Difference between revisions of "Burkitt lymphoma"
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===Regimen {{#subobject:39dc15|Variant=1}}=== | ===Regimen {{#subobject:39dc15|Variant=1}}=== | ||
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|[http://annonc.oxfordjournals.org/content/16/12/1928.long Diviné et al. 2005 (LMB95)] | |[http://annonc.oxfordjournals.org/content/16/12/1928.long Diviné et al. 2005 (LMB95)] | ||
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===Regimen {{#subobject:85f5b8|Variant=1}}=== | ===Regimen {{#subobject:85f5b8|Variant=1}}=== | ||
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|[https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)01317-3/fulltext Ribrag et al. 2016 (LMBA-02)] | |[https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)01317-3/fulltext Ribrag et al. 2016 (LMBA-02)] |
Revision as of 02:59, 19 August 2018
Section editor | |
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J.C. Villasboas Bisneto, MD Rochester, MN |
20 regimens on this page
27 variants on this page
|
Note 1: Regimens specifically intended for HIV-related Burkitt lymphoma can be found on the HIV-associated lymphoma page.
Note 2: The regimens on this page are primarily intended for the sporadic form of Burkitt lymphoma and some other high-grade B-cell lymphomas. In the future we plan to add regimens for the endemic form of Burkitt lymphoma.
Untreated, pre-phase
COP
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COP: Cyclophosphamide, Oncovin (Vincristine), Prednisone
Regimen
Study | Evidence |
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Diviné et al. 2005 (LMB95) | Phase II |
Ribrag et al. 2016 (LMBA-02) | Non-randomized |
This regimen is for group B (unresected stage I, non-abdominal stage II and any stage III or IV disease without CNS or bone marrow involvement) or group C (CNS and/or bone marrow involvement).
Chemotherapy
- Cyclophosphamide (Cytoxan) 300 mg/m2/day IV once on day 1
- Vincristine (Oncovin) 1 mg/m2 (maximum dose of 2 mg) IV once on day 1
- Prednisone (Sterapred) 60 mg/m2/day PO/IV on days 1 to 7
CNS prophylaxis (group B)
- Methotrexate (MTX) 15 mg IT once on day 1
- Hydrocortisone (Cortef) (dose not specified) IT once on day 1 (admixed with MTX)
CNS treatment (group C)
- Methotrexate (MTX) 15 mg IT once per day on days 1, 3, 5
- Cytarabine (Cytosar) 40 mg IT once per day on days 1, 3, 5
- Hydrocortisone (Cortef) (dose not specified) IT once per day on days 1, 3, 5 (admixed with MTX & Ara-C)
One cycle
Subsequent treatment
References
- Diviné M, Casassus P, Koscielny S, Bosq J, Sebban C, Le Maignan C, Stamattoulas A, Dupriez B, Raphaël M, Pico JL, Ribrag V; GELA; GOELAMS. Burkitt lymphoma in adults: a prospective study of 72 patients treated with an adapted pediatric LMB protocol. Ann Oncol. 2005 Dec;16(12):1928-35. Epub 2005 Nov 10. link to original article contains verified protocol PubMed
- Ribrag V, Koscielny S, Bosq J, Leguay T, Casasnovas O, Fornecker LM, Recher C, Ghesquieres H, Morschhauser F, Girault S, Gouill SL, Ojeda-Uribe M, Mariette C, Cornillon J, Cartron G, Verge V, Chassagne-Clément C, Dombret H, Coiffier B, Lamy T, Tilly H, Salles G. Rituximab and dose-dense chemotherapy for adults with Burkitt's lymphoma: a randomised, controlled, open-label, phase 3 trial. Lancet. 2016 Jun 11;387(10036):2402-11. Epub 2016 Apr 11. link to original article contains verified protocol PubMed
Cyclophosphamide & Prednisone
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Regimen
Study | Evidence |
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Oriol et al. 2008 (PETHEMA) | Non-randomized |
Chemotherapy
- Cyclophosphamide (Cytoxan) 200 mg/m2/day IV over 60 minutes once per day on days 1 to 5
- Prednisone (Sterapred) 60 mg/m2/day IV bolus once per day on days 1 to 5
CNS prophylaxis
- Cytarabine (Cytosar) 40 mg IT once on day 1, admixed with methotrexate and dexamethasone
- Methotrexate (MTX) 15 mg IT once on day 1, admixed with cytarabine and dexamethasone
- Dexamethasone (Decadron) 20 mg IT once on day 1, admixed with cytarabine and methotrexate
One cycle
Subsequent treatment
- PETHEMA induction; see text for details
References
- Oriol A, Ribera JM, Bergua J, Giménez Mesa E, Grande C, Esteve J, Brunet S, Moreno MJ, Escoda L, Hernandez-Rivas JM, Hoelzer D. High-dose chemotherapy and immunotherapy in adult Burkitt lymphoma: comparison of results in human immunodeficiency virus-infected and noninfected patients. Cancer. 2008 Jul 1;113(1):117-25. link to original article contains verified protocol PubMed
Untreated
BASIC
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BASIC: Brief, Anthracycline-Sparing, Intensive Cyclophosphamide
Regimen
Study | Evidence |
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Kasamon et al. 2012 | Non-randomized |
Chemotherapy
- Cyclophosphamide (Cytoxan) 1500 mg/m2 IV over 60 minutes 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
- Rituximab (Rituxan) 375 mg/m2 IV once per day on days 1 & 8
- Methotrexate (MTX) 3000 mg/m2 IV over 2 hours once on day 8
Supportive medications
- Mesna (Mesnex) 900 mg/m2 IV "in divided doses" on day 1
- Folinic acid (Leucovorin) 25 mg/m2 IV Q6H, starting 24 hours after start of IV Methotrexate (MTX), until clearance
- Filgrastim (Neupogen) 5 mcg/kg SC once per day, starting on day 3 and continuing until post-nadir ANC greater than 500/uL
CNS prophylaxis
- Cytarabine (Cytosar) 100 mg IT once per day on days 1, 4, 11 (also day 8 if no IV MTX given)
- Hydrocortisone (Cortef) 50 mg IT is optional (no parameters given)
14-day cycle for 2 cycles
Subsequent treatment
References
- Kasamon YL, Brodsky RA, Borowitz MJ, Ambinder RF, Crilley PA, Cho SY, Tsai HL, Smith BD, Gladstone DE, Carraway HE, Huff CA, Matsui WH, Bolaños-Meade J, Jones RJ, Swinnen LJ. Brief intensive therapy for older adults with newly diagnosed Burkitt or atypical Burkitt lymphoma/leukemia. Leuk Lymphoma. 2013 Mar;54(3):483-90. Epub 2012 Aug 17. link to original article contains verified protocol link to PMC article PubMed
CALGB 9251
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Regimen
Study | Evidence |
---|---|
Rizzieri et al. 2004 (CALGB 9251) | Phase II |
This is an earlier version of CALGB 10-002 that demonstrates that cranial radiation can be omitted in the treatment of Burkitt lymphoma. The regimen omits rituximab. We are unlikely to add this regimen to the site at this time, here for reference only.
References
- CALGB 9251: Rizzieri DA, Johnson JL, Niedzwiecki D, Lee EJ, Vardiman JW, Powell BL, Barcos M, Bloomfield CD, Schiffer CA, Peterson BA, Canellos GP, Larson RA. Intensive chemotherapy with and without cranial radiation for Burkitt leukemia and lymphoma: final results of Cancer and Leukemia Group B Study 9251. Cancer. 2004 Apr 1;100(7):1438-48. link to original article PubMed
CALGB 10-002
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Regimen
Study | Evidence |
---|---|
Rizzieri et al. 2014 (CALGB 10-002) | Phase II |
Chemotherapy, cycle 1
- Cyclophosphamide (Cytoxan) 200 mg/m2 IV once per day on days 1 to 5
- Prednisone (Sterapred) 60 mg/m2 PO once per day on days 1 to 7
Supportive medications
- Allopurinol (Zyloprim) 300 mg PO once per day on days 1 to 14 (includes first week of cycle 2)
One-week cycle, followed by alternation of the following:
Chemotherapy, cycles 2, 4, 6
- Ifosfamide (Ifex) 800 mg/m2 IV over 60 minutes once per day on days 1 to 5
- Dexamethasone (Decadron) 10 mg/m2 (route not specified) once per day on days 1 to 5
- Methotrexate (MTX) 150 mg/m2 IV load, then 1350 mg/m2 over 23.5 hours on day 1 (total dose per cycle: 1500 mg/m2)
- Vincristine (Oncovin) 2 mg IV push once on day 1
- Cytarabine (Cytosar) 1000 mg/m2 IV over 2 hours once per day on days 4 & 5
- Etoposide (Vepesid) 80 mg/m2 IV over 60 minutes once per day on days 4 & 5
- Rituximab (Rituxan) as follows:
- Cycle 2: 50 mg/m2 IV once on day 8, then 375 mg/m2 IV once per day on days 10 & 12
- Cycles 4 & 6: 375 mg/m2 IV once on day 8
CNS prophylaxis
- Cytarabine (Cytosar) 40 mg intrathecal on day 1
- Methotrexate (MTX) 15 mg intrathecal on day 1
- Hydrocortisone (Cortef) 50 mg intrathecal on day 1
Supportive medications
- Mesna (Mesnex) (dose not specified but presumably equal to ifosfamide dose) mixed with Ifosfamide (Ifex)
- Folinic acid (Leucovorin) 25 mg/m2 IV or PO once 36 hours after start of IV Methotrexate (MTX), then 10 mg/m2 Q6H until methotrexate level less than 50 nmol/L
- Filgrastim (Neupogen) 5 mcg/kg SC once per day, starting on day 7 and continuing until ANC greater than 500/uL
21-day cycles
Chemotherapy, cycles 3, 5, 7
- Cyclophosphamide (Cytoxan) 200 mg/m2 IV once per day on days 1 to 5
- Dexamethasone (Decadron) 10 mg/m2 PO or IV once per day on days 1 to 5
- Methotrexate (MTX) 150 mg/m2 IV load, then 1350 mg/m2 over 23.5 hours on day 1 (total dose per cycle: 1500 mg/m2)
- Vincristine (Oncovin) 2 mg IV push once on day 1
- Doxorubicin (Adriamycin) 25 mg/m2 IV once per day on days 4 & 5
- Rituximab (Rituxan) 375 mg/m2 IV once on day 8 of cycles 3, 5, 7
CNS prophylaxis
- Cytarabine (Cytosar) 40 mg intrathecal on day 1
- Methotrexate (MTX) 15 mg intrathecal on day 1
- Hydrocortisone (Cortef) 50 mg intrathecal on day 1
Supportive medications
- Folinic acid (Leucovorin) 50 mg/m2 IV or PO once 36 hours after start of IV Methotrexate (MTX), then 10 mg/m2 Q6H until methotrexate level less than 50 nmol/L
- Filgrastim (Neupogen) 5 mcg/kg SC once per day, starting on day 7 and continuing until ANC greater than 500/uL
21-day cycles
References
- Rizzieri DA, Johnson JL, Byrd JC, Lozanski G, Blum KA, Powell BL, Shea TC, Nattam S, Hoke E, Cheson BD, Larson RA; Alliance for Clinical Trials In Oncology (ACTION). Improved efficacy using rituximab and brief duration, high intensity chemotherapy with filgrastim support for Burkitt or aggressive lymphomas: cancer and Leukemia Group B study 10 002. Br J Haematol. 2014 Apr;165(1):102-11. Epub 2014 Jan 15. link to original article contains verified protocol link to PMC article PubMed
CODOX-M
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CODOX-M: Cyclophosphamide, Oncovin (Vincristine), DOXorubicin, Methotrexate
Variant #1, "Original Magrath"
Study | Evidence |
---|---|
Magrath et al. 1996 (89-C-41) | Phase II |
This is intended for low-risk patients.
Chemotherapy
- Cyclophosphamide (Cytoxan) 800 mg/m2 IV once on day 1, then 200 mg/m2 IV once per day on days 2 to 5
- Vincristine (Oncovin) 1.5 mg/m2 IV once per day on days 1 & 8
- Doxorubicin (Adriamycin) 40 mg/m2 IV once on day 1
- Methotrexate (MTX) as follows:
- Age 65 years or younger: 300 mg/m2 IV over 1 hour, then 2700 mg/m2 IV over the next 23 hours on day 10 (total dose per cycle: 3000 mg/m2)
- Age greater than 65 years: 100 mg/m2 IV over 1 hour, then 900 mg/m2 IV over the next 23 hours on day 10 (total dose per cycle: 1000 mg/m2)
Supportive medications
- Folinic acid (Leucovorin) 15 mg/m2 IV Q3H, starting 36 hours after start of IV Methotrexate (MTX) until 48 hours, then Q6H until methotrexate level undetectable
- Folinic acid (Leucovorin) 15 mg PO once 24 hours after intrathecal Methotrexate (MTX)
- Filgrastim (Neupogen) 5 mcg/kg SC once per day, starting on day 13 and continuing until ANC greater than 1000/uL
CNS prophylaxis
- Cytarabine (Cytosar) 70 mg IT once per day on days 1 & 3
- Methotrexate (MTX) 12 mg IT once on day 15
3 cycles
Variant #2, "Modified Magrath"
Study | Evidence |
---|---|
LaCasce et al. 2004 | Phase II, <20 pts |
Note that dose reductions for age greater than 65 years were not described in this publication. This is intended for low-risk patients (i.e., single site of disease less than 10 cm with normal LDH).
Chemotherapy
- Cyclophosphamide (Cytoxan) 800 mg/m2 IV once per day on days 1 & 2
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg) IV once per day on days 1 & 10
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Methotrexate (MTX) 3000 mg/m2 IV once on day 10
CNS prophylaxis
- Cytarabine (Cytosar) 50 mg intrathecal on day 1
- Methotrexate (MTX) 12 mg intrathecal on day 1
- Hydrocortisone (Cortef) 50 mg intrathecal admixed with all chemotherapy
Supportive medications
- Folinic acid (Leucovorin) 200 mg/m2 IV once 24 hours after start of IV Methotrexate (MTX), then 15 mg/m2 Q6H until methotrexate level undetectable
- Filgrastim (Neupogen) 5 mcg/kg SC once per day on days 3 to 8, held for MTX, and restarted after clearance continuing until ANC greater than 1000/uL
3 cycles
References
- Magrath I, Adde M, Shad A, Venzon D, Seibel N, Gootenberg J, Neely J, Arndt C, Nieder M, Jaffe E, Wittes RA, Horak ID. Adults and children with small non-cleaved-cell lymphoma have a similar excellent outcome when treated with the same chemotherapy regimen. J Clin Oncol. 1996 Mar;14(3):925-34. link to original article contains verified protocol PubMed
- Mead GM, Sydes MR, Walewski J, Grigg A, Hatton CS, Pescosta N, Guarnaccia C, Lewis MS, McKendrick J, Stenning SP, Wright D; UKLG LY06 collaborators. An international evaluation of CODOX-M and CODOX-M alternating with IVAC in adult Burkitt's lymphoma: results of United Kingdom Lymphoma Group LY06 study. Ann Oncol. 2002 Aug;13(8):1264-74. Erratum in: Ann Oncol. 2002 Dec;13(12):1961. Norbert, P [corrected to Pescosta, N]. link to original article contains verified protocol PubMed
- Lacasce A, Howard O, Lib S, Fisher D, Weng A, Neuberg D, Shipp M. Modified magrath regimens for adults with Burkitt and Burkitt-like lymphomas: preserved efficacy with decreased toxicity. Leuk Lymphoma. 2004 Apr;45(4):761-7. link to original article contains verified protocol PubMed
- Mead GM, Barrans SL, Qian W, Walewski J, Radford JA, Wolf M, Clawson SM, Stenning SP, Yule CL, Jack AS; UK National Cancer Research Institute Lymphoma Clinical Studies Group; Australasian Leukaemia and Lymphoma Group. A prospective clinicopathologic study of dose-modified CODOX-M/IVAC in patients with sporadic Burkitt lymphoma defined using cytogenetic and immunophenotypic criteria (MRC/NCRI LY10 trial). Blood. 2008 Sep 15;112(6):2248-60. Epub 2008 Jul 8. link to original article contains verified protocol link to PMC article PubMed
- Maruyama D, Watanabe T, Maeshima AM, Nomoto J, Taniguchi H, Azuma T, Mori M, Munakata W, Kim SW, Kobayashi Y, Matsuno Y, Tobinai K. Modified cyclophosphamide, vincristine, doxorubicin, and methotrexate (CODOX-M)/ifosfamide, etoposide, and cytarabine (IVAC) therapy with or without rituximab in Japanese adult patients with Burkitt lymphoma (BL) and B cell lymphoma, unclassifiable, with features intermediate between diffuse large B cell lymphoma and BL. Int J Hematol. 2010 Dec;92(5):732-43. Epub 2010 Dec 1. link to original article contains verified protocol PubMed
CODOX-M/IVAC
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CODOX-M/IVAC: Cyclophosphamide, Oncovin (Vincristine), DOXorubicin, Methotrexate alternating with Ifosfamide, Vepesid (Etoposide), Ara-C (Cytarabine)
Variant #1, "Original Magrath"
Study | Evidence |
---|---|
Magrath et al. 1996 (NCI 89-C-41) | Phase II |
This is intended for high-risk patients.
Chemotherapy, Part 1: CODOX-M
- Cyclophosphamide (Cytoxan) 800 mg/m2 IV once on day 1, then 200 mg/m2 IV once per day on days 2 to 5
- Vincristine (Oncovin) 1.5 mg/m2 IV once per day on days 1 & 8
- Doxorubicin (Adriamycin) 40 mg/m2 IV once on day 1
- Methotrexate (MTX) as follows:
- Age 65 years or younger: 300 mg/m2 IV over 1 hour, then 2700 mg/m2 IV over the next 23 hours on day 10 (total dose per cycle: 3000 mg/m2)
- Age greater than 65 years: 100 mg/m2 IV over 1 hour, then 900 mg/m2 IV over the next 23 hours on day 10 (total dose per cycle: 1000 mg/m2)
Supportive medications
- Folinic acid (Leucovorin) 15 mg/m2 IV Q3H, starting 36 hours after start of IV Methotrexate (MTX) until 48 hours, then Q6H until methotrexate level undetectable
- Folinic acid (Leucovorin) 15 mg PO once 24 hours after intrathecal Methotrexate (MTX)
- Filgrastim (Neupogen) 5 mcg/kg SC once per day, starting on day 13 and continuing until ANC greater than 1000/uL
CNS prophylaxis
- Cytarabine (Cytosar) 70 mg IT once per day on days 1 & 3
- Methotrexate (MTX) 12 mg IT once on day 15
Chemotherapy, Part 2: IVAC
- Ifosfamide (Ifex) as follows:
- Age 65 years or younger: 1500 mg/m2 IV over 60 minutes once per day on days 1 to 5
- Age greater than 65 years: 1000 mg/m2 IV over 60 minutes once per day on days 1 to 5
- Etoposide (Vepesid) 60 mg/m2 IV over 60 minutes once per day on days 1 to 5
- Cytarabine (Cytosar) as follows:
- Age 65 years or younger: 2000 mg/m2 IV over 3 hours Q12H on days 1 & 2 (4 doses)
- Age greater than 65 years: 1000 mg/m2 IV over 3 hours Q12H on days 1 & 2 (4 doses)
Supportive medications
- Mesna (Mesnex) as follows:
- Age 65 years or younger: 300 mg/m2 (mixed with Ifosfamide (Ifex)) over 1 hour, then 300mg/m2 IV every four hours x 2, on days 1 to 5
- Age greater than 65 years: 200 mg/m2 (mixed with Ifosfamide (Ifex)) over 1 hour, then 200mg/m2 IV every four hours x 2, on days 1 to 5
- Folinic acid (Leucovorin) 15 mg PO once 24 hours after intrathecal methotrexate
- Filgrastim (Neupogen) 5 mcg/kg SC once per day, starting on day 7 and continuing until ANC greater than 1000/uL
CNS prophylaxis
- Methotrexate (MTX) 12 mg IT once on day 5
2 cycles each of CODOX-M and IVAC (alternating)
Variant #2
Study | Evidence |
---|---|
Mead et al. 2002 (UKLG LY06) | Phase II |
This is intended for high-risk patients; modifications to the original NCI 89-C-41 are only in the CODOX-M portion.
Chemotherapy, Part 1: CODOX-M
- Cyclophosphamide (Cytoxan) 800 mg/m2 IV once on day 1, then 200 mg/m2 IV once per day on days 2 to 5
- Vincristine (Oncovin) 1.5 mg/m2 (maximum dose of 2 mg) IV once per day on days 1 & 8
- Doxorubicin (Adriamycin) 40 mg/m2 IV once on day 1
- Methotrexate (MTX) 1200 mg/m2 IV over 1 hour, then 5520 mg/m2 IV over the next 23 hours on day 10 (total dose per cycle: 6720 mg/m2)
Supportive medications
- Folinic acid (Leucovorin) 192 mg/m2 IV once at 36 hours after start of IV Methotrexate (MTX), then 12 mg/m2 IV Q6H until MTX level less than 0.05
- Filgrastim (Neupogen) 5 mcg/kg SC once per day, starting on day 13 and continuing until ANC greater than 1000/uL
CNS prophylaxis
- Cytarabine (Cytosar) 70 mg IT once per day on days 1 & 3
- Methotrexate (MTX) 12 mg IT once on day 15
Chemotherapy, Part 2: IVAC
- Ifosfamide (Ifex) as follows:
- Age 65 years or younger: 1500 mg/m2 IV over 60 minutes once per day on days 1 to 5
- Age greater than 65 years: 1000 mg/m2 IV over 60 minutes once per day on days 1 to 5
- Etoposide (Vepesid) 60 mg/m2 IV over 60 minutes once per day on days 1 to 5
- Cytarabine (Cytosar) as follows:
- Age 65 years or younger: 2000 mg/m2 IV over 3 hours Q12H on days 1 & 2 (4 doses)
- Age greater than 65 years: 1000 mg/m2 IV over 3 hours Q12H on days 1 & 2 (4 doses)
Supportive medications
- Mesna (Mesnex) as follows:
- Age 65 years or younger: 300 mg/m2 (mixed with Ifosfamide (Ifex)) over 1 hour, then 300mg/m2 IV every four hours x 2, on days 1 to 5
- Age greater than 65 years: 200 mg/m2 (mixed with Ifosfamide (Ifex)) over 1 hour, then 200mg/m2 IV every four hours x 2, on days 1 to 5
- Folinic acid (Leucovorin) 15 mg PO once 24 hours after intrathecal methotrexate
- Filgrastim (Neupogen) 5 mcg/kg SC once per day, starting on day 7 and continuing until ANC greater than 1000/uL
CNS prophylaxis
- Methotrexate (MTX) 12 mg IT once on day 5
2 cycles each of CODOX-M and IVAC (alternating)
Variant #3, "Modified Magrath"
Study | Evidence |
---|---|
LaCasce et al. 2004 | Phase II, <20 pts |
All modifications are in Part 1: CODOX-M. Also note that dose reductions for age greater than 65 years were not described in this publication. This is intended for high-risk patients.
Chemotherapy, Part 1: CODOX-M
- Cyclophosphamide (Cytoxan) 800 mg/m2 IV once per day on days 1 & 2
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg) IV once per day on days 1 & 10
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Methotrexate (MTX) 3000 mg/m2 IV once on day 10
CNS prophylaxis
- Cytarabine (Cytosar) 50 mg intrathecal once per day on days 1 & 3
- Methotrexate (MTX) 12 mg intrathecal on day 1
- Hydrocortisone (Cortef) 50 mg intrathecal admixed with all chemotherapy
Supportive medications
- Folinic acid (Leucovorin) 200 mg/m2 IV once 24 hours after start of IV Methotrexate (MTX), then 15 mg/m2 Q6H until methotrexate level undetectable
- Filgrastim (Neupogen) 5 mcg/kg SC once per day on days 3 to 8, held for MTX, and restarted after clearance continuing until ANC greater than 1000/uL
Chemotherapy, Part 2: IVAC
- Ifosfamide (Ifex) 1500 mg/m2 IV over 60 minutes once per day on days 1 to 5
- Etoposide (Vepesid) 60 mg/m2 IV over 60 minutes once per day on days 1 to 5
- Cytarabine (Cytosar) 2000 mg/m2 IV over 3 hours Q12H on days 1 & 2 (4 doses)
CNS prophylaxis
- Methotrexate (MTX) 12 mg intrathecal on day 5, admixed with Hydrocortisone (Cortef)
- Hydrocortisone (Cortef) 50 mg intrathecal on day 5, admixed with Methotrexate (MTX)
Supportive medications
- Mesna (Mesnex) 300 mg/m2 (mixed with Ifosfamide (Ifex)) over 1 hour, then 300mg/m2 IV q4h x 2, on days 1 to 5
- Filgrastim (Neupogen) 5 mcg/kg SC once per day, starting on day 6 and continuing until ANC greater than 1000/uL
2 cycles each of CODOX-M and IVAC (alternating)
Variant #4
Study | Evidence |
---|---|
Mead et al. 2008 (MRC/NCRI LY10) | Phase II |
This is intended for high-risk patients; modifications to the UKLG LY06 protocol are only in the CODOX-M portion.
Chemotherapy, Part 1: CODOX-M
- Cyclophosphamide (Cytoxan) 800 mg/m2 IV once on day 1, then 200 mg/m2 IV once per day on days 2 to 5
- Vincristine (Oncovin) 1.5 mg/m2 (maximum dose of 2 mg) IV once per day on days 1 & 8
- Doxorubicin (Adriamycin) 40 mg/m2 IV once on day 1
- Methotrexate (MTX) 300 mg/m2 IV over 1 hour, then 2700 mg/m2 IV over the next 23 hours on day 10 (total dose per cycle: 3000 mg/m2)
Supportive medications
- Folinic acid (Leucovorin) 15 mg/m2 IV once at 36 hours after start of IV Methotrexate (MTX), then 15 mg/m2 IV q3h between hours 36 and 48, then 15 mg/m2 IV q6h until MTX level less than 0.05
- Filgrastim (Neupogen) 5 mcg/kg SC once per day, starting on day 13 and continuing until ANC greater than 1000/uL
CNS prophylaxis
- Cytarabine (Cytosar) 70 mg IT once per day on days 1 & 3
- Methotrexate (MTX) 12 mg IT once on day 15
Chemotherapy, Part 2: IVAC
- Ifosfamide (Ifex) as follows:
- Age 65 years or younger: 1500 mg/m2 IV over 60 minutes once per day on days 1 to 5
- Age greater than 65 years: 1000 mg/m2 IV over 60 minutes once per day on days 1 to 5
- Etoposide (Vepesid) 60 mg/m2 IV over 60 minutes once per day on days 1 to 5
- Cytarabine (Cytosar) as follows:
- Age 65 years or younger: 2000 mg/m2 IV over 3 hours Q12H on days 1 & 2 (4 doses)
- Age greater than 65 years: 1000 mg/m2 IV over 3 hours Q12H on days 1 & 2 (4 doses)
Supportive medications
- Mesna (Mesnex) as follows:
- Age 65 years or younger: 300 mg/m2 (mixed with Ifosfamide (Ifex)) over 1 hour, then 300mg/m2 IV every four hours x 2, on days 1 to 5
- Age greater than 65 years: 200 mg/m2 (mixed with Ifosfamide (Ifex)) over 1 hour, then 200mg/m2 IV every four hours x 2, on days 1 to 5
- Folinic acid (Leucovorin) 15 mg PO once 24 hours after intrathecal methotrexate
- Filgrastim (Neupogen) 5 mcg/kg SC once per day, starting on day 7 and continuing until ANC greater than 1000/uL
CNS prophylaxis
- Methotrexate (MTX) 12 mg IT once on day 5
2 cycles each of CODOX-M and IVAC (alternating)
References
- NCI 89-C-41: Magrath I, Adde M, Shad A, Venzon D, Seibel N, Gootenberg J, Neely J, Arndt C, Nieder M, Jaffe E, Wittes RA, Horak ID. Adults and children with small non-cleaved-cell lymphoma have a similar excellent outcome when treated with the same chemotherapy regimen. J Clin Oncol. 1996 Mar;14(3):925-34. link to original article contains verified protocol PubMed
- UKLG LY06: Mead GM, Sydes MR, Walewski J, Grigg A, Hatton CS, Pescosta N, Guarnaccia C, Lewis MS, McKendrick J, Stenning SP, Wright D; UKLG LY06 collaborators. An international evaluation of CODOX-M and CODOX-M alternating with IVAC in adult Burkitt's lymphoma: results of United Kingdom Lymphoma Group LY06 study. Ann Oncol. 2002 Aug;13(8):1264-74. Erratum in: Ann Oncol. 2002 Dec;13(12):1961. Norbert, P [corrected to Pescosta, N]. link to original article contains verified protocol PubMed
- Lacasce A, Howard O, Lib S, Fisher D, Weng A, Neuberg D, Shipp M. Modified Magrath regimens for adults with Burkitt and Burkitt-like lymphomas: preserved efficacy with decreased toxicity. Leuk Lymphoma. 2004 Apr;45(4):761-7. link to original article contains verified protocol PubMed
- MRC/NCRI LY10: Mead GM, Barrans SL, Qian W, Walewski J, Radford JA, Wolf M, Clawson SM, Stenning SP, Yule CL, Jack AS; UK National Cancer Research Institute Lymphoma Clinical Studies Group; Australasian Leukaemia and Lymphoma Group. A prospective clinicopathologic study of dose-modified CODOX-M/IVAC in patients with sporadic Burkitt lymphoma defined using cytogenetic and immunophenotypic criteria (MRC/NCRI LY10 trial). Blood. 2008 Sep 15;112(6):2248-60. Epub 2008 Jul 8. link to original article contains verified protocol link to PMC article PubMed
- Maruyama D, Watanabe T, Maeshima AM, Nomoto J, Taniguchi H, Azuma T, Mori M, Munakata W, Kim SW, Kobayashi Y, Matsuno Y, Tobinai K. Modified cyclophosphamide, vincristine, doxorubicin, and methotrexate (CODOX-M)/ifosfamide, etoposide, and cytarabine (IVAC) therapy with or without rituximab in Japanese adult patients with Burkitt lymphoma (BL) and B cell lymphoma, unclassifiable, with features intermediate between diffuse large B cell lymphoma and BL. Int J Hematol. 2010 Dec;92(5):732-43. Epub 2010 Dec 1. link to original article PubMed
COPAD
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COPAD: Cyclophosphamide, Oncovin (Vincristine), Prednisone, ADriamycin (Doxorubicin)
Regimen
Study | Evidence |
---|---|
Diviné et al. 2005 (LMB95) | Phase II, <20 pts in this subgroup |
This regimen is for group A (completely resected stage I or abdominal stage II disease).
Chemotherapy
- Cyclophosphamide (Cytoxan) 500 mg/m2/day IV (in 2 fractions) on days 2 to 4
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg) IV once per day on days 1 & 6
- Prednisone (Sterapred) 60 mg/m2/day PO/IV on days 1 to 6
- Doxorubicin (Adriamycin) 60 mg/m2 IV once on day 2
3 cycles; intervals were as short as possible, as soon as the ANC was greater than 1500/uL and platelet count was greater than 100 × 109/L
References
- Diviné M, Casassus P, Koscielny S, Bosq J, Sebban C, Le Maignan C, Stamattoulas A, Dupriez B, Raphaël M, Pico JL, Ribrag V; GELA; GOELAMS. Burkitt lymphoma in adults: a prospective study of 72 patients treated with an adapted pediatric LMB protocol. Ann Oncol. 2005 Dec;16(12):1928-35. Epub 2005 Nov 10. link to original article contains verified protocol PubMed
COPADM
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COPADM: Cyclophosphamide, Oncovin (Vincristine), Prednisone, ADriamycin (Doxorubicin), Methotrexate
Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Diviné et al. 2005 (LMB95) | Phase II | ||
Ribrag et al. 2016 (LMBA-02) | Phase III (C) | R-COPADM | Seems to have inferior EFS |
This regimen is for group B (unresected stage I, non-abdominal stage II and any stage III or IV disease without CNS or bone marrow involvement) or group C (CNS and/or bone marrow involvement). Diviné et al. 2005 list the dose of HD-MTX as 3 mg/m2 but this is presumed to be a typo.
Preceding treatment
Chemotherapy, COPADM #1
- Cyclophosphamide (Cytoxan) 500 mg/m2/day IV (in 2 fractions) on days 2 to 4
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg) IV once on day 1
- Prednisone (Sterapred) 60 mg/m2/day PO/IV on days 1 to 6
- Doxorubicin (Adriamycin) 60 mg/m2 IV once on day 2
- Methotrexate (MTX) 3000 mg/m2 IV over 3 hours once on day 1
Supportive medications
- Folinic acid (Leucovorin) 15 mg/m2 (route not specified) q6h on days 2 to 4
CNS prophylaxis (group B)
- Methotrexate (MTX) 15 mg IT once per day on days 2 & 6
- Hydrocortisone (Cortef) (dose not specified) IT once per day on days 2 & 6 (admixed with MTX)
CNS treatment (group C)
- Methotrexate (MTX) 15 mg IT once per day on days 2, 4, 6
- Cytarabine (Cytosar) 40 mg IT once per day on days 2, 4, 6
- Hydrocortisone (Cortef) (dose not specified) IT once per day on days 2, 4, 6 (admixed with MTX & Ara-C)
One cycle
As soon as the ANC was greater than 1500/uL and platelet count was greater than 100 × 109/L, patients proceeded to:
Chemotherapy, COPADM #2
- Cyclophosphamide (Cytoxan) 1000 mg/m2/day IV (in 2 fractions) on days 2 to 4
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg) IV once per day on days 1 & 6
- Prednisone (Sterapred) 60 mg/m2/day PO/IV on days 1 to 6
- Doxorubicin (Adriamycin) 60 mg/m2 IV once on day 2
- Methotrexate (MTX) 3000 mg/m2 IV over 3 hours once on day 1
Supportive medications
- Folinic acid (Leucovorin) 15 mg/m2 (route not specified) q6h on days 2 to 4
CNS prophylaxis (group B)
- Methotrexate (MTX) 15 mg IT once per day on days 2 & 6
- Hydrocortisone (Cortef) (dose not specified) IT once per day on days 2 & 6 (admixed with MTX)
CNS treatment (group C)
- Methotrexate (MTX) 15 mg IT once per day on days 2, 4, 6
- Cytarabine (Cytosar) 40 mg IT once per day on days 2, 4, 6
- Hydrocortisone (Cortef) (dose not specified) IT once per day on days 2, 4, 6 (admixed with MTX & Ara-C)
One cycle
Subsequent treatment
- As soon as the ANC was greater than 1500/uL and platelet count was greater than 100 × 109/L:
- Group B: CYM consolidation
- Group C: CYVE consolidation
References
- Diviné M, Casassus P, Koscielny S, Bosq J, Sebban C, Le Maignan C, Stamattoulas A, Dupriez B, Raphaël M, Pico JL, Ribrag V; GELA; GOELAMS. Burkitt lymphoma in adults: a prospective study of 72 patients treated with an adapted pediatric LMB protocol. Ann Oncol. 2005 Dec;16(12):1928-35. Epub 2005 Nov 10. link to original article contains verified protocol PubMed
- Ribrag V, Koscielny S, Bosq J, Leguay T, Casasnovas O, Fornecker LM, Recher C, Ghesquieres H, Morschhauser F, Girault S, Gouill SL, Ojeda-Uribe M, Mariette C, Cornillon J, Cartron G, Verge V, Chassagne-Clément C, Dombret H, Coiffier B, Lamy T, Tilly H, Salles G. Rituximab and dose-dense chemotherapy for adults with Burkitt's lymphoma: a randomised, controlled, open-label, phase 3 trial. Lancet. 2016 Jun 11;387(10036):2402-11. Epub 2016 Apr 11. link to original article PubMed
DA-R-EPOCH
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DA-R-EPOCH: Dose Adjusted Rituximab, Etoposide, Prednisone, Oncovin (Vincristine), Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin)
Regimen
Study | Evidence |
---|---|
Dunleavy et al. 2013 | Phase II, <20 pts in this subgroup |
Chemotherapy
- Rituximab (Rituxan) 375 mg/m2 IV over 3 hours once on day 1
- 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 PO BID 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
- Filgrastim (Neupogen) 300 mcg SC once per day, starting on day 6 and continuing until ANC greater than 5000/uL above the nadir level
- Trimethoprim/Sulfamethoxazole (Bactrim DS) one tablet PO TIW
- Omeprazole (Prilosec) 20 mg PO once per day or equivalent
- Docusate (Colace) as needed for constipation
- Sennosides (Senna) as needed for constipation
- Lactulose as needed for constipation
CNS prophylaxis
- Methotrexate (MTX) as follows:
- Cycles 3 to 6: 12 mg IT once per day on days 1 & 5
21-day cycle for 6 cycles if ANC greater than 1000/uL and platelets greater than 100 × 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.
Dose modifications
Note this is different than some other DA-EPOCH regimens!
- Start cycle 1 as described above.
- Obtain CBCs twice per week for nadir measurements.
- If nadir ANC greater than or equal to 500/uL, increase etoposide, doxorubicin, and cyclophosphamide by 20% compared to previous cycle.
- If nadir ANC less than 500/uL, use same doses as last cycle.
- If nadir platelet count less than 25 × 109/L, decrease etoposide, doxorubicin, and cyclophosphamide by 20% compared to previous cycle.
- Decreases below the cycle 1 starting dose only apply to cyclophosphamide, i.e., the lowest etoposide and doxorubicin would be dosed is at the original cycle 1 dose.
References
- Dunleavy K, Pittaluga S, Shovlin M, Steinberg SM, Cole D, Grant C, Widemann B, Staudt LM, Jaffe ES, Little RF, Wilson WH. Low-intensity therapy in adults with Burkitt's lymphoma. N Engl J Med. 2013 Nov 14;369(20):1915-25. link to original article link to supplement contains verified protocol in supplement link to PMC article PubMed
GMALL-B-ALL/NHL 2002
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Regimen
Study | Evidence |
---|---|
Hoelzer et al. 2014 (GMALL-B-ALL/NHL 2002) | Non-randomized |
This regimen is fairly similar to the GMALL-R regimen, with some minor differences. See text for details.
References
- Hoelzer D, Walewski J, Döhner H, Viardot A, Hiddemann W, Spiekermann K, Serve H, Dührsen U, Hüttmann A, Thiel E, Dengler J, Kneba M, Schaich M, Schmidt-Wolf IG, Beck J, Hertenstein B, Reichle A, Domanska-Czyz K, Fietkau R, Horst HA, Rieder H, Schwartz S, Burmeister T, Gökbuget N; German Multicenter Study Group for Adult Acute Lymphoblastic Leukemia. Improved outcome of adult Burkitt lymphoma/leukemia with rituximab and chemotherapy: report of a large prospective multicenter trial. Blood. 2014 Dec 18;124(26):3870-9. Epub 2014 Oct 30. link to original article contains verified protocol link to PMC article PubMed
GMALL-R
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GMALL-R: German Multicenter Study Group for the Treatment of Adult Acute Lymphoblastic Leukemia, Rituximab
Regimen
Study | Evidence |
---|---|
Ribera et al. 2013 (Burkimab) | Phase II |
Numbering of days is based on prephase->A->B->C; however, certain patient populations received different ordering of regimen, see below.
Prephase
- Cyclophosphamide (Cytoxan) 200 mg/m2 IV over 60 minutes once per day on days 1 to 5
- Prednisone (Sterapred) 60 mg/m2 IV bolus once per day on days 1 to 5
Cycle A
- Rituximab (Rituxan) 375 mg/m2 IV over 4 hours once on day 7
- Vincristine (Oncovin) 2 mg IV bolus once on day 8
- Methotrexate (MTX) 1500 mg/m2 IV over 24 hours once on day 8
- Older than 55 years: reduce dose by 50%
- Ifosfamide (Ifex) 800 mg/m2 IV over 60 minutes once per day on days 8 to 12
- Dexamethasone (Decadron) 10 mg/m2 IV bolus once per day on days 8 to 12
- Teniposide (Vumon) 100 mg/m2 IV over 60 minutes once per day on days 11 & 12
- Cytarabine (Cytosar) 150 mg/m2 IV over 60 minutes BID on days 11 & 12
- Older than 55 years: reduce dose by 50%
Supportive medications
- Folinic acid (Leucovorin) (dose/route/schedule not specified), starting 12 hours after Methotrexate (MTX) infusion
Cycle B
- Rituximab (Rituxan) 375 mg/m2 IV over 4 hours once on day 28
- Vincristine (Oncovin) 2 mg IV bolus once on day 29
- Methotrexate (MTX) 1500 mg/m2 IV over 24 hours once on day 29
- Older than 55 years: reduce dose by 50%
- Cyclophosphamide (Cytoxan) 200 mg/m2 IV over 60 minutes once per day on days 29 to 33
- Dexamethasone (Decadron) 10 mg/m2 IV bolus once per day on days 29 to 33
- Doxorubicin (Adriamycin) 25 mg/m2 IV over 15 minutes once per day on days 32 & 33
Supportive medications
- Folinic acid (Leucovorin) (dose/route/schedule not specified), starting 12 hours after Methotrexate (MTX) infusion
Cycle C
- Rituximab (Rituxan) 375 mg/m2 IV over 4 hours once on day 49
- Vindesine (Eldisine) 3 mg/m2 (maximum dose of 5 mg) IV bolus once on day 50
- Methotrexate (MTX) 1500 mg/m2 IV over 24 hours once on day 50
- Older than 55 years: reduce dose by 50%
- Dexamethasone (Decadron) 10 mg/m2 IV bolus once per day on days 50 to 54
- Etoposide (Vepesid) 250 mg/m2 IV over 60 minutes once per day on days 53 & 54
- Cytarabine (Cytosar) 2000 mg/m2 IV over 3 hours BID on day 54
- Older than 55 years: reduce dose by 50%
Supportive medications
- Folinic acid (Leucovorin) (dose/route/schedule not specified), starting 12 hours after Methotrexate (MTX) infusion
Give regimen as follows:
- Advanced stage and younger than 55 years: A->B->C for 2 courses (6 total cycles)
- Older than 55 years: Alternate A & B for 3 courses (6 total cycles)
- Localized stage: 4 total cycles (unclear from protocol if this means A alternating with B or A->B->C->A)
CNS Prophylaxis
- Methotrexate (MTX) 15 mg intrathecal once per day on days 1, 8, 12, 29, 33
- Cytarabine (Cytosar) 40 mg intrathecal once per day on days 1, 8, 12, 29, 33
- Dexamethasone (Decadron) 20 mg intrathecal once per day on days 1, 8, 12, 29, 33
8 doses total
References
- Ribera JM, García O, Grande C, Esteve J, Oriol A, Bergua J, González-Campos J, Vall-Llovera F, Tormo M, Hernández-Rivas JM, García D, Brunet S, Alonso N, Barba P, Miralles P, Llorente A, Montesinos P, Moreno MJ, Hernández-Rivas JÁ, Bernal T. Dose-intensive chemotherapy including rituximab in Burkitt's leukemia or lymphoma regardless of human immunodeficiency virus infection status: final results of a phase 2 study (Burkimab). Cancer. 2013 May 1;119(9):1660-8. Epub 2013 Jan 29. link to original article contains verified protocol PubMed
R-CODOX-M
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R-CODOX-M: Rituximab, Cyclophosphamide, Oncovin (Vincristine), DOXorubicin, Methotrexate
Regimen
Study | Evidence |
---|---|
Jacobson et al. 2014 | Expert Recommendation |
In the Jacobson et al. 2014 review, the authors describe a "Modified Magrath regimen of R-CODOX/R-IVAC" based on the timing and dosage of LaCasce et al. 2004. However, LaCasce et al. 2004 did not include rituximab in the schema. Others have published retrospective series of this regimen; doses here are based on the review article. This is for low-risk patients (i.e., single site of disease less than 10 cm with normal LDH).
Chemotherapy
- Rituximab (Rituxan) as follows:
- Cycle 1: 375 mg/m2 IV once no earlier than day 3
- Cycle 2 onwards: 375 mg/m2 IV once on day 1
- Cyclophosphamide (Cytoxan) 800 mg/m2 IV once per day on days 1 & 2
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg) IV once per day on days 1 & 15
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Methotrexate (MTX) 3000 mg/m2 IV over 2 to 4 hours once on day 15
CNS prophylaxis
- Cytarabine (Cytosar) 50 mg intrathecal once on day 1
- Methotrexate (MTX) 12 mg intrathecal once on day 1
CNS Treatment (for CSF positive)
- Treatment as per CNS prophylaxis PLUS:
- Cytarabine (Cytosar) 50 mg intrathecal once on day 5 of cycle 1 only
- Methotrexate (MTX) 12 mg intrathecal once on day 15 of cycle 1 only
Supportive medications
- Folinic acid (Leucovorin) 200 mg/m2 IV once 24 hours after start of IV Methotrexate (MTX), then 15 mg/m2 Q6H until methotrexate level undetectable
- Pegfilgrastim (Neulasta) 6 mg SC once on day 3
3 cycles
References
- Maruyama D, Watanabe T, Maeshima AM, Nomoto J, Taniguchi H, Azuma T, Mori M, Munakata W, Kim SW, Kobayashi Y, Matsuno Y, Tobinai K. Modified cyclophosphamide, vincristine, doxorubicin, and methotrexate (CODOX-M)/ifosfamide, etoposide, and cytarabine (IVAC) therapy with or without rituximab in Japanese adult patients with Burkitt lymphoma (BL) and B cell lymphoma, unclassifiable, with features intermediate between diffuse large B cell lymphoma and BL. Int J Hematol. 2010 Dec;92(5):732-43. Epub 2010 Dec 1. link to original article contains verified protocol PubMed
- Retrospective: Barnes JA, Lacasce AS, Feng Y, Toomey CE, Neuberg D, Michaelson JS, Hochberg EP, Abramson JS. Evaluation of the addition of rituximab to CODOX-M/IVAC for Burkitt's lymphoma: a retrospective analysis. Ann Oncol. 2011 Aug;22(8):1859-64. Epub 2011 Feb 21. link to original article PubMed
- Review: Jacobson C, LaCasce A. How I treat Burkitt lymphoma in adults. Blood. 2014 Nov 6;124(19):2913-20. Epub 2014 Sep 25. link to original article contains verified protocol PubMed
R-CODOX-M/R-IVAC
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R-CODOX-M/R-IVAC: Rituximab, Cyclophosphamide, Oncovin (Vincristine), DOXorubicin, Methotrexate alternating with Rituximab, Ifosfamide, Vepesid (etoposide), Ara-C (Cytarabine)
Regimen
Study | Evidence |
---|---|
Jacobson et al. 2014 | Expert Recommendation |
In the Jacobson et al. 2014 review, the authors describe a "Modified Magrath regimen of R-CODOX/R-IVAC" based on the timing and dosage of LaCasce et al. 2004. However, LaCasce et al. 2004 did not include rituximab in the schema. Others have published retrospective series of this regimen; doses here are based on the review article. This is for high-risk patients.
Chemotherapy, Part 1: R-CODOX-M
- Rituximab (Rituxan) as follows:
- Cycle 1: 375 mg/m2 IV once no earlier than day 3
- Cycle 2 onwards: 375 mg/m2 IV once on day 1
- Cyclophosphamide (Cytoxan) 800 mg/m2 IV once per day on days 1 & 2
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg) IV once per day on days 1 & 15
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Methotrexate (MTX) 3000 mg/m2 IV over 2 to 4 hours once on day 15
CNS prophylaxis
- Cytarabine (Cytosar) 50 mg intrathecal once per day on days 1 & 3
- Methotrexate (MTX) 12 mg intrathecal once on day 1
CNS Treatment (for CSF positive)
- Treatment as per CNS prophylaxis PLUS:
- Cytarabine (Cytosar) 50 mg intrathecal once on day 5 of cycle 1 only
- Methotrexate (MTX) 12 mg intrathecal once on day 15 of cycle 1 only
Supportive medications
- Folinic acid (Leucovorin) 200 mg/m2 IV once 24 hours after start of IV Methotrexate (MTX), then 15 mg/m2 Q6H until methotrexate level undetectable
- Pegfilgrastim (Neulasta) 6 mg SC once on day 3
Chemotherapy, Part 2: R-IVAC
- Rituximab (Rituxan) 375 mg/m2 IV once on day 1
- Ifosfamide (Ifex) 1500 mg/m2 IV over 2 hours once per day on days 1 to 5
- Etoposide (Vepesid) 60 mg/m2 IV over 60 minutes once per day on days 1 to 5
- Cytarabine (Cytosar) 2000 mg/m2 IV over 3 hours Q12H on days 1 & 2 (4 doses total)
CNS prophylaxis
- Methotrexate (MTX) 12 mg intrathecal once on day 5
CNS Treatment (for CSF positive)
- Treatment as per CNS prophylaxis PLUS:
- Cytarabine (Cytosar) 50 mg intrathecal once on day 3 of cycle 1 only
Supportive medications
- Mesna (Mesnex) 300 mg/m2 (mixed with Ifosfamide (Ifex)) over 1 hour, then 300mg/m2 IV every four hours x 2, on days 1 to 5
- Pegfilgrastim (Neulasta) 6 mg SC once on day 6
Patients receive 2 cycles each of R-CODOX-M and R-IVAC (alternating)
References
- Maruyama D, Watanabe T, Maeshima AM, Nomoto J, Taniguchi H, Azuma T, Mori M, Munakata W, Kim SW, Kobayashi Y, Matsuno Y, Tobinai K. Modified cyclophosphamide, vincristine, doxorubicin, and methotrexate (CODOX-M)/ifosfamide, etoposide, and cytarabine (IVAC) therapy with or without rituximab in Japanese adult patients with Burkitt lymphoma (BL) and B cell lymphoma, unclassifiable, with features intermediate between diffuse large B cell lymphoma and BL. Int J Hematol. 2010 Dec;92(5):732-43. Epub 2010 Dec 1. link to original article contains verified protocol PubMed
- Retrospective: Barnes JA, Lacasce AS, Feng Y, Toomey CE, Neuberg D, Michaelson JS, Hochberg EP, Abramson JS. Evaluation of the addition of rituximab to CODOX-M/IVAC for Burkitt's lymphoma: a retrospective analysis. Ann Oncol. 2011 Aug;22(8):1859-64. Epub 2011 Feb 21. link to original article PubMed
- Review: Jacobson C, LaCasce A. How I treat Burkitt lymphoma in adults. Blood. 2014 Nov 6;124(19):2913-20. Epub 2014 Sep 25. link to original article contains verified protocol PubMed
R-CODOX-M (Doxil substituted)
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R-CODOX-M: Rituximab, Cyclophosphamide, Oncovin (Vincristine), DOXil (Pegylated liposomal doxorubicin), M ethotrexate
Regimen
Study | Evidence |
---|---|
Evens et al. 2013 | Phase II |
This regimen is for low-risk patients.
Chemotherapy
- Rituximab (Rituxan) 500 mg/m2 IV once per day on days 0 & 8
- Cyclophosphamide (Cytoxan) 800 mg/m2 IV over 60 minutes once on day 1, then 200 mg/m2 IV over 60 minutes once per day on days 2 to 5
- Vincristine (Oncovin) 1.5 mg/m2 (maximum dose of 2 mg) IV push once per day on days 1 & 8
- Pegylated liposomal doxorubicin (Doxil) 40 mg/m2 IV once "per protocol" on day 1
- Methotrexate (MTX) 300 mg/m2 IV over 1 hour, then 2700 mg/m2 IV over next 23 hours on day 10 (total dose per cycle: 3000 mg/m2)
CNS prophylaxis
- Cytarabine (Cytosar) 70 mg intrathecal once on day 1
- Methotrexate (MTX) 12 mg intrathecal (or 6 mg into Ommaya) once on day 3
Supportive medications
- Folinic acid (Leucovorin) 200 mg/m2 IV once 36 hours after start of IV Methotrexate (MTX), then 15 mg/m2 IV Q6H until methotrexate level is less than 50 nmol/L
- Filgrastim (Neupogen) 5 mcg/kg SC once per day on days 6 & 7, then on day 14 onwards until ANC greater than 1500/uL
3 cycles
References
- Evens AM, Carson KR, Kolesar J, Nabhan C, Helenowski I, Islam N, Jovanovic B, Barr PM, Caimi PF, Gregory SA, Gordon LI. A multicenter phase II study incorporating high-dose rituximab and liposomal doxorubicin into the CODOX-M/IVAC regimen for untreated Burkitt's lymphoma. Ann Oncol. 2013 Dec;24(12):3076-81. Epub 2013 Oct 20. link to original article contains verified protocol link to PMC article PubMed
R-CODOX-M/R-IVAC (Doxil substituted)
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R-CODOX-M/R-IVAC: Rituximab, Cyclophosphamide, Oncovin (Vincristine), DOXil (Pegylated liposomal doxorubicin), M ethotrexate alternating with Rituximab, Ifosfamide, Vepesid (Etoposide), Ara-C (Cytarabine)
Regimen
Study | Evidence |
---|---|
Evens et al. 2013 | Phase II |
This regimen is for high-risk patients.
Chemotherapy, Part 1: R-CODOX-M
- Rituximab (Rituxan) 500 mg/m2 IV once per day on days 0 & 8
- Cyclophosphamide (Cytoxan) 800 mg/m2 IV over 60 minutes once on day 1, then 200 mg/m2 IV over 60 minutes once per day on days 2 to 5
- Vincristine (Oncovin) 1.5 mg/m2 (maximum dose of 2 mg) IV push once per day on days 1 & 8
- Pegylated liposomal doxorubicin (Doxil) 40 mg/m2 IV once "per protocol" on day 1
- Methotrexate (MTX) 300 mg/m2 IV over 1 hour, then 2700 mg/m2 IV over next 23 hours on day 10 (total dose per cycle: 3000 mg/m2)
CNS prophylaxis
- Cytarabine (Cytosar) 70 mg intrathecal once per day on days 1 & 3
- Methotrexate (MTX) 12 mg intrathecal (or 6 mg into Ommaya) once on day 15
Supportive medications
- Folinic acid (Leucovorin) 200 mg/m2 IV once 36 hours after start of IV Methotrexate (MTX), then 15 mg/m2 IV Q6H until methotrexate level is less than 50 nmol/L
- Filgrastim (Neupogen) 5 mcg/kg SC once per day on days 6 & 7, then on day 14 onwards until ANC greater than 1500/uL
Chemotherapy, Part 2: R-IVAC
- Rituximab (Rituxan) 375 mg/m2 IV onnce per day on days 0 & 6 or 7 (2 doses per cycle)
- Ifosfamide (Ifex) 1500 mg/m2 IV over 3 hours once per day on days 1 to 5
- Etoposide (Vepesid) 60 mg/m2 IV over 60 minutes once per day on days 1 to 5
- Cytarabine (Cytosar) 2000 mg/m2 IV over 3 hours Q12H on days 1 & 2 (4 doses per cycle)
CNS prophylaxis
- Methotrexate (MTX) 15 mg intrathecal once on day 5
Supportive medications
- Mesna (Mesnex) 500 mg/m2 mixed with first Ifosfamide (Ifex), then 1000 mg/m2/day IV continuous infusion on days 1 to 5
- Folinic acid (Leucovorin) 15 mg PO q6h x 4 doses, starting 24 hours after intrathecal Methotrexate (MTX)
- Filgrastim (Neupogen) 5 mcg/kg SC once per day, starting on day 6 or 7 and continuing until ANC greater than 1500/uL
Four alternating cycles of R-CODOX-M & R-IVAC
References
- Evens AM, Carson KR, Kolesar J, Nabhan C, Helenowski I, Islam N, Jovanovic B, Barr PM, Caimi PF, Gregory SA, Gordon LI. A multicenter phase II study incorporating high-dose rituximab and liposomal doxorubicin into the CODOX-M/IVAC regimen for untreated Burkitt's lymphoma. Ann Oncol. 2013 Dec;24(12):3076-81. Epub 2013 Oct 20. link to original article contains verified protocol link to PMC article PubMed
R-COPADM
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R-COPADM: Rituximab, Cyclophosphamide, Oncovin (Vincristine), Prednisone, ADriamycin (Doxorubicin), Methotrexate
Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Ribrag et al. 2016 (LMBA-02) | Phase III (E) | COPADM | Seems to have superior EFS |
This regimen is for group B (unresected stage I, non-abdominal stage II and any stage III or IV disease without CNS or bone marrow involvement); see manuscript for details about the regimen for group C.
Preceding treatment
Chemotherapy
- Rituximab (Rituxan) 375 mg/m2 IV once per day on days 0 & 6
- Cyclophosphamide (Cytoxan) 500 mg/m2/day IV on days 2 to 4
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg) IV once on day 1
- Prednisolone (Millipred) 60 mg/m2/day PO/IV on days 1 to 5
- Doxorubicin (Adriamycin) 60 mg/m2 IV once on day 2
- Methotrexate (MTX) 3000 mg/m2 IV once on day 1
Supportive medications
- Folinic acid (Leucovorin) (dose/route not specified) on days 2 to 6
CNS prophylaxis
- Methotrexate (MTX) 15 mg IT once per day on days 2 & 6
- Hydrocortisone (Cortef) (dose not specified) IT once per day on days 2 & 6 (admixed with MTX)
Two cycles
Subsequent treatment
References
- Ribrag V, Koscielny S, Bosq J, Leguay T, Casasnovas O, Fornecker LM, Recher C, Ghesquieres H, Morschhauser F, Girault S, Gouill SL, Ojeda-Uribe M, Mariette C, Cornillon J, Cartron G, Verge V, Chassagne-Clément C, Dombret H, Coiffier B, Lamy T, Tilly H, Salles G. Rituximab and dose-dense chemotherapy for adults with Burkitt's lymphoma: a randomised, controlled, open-label, phase 3 trial. Lancet. 2016 Jun 11;387(10036):2402-11. Epub 2016 Apr 11. link to original article PubMed
R-Hyper-CVAD/R-MA
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R-Hyper-CVAD/R-MA: Rituximab, Hyperfractionated Cyclophosphamide, Vincristine, Adriamycin (Doxorubicin), Dexamethasone altenating with Rituximab, Methotrexate, Ara-C (Cytarabine)
Regimen
Study | Evidence |
---|---|
Thomas et al. 2006 | Pilot, <20 pts |
Chemotherapy, part A (cycles 1, 3, 5, 7)
- Rituximab (Rituxan) as follows:
- Cycles 1 & 3: 375 mg/m2 IV over 2 to 6 hours once per day on days 1 & 11
- Cyclophosphamide (Cytoxan) 300 mg/m2 IV over 2 hours Q12H on days 1 to 3 (6 total doses)
- Vincristine (Oncovin) 2 mg IV once per day on days 4 & 11
- Doxorubicin (Adriamycin) 50 mg/m2/day IV continuous infusion on day 4 (total dose per cycle: 50 mg/m2)
- Dexamethasone (Decadron) 40 mg PO/IV once per day on days 1 to 4, 11 to 14
CNS prophylaxis
- Methotrexate (MTX) 12 mg (6 mg if given via Ommaya reservoir) IT once on day 2
- Cytarabine (Cytosar) 100 mg IT once on day 7
Given each cycle for a total of 16 intrathecal treatments. If CNS disease present, therapy augmented to twice-weekly alternating (MTX, ara-C) treatments until CSF cell count normalizes and cytology is negative, then continues for 4 more alternating weekly treatments; prophylaxis course then resumes.
Supportive medications
- Mesna (Mesnex) 600 mg/m2/day IV continuous infusion on days 1 to 3, starting 1 hour before Cyclophosphamide (Cytoxan) and completed 12 hours after the last dose of Cyclophosphamide (Cytoxan)
- Filgrastim (Neupogen) 10 mcg/kg SC once per day starting 24 hours after completion of chemotherapy, given until WBC greater than 3 x 109/L or bone pain present
- ONE of the following antibiotics:
- Fluoroquinolone
- Trimethoprim/Sulfamethoxazole (Bactrim DS) (160/800 mg) dose/route not specified
- Fluconazole (Diflucan) dose/route not specified
- ONE of the following antivirals:
- Acyclovir (Zovirax) dose/route not specified
- Valacyclovir (Valtrex) dose/route not specified
Next cycle to start no sooner than 14 days or as soon as "unmaintained" WBC count is greater than 3 x 109/L and platelet count greater than 50 x 109/L
Dose modifications
- Vincristine (Oncovin) reduced to 1 mg for bilirubin greater than 2 mg/dL or NCI common toxicity criteria Grade 2+ peripheral neuropathy, omitted for bilirubin greater than 3 mg/dL or for ileus
- Doxorubicin (Adriamycin) reduced by 50% for bilirubin 2 to 3 mg/dL, by 75% for bilirubin 3 to 5 mg/dL (eliminated for bilirubin greater than 5 mg/dL or for gastric/small-bowel involvement with Course 1 to reduce duration of myelosuppression given risk of perforation)
Chemotherapy, part B (cycles 2, 4, 6, 8)
- Rituximab (Rituxan) as follows:
- Cycles 2 & 4: 375 mg/m2 IV over 2 to 6 hours once per day on days 2 & 8
- Methotrexate (MTX) 1000 mg/m2/day IV continuous infusion on day 1 (total dose per cycle: 1000 mg/m2)
- Cytarabine (Cytosar) 3000 mg/m2 IV over 2 hours Q12H on days 2 & 3 (4 total doses)
CNS prophylaxis
- Methotrexate (MTX) 12 mg (6 mg if given via Ommaya reservoir) IT once on day 2
- Cytarabine (Cytosar) 100 mg IT once on day 7
Given each cycle for a total of 16 intrathecal treatments. If CNS disease present, therapy augmented to twice-weekly alternating (MTX, ara-C) treatments until CSF cell count normalizes and cytology is negative, then continues for 4 more alternating weekly treatments; prophylaxis course then resumes.
Supportive medications
- Folinic acid (Leucovorin) 50 mg IV x1 12 hours after Methotrexate (MTX) is complete, then 15 mg IV Q6H x 8 doses until serum methotrexate level less than 100 nmol/L
- Filgrastim (Neupogen) 10 mcg/kg SC once per day starting 24 hours after completion of chemotherapy, given until WBC greater than 3 x 109/L or bone pain present
- ONE of the following antibiotics:
- Fluoroquinolone
- Trimethoprim/Sulfamethoxazole (Bactrim DS) (160/800 mg) dose/route not specified
- Fluconazole (Diflucan) dose/route not specified
- ONE of the following antivirals:
- Acyclovir (Zovirax) dose/route not specified
- Valacyclovir (Valtrex) dose/route not specified
Next cycle to start no sooner than 14 days or as soon as "unmaintained" WBC count is greater than 3 x 109/L and platelet count greater than 50 x 109/L
Dose modifications
- Cytarabine (Cytosar) reduced to 1000 mg/m2 for patients greater than or equal to 60 years old, creatinine greater than or equal to 1.5 mg/dL or 0 hour MTX level greater than or equal to 20,000 nmol/L
- Methotrexate (MTX) reduced by 50% for creatinine clearance 10 to 50 mL/min (eliminated for less than 10 mL/min), by 25% to 75% for delayed excretion and/or nephrotoxicity with prior course (dependent on severity) or by 50% for pleural effusions/ascites with drainage of fluid as feasible.
References
- Thomas DA, Faderl S, O'Brien S, Bueso-Ramos C, Cortes J, Garcia-Manero G, Giles FJ, Verstovsek S, Wierda WG, Pierce SA, Shan J, Brandt M, Hagemeister FB, Keating MJ, Cabanillas F, Kantarjian H. Chemoimmunotherapy with hyper-CVAD plus rituximab for the treatment of adult Burkitt and Burkitt-type lymphoma or acute lymphoblastic leukemia. Cancer. 2006 Apr 1;106(7):1569-80. link to original article contains verified protocol PubMed
Consolidation/Intensification therapy
BASIC
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BASIC: Brief, Anthracycline-Sparing, Intensive Cyclophosphamide
Regimen
Study | Evidence |
---|---|
Kasamon et al. 2012 | Non-randomized |
Preceding treatment
Chemotherapy, part 1
- Rituximab (Rituxan) 375 mg/m2 IV once on day 1
- Cyclophosphamide (Cytoxan) 50 mg/kg IV over 1 to 2 hours once per day on days 2 to 5
Supportive medications
- Mesna (Mesnex) 40 mg/kg/day IV "in divided doses" on days 2 to 5
- Filgrastim (Neupogen) 5 mcg/kg SC once per day, starting on day 11 and continuing until post-nadir ANC greater than 1000/uL
One course, followed once post-nadir ANC greater than 1000/uL by:
Chemotherapy, part 2
- Rituximab (Rituxan) 375 mg/m2 IV once per week for 4 doses
CNS treatment
- (only given if there was prior CNS involvement):
- Cytarabine (Cytosar) 100 mg IT once per week for 4 doses, then once every other week for 4 doses
- Hydrocortisone (Cortef) 50 mg IT is optional (no parameters given)
References
- Kasamon YL, Brodsky RA, Borowitz MJ, Ambinder RF, Crilley PA, Cho SY, Tsai HL, Smith BD, Gladstone DE, Carraway HE, Huff CA, Matsui WH, Bolaños-Meade J, Jones RJ, Swinnen LJ. Brief intensive therapy for older adults with newly diagnosed Burkitt or atypical Burkitt lymphoma/leukemia. Leuk Lymphoma. 2013 Mar;54(3):483-90. Epub 2012 Aug 17. link to original article contains verified protocol link to PMC article PubMed
CYM
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CYM: CYtarabine, Methotrexate
Regimen
Study | Evidence |
---|---|
Diviné et al. 2005 (LMB95) | Phase II |
This regimen is for group B (unresected stage I, non-abdominal stage II and any stage III or IV disease without CNS or bone marrow involvement).
Preceding treatment
Chemotherapy
- Cytarabine (Cytosar) 100 mg/m2/day IV continuous infusion on days 2 to 6 (total dose per cycle: 500 mg/m2)
- Methotrexate (MTX) 3000 mg/m2 IV over 3 hours once on day 1
Supportive medications
- Folinic acid (Leucovorin) 15 mg/m2 (route not specified) q6h on days 2 to 4
CNS prophylaxis
- Methotrexate (MTX) 15 mg IT once on day 2
- Cytarabine (Cytosar) 30 mg IT once on day 6
- Hydrocortisone (Cortef) 15 mg IT once per day on days 2 & 6 (admixed with chemo)
2 cycles; intervals were as short as possible, as soon as the ANC was greater than 1500/uL and platelet count was greater than 100 × 109/L
Subsequent treatment
References
- LMB95: Diviné M, Casassus P, Koscielny S, Bosq J, Sebban C, Le Maignan C, Stamattoulas A, Dupriez B, Raphaël M, Pico JL, Ribrag V; GELA; GOELAMS. Burkitt lymphoma in adults: a prospective study of 72 patients treated with an adapted pediatric LMB protocol. Ann Oncol. 2005 Dec;16(12):1928-35. Epub 2005 Nov 10. link to original article contains verified protocol PubMed
CYVE
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CYVE: CYtarabine, VEpesid (Etoposide)
Regimen
Study | Evidence |
---|---|
Diviné et al. 2005 (LMB95) | Phase II, <20 pts in this subgroup |
This regimen is for group C (CNS and/or bone marrow involvement). Note the unusual schedule of cytarabine; presumably the low-dose and high-dose portions are given at separate times in the 24 hour period but this detail is not further specified in the manuscript.
Preceding treatment
Chemotherapy
- Cytarabine (Cytosar) as follows:
- 50 mg/m2 IV over 12 hours once per day on days 1 to 5
- 3000 mg/m2 IV over 3 hours once per day on days 2 to 5
- Etoposide (Vepesid) 200 mg/m2 IV once per day on days 2 to 5
2 cycles; intervals were as short as possible, as soon as the ANC was greater than 1500/uL and platelet count was greater than 100 × 109/L
Subsequent treatment
References
- Diviné M, Casassus P, Koscielny S, Bosq J, Sebban C, Le Maignan C, Stamattoulas A, Dupriez B, Raphaël M, Pico JL, Ribrag V; GELA; GOELAMS. Burkitt lymphoma in adults: a prospective study of 72 patients treated with an adapted pediatric LMB protocol. Ann Oncol. 2005 Dec;16(12):1928-35. Epub 2005 Nov 10. link to original article contains verified protocol PubMed
Maintenance therapy
COPAD/CYVE
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COPAD/CYVE: Cyclophosphamide, Oncovin (Vincristine), Prednisone, ADriamycin (Doxorubicin) alternating with CYtarabine, VEpesid (Etoposide)
Regimen
Study | Evidence |
---|---|
Diviné et al. 2005 (LMB95) | Phase II, <20 pts in this subgroup |
This regimen is for group C (CNS and/or bone marrow involvement). Note that the days of administration for the CYVE cycles are counted from the start of the respective COPAD cycles.
Preceding treatment
Chemotherapy, COPAD cycles
- Cyclophosphamide (Cytoxan) 500 mg/m2 IV once per day on days 1 & 2
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg) IV once on day 1
- Prednisone (Sterapred) 60 mg/m2/day PO on days 1 to 5
- Doxorubicin (Adriamycin) 60 mg/m2 IV once on day 2
CNS treatment
Note: this is only given with the first cycle of maintenance; patients with positive CNS at diagnosis were to also undergo 24 Gy of cranial irradiation.
- Methotrexate (MTX) 15 mg IT once on day 2
- Cytarabine (Cytosar) 40 mg IT once on day 2
- Hydrocortisone (Cortef) 15 mg IT once on day 2 (admixed with MTX & Ara-C)
Chemotherapy, CYVE cycles
- Cytarabine (Cytosar) 50 mg/m2 SC BID on days 28 to 32
- Etoposide (Vepesid) 150 mg/m2 IV once per day on days 28 to 30
4 alternating cycles (COPAD, then CYVE, then COPAD, then CYVE)
References
- Diviné M, Casassus P, Koscielny S, Bosq J, Sebban C, Le Maignan C, Stamattoulas A, Dupriez B, Raphaël M, Pico JL, Ribrag V; GELA; GOELAMS. Burkitt lymphoma in adults: a prospective study of 72 patients treated with an adapted pediatric LMB protocol. Ann Oncol. 2005 Dec;16(12):1928-35. Epub 2005 Nov 10. link to original article contains verified protocol PubMed
COPADM
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COPADM: Cyclophosphamide, Oncovin (Vincristine), Prednisone, ADriamycin (Doxorubicin), Methotrexate
Regimen
Study | Evidence |
---|---|
Diviné et al. 2005 (LMB95) | Phase II |
This regimen is for group B (unresected stage I, non-abdominal stage II and any stage III or IV disease without CNS or bone marrow involvement).
Preceding treatment
Chemotherapy
- Cyclophosphamide (Cytoxan) 500 mg/m2 IV once per day on days 1 & 2
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg) IV once on day 1
- Prednisone (Sterapred) 60 mg/m2/day PO on days 1 to 5
- Doxorubicin (Adriamycin) 60 mg/m2 IV once on day 2
- Methotrexate (MTX) 3000 mg/m2 IV over 3 hours once on day 1
Supportive medications
- Folinic acid (Leucovorin) 15 mg/m2 (route not specified) q6h on days 2 to 4
CNS prophylaxis
- Methotrexate (MTX) 15 mg IT once on day 2
- Hydrocortisone (Cortef) 15 mg IT once on day 2 (admixed with MTX)
One cycle
References
- Diviné M, Casassus P, Koscielny S, Bosq J, Sebban C, Le Maignan C, Stamattoulas A, Dupriez B, Raphaël M, Pico JL, Ribrag V; GELA; GOELAMS. Burkitt lymphoma in adults: a prospective study of 72 patients treated with an adapted pediatric LMB protocol. Ann Oncol. 2005 Dec;16(12):1928-35. Epub 2005 Nov 10. link to original article contains verified protocol PubMed