Vorinostat Combined with High-Dose Gemcitabine, Busulfan, and Melphalan with Autologous Stem Cell Transplantation in Patients with Refractory Lymphomas

Biology of Blood and Marrow Transplantation

Volumn 21, Issue 11, 2015, Pages 1914-1920

  Nieto, Yago ^a   Valdez, Benigno C ^a   Thall, Peter F ^a   Ahmed, Sairah ^a   Jones, Roy B ^a   Hosing, Chitra ^a   Popat, Uday ^a   Shpall, Elizabeth J ^a   Qazilbash, Muzaffar ^a   Gulbis, Alison ^a   Anderlini, Paolo ^a   Alousi, Amin ^a   Shah, Nina ^a   Bashir, Qaiser ^a   Liu, Yan ^a   Oki, Yasuhiro ^a   Hagemeister, Frederick ^a   Fanale, Michelle ^a   Dabaja, Bouthaina ^a   Pinnix, Chelsea ^a   Champlin, Richard ^a   Andersson, Borje S ^a   more..

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

Author keywords

Autologous stem cell transplantation; High dose chemotherapy; Lymphoma; Phase 1 trial; Vorinostat

Indexed keywords

BUSULFAN; CD20 ANTIGEN; CYCLOPHOSPHAMIDE; DOXORUBICIN; GEMCITABINE; MELPHALAN; PREDNISONE; RITUXIMAB; VINCRISTINE; VORINOSTAT; ANTINEOPLASTIC AGENT; DEOXYCYTIDINE; HYDROXAMIC ACID;

ADOLESCENT; ADULT; AGED; ARTICLE; AUTOLOGOUS STEM CELL TRANSPLANTATION; BACTEREMIA; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; CANCER RECURRENCE; CANDIDEMIA; CLINICAL TRIAL; CONTINUOUS INFUSION; DERMATITIS; DIARRHEA; DRUG DOSE ESCALATION; DRUG MEGADOSE; DRUG SAFETY; ENTEROCOCCAL INFECTION; ERYTHEMA; EVENT FREE SURVIVAL; FEMALE; FOLLOW UP; HODGKIN DISEASE; HUMAN; HUMAN CELL; HYPERBILIRUBINEMIA; HYPERTRANSAMINASEMIA; LARGE CELL LYMPHOMA; LOADING DRUG DOSE; LOWER RESPIRATORY TRACT INFECTION; MAJOR CLINICAL STUDY; MALE; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; NEPHROTOXICITY; NEUTROPHIL; OVERALL SURVIVAL; PNEUMONIA; POSITRON EMISSION TOMOGRAPHY; SKIN TOXICITY; STAPHYLOCOCCAL PNEUMONIA; T CELL LYMPHOMA; THROMBOCYTE; TREATMENT OUTCOME; TREATMENT RESPONSE; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; VIRUS PNEUMONIA; ANALOGS AND DERIVATIVES; AUTOTRANSPLANTATION; DRUG ADMINISTRATION; HEMATOPOIETIC STEM CELL TRANSPLANTATION; IMMUNOLOGY; LYMPHOMA, LARGE B-CELL, DIFFUSE; LYMPHOMA, T-CELL; MIDDLE AGED; MORTALITY; PATHOLOGY; PHASE 1 CLINICAL TRIAL; PROCEDURES; RECURRENT DISEASE; SURVIVAL ANALYSIS; TRANSPLANTATION CONDITIONING;

ADOLESCENT; ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BUSULFAN; DEOXYCYTIDINE; DRUG ADMINISTRATION SCHEDULE; FEMALE; FOLLOW-UP STUDIES; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HODGKIN DISEASE; HUMANS; HYDROXAMIC ACIDS; LYMPHOMA, LARGE B-CELL, DIFFUSE; LYMPHOMA, T-CELL; MALE; MELPHALAN; MIDDLE AGED; RECURRENCE; SURVIVAL ANALYSIS; TRANSPLANTATION CONDITIONING; TRANSPLANTATION, AUTOLOGOUS;

EID: 84943454965     PISSN: 10838791     EISSN: 15236536     Source Type: Journal    
DOI: 10.1016/j.bbmt.2015.06.003     Document Type: Article

References (38)

1. Linch D.C., Winfield D., Goldstone A.H., et al. Dose intensification with autologous bone-marrow transplantation in relapsed and resistant Hodgkin's disease: results of a BNLI randomised trial. Lancet 1993, 341:1051-1054.
2. Schmitz N., Pfistner B., Sextro M., et al. Aggressive conventional chemotherapy compared with high-dose chemotherapy with autologous haemopoietic stem-cell transplantation for relapsed chemosensitive Hodgkin's disease: a randomised trial. Lancet 2002, 359:2065-2071.
3. Philip T., Guglielmi C., Hagenbeek A., et al. Autologous bone marrow transplantation as compared with salvage chemotherapy in relapses of chemotherapy-sensitive non-Hodgkin's lymphoma. N Engl J Med 1995, 333:1540-1545.
4. Gisselbrecht C., Glass B., Mounier N., et al. Salvage regimens with autologous transplantation for relapsed large B-cell lymphoma in the rituximab era. J Clin Oncol 2010, 28:4184-4190.
5. Blay J., Gomez F., Sebban C., et al. The International Prognostic Index correlates to survival in patients with aggressive lymphoma in relapse: analysis of the PARMA trial. Parma Group. Blood 1998, 92:3562-3568.
6. Guglielmi C., Gomez F., Philip T., et al. Time to relapse has prognostic value in patients with aggressive lymphoma enrolled onto the Parma trial. J Clin Oncol 1998, 16:3264-3269.
7. Caballero M.D., Pérez-Simón J.A., Iriondo A., et al. High-dose therapy in diffuse large cell lymphoma: results and prognostic factors in 452 patients from the GEL-TAMO Spanish Cooperative Group. Ann Oncol 2003, 14:140-151.
8. Vose J.M., Zhang M.-J., Rowlings P.A., et al. Autologous transplantation for diffuse aggressive non-Hodgkin's lymphoma in patients never achieving remission: a report from the Autologous Blood and Marrow Transplant Registry. J Clin Oncol 2011, 19:406-413.
9. Lazarus H.M., Loberiza F.R., Zhang M.J., et al. Autotransplants for Hodgkin's disease in first relapse or second remission: a report from the autologous blood and marrow transplant registry (ABMTR). Bone Marrow Transplant 2001, 27:387-396.
10. Sureda A., Constans M., Iriondo A., et al. Prognostic factors affecting long-term outcome after stem cell transplantation in Hodgkin's lymphoma autografted after a first relapse. Ann Oncol 2005, 16:625-633.
11. Nieto Y., Thall P., Valdez B., et al. High-dose infusional gemcitabine combined with busulfan and melphalan with autologous stem-cell transplantation in patients with refractory lymphoid malignancies. Biol Blood Marrow Transplant 2012, 18:1677-1686.
12. Grunewald R., Kantarjian H., Du M., et al. Gemcitabine in leukemia: a phase I clinical, plasma, and cellular pharmacology study. J Clin Oncol 1992, 10:406-413.
13. Gandhi V., Plunkett W., Du M., et al. Prolonged infusion of gemcitabine: clinical and pharmacodynamic studies during a phase I trial in relapsed acute myelogenous leukemia. J Clin Oncol 2002, 20:665-673.
14. Nieto Y., Popat U., Anderlini P., et al. Autologous stem cell transplantation for refractory or poor-risk relapsed Hodgkin's lymphoma: effect of the specific high-dose chemotherapy regimen on outcome. Biol Blood Marrow Transplant 2013, 19:410-417.
15. Bolden J.E., Peart M.J., Johnstone R.W. Anticancer activities of histone deacetylase inhibitors. Nat Rev Drug Discov 2006, 5:769-784.
16. Valdez B.C., Nieto Y., Murray D., et al. Epigenetic modifiers the synergistic cytotoxicity of combined nucleoside analog-DNA alkylating agents in lymphoma cell lines. Exp Hematol 2012, 40:800-810.
17. Rogakou E.P., Pilch D.R., Orr A.H., et al. DNA double-stranded breaks induce histone H2AX phosphorylation on serine 139. J Biol Chem 1998, 273:5858-5868.
18. Kelly W.K., O'Connor O.A., Krug L.M., et al. Phase I study of an oral histone deacetylase inhibitor, suberoylanilide hydroxamic acid, in patients with advanced cancer. J Clin Oncol 2005, 23:3923-3931.
19. Juweid M.E., Stroobants S., Hoekstra O.S., et al. Use of positron emission tomography for response assessment of lymphoma: consensus of the Imaging Subcommittee of International Harmonization Project in Lymphoma. J Clin Oncol 2007, 25:571-578.
20. De Lima M., Couriel D., Thall P.F., et al. Once-daily intravenous busulfan and fludarabine: clinical and pharmacokinetic results of a myeloablative, reduced-toxicity conditioning regimen for allogeneic stem cell transplantation in AML and MDS. Blood 2004, 104:857-864.
21. Kebriaei P., Madden T., Kazerooni R., et al. Intravenous busulfan plus melphalan is a highly effective, well-tolerated preparative regimen for autologous stem cell transplantation in patients with advanced lymphoid malignancies. Biol Blood Marrow Transplant 2011, 17:412-420.
22. O'Quigley J., Pepe M., Fisher L. Continual reassessment method: A practical design for phase I clinical trial in cancer. Biometrics 1990, 46:33-48.
23. NCI Common Toxicity Critera v 3.0. Available at: http://ctep.cancer.gov/protocoldevelopment/electronic.../ctcaev3.pdf.
24. Ewald B., Sampath D., Plunkett W. H2AX phosphorylation marks gemcitabine-induced stalled replication forks and their collapse upon S-phase checkpoint abrogation. Mol Cancer Ther 2007, 6:1239-1248.
25. Cheson B.D., Pfistner B., Juweid M.E., et al. Revised response criteria for malignant lymphoma. J Clin Oncol 2007, 25:579-586. International Harmonization Project on Lymphoma.
26. Kaplan E.L., Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958, 53:457-481.
27. Mantel N. Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemother Rep 1966, 50:163-176.
28. Fisher R. On the interpretation of x2 from contingency tables, and the calculation of P. J Royal Stat Soc 1922, 85:87-94.
29. D'Amours D., Desnoyers S., D'Silva I., Poirier G.G. Poly(ADP-ribosyl)ation reactions in the regulation of nuclear functions. Biochem J 1999, 342:249-268.
30. Garcia-Manero G., Tambaro F.P., Bekele N.B., et al. Phase II trial of vorinostat with idarubicin and cytarabine for patients with newly diagnosed acute myelogenous leukemia or myelodysplastic syndrome. J Clin Oncol 2012, 30:2204-2210.
31. Munster P.N., Marchion D., Thomas S., et al. Phase I trial of vorinostat and doxorubicin in solid tumors: Histone deacetylase 2 expression as a predictive marker. Br J Cancer 2009, 101:1044-1050.
32. Fakih M.G., Pendyala L., Fetterly G., et al. A phase I, pharmacokinetic and pharmacodynamic study of vorinostat in combination with 5-fluorouracil, leucovorin, and oxaliplatin in patients with refractory colorectal cancer. Clin Cancer Res 2009, 15:3189-3195.
33. Ramalingam S.S., Maitland M.L., Frankel P., et al. Carboplatin and paclitaxel in combination with either vorinostat or placebo for first-line therapy of advanced non-small-cell lung cancer. J Clin Oncol 2010, 28:56-62.
34. Buglio D., Georgakis G.V., Hanabuchi S., et al. Vorinostat inhibits STAT6-mediated TH2 cytokine and TARC production and induces cell death in Hodgkin lymphoma cell lines. Blood 2008, 112:1424-1433.
35. Artz A.S., Wickrema A., Dinner S., et al. Pretreatment C-reactive protein is a predictor for outcomes after reduced-intensity allogeneic hematopoietic cell transplantation. Biol Blood Marrow Transplant 2008, 14:1209-1216.
36. Lim Z.Y., Fiaccadori V., Gandhi S., et al. Impact of pre-transplant serum ferritin on outcomes of patients with myelodysplastic syndromes or secondary acute myeloid leukaemia receiving reduced intensity conditioning allogeneic haematopoietic stem cell transplantation. Leuk Res 2010, 34:723-727.
37. Kataoka K., Nannya Y., Iwata H., et al. Plasma brain natriuretic peptide is associated with hepatic veno-occlusive disease and early mortality after allogeneic hematopoietic stem cell transplantation. Bone Marrow Transplant 2010, 45:1631-1637.
38. Matsubara J., Ono M., Negishi A., et al. Identification of a predictive biomarker for hematologic toxicities of gemcitabine. J Clin Oncol 2009, 27:2261-2268.