Evaluation of the pharmacokinetics, preclinical and clinical efficacy of pralatrexate for the treatment of T-cell lymphoma

Bibliography

• Rodriguez-Abreu D, Filho VB, Zucca E. Peripheral T-cell lymphomas, unspecified (or not otherwise specified): a review. Hematol Oncol 2008;7(1):8-20
   Google Scholar
• Vose J, Armitage J, Weisenburger D. International peripheral T-cell and natural killer/T-cell lymphoma study: pathology findings and clinical outcomes. J Clin Oncol 2008;26(25):4124-30
   PubMed Web of Science ®Google Scholar
• The Non-Hodgkin's Lymphoma Classification Project. A clinical evaluation of the International Lymphoma Study Group classification of non-Hodgkin's lymphoma. Blood 1997;89(11):3909-18
   PubMed Web of Science ®Google Scholar
• NCCN GuidelinesTM Non-Small Cell Lung Cancer Panel. NCCN clinical practice guidelines in oncology: non-small cell lung cancer. v 2.2011. Fort Washington, PA: National Comprehensive Cancer Network; 2010. Available from: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp [Accessed 22 Dec 2010]
   Google Scholar
• Chen AI, Advani RH. Beyond the guidelines in the treatment of peripheral T-cell lymphoma: new drug development. J Natl Compr Canc Netw 2008;6(4):428-35
   PubMedGoogle Scholar
• Mercieca J, Matutes E, Dearden C, The role of pentostatin in the treatment of T-cell malignancies: analysis of response rate in 145 patients according to disease subtype. J Clin Oncol 1994;12(12):2588-93
   PubMed Web of Science ®Google Scholar
• Tsimberidou AM, Giles F, Duvic M, Phase II study of pentostatin in advanced T-cell lymphoid malignancies: update of an M.D. Anderson Cancer Center series. Cancer 2004;100(2):342-9
   PubMed Web of Science ®Google Scholar
• Zinzani PL, Martelli M, Magagnoli M, Anaplastic large cell lymphoma Hodgkin's-Like: a randomized trial of ABVD Versus MACOP-B with and without radiation therapy. Blood 1998;92(3):790-4
   PubMed Web of Science ®Google Scholar
• Sallah S, Wan JY, Nguyen NP. Treatment of refractory T-cell malignancies using gemcitabine. Br J Haematol 2001;113(1):185-7
   PubMed Web of Science ®Google Scholar
• Enblad G, Hagberg H, Erlanson M, A pilot study of alemtuzumab (anti-CD52 monoclonal antibody) therapy for patients with relapsed or chemotherapy-refractory peripheral T-cell lymphomas. Blood 2004;103(8):2920-4
   PubMed Web of Science ®Google Scholar
• Dang NH, Pro B, Hagemeister FB, Phase II trial of denileukin diftitox for relapsed/refractory T-cell non-Hodgkin lymphoma. Br J Haematol 2007;136(3):439-47
   PubMed Web of Science ®Google Scholar
• Zinzani PL, Musuraca G, Tani M, Phase II trial of proteasome inhibitor bortezomib in patients with relapsed or refractory cutaneous T-cell lymphoma. J Clin Oncol 2007;25(27):4293-7
   PubMed Web of Science ®Google Scholar
• Czuczman MS, Porcu P, Johnson J, Results of a phase II study of 506U78 in cutaneous T-cell lymphoma and peripheral T-cell lymphoma: CALGB 59901. Leuk Lymphoma 2007;48(1):97-103
   PubMed Web of Science ®Google Scholar
• Dueck GS, Chua N, Prasad A, Activity of lenalidomide in a phase II trial for T-cell lymphoma: Report on the first 24 cases. (Meeting Abstracts). J Clin Oncol 2009;27(15S):abstract 8524
   Google Scholar
• O'Connor O, Pro B, Pinter-Brown L, Pralatrexate in patients with relapsed or refractory peripheral T-Cell lymphoma (PTCL): results from the pivotal PROPEL study. J Clin Oncol 2011;29(9):1182-9
   PubMed Web of Science ®Google Scholar
• Thompson CA. FDA approves pralatrexate for treatment of rare lymphoma. Am J Health Syst Pharm 2009;66(21):1890
   PubMed Web of Science ®Google Scholar
• Allos Therapeutics I. FOLOTYN® US Prescribing Information/ Patient Package Insert Rev. 3. In; 2011
   Google Scholar
• Azzoli CG, Krug LM, Gomez J, A phase 1 study of pralatrexate in combination with paclitaxel or docetaxel in patients with advanced solid tumors. Clin Cancer Res 2007;13(9):2692-8
   PubMed Web of Science ®Google Scholar
• Horwitz S, Kim YH, Foss F, Identification of an active, well-tolerated dose of pralatrexate in patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL): Results of a multicenter dose-finding study (poster 2800. Presented at American Society of Hematology (ASH) 52nd Annual Meeting, Dec 4-7; Orlando, FL, 2010
   Google Scholar
• Fury MG, Krug LM, Azzoli CG, A phase I clinical pharmacologic study of pralatrexate in combination with probenecid in adults with advanced solid tumors. Cancer Chemother Pharmacol 2005;57(5):1-7
   PubMedGoogle Scholar
• Krug LM, Azzoli CG, Kris MG, 10-propargyl-10-deazaaminopterin: an antifolate with activity in patients with previously treated non-small cell lung cancer. Clin Cancer Res 2003;9(6):2072-8
   PubMed Web of Science ®Google Scholar
• Kelly K, Azzoli CG, Patel JD, Randomized phase 2B study of pralatrexate vs erlotinib in patients with stage IIIB/IV non-small cell lung cancer (NSCLC) after failure of prior platinum based therapy (abstract LBA17). Presented at 35th European Society for Medical Oncology (ESMO) Congress, Milan, IT. Ann Oncol 2010;21(Suppl 8):viii8
   Google Scholar
• Sirotnak FM, DeGraw JI. Selective antitumor action of folate analogs. In: Sirotnak FM, Burchall JJ, Ensminger WD, Montgomery JA. editors, Folate antagonists as therapeutic agents. Academic Press, Inc; NY; 1984. p. 43-95
   Google Scholar
• Sirotnak FM, Schmid FA, Samuels LL, 10-Ethyl-10-deaza-aminopterin: structural design and biochemical, pharmacologic, and antitumor properties. NCI Monogr 1987;5:127-31
   PubMedGoogle Scholar
• Sirotnak FM, DeGraw JI, Schmid FA, New folate analogs of the 10-deaza-aminopterin series. Further evidence for markedly increased antitumor efficacy compared with methotrexate in ascitic and solid murine tumor models. Cancer Chemother Pharmacol 1984;12(1):26-30
   PubMed Web of Science ®Google Scholar
• Izbicka E, Diaz A, Campos D, Differential activity and potential mechanism of action of pralatrexate (PDX) methotrexate, and pemetrexed (Alimta) in human cancer models in vivo and in vitro (abstract A135). Proceedings of AACR-NCI-EORTC International Conference Molecular Targets and Cancer Therapeutics: Discovery, Biology, and Clinical Applications. October 22-26, 2007. p. 108
   Google Scholar
• Wang AR, Zhu S, Matyjaszewski K. ESR study and radical observation in transition metal-mediated polymerization: unified view of atom transfer radical polymerization mechanism. ACS Symposium Series. (Advances in Controlled/Living Radical Polymerization). Volume 854 2003. p. 161-79
   Google Scholar
• Serova M, Bieche I, Sablin M-P, Single agent and combination studies of pralatrexate and molecular correlates of sensitivity. Br J Cancer 2011;104:272-80
   PubMed Web of Science ®Google Scholar
• Wang ES, O'Connor O, She Y, Activity of a novel anti-folate (PDX, 10-propargyl 10-deazaaminopterin) against human lymphoma is superior to methotrexate and correlates with tumor RFC-1 Gene Expression. Leuk Lymphoma 2003;44(6):1027-35
   PubMed Web of Science ®Google Scholar
• Sirotnak FM, DeGraw JI, Colwell WT, A new analogue of 10-deazaaminopterin with markedly enhanced curative effects against human tumor xenografts in mice. Cancer Chemother Pharmacol 1998;42(4):313-18
   PubMed Web of Science ®Google Scholar
• Venitz J, Brar SS, Pronk GJ, Pralatrexate pharmacokinetics with intravenous administration to oncology patients (poster # B211). J Clin Oncol 2009;25(Suppl 1):608s
   Google Scholar
• Toner LE, Vrhovac R, Smith EA, The schedule-dependent effects of the novel antifolate pralatrexate and gemcitabine are superior to methotrexate and cytarabine in models of human non-Hodgkin's lymphoma. Clin Cancer Res 2006;12(3):924-32
   PubMed Web of Science ®Google Scholar
• Marchi E, Paoluzzi L, Sesham VE, Pralatrexate shows synergistic activity with the proteasome inhibitor Bortezomib in in vitro and in vivo models of lymphoid T-cell malignancies. presented at: Italian Society of Hematology (SIE) - Corso Nazionale di Aggiormento in Ematologia Clinica, June 18-19, Bolzano, Italy 2009
   Google Scholar
• Krug LM, Ng KK, Kris MG, Phase I and pharmacokinetic study of 10-propargyl-10-deazaaminopterin, a new antifolate. Clin Cancer Res 2000;6(9):3493-8
   PubMed Web of Science ®Google Scholar
• Azzoli CG, Krug LM, Miller VA, Phase II Study of 10-propargyl-10-deazaaminopterin (PDX) in previously-treated patients with advanced non-small cell lung cancer (NCSLC) [abstract 1321]. Proc Am Soc Clin Oncol 2001;20:331a
   Google Scholar
• Azzoli CG, Krug LM, Miller VA, Phase I study of 10-propargyl-10-deazaaminopterin (PDX) plus docetaxel or paclitaxel in patients with advanced cancer (abstract A182) from AACR-NCI-EORTC International Conference on "Molecular Targets and Cancer Therapeutics". Clin Cancer Res 2003;9(16 Pt 2):6114s
   Google Scholar
• Gomez J, Azzoli C, Krug L, Phase 1 study of 10-propargyl-10-deazaaminopterin (PDX, pralatrexate) plus docetaxel in patients with advanced non-small cell lung cancer (NSCLC) (abstract P-486). Presented at the 11th World Conference on Lung Cancer. Lung Cancer 2005;49(Suppl 2):s244-5
   Google Scholar
• Krug LM, Heelan RT, Kris MG, Phase II Trial of Pralatrexate (10-Propargyl-10-deazaaminopterin, PDX) in patients with Unresectable Malignant Pleural Mesothelioma. J Thorac Oncol 2007;2(4):317-20
   PubMed Web of Science ®Google Scholar
• Azzoli C, Krug L, Miller V, Phase I study of the antifolate pralatrexate given with vitamin B12 and folic acid supplementation in patients (pts) with advanced non-small cell lung cancer (NSCLC). J Clin Oncol ASCO Annual Meeting Proceedings Part 1 2007;25(18S):abstract 13006
   Google Scholar
• O'Connor OA, Horwitz S, Hamlin P, Phase II-I-II study of two different doses and schedules of pralatrexate, a high-affinity substrate for the reduced folate carrier, in patients with relapsed or refractory lymphoma reveals marked activity in T-cell malignancies. J Clin Oncol 2009;27(26):4357-64
   PubMed Web of Science ®Google Scholar
• Mould DR, Sweeney K, Duffull SB, A population pharmacokinetic and pharmacodynamic evaluation of pralatrexate in patients with relapsed or refractory non-Hodgkin's or Hodgkin's lymphoma. Clin Pharmacol Ther 2009;86(2):190-6
   PubMed Web of Science ®Google Scholar
• Horwitz SM, Duvic M, Kim Y, Pralatrexate is active in cutaneous T-cell lymphoma (CTCL): results of a multicenter, dose-finding trial. [abstract 919]. Proceedings of the American Society of Hematology (ASH) 51st Annual Meeting. Blood 2009;114(22):379
   Google Scholar
• Horwitz SM, Vose JM, Advani R, Pralatrexate and gemcitabine in patients with relapsed or refractory lymphoproliferative malignancies: phase 1 results. (abstract 1674). Proceedings of the American Society of Hematology (ASH) 51st Annual Meeting. Blood 2009;114(22):667
   PubMed Web of Science ®Google Scholar
• Marneros AG, Grossman ME, Silvers DN, Pralatrexate-induced tumor cell apoptosis in the epidermis of a patient with HTLV-1 adult T-cell lymphoma/leukemia causing skin erosions. Blood 2009;113(25):6338-41
   PubMed Web of Science ®Google Scholar
• Campo E, Gaulard P, Zucca E, Report of the European Task Force on Lymphomas: workshop on peripheral T-cell lymphomas. Ann Oncol 1998;9(8):835-43
   PubMed Web of Science ®Google Scholar