T-cell lymphoma

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Extranodal NK/T-cell lymphoma, nasal type

AspaMetDex

AspaMetDex: Asparaginase, Methotrexate, Dexamethasone

Regimen, Jaccard, et al. 2011

21-day cycles x 3 cycles; see Jaccard, et al. 2011 for details about further treatment

Supportive medications:

References

  1. Jaccard A, Gachard N, Marin B, Rogez S, Audrain M, Suarez F, Tilly H, Morschhauser F, Thieblemont C, Ysebaert L, Devidas A, Petit B, de Leval L, Gaulard P, Feuillard J, Bordessoule D, Hermine O; GELA and GOELAMS Intergroup. Efficacy of L-asparaginase with methotrexate and dexamethasone (AspaMetDex regimen) in patients with refractory or relapsing extranodal NK/T-cell lymphoma, a phase 2 study. Blood. 2011 Feb 10;117(6):1834-9. link to original article contains verified protocol PubMed

Cisplatin & Concurrent RT -> VIPD

VIPD: VP-16, Ifosfamide, Platinol, Dexamethasone

Regimen, Kim et al. 2009

Chemoradiation

  • Cisplatin (Platinol) 30 mg/m2 IV once per week
  • Concurrent radiation therapy to the primary tumor, 1.8 to 2 Gy fractions (median total dose: 40 Gy), given 5 times per week.

Chemotherapy

Chemotherapy starts 3 to 5 weeks after the last dose of cisplatin

21-day cycles x up to 3 cycles

Supportive medications:

  • G-CSF given for grade 3 or 4 neutropenia

References

  1. Kim SJ, Kim K, Kim BS, Kim CY, Suh C, Huh J, Lee SW, Kim JS, Cho J, Lee GW, Kang KM, Eom HS, Pyo HR, Ahn YC, Ko YH, Kim WS. Phase II trial of concurrent radiation and weekly cisplatin followed by VIPD chemotherapy in newly diagnosed, stage IE to IIE, nasal, extranodal NK/T-Cell Lymphoma: Consortium for Improving Survival of Lymphoma study. J Clin Oncol. 2009 Dec 10;27(35):6027-32. link to original article contains verified protocol PubMed

DeVIC & Concurrent RT

DeVIC: Dexamethasone, VP-16, Ifosfamide, Carboplatin

Regimen, Yamaguchi et al. 2009 - JCOG0211

Dose Level I

Dose Level II

21-day cycles x 3 cycles

Supportive medications:

  • Filgrastim (Neupogen) (dose/route/schedule not specified) started for leukocyte count <2,000/μL or ANC <1,000/μL; discontinued if leukocyte count >5,000/μL.

Concurrent radiation therapy

Started simultaneously with the beginning of cycle 1 of chemotherapy

  • Stage IE disease: Concurrent radiation therapy, 2 Gy fractions x 25 fractions (total dose: 50 Gy) over 5 weeks
  • Stage IIE disease: Concurrent radiation therapy, 1.8 Gy fractions x 28 fractions (total dose: 50.4 Gy) over 6 weeks

References

  1. Yamaguchi M, Tobinai K, Oguchi M, Ishizuka N, Kobayashi Y, Isobe Y, Ishizawa K, Maseki N, Itoh K, Usui N, Wasada I, Kinoshita T, Ohshima K, Matsuno Y, Terauchi T, Nawano S, Ishikura S, Kagami Y, Hotta T, Oshimi K. Phase I/II study of concurrent chemoradiotherapy for localized nasal natural killer/T-cell lymphoma: Japan Clinical Oncology Group Study JCOG0211. J Clin Oncol. 2009 Nov 20;27(33):5594-600. link to original article contains verified protocol PubMed

SMILE

SMILE: Steroid (dexamethasone), Methotrexate, Ifosfamide, L-asparaginase, Etoposide

Regimen

28-day cycles x 2 cycles; after 2 cycles, patients could receive additional treatment with SMILE and/or other chemotherapy, with or without autologous/allogeneic stem cell transplant.

Supportive medications:

References

  1. Yamaguchi M, Suzuki R, Kwong YL, Kim WS, Hasegawa Y, Izutsu K, Suzumiya J, Okamura T, Nakamura S, Kawa K, Oshimi K. Phase I study of dexamethasone, methotrexate, ifosfamide, L-asparaginase, and etoposide (SMILE) chemotherapy for advanced-stage, relapsed or refractory extranodal natural killer (NK)/T-cell lymphoma and leukemia. Cancer Sci. 2008 May;99(5):1016-20. doi:10.1111/j.1349-7006.2008.00768.x. Epub 2008 Feb 19. link to original article contains verified protocol PubMed content property of HemOnc.org
  2. Yamaguchi M, Kwong YL, Kim WS, Maeda Y, Hashimoto C, Suh C, Izutsu K, Ishida F, Isobe Y, Sueoka E, Suzumiya J, Kodama T, Kimura H, Hyo R, Nakamura S, Oshimi K, Suzuki R. Phase II study of SMILE chemotherapy for newly diagnosed stage IV, relapsed, or refractory extranodal natural killer (NK)/T-cell lymphoma, nasal type: the NK-Cell Tumor Study Group study. J Clin Oncol. 2011 Nov 20;29(33):4410-6. doi: 10.1200/JCO.2011.35.6287. Epub 2011 Oct 11. link to original article contains verified protocol PubMed

NK/T-cell lymphoma

SMILE

SMILE: Steroid (dexamethasone), Methotrexate, Ifosfamide, L-asparaginase, Etoposide

Regimen

  • Dexamethasone (Decadron) 40 mg PO once daily on days 2-4
  • Methotrexate (MTX) 2000 mg/m2 in 500 mL normal saline IV over 6 hours once on day 1
    • Methotrexate levels checked at 24, 48, and 72 hours after methotrexate is given, or until methotrexate levels fall below toxic range. Folinic acid should be continued until methotrexate levels are below toxic range.
  • Folinic acid (Leucovorin) 45 mg PO Q6H x 4 doses per day on days 2-4 (or until methotrexate is below the toxic range), starting 24 hours after completion of methotrexate
  • Ifosfamide (Ifex) 1500 mg/m2 in 1 liter normal saline IV over 6 hours once daily on days 2-4, given together with mesna
  • Mesna (Mesnex) 900 mg/m2 IV over 6 hours once daily on days 2-4, given together with ifosfamide
  • Asparaginase (Elspar) 6000 units/m2 in 250 mL normal saline IV over 2 hours once daily on days 8, 10, 12, 14, 16, 18, 20
  • Etoposide (Vepesid) 100 mg/m2 in 500 mL normal saline IV over 2 hours once daily on days 2-4

up to 6 cycles given; paper and supplement did not specify the length of each cycle, but other SMILE regimens, e.g. Yamaguchi, et al. 2011 above, describe 28-day cycles

Supportive medications:

  • Hydration with normal saline (no volume specified) Q8H x 1 day prior to methotrexate
  • Patients told to drink at least 2 liters of fluid daily on days 1-4; target urine output of ≥3 liters per day on days 1-4
  • Filgrastim (Neupogen) 300 mcg SC once daily, starting on day 6, given until ANC >1 x 109/L
  • Cotrimoxazole or Pentamidine (Nebupent) for PJP prophylaxis
  • Famotidine (Pepcid) and potassium slow release tablets (no dose specified) "for dexamethasone" on days 2-4
  • Chlorpheniramine (note: was spelled in the protocol as "chlorphenarime") 10 mg PO once prior to L-asparaginase infusions on days 8, 10, 12, 14, 16, 18, 20
  • Hydrocortisone (Cortef) 100 mg IV once prior to L-asparaginase infusions on days 8, 10, 12, 14, 16, 18, 20

References

  1. Kwong YL, Kim WS, Lim ST, Kim SJ, Tang T, Tse E, Leung AY, Chim CS. SMILE for natural killer/T-cell lymphoma: analysis of safety and efficacy from the Asia Lymphoma Study Group. Blood. 2012 Oct 11;120(15):2973-80. doi:10.1182/blood-2012-05-431460. Epub 2012 Aug 23. link to original article supplemental materials supplemental materials contain verified protocol PubMed

Peripheral T-cell Lymphoma (PTCL)

Bendamustine (Treanda)

Regimen, Demaj, et al. 2013 (BENTLY)

Level of Evidence: Phase II

3-week cycles x 6 cycles

References

  1. 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. doi: 10.1200/JCO.2012.43.7285. Epub 2012 Oct 29. link to original article contains verified protocol PubMed

Lenalidomide (Revlimid)

Regimen, Morschhauser, et al. 2013 (EXPECT)

Level of Evidence: Phase II

28-day cycles, up to 2 years

References

  1. 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 May 31. doi:pii: S0959-8049(13)00363-8. 10.1016/j.ejca.2013.04.029. [Epub ahead of print] link to original article contains protocol PubMed

Pralatrexate (Folotyn)

Regimen, O'Connor, et al. 2011 (PROPEL)

Level of Evidence: Phase II

7-week cycles, given until progression of disease, unacceptable toxicity, or patient/physician preference

Supportive medications:

  • Cyanocobalamin (Vitamin B12) 1 mg IM once every 8 to 10 weeks
  • Folic acid 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 vitamins ≥ 10 days before the first dose of pralatrexate."

References

  1. 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 PubMed

Romidepsin (Istodax)

Regimen, Coiffier, et al. 2012

Level of Evidence: Phase II

28-day cycles, up to 6 cycles, with optional extension of treatment for patients with stable disease or response

References

  1. 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. doi: 10.1200/JCO.2011.37.4223. Epub 2012 Jan 23. link to original article contains verified protocol PubMed

Cutaneous T-cell Lymphoma (CTCL)

Bendamustine (Treanda)

Regimen, Demaj, et al. 2013 (BENTLY)

Level of Evidence: Phase II

3-week cycles x 6 cycles

References

  1. 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. doi: 10.1200/JCO.2012.43.7285. Epub 2012 Oct 29. link to original article contains verified protocol PubMed

Denileukin Diftitox (Ontak)

Regimen, Olsen, et al. 2001 & Prince, et al. 2010

Dose is that which was recommended by Prince, et al. 2010 based on superior response.

21-day cycles x up to 8 cycles; up to 3 additional cycles allowed in the Olsen, et al. 2001 trial for patients who had ongoing response

Supportive medications:

  • "Premedication with acetaminophen [≤ 650 mg in Olsen, et al. 2001] and an antihistamine was required 30 to 60 minutes before each infusion" and could be used after infusions as needed.
  • Olsen, et al. 2001 used Promethazine (Phenergan) 25 mg or Prochlorperazine (Compazine) 10 mg (route/schedule not specified) as needed for nausea.
  • Corticosteroid use was not allowed.

References

  1. Olsen E, Duvic M, Frankel A, Kim Y, Martin A, Vonderheid E, Jegasothy B, Wood G, Gordon M, Heald P, Oseroff A, Pinter-Brown L, Bowen G, Kuzel T, Fivenson D, Foss F, Glode M, Molina A, Knobler E, Stewart S, Cooper K, Stevens S, Craig F, Reuben J, Bacha P, Nichols J. Pivotal phase III trial of two dose levels of denileukin diftitox for the treatment of cutaneous T-cell lymphoma. J Clin Oncol. 2001 Jan 15;19(2):376-88. link to original article contains verified protocol PubMed
  2. Prince HM, Duvic M, Martin A, Sterry W, Assaf C, Sun Y, Straus D, Acosta M, Negro-Vilar A. Phase III placebo-controlled trial of denileukin diftitox for patients with cutaneous T-cell lymphoma. J Clin Oncol. 2010 Apr 10;28(11):1870-7. doi: 10.1200/JCO.2009.26.2386. Epub 2010 Mar 8. link to original article contains verified protocol PubMed

Pralatrexate (Folotyn)

Regimen

4-week cycles, given until progression of disease, unacceptable toxicity, or patient/physician preference

Supportive medications:

  • Cyanocobalamin (Vitamin B12) 1 mg IM once every 8 to 10 weeks, within 10 weeks of treatment initiation
  • Folic acid 1 mg PO once per day, starting at least 10 days prior to treatment initiation

References

  1. Horwitz SM, Kim YH, Foss F, Zain JM, Myskowski PL, Lechowicz MJ, Fisher DC, Shustov AR, Bartlett NL, Delioukina ML, Koutsoukos T, Saunders ME, O'Connor OA, Duvic M. Identification of an active, well-tolerated dose of pralatrexate in patients with relapsed or refractory cutaneous T-cell lymphoma. Blood. 2012 May 3;119(18):4115-22. doi: 10.1182/blood-2011-11-390211. Epub 2012 Mar 6. link to original article contains verified protocol PubMed

Romidepsin (Istodax)

Regimen, Whittaker, et al. 2010

28-day cycles, up to 6 cycles, with optional extension of treatment for patients with stable disease or response

References

  1. Whittaker SJ, Demierre MF, Kim EJ, Rook AH, Lerner A, Duvic M, Scarisbrick J, Reddy S, Robak T, Becker JC, Samtsov A, McCulloch W, Kim YH. Final results from a multicenter, international, pivotal study of romidepsin in refractory cutaneous T-cell lymphoma. J Clin Oncol. 2010 Oct 10;28(29):4485-91. doi: 10.1200/JCO.2010.28.9066. Epub 2010 Aug 9. link to original article contains verified protocol PubMed

Vorinostat (Zolinza)

Regimen, Olsen, et al. 2007

Continued on drug until disease progression or intolerable toxicity

References

  1. Olsen EA, Kim YH, Kuzel TM, Pacheco TR, Foss FM, Parker S, Frankel SR, Chen C, Ricker JL, Arduino JM, Duvic M. Phase IIb multicenter trial of vorinostat in patients with persistent, progressive, or treatment refractory cutaneous T-cell lymphoma. J Clin Oncol. 2007 Jul 20;25(21):3109-15. link to original article contains verified protocol PubMed
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