T-cell lymphoma

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Extranodal NK/T-cell lymphoma, nasal type

SMILE

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

Regimen

• Dexamethasone (Decadron) 40 mg PO/IV once daily on days 2-4
• Methotrexate (MTX) 2000 mg/m2 IV over 6 hours once on day 1
• Folinic acid (Leucovorin) 15 mg PO/IV Q6H x 4 doses per day on days 2-4, beginning 30 hours after completion of methotrexate
• Ifosfamide (Ifex) 1500 mg/m2 IV once daily on days 2-4
• Mesna (Mesnex) 300 mg/m2 IV three times per day on days 2-4; first dose given together with ifosfamide, second dose given at 4 hours after start of ifosfamide, and third dose given 8 hours after start of ifosfamide
• Asparaginase (Elspar) 6000 units/m2 IV once daily on days 8, 10, 12, 14, 16, 18, 20
• Etoposide (Vepesid) 100 mg/m2 IV once daily on days 2-4

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:

• Filgrastim (Neupogen) (dose not specified) SC/IV once daily starting on day 6, given until WBC >5 x 10⁹/L
• Trimethoprim/Sulfamethoxazole (Bactrim DS) prophylaxis recommended

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
  • Skin test done for asparaginase before each dose; Asparaginase Erwinia chrysanthemi (Erwinaze) used for patients who developed sensitivity to L-asparaginase from E. coli
• 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

Cutaneous T-cell Lymphoma

Romidepsin (Istodax)

Regimen, Whittaker, et al. 2010

• Romidepsin (Istodax) 14 mg/m2 IV over 4 hours once daily on days 1, 8, 15

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

• Vorinostat (Zolinza) 400 mg PO once daily

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