A phase II trial of the oral mTOR inhibitor everolimus in relapsed aggressive lymphoma

Leukemia - Tập 25 Số 2 - Trang 341-347 - 2011
Thomas E. Witzig1, Craig B. Reeder2, Betsy LaPlant3, Mamta Gupta4, Patrick B. Johnston4, Ivana N. Micallef4, Luis F. Porrata4, Stephen M. Ansell4, Joseph P. Colgan4, Eric Jacobsen5, Irene M. Ghobrial5, Thomas M. Habermann4
1Division of Hematology, Department of Medicine, Mayo Clinic College of Medicine and Mayo Foundation, Rochester, MN 55905, USA.
2Division of Hematology Oncology, Department of Medicine, Mayo Clinic, Phoenix, USA
3Division of Biomedical Statistics and Informatics, Department of Health Sciences Research, Mayo Clinic College of Medicine and Mayo Foundation, Rochester, USA
4Division of Hematology, Department of Medicine, Mayo Clinic College of Medicine and Mayo Foundation, Rochester, USA
5Dana-Farber Cancer Center, Boston, USA

Tóm tắt

Từ khóa


Tài liệu tham khảo

Habermann TM, Weller EA, Morrison VA, Gascoyne RD, Cassileth PA, Cohn JB et al. Rituximab-CHOP versus CHOP alone or with maintenance rituximab in older patients with diffuse large B-cell lymphoma. J Clin Oncol 2006; 24: 3121–3127.

Geisler CH, Kolstad A, Laurell A, Andersen NS, Pedersen LB, Jerkeman M et al. Long-term progression-free survival of mantle cell lymphoma after intensive front-line immunochemotherapy with in vivo-purged stem cell rescue: a nonrandomized phase 2 multicenter study by the Nordic Lymphoma Group. Blood 2008; 112: 2687–2693.

Inwards DJ, Fishkin PA, Hillman DW, Brown DW, Ansell SM, Kurtin PJ et al. Long-term results of the treatment of patients with mantle cell lymphoma with cladribine (2-CDA) alone (95-80-53) or 2-CDA and rituximab (N0189) in the North Central Cancer Treatment Group. Cancer 2008; 113: 108–116.

Al-Tourah AJ, Gill KK, Chhanabhai M, Hoskins PJ, Klasa RJ, Savage KJ et al. Population-based analysis of incidence and outcome of transformed non-Hodgkin's lymphoma. J Clin Oncol 2008; 26: 5165–5169.

Witzig TE, Kaufmann SH . Inhibition of the phosphatidylinositol 3-kinase/mammalian target of rapamycin pathway in hematologic malignancies. Curr Treat Options Oncol 2006; 7: 285–294.

Cully M, You H, Levine AJ, Mak TW . Beyond PTEN mutations: the PI3 K pathway as an integrator of multiple inputs during tumorigenesis. Nat Rev Cancer 2006; 6: 184–192.

LoPiccolo J, Blumenthal GM, Bernstein WB, Dennis PA . Targeting the PI3K/Akt/mTOR pathway: effective combinations and clinical considerations. Drug Resist Updat 2008; 11: 32–50.

Dowling RJ, Topisirovic I, Fonseca BD, Sonenberg N . Dissecting the role of mTOR: lessons from mTOR inhibitors. Biochim Biophys Acta 2010; 1804: 433–439.

Sehgal SN, Baker H, Vezina C . Rapamycin (AY-22,989), a new antifungal antibiotic. II. Fermentation, isolation and characterization. J Antibiot (Tokyo) 1975; 28: 727–732.

Hudes G, Carducci M, Tomczak P, Dutcher J, Figlin R, Kapoor A et al. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med 2007; 356: 2271–2281.

Motzer RJ, Escudier B, Oudard S, Hutson TE, Porta C, Bracarda S et al. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial. Lancet 2008; 372: 449–456.

Gupta M, Ansell SM, Novak AJ, Kumar S, Kaufmann SH, Witzig TE . Inhibition of histone deacetylase overcomes rapamycin-mediated resistance in diffuse large B-cell lymphoma by inhibiting Akt signaling through mTORC2. Blood 2009; 114: 2926–2935.

Witzig TE, Geyer SM, Ghobrial I, Inwards DJ, Fonseca R, Kurtin P et al. Phase II trial of single-agent temsirolimus (CCI-779) for relapsed mantle cell lymphoma. J Clin Oncol 2005; 23: 5347–5356.

Ansell SM, Inwards DJ, Rowland Jr KM, Flynn PJ, Morton RF, Moore Jr DF et al. Low-dose, single-agent temsirolimus for relapsed mantle cell lymphoma: a phase 2 trial in the North Central Cancer Treatment Group. Cancer 2008; 113: 508–514.

Hess G, Herbrecht R, Romaguera J, Verhoef G, Crump M, Gisselbrecht C et al. Phase III study to evaluate temsirolimus compared with investigator's choice therapy for the treatment of relapsed or refractory mantle cell lymphoma. J Clin Oncol 2009; 27: 3822–3829.

Yee KW, Zeng Z, Konopleva M, Verstovsek S, Ravandi F, Ferrajoli A et al. Phase I/II study of the mammalian target of rapamycin inhibitor everolimus (RAD001) in patients with relapsed or refractory hematologic malignancies. Clin Cancer Res 2006; 12: 5165–5173.

Ghobrial IM, Gertz M, Laplant B, Camoriano J, Hayman S, Lacy M et al. Phase II trial of the oral mammalian target of rapamycin inhibitor everolimus in relapsed or refractory Waldenstrom macroglobulinemia. J Clin Oncol 2010; 28: 1408–1414.

Zent CS, LaPlant BR, Johnston PB, Call TG, Habermann TM, Micallef IN et al. The treatment of recurrent/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL) with everolimus results in clinical responses and mobilization of CLL cells into the circulation. Cancer 2010; 116: 2201–2207.

Johnston PB, Inwards DJ, Colgan JP, Laplant BR, Kabat BF, Habermann TM et al. A phase II trial of the oral mTOR inhibitor everolimus in relapsed Hodgkin lymphoma. Am J Hematol 2010; 85: 320–324.

Cheson B, Horning S, Coiffier B, Shipp M, Fisher R, Connors J et al. Report of an international workshop to standardize response criteria for non-Hodgkin's lymphoma. J Clin Oncol 1999; 17: 1244–1253.

Simon R . Optimal two-stage designs for phase II clinical trials. Control Clin Trials 1989; 10: 1–10.

Kaplan E, Meier P . Nonparametric estimation for incomplete observations. J Am Stat Assoc 1958; 53: 457–481.

Wlodarski P, Kasprzycka M, Liu X, Marzec M, Robertson ES, Slupianek A et al. Activation of mammalian target of rapamycin in transformed B lymphocytes is nutrient dependent but independent of Akt, mitogen-activated protein kinase/extracellular signal-regulated kinase kinase, insulin growth factor-I, and serum. Cancer Res 2005; 65: 7800–7808.

Dutton A, Reynolds GM, Dawson CW, Young LS, Murray PG . Constitutive activation of phosphatidyl-inositide 3 kinase contributes to the survival of Hodgkin's lymphoma cells through a mechanism involving Akt kinase and mTOR. J Pathol 2005; 205: 498–506.

Haritunians T, Mori A, O’Kelly J, Luong QT, Giles FJ, Koeffler HP . Antiproliferative activity of RAD001 (everolimus) as a single agent and combined with other agents in mantle cell lymphoma. Leukemia 2007; 21: 333–339.

Wanner K, Hipp S, Oelsner M, Ringshausen I, Bogner C, Peschel C et al. Mammalian target of rapamycin inhibition induces cell cycle arrest in diffuse large B cell lymphoma (DLBCL) cells and sensitises DLBCL cells to rituximab. Br J Haematol 2006; 134: 475–484.

Wiernik PH, Lossos IS, Tuscano JM, Justice G, Vose JM, Cole CE et al. Lenalidomide monotherapy in relapsed or refractory aggressive non-Hodgkin's lymphoma. J Clin Oncol 2008; 26: 4952–4957.

Ellard SL, Clemons M, Gelmon KA, Norris B, Kennecke H, Chia S et al. Randomized phase II study comparing two schedules of everolimus in patients with recurrent/metastatic breast cancer: NCIC Clinical Trials Group IND163. J Clin Oncol 2009; 27: 4536–4541.

Yao JC, Lombard-Bohas C, Baudin E, Kvols LK, Rougier P, Ruszniewski P et al. Daily oral everolimus activity in patients with metastatic pancreatic neuroendocrine tumors after failure of cytotoxic chemotherapy: a phase II trial. J Clin Oncol 2010; 28: 69–76.

Armand P, Gannamaneni S, Kim HT, Cutler CS, Ho VT, Koreth J et al. Improved survival in lymphoma patients receiving sirolimus for graft-versus-host disease prophylaxis after allogeneic hematopoietic stem-cell transplantation with reduced-intensity conditioning. J Clin Oncol 2008; 26: 5767–5774.

Ramakrishnan V, Timm M, Haug JL, Kimlinger TK, Wellik LE, Witzig TE et al. Sorafenib, a dual Raf kinase/vascular endothelial growth factor receptor inhibitor has significant anti-myeloma activity and synergizes with common anti-myeloma drugs. Oncogene 2010; 29: 1190–1202.