GM-CSF and ipilimumab therapy in metastatic melanoma: Clinical outcomes and immunologic responses

OncoImmunology

Volumn 5, Issue 4, 2016, Pages

  Kwek, Serena S ^a   Kahn, James ^b   Greaney, Samantha K ^b   Lewis, Jera ^a   Cha, Edward ^a   Zhang, Li ^a   Weber, Robert W ^b   Leonard, Lonnie ^b   Markovic, Svetomir N ^c   Fong, Lawrence ^a   Spitler, Lynn E ^b  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b ST MARY S MEDICAL CENTER   (United States)

^c MAYO CLINIC   (United States)

Author keywords

CD4+ effector T cells; CD8+ T cells; clinical trial; CTLA 4; GM CSF; immunotherapy; ipilimumab; metastatic melanoma; PD 1

Indexed keywords

GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; IPILIMUMAB; LACTATE DEHYDROGENASE;

ADULT; AGED; ANOREXIA; ARTHRALGIA; ARTICLE; ATRIAL FIBRILLATION; BLURRED VISION; CANCER IMMUNOTHERAPY; CLINICAL ARTICLE; COLITIS; COLON PERFORATION; CONTROLLED STUDY; CORTICOTROPIN DEFICIENCY; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; ENDOCRINE DISEASE; EYE DISEASE; EYE PAIN; FATIGUE; FEMALE; FEVER; FLOW CYTOMETRY; FLUORESCENCE ACTIVATED CELL SORTING; FOLLOW UP; GASTROINTESTINAL DISEASE; HEADACHE; HUMAN; HUMAN CELL; HYPERTHYROIDISM; HYPERTRANSAMINASEMIA; IMMUNE RESPONSE; INFUSION RELATED REACTION; INJECTION SITE REACTION; MALE; METABOLIC DISORDER; METASTATIC MELANOMA; MONOTHERAPY; MULTIPLE CYCLE TREATMENT; MUSCULOSKELETAL DISEASE; NAUSEA; NEUROLOGIC DISEASE; OPTIC NERVE DISEASE; OVERALL SURVIVAL; PERICARDITIS; PHASE 2 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL (TOPIC); PROGRESSION FREE SURVIVAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL (TOPIC); RASH; RETINITIS; TREATMENT OUTCOME; URTICARIA; WEIGHT REDUCTION;

EID: 84962786637     PISSN: 21624011     EISSN: 2162402X     Source Type: Journal    
DOI: 10.1080/2162402X.2015.1101204     Document Type: Article

References (35)

1. F.S.Hodi, S.J.O'Day, D.F.McDermott, R.W.Weber, J.A.Sosman, J.B.Haanen, R.Gonzalez, C.Robert, D.Schadendorf, J.C.Hassel et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med 2010; 363:711-23; PMID:20525992; http://dx.doi.org/10.1056/NEJMoa1003466
2. E.J.Lipson, C.G.Drake. Ipilimumab: an anti-CTLA-4 antibody for metastatic melanoma. Clin Cancer Res 2011; 17:6958-62; PMID:21900389; http://dx.doi.org/10.1158/1078-0432.CCR-11-1595
3. S.L.Nightingale. From the Food and Drug Administration. JAMA 1991; 265:2315; PMID:21900389; http://dx.doi.org/10.1001/jama.1991.03460180021009
4. I.J.Fidler, E.S.Kleinerman. Lymphokine-activated human blood monocytes destroy tumor cells but not normal cells under cocultivation conditions. J Clin Oncol 1984; 2:937-43; PMID:6379124
5. K.H.Grabstein, D.L.Urdal, R.J.Tushinski, D.Y.Mochizuki, V.L.Price, M.A.Cantrell, S.Gillis, P.J.Conlon. Induction of macrophage tumoricidal activity by granulocyte-macrophage colony-stimulating factor. Science 1986; 232:506-8; PMID:3083507; http://dx.doi.org/10.1126/science.3083507
6. M.J.Thomassen, B.P.Barna, D.Rankin, H.P.Wiedemann, M.Ahmad. Differential effect of recombinant granulocyte macrophage colony-stimulating factor on human monocytes and alveolar macrophages. Cancer Res 1989; 49:4086-9; PMID:2545332
7. A.Chachoua, R.Oratz, R.Hoogmoed, D.Caron, D.Peace, L.Liebes, R.H.Blum, J.Vilcek. Monocyte activation following systemic administration of granulocyte-macrophage colony-stimulating factor. J Immunother Emphasis Tumor Immunol 1994; 15:217-24; PMID:8032545; http://dx.doi.org/10.1097/00002371-199404000-00008
8. G.Demir, H.O.Klein, N.Tuzuner. Low dose daily rhGM-CSF application activates monocytes and dendritic cells in vivo. Leukemia Res 2003; 27:1105-8; PMID:12921948; http://dx.doi.org/10.1016/S0145-2126(03)00097-3
9. Z.Dong, R.Kumar, X.Yang, I.J.Fidler. Macrophage-derived metalloelastase is responsible for the generation of angiostatin in Lewis lung carcinoma. Cell 1997; 88:801-10; PMID:9118223; http://dx.doi.org/10.1016/S0092-8674(00)81926-1
10. J.W.Young, P.Szabolcs, M.A.Moore. Identification of dendritic cell colony-forming units among normal human CD34+ bone marrow progenitors that are expanded by c-kit-ligand and yield pure dendritic cell colonies in the presence of granulocyte/macrophage colony-stimulating factor and tumor necrosis factor α. J Exp Med 1995; 182:1111-9; PMID:7561684; http://dx.doi.org/10.1084/jem.182.4.1111
11. P.Szabolcs, M.A.Moore, J.W.Young. Expansion of immunostimulatory dendritic cells among the myeloid progeny of human CD34+ bone marrow precursors cultured with c-kit ligand, granulocyte-macrophage colony-stimulating factor, and TNF-α. J Immunol 1995; 154:5851-61; PMID:7538534
12. P.Szabolcs, D.Avigan, S.Gezelter, D.H.Ciocon, M.A.Moore, R.M.Steinman, J.W.Young. Dendritic cells and macrophages can mature independently from a human bone marrow-derived, post-colony-forming unit intermediate. Blood 1996; 87:4520-30; PMID:8639819; http://dx.doi.org.ucsf.idm.oclc.org/
13. L.E.Spitler, M.L.Grossbard, M.S.Ernstoff, G.Silver, M.Jacobs, F.A.Hayes, S.J.Soong. Adjuvant therapy of stage III and IV malignant melanoma using granulocyte-macrophage colony-stimulating factor. J Clin Oncol 2000; 18:1614-21; PMID:10764421
14. T.E.Grotz, L.Kottschade, E.S.Pavey, S.N.Markovic, J.W.Jakub. Adjuvant GM-CSF improves survival in high-risk stage iiic melanoma: a single-center Study. Am J Clin Oncol 2014; 37:467-72; PMID:23428946; http://dx.doi.org/10.1097/COC.0b013e31827def82
15. D.H.Lawson, S.Lee, F.Zhao, A.A.Tarhini, K.A.Margolin, M.S.Ernstoff, M.B.Atkins, G.I.Cohen, T.L.Whiteside, L.H.Butterfield et al. Randomized, Placebo-Controlled, Phase III Trial of Yeast-Derived Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Versus Peptide Vaccination Versus GM-CSF Plus Peptide Vaccination Versus Placebo in Patients With No Evidence of Disease After Complete Surgical Resection of Locally Advanced and/or Stage IV Melanoma: A Trial of the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network Cancer Research Group (E4697). J Clin Oncol 2015; 33(34):4066-76; PMID:26351350; http://dx.doi.org/10.1200/JCO.2015.62.0500
16. L.Fong, S.S.Kwek, S.O'Brien, B.Kavanagh, D.G.McNeel, V.Weinberg, A.M.Lin, J.Rosenberg, C.J.Ryan, B.I.Rini et al. Potentiating endogenous antitumor immunity to prostate cancer through combination immunotherapy with CTLA4 blockade and GM-CSF. Cancer Res 2009; 69:609-15; PMID:19147575; http://dx.doi.org/10.1158/0008-5472.CAN-08-3529
17. F.S.Hodi, S.Lee, D.F.McDermott, U.N.Rao, L.H.Butterfield, A.A.Tarhini, P.Leming, I.Puzanov, D.Shin, J.M.Kirkwood. Ipilimumab plus sargramostim vs ipilimumab alone for treatment of metastatic melanoma: a randomized clinical trial. JAMA 2014; 312:1744-53; PMID:25369488; http://dx.doi.org/10.1001/jama.2014.13943
18. AJCC Cancer Staging Manual. New York: Springer, 2010
19. C.M.Balch, S.J.Soong, J.E.Gershenwald, J.F.Thompson, D.S.Reintgen, N.Cascinelli, M.Urist, K.M.McMasters, M.I.Ross, J.M.Kirkwood et al. Prognostic factors analysis of 17,600 melanoma patients: validation of the American Joint Committee on Cancer melanoma staging system. J Clin Oncol 2001; 19:3622-34; PMID:11504744
20. C.M.Balch, S.J.Soong, T.M.Murad, J.W.Smith, W.A.Maddox, J.R.Durant. A multifactorial analysis of melanoma. IV. Prognostic factors in 200 melanoma patients with distant metastases (stage III). J Clin Oncol 1983; 1:126-34; PMID:6668496
21. C.U.Brand, U.Ellwanger, W.Stroebel, F.Meier, B.Schlagenhauff, G.Rassner, C.Garbe. Prolonged survival of 2 years or longer for patients with disseminated melanoma. An analysis of related prognostic factors. Cancer 1997; 79:2345-53; PMID:9191522; http://dx.doi.org/10.1002/(SICI)1097-0142(19970615)79:12<2345::AID-CNCR8>3.0.CO;2-K
22. J.Manola, M.Atkins, J.Ibrahim, J.Kirkwood. Prognostic factors in metastatic melanoma: a pooled analysis of Eastern Cooperative Oncology Group trials. J Clin Oncol 2000; 18:3782-93; PMID:11078491
23. −2 antisense (oblimersen sodium) plus dacarbazine in patients with advanced melanoma: the Oblimersen Melanoma Study Group. J Clin Oncol 2006; 24:4738-45; PMID:16966688; http://dx.doi.org/10.1200/JCO.2006.06.0483
24. E.M.Hersh, S.J.O'Day, A.Ribas, W.E.Samlowski, M.S.Gordon, D.E.Shechter, A.A.Clawson, R.Gonzalez. A phase 2 clinical trial of nab-paclitaxel in previously treated and chemotherapy-naive patients with metastatic melanoma. Cancer 2010; 116:155-63; PMID:19877111; http://dx.doi.org/10.1002/cncr.24720
25. C.Robert, L.Thomas, I.Bondarenko, S.O'Day, D.MDJ, C.Garbe, C.Lebbe, J.F.Baurain, A.Testori, J.J.Grob et al. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med 2011; 364:2517-26; PMID:21639810; http://dx.doi.org/10.1056/NEJMoa1104621
26. S.Bhatia, B.R.Huber, M.P.Upton, J.A.Thompson. Inflammatory enteric neuropathy with severe constipation after ipilimumab treatment for melanoma: a case report. J Immunother 2009; 32:203-5; PMID:19238020; http://dx.doi.org/10.1097/CJI.0b013e318193a206
27. G.Q.Phan, J.C.Yang, R.M.Sherry, P.Hwu, S.L.Topalian, D.J.Schwartzentruber, N.P.Restifo, L.R.Haworth, C.A.Seipp, L.J.Freezer et al. Cancer regression and autoimmunity induced by cytotoxic T lymphocyte-associated antigen 4 blockade in patients with metastatic melanoma. Proc Natl Acad Sci U S A 2003; 100:8372-7; PMID:12826605; http://dx.doi.org/10.1073/pnas.1533209100
28. J.S.Weber, K.C.Kahler, A.Hauschild. Management of immune-related adverse events and kinetics of response with ipilimumab. J Clin Oncol 2012; 30:2691-7; PMID:22614989; http://dx.doi.org/10.1200/JCO.2012.41.6750
29. J.Delyon, C.Mateus, D.Lefeuvre, E.Lanoy, L.Zitvogel, N.Chaput, S.Roy, A.M.Eggermont, E.Routier, C.Robert. Experience in daily practice with ipilimumab for the treatment of patients with metastatic melanoma: an early increase in lymphocyte and eosinophil counts is associated with improved survival. Ann Oncol 2013; 24:1697-703; PMID:23439861; http://dx.doi.org/10.1093/annonc/mdt027
30. G.Y.Ku, J.Yuan, D.B.Page, S.E.Schroeder, K.S.Panageas, R.D.Carvajal, P.B.Chapman, G.K.Schwartz, J.P.Allison, J.D.Wolchok. Single-institution experience with ipilimumab in advanced melanoma patients in the compassionate use setting: lymphocyte count after 2 doses correlates with survival. Cancer 2010; 116:1767-75; PMID:20143434; http://dx.doi.org/10.1002/cncr.24951
31. A.A.Tarhini, H.Edington, L.H.Butterfield, Y.Lin, Y.Shuai, H.Tawbi, C.Sander, Y.Yin, M.Holtzman, J.Johnson et al. Immune monitoring of the circulation and the tumor microenvironment in patients with regionally advanced melanoma receiving neoadjuvant ipilimumab. PloS one 2014; 9:e87705; PMID:24498358; http://dx.doi.org/10.1371/journal.pone.0087705
32. E.Simeone, G.Gentilcore, D.Giannarelli, A.M.Grimaldi, C.Caraco, M.Curvietto, A.Esposito, M.Paone, M.Palla, E.Cavalcanti et al. Immunological and biological changes during ipilimumab treatment and their potential correlation with clinical response and survival in patients with advanced melanoma. Cancer Immunol Immunother 2014; 63:675-83; PMID:24695951; http://dx.doi.org/10.1007/s00262-014-1545-8
33. S.S.Kwek, J.Lewis, L.Zhang, V.Weinberg, S.Greaney, A.Harzstark, A.Lin, C.Ryan, E.J.Small, L.Fong. Pre-existing levels of CD4 T cells expressing PD-1 are related to overall survival in prostate cancer patients treated with ipilimumab. Cancer Immunol Res 2015; 3(9):1008-16; PMID:25968455; http://dx.doi.org/10.1158/2326-6066.CIR-14-0227
34. J.D.Wolchok, A.Hoos, S.O'Day, J.S.Weber, O.Hamid, C.Lebbé, M.Maio, M.Binder, O.Bohnsack, G.Nichol. Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Clin Cancer Res 2009:15: 1742; PMID:19934295; http://dx.doi.org/10.1158/1078-0432.CCR-09-1624
35. E.L.Kaplan, P.Meier. Nonparametric estimation from incomplete observations. J Am Statistical Assoc 1958; 53:457-81; http://dx.doi.org/10.1080/01621459.1958.10501452