Difference between revisions of "Peripheral T-cell lymphoma"
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|style="background-color:#eeee00"|Phase III, <20 in this arm | |style="background-color:#eeee00"|Phase III, <20 in this arm | ||
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|[[Peripheral_T-cell_lymphoma#DHAP|DHAP]] | |[[Peripheral_T-cell_lymphoma#DHAP|DHAP]] | ||
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Revision as of 19:36, 26 December 2017
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30 regimens on this page
37 variants on this page
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Guidelines
ESMO
- Peripheral T-cell lymphomas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. (2015) PubMed
- ESMO Consensus conferences: guidelines on malignant lymphoma. part 2: marginal zone lymphoma, mantle cell lymphoma, peripheral T-cell lymphoma. (2013) PubMed
NCCN
Untreated, randomized data
CHOP
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CHOP: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Prednisone
Synonyms: CHOP-21, ACOP, CAVP, COPA, VACP, VCAP
Structured Concept: C9549 (NCI-T), C0055598 (NCI-MT/UMLS)
Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Simon et al. 2010 (GOELAMS LTP95) | Phase III | VIP-rABVD | Seems not superior |
Chemotherapy
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose per cycle: 2 mg) IV once on day 1
- Prednisone (Sterapred) 100 mg/m2 PO once per day on days 1 to 5
21-day cycle for 8 cycles
Radiation therapy for initial bulky disease
"Initial bulky disease": patients with "diameter = 5 cm"
- Radiation therapy, 40 Gy at 1.8 Gy/day to the involved field
References
- Simon A, Peoch M, Casassus P, Deconinck E, Colombat P, Desablens B, Tournilhac O, Eghbali H, Foussard C, Jaubert J, Vilque JP, Rossi JF, Lucas V, Delwail V, Thyss A, Maloisel F, Milpied N, le Gouill S, Lamy T, Gressin R. Upfront VIP-reinforced-ABVD (VIP-rABVD) is not superior to CHOP/21 in newly diagnosed peripheral T cell lymphoma. Results of the randomized phase III trial GOELAMS-LTP95. Br J Haematol. 2010 Oct;151(2):159-66. Epub 2010 Aug 25. link to original article contains verified protocol PubMed
Untreated, non-randomized or retrospective data
CHOEP-14
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CHOEP-14: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Etoposide, Prednisone every 14 days
Regimen
Study | Evidence |
d'Amore et al. 2012 (NLG-T-01) | Phase II |
Chemotherapy
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg) IV once on day 1
- Etoposide (Vepesid) as follows:
- Up to age 60: 100 mg/m2 IV once per day on days 1 to 3
- Older than 60: omitted
- Prednisone (Sterapred) 50 mg PO BID on days 1 to 5
14-day cycle for 6 cycles
If patients in PR or CR after three cycles, stem cells are mobilized off of cycles 5 and 6, followed by BEAC or BEAM, then auto HSCT.
References
- d'Amore F, Relander T, Lauritzsen GF, Jantunen E, Hagberg H, Anderson H, Holte H, Österborg A, Merup M, Brown P, Kuittinen O, Erlanson M, Østenstad B, Fagerli UM, Gadeberg OV, Sundström C, Delabie J, Ralfkiaer E, Vornanen M, Toldbod HE. Up-front autologous stem-cell transplantation in peripheral T-cell lymphoma: NLG-T-01. J Clin Oncol. 2012 Sep 1;30(25):3093-9. Epub 2012 Jul 30. link to original article contains verified protocol PubMed
CHOP
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CHOP: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Prednisone
Synonyms: CHOP-21, ACOP, CAVP, COPA, VACP, VCAP
Structured Concept: C9549 (NCI-T), C0055598 (NCI-MT/UMLS)
Regimen
Study | Evidence |
Reimer et al. 2004 | Phase II |
This study reports using CHOP but doesn't specify the doses; below is a fairly standard CHOP regimen:
Chemotherapy
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg) IV once on day 1
- Prednisone (Sterapred) 100 mg PO once per day on days 1 to 5
21-day cycle for 4 to 6 cycles
If CR obtained after 4 cycles or at least a PR after 6 cycles, patients proceeded to autologous HSCT.
References
- Reimer P, Schertlin T, Rüdiger T, Geissinger E, Roth S, Kunzmann V, Weissinger F, Nerl C, Schmitz N, Müller-Hermelink HK, Wilhelm M. Myeloablative radiochemotherapy followed by autologous peripheral blood stem cell transplantation as first-line therapy in peripheral T-cell lymphomas: first results of a prospective multicenter study. Hematol J. 2004;5(4):304-11. PubMed
- Update: Reimer P, Rüdiger T, Geissinger E, Weissinger F, Nerl C, Schmitz N, Engert A, Einsele H, Müller-Hermelink HK, Wilhelm M. Autologous stem-cell transplantation as first-line therapy in peripheral T-cell lymphomas: results of a prospective multicenter study. J Clin Oncol. 2009 Jan 1;27(1):106-13. Epub 2008 Nov 24. link to original article PubMed
- Meta-analysis: Abouyabis AN, Shenoy PJ, Sinha R, Flowers CR, Lechowicz MJ. A Systematic Review and Meta-Analysis of Front-line Anthracycline-Based Chemotherapy Regimens for Peripheral T-Cell Lymphoma. ISRN Hematol. 2011;2011:623924. Epub 2011 Jun 16. link to original article link to PMC article PubMed
CHOP & Everolimus
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CHOP: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Prednisone
Regimen
Study | Evidence |
Kim et al. 2016 | Phase II |
This study reports using CHOP but doesn't specify the doses in the abstract; below is a fairly standard CHOP regimen:
Chemotherapy
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg) IV once on day 1
- Prednisone (Sterapred) 100 mg PO once per day on days 1 to 5
- Everolimus (Afinitor) 5 mg PO once per day on days 1 to 14
21-day cycle for 6 cycles
References
- Kim SJ, Shin DY, Kim JS, Yoon DH, Lee WS, Lee H, Do YR, Kang HJ, Eom HS, Ko YH, Lee SH, Yoo HY, Hong M, Suh C, Kim WS. A phase II study of everolimus (RAD001), an mTOR inhibitor plus CHOP for newly diagnosed peripheral T-cell lymphomas. Ann Oncol. 2016 Apr;27(4):712-8. link to original article contains protocol PubMed
CHOP-AL, then HyperCHidam
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CHOP-AL: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Prednisone, ALemtuzumab
HyperCHidam: Hyperfractionated Cyclophosphamide, Hiigh-dose ara-c (Cytarabine) & methotrexate
Regimen
Study | Evidence |
Corradini et al. 2014 | Phase II |
These are the details for "Clin A" which was the regimen used for patients younger than 60.
Chemotherapy, CHOP portion
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg) IV once on day 1
- Prednisone (Sterapred) 100 mg PO once per day on days 1 to 5
- Alemtuzumab (Campath) as follows
- 3 mg IV once on day -2 before cycle 1
- 10 mg IV once on day -1 before cycle 1
- 20 mg IV once on day 0 before cycle 1
- 30 mg IV once on day 0 before cycle 2 (= day 21 of cycle 1)
21-day cycle for 2 cycles, followed by:
Chemotherapy, HyperCHidam portion
- Methotrexate (MTX) 1.6 g/m2 IV as a continuous infusion on day 1
- Cyclophosphamide (Cytoxan) 300 mg/m2 IV q12h for 3 days (start day not specified)
- Cytarabine (Cytosar) 2 g/m2 IV q12h for 3 days (start day not specified)
Supportive medications
- Granulocyte-colony stimulating factor 5 mcg/kg once per day was given from day +5 (stop date not specified)
Duration not specified x 2 cycles
Responders (PR/CR) proceeded to allogeneic HSCT.
References
- Corradini P, Vitolo U, Rambaldi A, Miceli R, Patriarca F, Gallamini A, Olivieri A, Benedetti F, Todeschini G, Rossi G, Salvi F, Bruno B, Baldini L, Ferreri A, Patti C, Tarella C, Pileri S, Dodero A. Intensified chemo-immunotherapy with or without stem cell transplantation in newly diagnosed patients with peripheral T-cell lymphoma. Leukemia. 2014 Sep;28(9):1885-91. Epub 2014 Feb 20. link to original article contains verified protocol PubMed
DA-EPOCH
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DA-EPOCH: Dose Adjusted Etoposide, Prednisone, Oncovin (Vincristine), Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin)
Regimen
Study | Evidence | Efficacy |
---|---|---|
Maeda et al. 2017 (West-JHOG PTCL0707) | Phase II | ORR: 78% (95% CI 62-89) |
Note: the authors state that they followed the Wilson et al. 2002 protocol, but there are some differences, in particular 1) it isn't clear whether prednisone is given once or twice per day; and 2) dose adjustments below level 1 are different based on age.
Chemotherapy
- Etoposide (Vepesid) 50 mg/m2/day IV continuous infusion on days 1 to 4 (total dose per cycle: 200 mg/m2)
- Prednisone (Sterapred) 60 mg/m2 on days 1 to 5
- Vincristine (Oncovin) 0.4 mg/m2/day IV continuous infusion on days 1 to 4 (total dose per cycle: 1.6 mg/m2)
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV over 2 hours once on day 5
- Doxorubicin (Adriamycin) 10 mg/m2/day IV continuous infusion on days 1 to 4 (total dose per cycle: 40 mg/m2)
Supportive medications
- G-CSF starting on day 6 and continuing until ANC greater than 5000/uL past nadir
- Trimethoprim/Sulfamethoxazole (Bactrim DS) (dose not specified)
- Fluconazole (Diflucan) (dose not specified)
21-day cycle for 6 to 8 cycles
Dose-adjustments
- Start cycle 1 as described above.
- Obtain CBCs twice per week for nadir measurements.
- If nadir ANC greater than 500/uL, increase etoposide, doxorubicin, and cyclophosphamide by 20% compared to previous cycle.
- If nadir ANC less than 500/uL on 1 or 2 measurements, use same doses as last cycle.
- If nadir ANC less than 500/uL on at least 3 measurements, decrease etoposide, doxorubicin, and cyclophosphamide by 20% compared to previous cycle.
- And/or if nadir platelet count less than 25 x 109/L on at least 1 measurement, decrease etoposide, doxorubicin, and cyclophosphamide by 20% compared to previous cycle.
- Patients younger than 70: Dose adjustments below the cycle 1 starting dose only apply to cyclophosphamide. That is, the lowest etoposide and doxorubicin would be dosed is at the original cycle 1 dose.
- Patients 70 and older: Dose adjustments below the cycle 1 starting dose apply to all drugs
- (Presumed, based on Wilson et al. 2002): Can start new cycle every 21 days if ANC greater than 1000/uL and platelets greater than 100 x 109/L. If counts are below those levels, check daily CBC and continue growth factor support until counts are adequate and next cycle can start.
References
- Maeda Y, Nishimori H, Yoshida I, Hiramatsu Y, Uno M, Masaki Y, Sunami K, Masunari T, Nawa Y, Yamane H, Gomyo H, Takahashi T, Yano T, Matsuo K, Ohshima K, Nakamura S, Yoshino T, Tanimoto M. Dose-adjusted EPOCH chemotherapy for untreated peripheral T-cell lymphomas: a multicenter phase II trial of West-JHOG PTCL0707. Haematologica. 2017 Dec;102(12):2097-2103. Epub 2017 Sep 29. link to original article contains verified protocol PubMed
DD-CHOP
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DD-CHOP: Denileukin, Diftitox, Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Prednisone
Regimen
Study | Evidence | Efficacy |
---|---|---|
Foss et al. 2013 (CONCEPT) | Phase II | ORR: 65% |
Chemotherapy
- Denileukin diftitox (Ontak) 18 mcg/kg IV over 60 minutes once per day on days 1 & 2
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 3
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 3
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg) IV once on day 3
- Prednisone (Sterapred) 100 mg PO once per day on days 3 to 7
Supportive medications
- Dexamethasone (Decadron) 4 to 8 mg IV/PO prior to Denileukin diftitox (Ontak)
- Acetaminophen (Tylenol) 650 mg PO prior to Denileukin diftitox (Ontak)
- Diphenhydramine (Benadryl) 25 mg IV prior to Denileukin diftitox (Ontak)
- Normal saline 250 to 500 cc before and after each Denileukin diftitox (Ontak) infusion
- Antiemetics "per institutional standard"
- G-CSF support beginning on day 4
21-day cycle for 6 to 8 cycles
References
- Foss FM, Sjak-Shie N, Goy A, Jacobsen E, Advani R, Smith MR, Komrokji R, Pendergrass K, Bolejack V. A multicenter phase II trial to determine the safety and efficacy of combination therapy with denileukin diftitox and cyclophosphamide, doxorubicin, vincristine and prednisone in untreated peripheral T-cell lymphoma: the CONCEPT study. Leuk Lymphoma. 2013 Jul;54(7):1373-9. Epub 2013 Jan 29. link to original article contains verified protocol PubMed
Consolidation and/or maintenance after upfront therapy
Allogeneic hematopoietic stem cell transplant
To be completed. Usually reserved for younger and very fit individuals. See details about preparative regimens.
Regimen
Study | Evidence |
Corradini et al. 2014 | Phase II |
Preceding treatment
Details to be completed.
Chemotherapy
References
- Corradini P, Tarella C, Olivieri A, Gianni AM, Voena C, Zallio F, Ladetto M, Falda M, Lucesole M, Dodero A, Ciceri F, Benedetti F, Rambaldi A, Sajeva MR, Tresoldi M, Pileri A, Bordignon C, Bregni M. Reduced-intensity conditioning followed by allografting of hematopoietic cells can produce clinical and molecular remissions in patients with poor-risk hematologic malignancies. Blood. 2002 Jan 1;99(1):75-82. link to original article PubMed
- Corradini P, Vitolo U, Rambaldi A, Miceli R, Patriarca F, Gallamini A, Olivieri A, Benedetti F, Todeschini G, Rossi G, Salvi F, Bruno B, Baldini L, Ferreri A, Patti C, Tarella C, Pileri S, Dodero A. Intensified chemo-immunotherapy with or without stem cell transplantation in newly diagnosed patients with peripheral T-cell lymphoma. Leukemia. 2014 Sep;28(9):1885-91. Epub 2014 Feb 20. link to original article contains verified protocol PubMed
Autologous hematopoietic stem cell transplant
To be completed. See details about preparative regimens.
Regimen
Study | Evidence |
Reimer et al. 2004 | Phase II |
Preceding treatment
Patients received either DexaBEAM or ESHAP followed by autologous stem cell transplant. Details are not available with regards to the conditioning regimens.
References
- Reimer P, Schertlin T, Rüdiger T, Geissinger E, Roth S, Kunzmann V, Weissinger F, Nerl C, Schmitz N, Müller-Hermelink HK, Wilhelm M. Myeloablative radiochemotherapy followed by autologous peripheral blood stem cell transplantation as first-line therapy in peripheral T-cell lymphomas: first results of a prospective multicenter study. Hematol J. 2004;5(4):304-11. PubMed
- Update: Reimer P, Rüdiger T, Geissinger E, Weissinger F, Nerl C, Schmitz N, Engert A, Einsele H, Müller-Hermelink HK, Wilhelm M. Autologous stem-cell transplantation as first-line therapy in peripheral T-cell lymphomas: results of a prospective multicenter study. J Clin Oncol. 2009 Jan 1;27(1):106-13. Epub 2008 Nov 24. link to original article PubMed
- d'Amore F, Relander T, Lauritzsen GF, Jantunen E, Hagberg H, Anderson H, Holte H, Österborg A, Merup M, Brown P, Kuittinen O, Erlanson M, Østenstad B, Fagerli UM, Gadeberg OV, Sundström C, Delabie J, Ralfkiaer E, Vornanen M, Toldbod HE. Up-front autologous stem-cell transplantation in peripheral T-cell lymphoma: NLG-T-01. J Clin Oncol. 2012 Sep 1;30(25):3093-9. Epub 2012 Jul 30. link to original article contains verified protocol PubMed
Relapsed or refractory, randomized data
DHAP
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DHAP: Dexamethasone, High-dose Ara-C (Cytarabine), Platinol (Cisplatin)
Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Crump et al. 2014 (NCIC-CTG LY.12) | Phase III, <20 in this arm | GDP | Seems non-inferior |
Chemotherapy
- Dexamethasone (Decadron) 40 mg PO once per day on days 1 to 4
- Cytarabine (Cytosar) 2000 mg/m2 IV over 3 hours Q12H x 2 doses on day 2 (total of 2 doses)
- Cisplatin (Platinol) 100 mg/m2 IV continuous infusion over 24 hours on day 1
21-day cycle for up to 3 cycles
References
- Crump M, Kuruvilla J, Couban S, MacDonald DA, Kukreti V, Kouroukis CT, Rubinger M, Buckstein R, Imrie KR, Federico M, Di Renzo N, Howson-Jan K, Baetz T, Kaizer L, Voralia M, Olney HJ, Turner AR, Sussman J, Hay AE, Djurfeldt MS, Meyer RM, Chen BE, Shepherd LE. Randomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG LY.12. J Clin Oncol. 2014 Nov 1;32(31):3490-6. Epub 2014 Sep 29. link to original article contains verified protocol PubMed
GDP
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GDP: Gemcitabine, Dexamethasone, Platinol (Cisplatin)
Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Crump et al. 2014 (NCIC-CTG LY.12) | Phase III, <20 in this arm | DHAP | Seems non-inferior |
Chemotherapy
- Gemcitabine (Gemzar) 1000 mg/m2 IV once per day on days 1 & 8
- Dexamethasone (Decadron) 40 mg PO once per day on days 1 to 4
- Cisplatin (Platinol) 75 mg/m2 IV once on day 1
21-day cycle for up to 3 cycles
References
- Crump M, Kuruvilla J, Couban S, MacDonald DA, Kukreti V, Kouroukis CT, Rubinger M, Buckstein R, Imrie KR, Federico M, Di Renzo N, Howson-Jan K, Baetz T, Kaizer L, Voralia M, Olney HJ, Turner AR, Sussman J, Hay AE, Djurfeldt MS, Meyer RM, Chen BE, Shepherd LE. Randomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG LY.12. J Clin Oncol. 2014 Nov 1;32(31):3490-6. Epub 2014 Sep 29. link to original article contains verified protocol PubMed
Relapsed or refractory, non-randomized or retrospective data
Belinostat monotherapy
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Regimen
Study | Evidence |
Foss et al. 2014 | Phase II |
O'Connor et al. 2015 (BELIEF) | Phase II |
Chemotherapy
- Belinostat (Beleodaq) 1000 mg/m2 IV over 30 minutes once per day on days 1 to 5
21-day cycles
References
- Foss F, Advani R, Duvic M, Hymes KB, Intragumtornchai T, Lekhakula A, Shpilberg O, Lerner A, Belt RJ, Jacobsen ED, Laurent G, Ben-Yehuda D, Beylot-Barry M, Hillen U, Knoblauch P, Bhat G, Chawla S, Allen LF, Pohlman B. A Phase II trial of Belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T-cell lymphoma. Br J Haematol. 2015 Mar;168(6):811-9. Epub 2014 Nov 17. link to original article contains protocol PubMed
- O'Connor OA, Horwitz S, Masszi T, Van Hoof A, Brown P, Doorduijn J, Hess G, Jurczak W, Knoblauch P, Chawla S, Bhat G, Choi MR, Walewski J, Savage K, Foss F, Allen LF, Shustov A. Belinostat in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma: Results of the Pivotal Phase II BELIEF (CLN-19) Study. J Clin Oncol. 2015 Aug 10;33(23):2492-9. Epub 2015 Jun 22. link to original article contains verified protocol link to PMC article PubMed
Bendamustine monotherapy
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Regimen
Study | Evidence |
Demaj et al. 2013 (BENTLY) | Phase II |
Chemotherapy
Note: these infusion instructions are for the Treanda formulation, which was discontinued on 3/31/2016.
- Bendamustine 120 mg/m2 IV over 30 to 60 minutes once per day on days 1 & 2
21-day cycle for 6 cycles
References
- Damaj G, Gressin R, Bouabdallah K, Cartron G, Choufi B, Gyan E, Banos A, Jaccard A, Park S, Tournilhac O, Schiano-de Collela JM, Voillat L, Joly B, Le Gouill S, Saad A, Cony-Makhoul P, Vilque JP, Sanhes L, Schmidt-Tanguy A, Bubenheim M, Houot R, Diouf M, Marolleau JP, Béné MC, Martin A, Lamy T. Results from a prospective, open-label, phase II trial of bendamustine in refractory or relapsed T-cell lymphomas: the BENTLY trial. J Clin Oncol. 2013 Jan 1;31(1):104-10. Epub 2012 Oct 29. link to original article contains verified protocol PubMed
Bortezomib & Panobinostat
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Regimen
Study | Evidence | ORR |
Tan et al. 2015 (SGH651) | Phase II | 43% (95% CI 23-63) |
Chemotherapy
- Bortezomib (Velcade) 1.3 mg/m2 IV once per day on days 1, 4, 8, 11
- Panobinostat (Farydak) 20 mg PO TIW during weeks 1 & 2
21-day cycle for up to 8 cycles
References
- Tan D, Phipps C, Hwang WY, Tan SY, Yeap CH, Chan YH, Tay K, Lim ST, Lee YS, Kumar SG, Ng SC, Fadilah S, Kim WS, Goh YT; SGH651 Investigators. Panobinostat in combination with bortezomib in patients with relapsed or refractory peripheral T-cell lymphoma: an open-label, multicentre phase 2 trial. Lancet Haematol. 2015 Aug;2(8):e326-33. Epub 2015 Jul 7. link to original article contains verified protocol PubMed
Brentuximab vedotin monotherapy
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Regimen
Study | Evidence | ORR |
Horwitz et al. 2014 | Phase II | 41% |
Chemotherapy
- Brentuximab vedotin (Adcetris) 1.8 mg/kg IV on day 1
21-day cycle until progression or unacceptable toxicity
References
- Horwitz SM, Advani RH, Bartlett NL, Jacobsen ED, Sharman JP, O'Connor OA, Siddiqi T, Kennedy DA, Oki Y. Objective responses in relapsed T-cell lymphomas with single-agent brentuximab vedotin. Blood. 2014 May 15;123(20):3095-100. Epub 2014 Mar 20. link to original article contains verified protocol link to PMC article PubMed
Lenalidomide monotherapy
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Regimen
Study | Evidence |
Dueck et al. 2010 | Phase II |
Morschhauser et al. 2013 (EXPECT) | Phase II |
Chemotherapy
- Lenalidomide (Revlimid) 25 mg PO once per day on days 1 to 21
28-day cycles
Dueck et al. 2010 specifies indefinite duration, stopping for progression or intolerance. EXPECT specifies a treatment duration of up to 2 years.
References
- Morschhauser F, Fitoussi O, Haioun C, Thieblemont C, Quach H, Delarue R, Glaisner S, Gabarre J, Bosly A, Lister J, Li J, Coiffier B. A phase 2, multicentre, single-arm, open-label study to evaluate the safety and efficacy of single-agent lenalidomide (Revlimid®) in subjects with relapsed or refractory peripheral T-cell non-Hodgkin lymphoma: The EXPECT trial. Eur J Cancer. 2013 Sep;49(13):2869-76. Epub 2013 May 31. link to original article contains protocol PubMed
- Dueck G, Chua N, Prasad A, Finch D, Stewart D, White D, van der Jagt R, Johnston J, Belch A, Reiman T. Interim report of a phase 2 clinical trial of lenalidomide for T-cell non-Hodgkin lymphoma. Cancer. 2010 Oct 1;116(19):4541-8. link to original article contains verified protocol PubMed
- Update: Toumishey E, Prasad A, Dueck G, Chua N, Finch D, Johnston J, van der Jagt R, Stewart D, White D, Belch A, Reiman T. Final report of a phase 2 clinical trial of lenalidomide monotherapy for patients with T-cell lymphoma. Cancer. 2015 Mar 1;121(5):716-23. Epub 2014 Oct 29. link to original article PubMed
Pralatrexate monotherapy
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Example orders
Regimen
Study | Evidence |
O'Connor et al. 2011 (PROPEL) | Phase II |
Chemotherapy
- Pralatrexate (Folotyn) 30 mg/m2 IV push over 3 to 5 minutes once per day on days 1, 8, 15, 22, 29, 36
Supportive medications
- Cyanocobalamin (Vitamin B12) 1 mg IM once every 8 to 10 weeks
- Folic acid (Folate) 1 to 1.25 mg PO once per day
- "Elevated methylmalonic acid (>200 nmol/L) and/or homocysteine (>10 µmol/L) at screening required initiation of Folic acid (Folate) and Cyanocobalamin (Vitamin B12) = 10 days before the first dose of Pralatrexate (Folotyn)."
7-week cycles, given until progression of disease, unacceptable toxicity, or patient/physician preference
References
- O'Connor OA, Pro B, Pinter-Brown L, Bartlett N, Popplewell L, Coiffier B, Lechowicz MJ, Savage KJ, Shustov AR, Gisselbrecht C, Jacobsen E, Zinzani PL, Furman R, Goy A, Haioun C, Crump M, Zain JM, Hsi E, Boyd A, Horwitz S. Pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma: results from the pivotal PROPEL study. J Clin Oncol. 2011 Mar 20;29(9):1182-9. link to original article contains verified protocol link to PMC article PubMed
Romidepsin monotherapy
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Regimen
Study | Evidence | ORR | Pt Population |
Piekarz et al. 2011 | Phase II | 38% (95% CI 24-53) | Median of 3 prior treatments (range 1-11) |
Coiffier et al. 2012 | Phase II | Investigator assessment: 29% Central review: 25% |
Median of 2 prior treatments (range 1-8) |
Chemotherapy
- Romidepsin (Istodax) 14 mg/m2 IV over 4 hours once per day on days 1, 8, 15
28-day cycle for up to 6 cycles, with optional extension of treatment for patients with stable disease or response
References
- Piekarz RL, Frye R, Prince HM, Kirschbaum MH, Zain J, Allen SL, Jaffe ES, Ling A, Turner M, Peer CJ, Figg WD, Steinberg SM, Smith S, Joske D, Lewis I, Hutchins L, Craig M, Fojo AT, Wright JJ, Bates SE. Phase 2 trial of romidepsin in patients with peripheral T-cell lymphoma. Blood. 2011 Jun 2;117(22):5827-34. Epub 2011 Feb 25. link to original article contains verified protocol link to PMC article PubMed
- Coiffier B, Pro B, Prince HM, Foss F, Sokol L, Greenwood M, Caballero D, Borchmann P, Morschhauser F, Wilhelm M, Pinter-Brown L, Padmanabhan S, Shustov A, Nichols J, Carroll S, Balser J, Balser B, Horwitz S. Results from a pivotal, open-label, phase II study of romidepsin in relapsed or refractory peripheral T-cell lymphoma after prior systemic therapy. J Clin Oncol. 2012 Feb 20;30(6):631-6. Epub 2012 Jan 23. link to original article contains verified protocol PubMed
- Update: Coiffier B, Pro B, Prince HM, Foss F, Sokol L, Greenwood M, Caballero D, Morschhauser F, Wilhelm M, Pinter-Brown L, Padmanabhan Iyer S, Shustov A, Nielsen T, Nichols J, Wolfson J, Balser B, Horwitz S. Romidepsin for the treatment of relapsed/refractory peripheral T-cell lymphoma: pivotal study update demonstrates durable responses. J Hematol Oncol. 2014 Jan 23;7(1):11. link to original article link to PMC article PubMed
- Update: Foss F, Horwitz S, Pro B, Prince HM, Sokol L, Balser B, Wolfson J, Coiffier B. Romidepsin for the treatment of relapsed/refractory peripheral T cell lymphoma: prolonged stable disease provides clinical benefits for patients in the pivotal trial. J Hematol Oncol. 2016 Mar 10;9:22. link to original article link to PMC article PubMed
Investigational agents
These are drugs under study or approved outside of the United States, with at least some promising results for this disease.