T-cell lymphoma

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Anaplastic large-cell lymphoma (ALCL)

Relapsed/refractory

Brentuximab vedotin (Adcetris)

Regimen, Pro et al. 2012

Phase II

• Brentuximab vedotin (Adcetris) 1.8 mg/kg IV over 30 minutes on day 1

3-week cycles up to 16 infusions

References

1. Pro B, Advani R, Brice P, Bartlett NL, Rosenblatt JD, Illidge T, Matous J, Ramchandren R, Fanale M, Connors JM, Yang Y, Sievers EL, Kennedy DA, Shustov A. Brentuximab vedotin (SGN-35) in patients with relapsed or refractory systemic anaplastic large-cell lymphoma: results of a phase II study. J Clin Oncol. 2012 Jun 20;30(18):2190-6. Epub 2012 May 21. link to original article contains verified protocol PubMed

Extranodal NK/T-cell lymphoma (ENKTCL), nasal type

Untreated

Cisplatin & Concurrent RT -> VIPD

VIPD: VP-16, Ifosfamide, Platinol, Dexamethasone

Regimen, Kim et al. 2009

Phase II

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

• Etoposide (Vepesid) 100 mg/m2 IV over 90 minutes once per day on days 1 to 3
• Ifosfamide (Ifex) 1200 mg/m2 IV over 1 hour once per day on days 1 to 3
• Cisplatin (Platinol) 33 mg/m2 IV over 1 hour once per day on days 1 to 3
• Dexamethasone (Decadron) 40 mg PO/IV once per day on days 1 to 4

Supportive medications:

• Mesna (Mesnex) 240 mg/m2 IV over 15 minutes once per day on days 1 to 3
• G-CSF given for grade 3 or 4 neutropenia

21-day cycles x up to 3 cycles

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)

Phase II

Dose Level I

• Dexamethasone (Decadron) 40 mg IV once per day on days 1 to 3
• Etoposide (Vepesid) 67 mg/m2 IV over 2 hours once per day on days 1 to 3
• Ifosfamide (Ifex) 1000 mg/m2 IV over 3 hours once per day on days 1 to 3
• Carboplatin (Paraplatin) 200 mg/m2 IV over 30 minutes once on day 1

Dose Level II

• Dexamethasone (Decadron) 40 mg IV once per day on days 1 to 3
• Etoposide (Vepesid) 100 mg/m2 IV over 2 hours once per day on days 1 to 3
• Ifosfamide (Ifex) 1500 mg/m2 IV over 3 hours once per day on days 1 to 3
• Carboplatin (Paraplatin) 300 mg/m2 IV over 30 minutes once on day 1

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.

21-day cycles x 3 cycles

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
2. Update: Yamaguchi M, Tobinai K, Oguchi M, Ishizuka N, Kobayashi Y, Isobe Y, Ishizawa K, Maseki N, Itoh K, Usui N, Wasada I, Kinoshita T, Hotta T, Tsukasaki K, Oshimi K. Concurrent chemoradiotherapy for localized nasal natural killer/T-cell lymphoma: an updated analysis of the Japan clinical oncology group study JCOG0211. J Clin Oncol. 2012 Nov 10;30(32):4044-6. Epub 2012 Oct 8. link to original article PubMed

GELOX

GELOX: Gemcitabine, L-asparaginase, Oxaliplatin

Regimen

Phase II

• Gemcitabine (Gemzar) 1000 mg/m2 IV once per day on days 1 & 8
• Asparaginase (Elspar) 6000 units/m2 IV once per day on days 1 to 7
• Oxaliplatin (Eloxatin) 130 mg/m2 once on day 1

3-weeks cycles for at least 2 cycles, then:

• Involved field radiation to 56 grays (Gy) in 28 fractions, 5 fractions per week

Followed by more chemotherapy within one week of radiation completion, up to 6 total cycles

References

1. Wang L, Wang ZH, Chen XQ, Li YJ, Wang KF, Xia YF, Xia ZJ. First-line combination of gemcitabine, oxaliplatin, and L-asparaginase (GELOX) followed by involved-field radiation therapy for patients with stage IE/IIE extranodal natural killer/T-cell lymphoma. Cancer. 2013 Jan 15;119(2):348-55. Epub 2012 Jul 18. link to original article contains verified protocol PubMed

LVP "Sandwich"

LVP: L-asparaginase, Vincristine, Prednisolone

Regimen

Phase II

• Asparaginase (Elspar) 6000 units/m2 IV once per day on days 1 to 5
• Vincristine (Oncovin) 1.4 mg/m2 IV once on day 1
• Prednisolone (Millipred) 100 mg PO once per day on days to 5

3-week cycles x 2 cycles, then

• Radiation to the nasal cavity and surrounding sinuses, 56 Gy in 28 fractions, once per day, five days per week

Resume chemotherapy one week after completion of radiation, up to 6 total cycles

References

1. Jiang M, Zhang H, Jiang Y, Yang Q, Xie L, Liu W, Zhang W, Ji X, Li P, Chen N, Zhao S, Wang F, Zou L. Phase 2 trial of "sandwich" L-asparaginase, vincristine, and prednisone chemotherapy with radiotherapy in newly diagnosed, stage IE to IIE, nasal type, extranodal natural killer/T-cell lymphoma. Cancer. 2012 Jul 1;118(13):3294-301. Epub 2011 Dec 2. link to original article contains verified protocol PubMed

SMILE

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

Regimen

Phase II

• Dexamethasone (Decadron) 40 mg PO/IV once per day on days 2 to 4
• Methotrexate (MTX) 2000 mg/m2 IV over 6 hours once on day 1
• Ifosfamide (Ifex) 1500 mg/m2 IV once per day on days 2 to 4
• Asparaginase (Elspar) 6000 units/m2 IV once per day on days 8, 10, 12, 14, 16, 18, 20
• Etoposide (Vepesid) 100 mg/m2 IV once per day on days 2 to 4

Supportive medications:

• Folinic acid (Leucovorin) 15 mg PO/IV Q6H x 4 doses per day on days 2 to 4, beginning 30 hours after completion of Methotrexate (MTX)
• Mesna (Mesnex) 300 mg/m2 IV three times per day on days 2 to 4; first dose given together with Ifosfamide (Ifex), second dose given at 4 hours after start of Ifosfamide (Ifex), and third dose given 8 hours after start of Ifosfamide (Ifex)
• Filgrastim (Neupogen) (dose not specified) SC/IV once per day starting on day 6, given until WBC >5 x 10⁹/L
• Trimethoprim/Sulfamethoxazole (Bactrim DS) prophylaxis recommended

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.

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. 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. Epub 2011 Oct 11. link to original article contains verified protocol PubMed

Relapsed/refractory

AspaMetDex

AspaMetDex: Asparaginase, Methotrexate, Dexamethasone

Regimen, Jaccard et al. 2011

Phase II

• Asparaginase (Elspar) 6000 units/m2 IM once per day on days 2, 4, 6, 8
  • Patients who had allergies to Asparaginase (Elspar) received Asparaginase Erwinia chrysanthemi (Erwinaze) 20,000 units/m2 IM once per day on days 2, 4, 6, 8
• Methotrexate (MTX) 3000 mg/m2 (route not specified) once on day 1
  • Patients >70 years old received Methotrexate (MTX) 2000 mg/m2 (route not specified) once on day 1
• Dexamethasone (Decadron) 40 mg PO once per day on days 1 to 4
  • Patients >70 years old received Dexamethasone (Decadron) 20 mg PO once per day on days 1 to 4

Supportive medications:

• Trimethoprim/Sulfamethoxazole (Bactrim DS) (dose/route/schedule not specified) prophylaxis, discontinued during Methotrexate (MTX) administration
• Valacyclovir (Valtrex) (dose/route/schedule not specified) prophylaxis
• For Methotrexate (MTX): alkaline hydration and Folinic acid (Leucovorin) rescue (dose/route/schedule not specified)

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

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

LVP

LVP: L-asparaginase, Vincristine, Prednisolone

Regimen

Phase II, <20 patients reported

Regimen details are from a review article; original article is not available through PubMed

• Asparaginase (Elspar) 6000 units/m2 IV once per day on days 1 to 5
• Vincristine (Oncovin) 1.4 mg/m2 IV once on day 1
• Prednisolone (Millipred) 100 mg PO once per day on days to 5

References

1. Yong W, Zheng W, Zhang Y, Zhu J, Wei Y, Zhu D, Li J. L-asparaginase-based regimen in the treatment of refractory midline nasal/nasal-type T/NK-cell lymphoma. Int J Hematol. 2003 Aug;78(2):163-7. PubMed

SMILE

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

Regimen

Phase II

• Dexamethasone (Decadron) 40 mg PO/IV once per day on days 2 to 4
• Methotrexate (MTX) 2000 mg/m2 IV over 6 hours once on day 1
• Ifosfamide (Ifex) 1500 mg/m2 IV once per day on days 2 to 4
• Asparaginase (Elspar) 6000 units/m2 IV once per day on days 8, 10, 12, 14, 16, 18, 20
• Etoposide (Vepesid) 100 mg/m2 IV once per day on days 2 to 4

Supportive medications:

• Folinic acid (Leucovorin) 15 mg PO/IV Q6H x 4 doses per day on days 2 to 4, beginning 30 hours after completion of Methotrexate (MTX)
• Mesna (Mesnex) 300 mg/m2 IV three times per day on days 2 to 4; first dose given together with Ifosfamide (Ifex), second dose given at 4 hours after start of Ifosfamide (Ifex), and third dose given 8 hours after start of Ifosfamide (Ifex)
• Filgrastim (Neupogen) (dose not specified) SC/IV once per day starting on day 6, given until WBC >5 x 10⁹/L
• Trimethoprim/Sulfamethoxazole (Bactrim DS) prophylaxis recommended

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.

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. 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. Epub 2011 Oct 11. link to original article contains verified protocol PubMed

NK/T-cell lymphoma

Untreated

SMILE

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

Regimen

Phase II

• Dexamethasone (Decadron) 40 mg PO once per day on days 2 to 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.
• Ifosfamide (Ifex) 1500 mg/m2 in 1 liter normal saline IV over 6 hours once per day on days 2 to 4, given together with mesna
• Asparaginase (Elspar) 6000 units/m2 in 250 mL normal saline IV over 2 hours once per day 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 per day on days 2 to 4

Supportive medications:

• Folinic acid (Leucovorin) 45 mg PO Q6H x 4 doses per day on days 2 to 4 (or until serum methotrexate level is below the toxic range), starting 24 hours after completion of Methotrexate (MTX)
• Mesna (Mesnex) 900 mg/m2 IV over 6 hours once per day on days 2 to 4, given together with Ifosfamide (Ifex)
• Hydration with normal saline (no volume specified) Q8H x 1 day prior to Methotrexate (MTX)
• Patients told to drink at least 2 liters of fluid per day on days 1 to 4; target urine output of ≥3 liters per day on days 1 to 4
• Filgrastim (Neupogen) 300 mcg SC once per day, 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 (Decadron)" on days 2 to 4
• Chlorpheniramine (note: was spelled in the protocol as "chlorphenarime") 10 mg PO once prior to Asparaginase (Elspar) infusions on days 8, 10, 12, 14, 16, 18, 20
• Hydrocortisone (Cortef) 100 mg IV once prior to Asparaginase (Elspar) infusions on days 8, 10, 12, 14, 16, 18, 20

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

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. Epub 2008 Feb 19. link to original article contains verified protocol PubMed content property of HemOnc.org
2. 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. Epub 2012 Aug 23. link to original article supplemental materials supplemental materials contain verified protocol PubMed

Relapsed/refractory

SMILE

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

Regimen

Phase II

• Dexamethasone (Decadron) 40 mg PO once per day on days 2 to 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.
• Ifosfamide (Ifex) 1500 mg/m2 in 1 liter normal saline IV over 6 hours once per day on days 2 to 4, given together with mesna
• Asparaginase (Elspar) 6000 units/m2 in 250 mL normal saline IV over 2 hours once per day 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 per day on days 2 to 4

Supportive medications:

• Folinic acid (Leucovorin) 45 mg PO Q6H x 4 doses per day on days 2 to 4 (or until serum methotrexate level is below the toxic range), starting 24 hours after completion of Methotrexate (MTX)
• Mesna (Mesnex) 900 mg/m2 IV over 6 hours once per day on days 2 to 4, given together with Ifosfamide (Ifex)
• Hydration with normal saline (no volume specified) Q8H x 1 day prior to methotrexate
• Patients told to drink at least 2 liters of fluid per day on days 1 to 4; target urine output of ≥3 liters per day on days 1 to 4
• Filgrastim (Neupogen) 300 mcg SC once per day, 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 (Decadron)" on days 2 to 4
• Chlorpheniramine (note: was spelled in the protocol as "chlorphenarime") 10 mg PO once prior to Asparaginase (Elspar) infusions on days 8, 10, 12, 14, 16, 18, 20
• Hydrocortisone (Cortef) 100 mg IV once prior to Asparaginase (Elspar) infusions on days 8, 10, 12, 14, 16, 18, 20

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

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. Epub 2008 Feb 19. link to original article contains verified protocol PubMed content property of HemOnc.org
2. 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. Epub 2012 Aug 23. link to original article supplemental materials supplemental materials contain verified protocol PubMed