{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,13]],"date-time":"2026-05-13T09:55:24Z","timestamp":1778666124262,"version":"3.51.4"},"reference-count":45,"publisher":"SAGE Publications","issue":"2","license":[{"start":{"date-parts":[[2011,9,26]],"date-time":"2011-09-26T00:00:00Z","timestamp":1316995200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Oncol Pharm Pract"],"published-print":{"date-parts":[[2012,6]]},"abstract":"<jats:p>Purpose: The pharmacology, pharmacokinetics, clinical trials, adverse effects, dosage, and economic considerations of pralatrexate (PDX) are reviewed.<\/jats:p>\n                  <jats:p>\n                    Summary: Peripheral T-cell lymphoma (PTCL) comprises approximately 15\u201320% of all aggressive lymphomas and 5\u201310% of all non-Hodgkin\u2019s lymphomas. Advanced PTCL is often refractory to traditional first-line chemotherapy regimens. PDX was developed as a synthetic folate analog antimetabolite that competitively inhibits dihydrofolate reductase (DHFR). This results in the depletion of thymidine, leading to interference with deoxyribonucleic acid synthesis and cancer cell death. PDX has a higher potency than methotrexate and edatrexate (EDX). The efficacy and safety of PDX have been demonstrated in the PROPEL trial, a prospective phase II trial in patients with relapsed or refractory PTCL. Patients with prior stem cell transplantation receiving PDX also had similar response rates (RRs). PDX was investigated on the treatment of relapsed or refractory cutaneous T-cell lymphoma, previously treated advanced non-small cell lung cancer and other solid malignancies. PDX has similar side effects to other DHFR inhibitors. The most common side effect of PDX is mucositis. The recommended dose of PDX is 30\u2009mg\/m\n                    <jats:sup>2<\/jats:sup>\n                    weekly once for 6\u2009weeks in 7-week cycle until disease progresses or unacceptable toxicity for PTCL and may require dose reduction or discontinuation. Patients should be supplemented with oral folic acid and intramuscular vitamin B\n                    <jats:sub>12<\/jats:sub>\n                    injections.\n                  <\/jats:p>\n                  <jats:p>Conclusion: PDX provides clinical benefit to patients with relapsed or refractory PTCL with durable complete and partial responses in patients who had not responded to multiple prior treatment regimens.<\/jats:p>","DOI":"10.1177\/1078155211420605","type":"journal-article","created":{"date-parts":[[2011,9,27]],"date-time":"2011-09-27T01:45:05Z","timestamp":1317087905000},"page":"275-283","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":12,"title":["Pralatrexate: A novel synthetic antifolate for relapsed or refractory peripheral T-cell lymphoma and other potential uses"],"prefix":"10.1177","volume":"18","author":[{"given":"John","family":"Hui","sequence":"first","affiliation":[{"name":"Department of Pharmacy, Roswell Park Cancer Institute, Buffalo, NY, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eugene","family":"Przespo","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Roswell Park Cancer Institute, Buffalo, NY, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anjana","family":"Elefante","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Roswell Park Cancer Institute, Buffalo, NY, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2011,9,26]]},"reference":[{"key":"bibr1-1078155211420605","doi-asserted-by":"publisher","DOI":"10.1023\/A:1008200307625"},{"key":"bibr2-1078155211420605","doi-asserted-by":"publisher","DOI":"10.1023\/A:1008265532487"},{"key":"bibr3-1078155211420605","doi-asserted-by":"publisher","DOI":"10.1080\/10428190802455867"},{"key":"bibr4-1078155211420605","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2005-06-2508"},{"key":"bibr5-1078155211420605","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdf033"},{"key":"bibr6-1078155211420605","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.1998.16.8.2780"},{"key":"bibr7-1078155211420605","doi-asserted-by":"publisher","DOI":"10.1023\/A:1008418727472"},{"key":"bibr8-1078155211420605","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2003-09-3080"},{"key":"bibr9-1078155211420605","doi-asserted-by":"publisher","DOI":"10.3109\/07357900009032827"},{"key":"bibr10-1078155211420605","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.20999"},{"key":"bibr11-1078155211420605","doi-asserted-by":"publisher","DOI":"10.1023\/A:1008439620513"},{"key":"bibr12-1078155211420605","unstructured":"National Comprehensive Cancer Network, Inc. The NCCN clinical practice guidelines in oncology\u2122 Non-Hodgkin\u2019s Lymphoma (Version 2011), NCCN.org (accessed March 23, 2011). To view the most recent and complete version of the NCCN Guidelines.NCCN.org (accessed 23 March, 2011)"},{"key":"bibr13-1078155211420605","doi-asserted-by":"publisher","DOI":"10.1021\/jm00067a020"},{"key":"bibr14-1078155211420605","doi-asserted-by":"publisher","DOI":"10.1007\/s002800050823"},{"issue":"9","key":"bibr15-1078155211420605","first-page":"3493","volume":"6","author":"Krug LM","year":"2000","journal-title":"Clin Cancer Res"},{"key":"bibr16-1078155211420605","doi-asserted-by":"publisher","DOI":"10.1007\/s00280-005-0080-x"},{"key":"bibr17-1078155211420605","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-06-1754"},{"issue":"6","key":"bibr18-1078155211420605","first-page":"2072","volume":"9","author":"Krug LM","year":"2003","journal-title":"Clin Cancer Res"},{"key":"bibr19-1078155211420605","doi-asserted-by":"publisher","DOI":"10.1097\/01.JTO.0000263715.84567.5f"},{"key":"bibr20-1078155211420605","unstructured":"Folotyn (pralatrexate)\n                      [Package insert]. Westminster, CO: Allos Therapeutics, Inc., 2011"},{"key":"bibr21-1078155211420605","doi-asserted-by":"publisher","DOI":"10.1080\/1042819031000077124"},{"key":"bibr22-1078155211420605","doi-asserted-by":"publisher","DOI":"10.1007\/s00280-009-0954-4"},{"key":"bibr23-1078155211420605","author":"Serova M","year":"2009","journal-title":"In: Proceedings of the 100th annual meeting of the American Association for Cancer Research,"},{"key":"bibr24-1078155211420605","doi-asserted-by":"publisher","DOI":"10.1158\/1535-7163.TARG-09-B211"},{"key":"bibr25-1078155211420605","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2008.20.8470"},{"key":"bibr26-1078155211420605","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2009.80"},{"key":"bibr27-1078155211420605","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2010.29.9024"},{"key":"bibr28-1078155211420605","doi-asserted-by":"crossref","unstructured":"O\u2019Connor O, Pro B, Pinter-Brown L, Poppelwell L, Bartlett N, Lechowicz MJ, PROPEL: Results of the pivotal, multicenter, phase II study of pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) [poster abstract 8561]. J Clin Oncol 2009; 27(Suppl. 15). In: Proceedings of the 45th annual meeting of the American Society of Clinical Oncology, Orlando, FL, 29 May\u20132 June 2009.","DOI":"10.1200\/jco.2009.27.15_suppl.8561"},{"key":"bibr29-1078155211420605","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2008.16.4558"},{"key":"bibr30-1078155211420605","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.1999.17.4.1244"},{"key":"bibr31-1078155211420605","doi-asserted-by":"crossref","unstructured":"Shustov AR, Pro B, Horwitz SM, Jacobsen ED, Fruchtman S, O\u2019Connor OA. Pralatrexate in patients with relapsed\/refractory peripheral T-cell lymphoma (PTCL): Relationship between response and survival [poster abstract]. J Clin Oncol 2010; 28(Suppl. 15). In: Proceedings of the 46th annual meeting of the American Society of Clinical Oncology, Chicago, IL. 4\u20138 June 2010.","DOI":"10.1200\/jco.2010.28.15_suppl.8054"},{"key":"bibr32-1078155211420605","author":"Coiffier B","year":"2010","journal-title":"In: Proceeding of the 15thCongress of the European Hematology Association,"},{"key":"bibr33-1078155211420605","unstructured":"Poppelwell L, Pro B, Jacobsen ED, Horwitz SA, Boyd A, Patterson M, Stem Cell Transplant (SCT) and pralatrexate therapy: Outcome of patients with relapsed or refractory peripheral T-cell lymphoma who received SCT prior to or following pralatrexate therapy [poster abstract]. Blood 2009. In: Proceedings of the 51st annual meeting of the American Society of Hematology (ASH), New Orleans, LA, 668\u2013668. 5\u20138 December 2009."},{"key":"bibr34-1078155211420605","doi-asserted-by":"crossref","unstructured":"Horwitz SM, Vose J, Advani R, Sankhala K, Padmanabhan S, Hamlin P, Pralatrexate and gemcitabine in patients with relapsed or refractory lymphoproliferative malignancies: Phase 1 results [poster abstract]. Blood 2009, In: Proceedings of the 51st annual meeting of the American Society of Hematology (ASH), New Orleans, LA114(22) 667\u2013668.  5\u20138 December 2009.","DOI":"10.1182\/blood.V114.22.1674.1674"},{"key":"bibr35-1078155211420605","first-page":"120","volume":"95","author":"Horwitz SM","year":"2010","journal-title":"Haemetologica"},{"key":"bibr36-1078155211420605","unstructured":"ClinicalTrials.gov. Pralatrexate and bexarotene in patients with relapsed or refractory cutaneously T-cell lymphoma.www.clinicaltrials.gov\/ct2\/show\/NCT01134341?term=pralatrexate&rank=11(accessed 10 December 2010)"},{"key":"bibr37-1078155211420605","doi-asserted-by":"publisher","DOI":"10.1016\/S1359-6349(09)71799-9"},{"key":"bibr38-1078155211420605","unstructured":"Kelly K, Azzoli CG, Patel J. 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. Ann Oncology 2010; In: Proceedings of the 35th Congress of the European Society for Medical Oncology, Milan, Italy. viii9\u2013viii9. 8\u201312 October 2010."},{"key":"bibr39-1078155211420605","unstructured":"Allos Therapeutic I and Kelly K. Presentation: Study PDX-012: A randomized, phase 2b study of pralatrexate versus erlotinib in patients with stage IIIb\/IV non-small cell lung cancer after failure of prior platinum-based treatment,http:\/\/ir.allos.com\/phoenix.zhtml?c=125475&p=irol-presentations(accessed 11 October 2010)"},{"key":"bibr40-1078155211420605","unstructured":"Allos Therapeutic I. Press releases: Allos theraprutics announces presentation of favorable survival data from randomized phase 2b study of FOLOTYN in patients with advanced non-small cell lung cancer, Milan.http:\/\/ir.allos.com\/phoenix.zhtml?c=125475&p=irol-newsArticle&ID=1480941&highlight=(accessed 11 October 2010)"},{"key":"bibr41-1078155211420605","unstructured":"ClinicalTrials.gov. Study of pralatrexate to treat advanced or metastatic relapsed transitional cell carcinoma of the urinary bladder.http:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT00722553?term=pralatrexate&rank=9(accessed 10 December 2010)"},{"key":"bibr42-1078155211420605","unstructured":"ClinicalTrials.gov. Study of pralatrexate in female patientswith previously-treated breast cancer.http:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT01118624?term=pralatrexate&rank=10(accessed 10 December 2010)"},{"key":"bibr43-1078155211420605","unstructured":"Goy A, Pro B, Lechowicz MJ, Jacobsen ED, Young F, Crump M, Pralatrexate is effective in patients with relapsed\/refractory Peripheral T-Cell Lymphoma (PTCL) after progression following prior Ifosfamide, Carboplatin, and Etoposide (ICE)-based regimens. In: Proceedings of the 52nd ASH annual meeting and exposition, ASH, Orlando, FL, 4\u20137 December 2010."},{"key":"bibr44-1078155211420605","author":"Horwitz SM","journal-title":"In: Proceedings of the 52nd ASH annual meeting and exposition,"},{"key":"bibr45-1078155211420605","unstructured":"Foss F, Horwitz SM, Pinter-Brown L, Goy A, Pro B, Coiffier B, Pralatrexate is an effective treatment for heavily pretreated patients with relapsed\/refractory transformed Mycosis Fungoides (tMF). 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