatment of recurrent previously irradiated primary brain tumors and brain metastases: Final report of RTOG protocol 90-05. Int J Radiat Oncol Biol Phys 47 (2000), 291–298.
26. Wolchok, J.D., Neyns, B., Linette, G., et al. Ipilimumab monotherapy in patients with pretreated advanced melanoma: A randomised, double-blind, multicentre, phase 2, dose-ranging study. Lancet Oncol 11 (2010), 155–164.
27. Eisenhauer, E.A., Therasse, P., Bogaerts, J., et al. New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1). Eur J Cancer 45 (2009), 228–247.
28. Wolchok, J.D., Hoos, A., O'Day, S., et al. Guidelines for the evaluation of immune therapy activity in solid tumors: Immune-related response criteria. Clin Cancer Res 15 (2009), 7412–7420.
29. Storer, B.E., Design and analysis of phase I clinical trials. Biometrics 45 (1989), 925–937.
30. Margolin, K., Ernstoff, M.S., Hamid, O., et al. Ipilimumab in patients with melanoma and brain metastases: An open-label, phase 2 trial. Lancet Oncol 13 (2012), 459–465.
31. 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.
32. Johnson, A.G., Ruiz, J., Hughes, R., et al. Impact of systemic targeted agents on the clinical outcomes of patients with brain metastases. Oncotarget 6 (2015), 18945–18955.
33. Kiess, A.P., Wolchok, J.D., Barker, C.A., et al. 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.
34. Patel, K.R., Shoukat, S., Oliver, D.E., et al. Ipilimumab and stereotactic radiosurgery versus stereotactic radiosurgery alone for newly diagnosed melanoma brain metastases. Am J Clin Oncol, 2015 May 16 [Epub ahead of print].
35. Shen, C., Lin, D.D., Redmond, K.J., et al. Imaging and clinical profile following concurrent stereotactic radiation and immune therapy for melanoma brain metastases: Preliminary results. Int J Radiat Oncol Biol Phys, 96, 2016, E134.
36. Mole, R.H., Whole body irradiation: Radiobiology or medicine?. Br J Radiol 26 (1953), 234–241.
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. National Comprehensive Cancer Network. Melanoma (version 1.2017). Available at: https://www.nccn.org/professionals/physician_gls/PDF/melanoma.pdf. Accessed February 7, 2017.
39. 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.
40. Postow, M.A., Chesney, J., Pavlick, A.C., et al. Nivolumab and ipilimumab versus ipilimumab in untreated melanoma. N Engl J Med 372 (2015), 2006–2017.
41. Robert, C., Schachter, J., Long, G.V., et al., KEYNOTE-006 Investigators. Pembrolizumab versus Ipilimumab in advanced melanoma. N Engl J Med 372 (2015), 2521–2532.
42. Colaco, R.J., Martin, P., Kluger, H.M., et al. Does immunotherapy increase the rate of radiation necrosis after radiosurgical treatment of brain metastases?. J Neurosurg 125 (2016), 17–23.
43. Vatner, R.E., Cooper, B.T., Vanpouille-Box, C., et al. Combinations of immunotherapy and radiation in cancer therapy. Front Oncol, 4, 2014, 325.