Difference between revisions of "Non-Hodgkin lymphoma, pediatric"
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− | {{#lst: | + | <span id="BackToTop"></span> |
− | + | <div class="noprint" style="background-color:LightGray; position:fixed; bottom:2%; right:0.25%; padding-left:5px; padding-right:5px; margin: 15px; opacity:0.8; border-style: solid; border-color:DarkGray; border-width: 1px"> | |
+ | [[#top|Back to Top]] | ||
+ | </div> | ||
+ | {{#lst:Editorial board transclusions|peds}} | ||
+ | ''This page contains studies that were specific to pediatric populations, who are generally treated based on risk-stratification, not on the underlying histology. See individual trials for inclusion criteria. | ||
{| class="wikitable" style="float:right; margin-right: 5px;" | {| class="wikitable" style="float:right; margin-right: 5px;" | ||
|- | |- | ||
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|} | |} | ||
{{TOC limit|limit=3}} | {{TOC limit|limit=3}} | ||
+ | =Guidelines= | ||
+ | '''Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.''' | ||
+ | ==NCCN== | ||
+ | *[https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1504 NCCN Guidelines - Pediatric Aggressive Mature B-Cell Lymphomas] | ||
=Untreated, pre-phase= | =Untreated, pre-phase= | ||
==CVP {{#subobject:1a817a|Regimen=1}}== | ==CVP {{#subobject:1a817a|Regimen=1}}== | ||
− | |||
CVP: '''<u>C</u>'''yclophosphamide, '''<u>V</u>'''incristine, '''<u>P</u>'''rednisone | CVP: '''<u>C</u>'''yclophosphamide, '''<u>V</u>'''incristine, '''<u>P</u>'''rednisone | ||
<br>COP: '''<u>C</u>'''yclophosphamide, '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''rednisone | <br>COP: '''<u>C</u>'''yclophosphamide, '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''rednisone | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen {{#subobject:865d9b|Variant=1}}=== | ===Regimen {{#subobject:865d9b|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 60%; text-align:center;" | {| class="wikitable sortable" style="width: 60%; text-align:center;" | ||
!style="width: 33%"|Study | !style="width: 33%"|Study | ||
− | !style="width: 33%"| | + | !style="width: 33%"|Dates of enrollment |
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
|- | |- | ||
|[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc1852229/ Patte et al. 2007 (FAB/LMB96)] | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc1852229/ Patte et al. 2007 (FAB/LMB96)] | ||
|1996-2001 | |1996-2001 | ||
− | |style="background-color:#91cf61"|Non-randomized | + | |style="background-color:#91cf61"|Non-randomized part of phase 3 RCT |
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
*[[Cyclophosphamide (Cytoxan)]] 300 mg/m<sup>2</sup> IV once on day 1 | *[[Cyclophosphamide (Cytoxan)]] 300 mg/m<sup>2</sup> IV once on day 1 | ||
Line 29: | Line 38: | ||
====Glucocorticoid therapy==== | ====Glucocorticoid therapy==== | ||
*[[Prednisone (Sterapred)]] 60 mg/m<sup>2</sup>/day IV or PO on days 1 to 7 | *[[Prednisone (Sterapred)]] 60 mg/m<sup>2</sup>/day IV or PO on days 1 to 7 | ||
− | + | ====CNS therapy, prophylaxis==== | |
− | ====CNS prophylaxis==== | ||
*[[Methotrexate (MTX)]] (dose not specified) IT once on day 1 | *[[Methotrexate (MTX)]] (dose not specified) IT once on day 1 | ||
− | |||
'''7-day course''' | '''7-day course''' | ||
+ | </div> | ||
+ | <div class="toccolours" style="background-color:#cbd5e7"> | ||
====Subsequent treatment==== | ====Subsequent treatment==== | ||
− | *[[#COPADM|COPADM | + | *[[#COPADM|COPADM]] induction |
− | + | </div></div> | |
===References=== | ===References=== | ||
− | # '''FAB/LMB96:''' Patte C, Auperin A, Gerrard M, Michon J, Pinkerton R, Sposto R, Weston C, Raphael M, Perkins SL, McCarthy K, Cairo MS; FAB/LMB96 International Study Committee. Results of the randomized international FAB/LMB96 trial for intermediate risk B-cell non-Hodgkin lymphoma in children and adolescents: it is possible to reduce treatment for the early responding patients. Blood. 2007 Apr 1;109(7):2773-80. [https://doi.org/10.1182/blood-2006-07-036673 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc1852229/ link to PMC article] ''' | + | # '''FAB/LMB96:''' Patte C, Auperin A, Gerrard M, Michon J, Pinkerton R, Sposto R, Weston C, Raphael M, Perkins SL, McCarthy K, Cairo MS; FAB/LMB96 International Study Committee. Results of the randomized international FAB/LMB96 trial for intermediate risk B-cell non-Hodgkin lymphoma in children and adolescents: it is possible to reduce treatment for the early responding patients. Blood. 2007 Apr 1;109(7):2773-80. [https://doi.org/10.1182/blood-2006-07-036673 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc1852229/ link to PMC article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/17132719/ PubMed] [https://clinicaltrials.gov/study/NCT00002757 NCT00002757] |
− | |||
=Untreated, induction= | =Untreated, induction= | ||
==COPADM {{#subobject:841673|Regimen=1}}== | ==COPADM {{#subobject:841673|Regimen=1}}== | ||
− | |||
COPADM: '''<u>C</u>'''yclophosphamide, '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''rednisone, '''<u>AD</u>'''riamycin (Doxorubicin), '''<u>M</u>'''ethotrexate | COPADM: '''<u>C</u>'''yclophosphamide, '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''rednisone, '''<u>AD</u>'''riamycin (Doxorubicin), '''<u>M</u>'''ethotrexate | ||
− | === | + | <div class="toccolours" style="background-color:#eeeeee"> |
+ | ===Regimen variant #1 {{#subobject:39dc15|Variant=1}}=== | ||
+ | {| class="wikitable sortable" style="width: 60%; text-align:center;" | ||
+ | !style="width: 33%"|Study | ||
+ | !style="width: 33%"|Dates of enrollment | ||
+ | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | |- | ||
+ | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc1852229/ Patte et al. 2007 (FAB/LMB96)] | ||
+ | |1996-2001 | ||
+ | |style="background-color:#91cf61"|Non-randomized part of phase 3 RCT | ||
+ | |- | ||
+ | |} | ||
+ | ''Note: It is not clear from Patte et al. 2007 whether the cyclophosphamide was fractionated.'' | ||
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
+ | ====Preceding treatment==== | ||
+ | *[[#CVP|COP]] pre-phase | ||
+ | </div> | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Chemotherapy==== | ||
+ | *[[Cyclophosphamide (Cytoxan)]] 250 mg/m<sup>2</sup> IV twice per day on days 2 to 4 (total dose: 1500 mg/m<sup>2</sup>) | ||
+ | *[[Vincristine (Oncovin)]] 2 mg/m<sup>2</sup> IV once on day 1 | ||
+ | *[[Doxorubicin (Adriamycin)]] 60 mg/m<sup>2</sup> IV once on day 2 | ||
+ | *[[Methotrexate (MTX)]] 3000 mg/m<sup>2</sup> IV over 3 hours once on day 1 | ||
+ | ====Glucocorticoid therapy==== | ||
+ | *[[Prednisone (Sterapred)]] 60 mg/m<sup>2</sup>/day IV or PO on days 1 to 7 | ||
+ | ====Supportive therapy==== | ||
+ | *[[Leucovorin (Folinic acid)]] | ||
+ | ====CNS therapy, prophylaxis==== | ||
+ | *[[Methotrexate (MTX)]] (dose not specified) IT once per day on days 2 & 6 | ||
+ | '''One course''' | ||
+ | </div> | ||
+ | <div class="toccolours" style="background-color:#cbd5e7"> | ||
+ | ====Subsequent treatment==== | ||
+ | *[[#COPADM|COPADM]] re-induction; reduced-dose versus [[#COPADM|COPADM]] re-induction; standard-dose | ||
+ | </div></div><br> | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen variant #2 {{#subobject:39dc15|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
|[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7720281/ Minard-Colin et al. 2020 (Inter-B-NHL Ritux 2010)] | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7720281/ Minard-Colin et al. 2020 (Inter-B-NHL Ritux 2010)] | ||
Line 65: | Line 102: | ||
|- | |- | ||
|} | |} | ||
− | ''Note: | + | ''Note: Cycle 2 should start as soon as peripheral blood counts have recovered (ANC approximately 1000/uL and platelets approximately 100 x 10<sup>9</sup>/L), which is usually days 18 to 21. The main difference between this and the above variant is the capped vincristine and the tapering of the steroids.'' |
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
====Preceding treatment==== | ====Preceding treatment==== | ||
− | *[[#CVP|COP | + | *Inter-B-NHL Ritux 2010, high-risk: [[#CVP|COP]] pre-phase |
+ | </div> | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | *[[Cyclophosphamide (Cytoxan)]] 250 mg/m<sup>2</sup> IV | + | *[[Cyclophosphamide (Cytoxan)]] 250 mg/m<sup>2</sup> IV over 15 minutes every 12 hours on days 2 to 4 (total dose: 1500 mg/m<sup>2</sup>) |
− | *[[Vincristine (Oncovin)]] 2 mg/m<sup>2</sup> IV once on day 1 | + | *[[Vincristine (Oncovin)]] 2 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 1 |
− | *[[Doxorubicin (Adriamycin)]] 60 mg/m<sup>2</sup> IV once on day 2 | + | *[[Doxorubicin (Adriamycin)]] 60 mg/m<sup>2</sup> IV over 60 minutes once on day 2 |
*[[Methotrexate (MTX)]] 3000 mg/m<sup>2</sup> IV over 3 hours once on day 1 | *[[Methotrexate (MTX)]] 3000 mg/m<sup>2</sup> IV over 3 hours once on day 1 | ||
====Glucocorticoid therapy==== | ====Glucocorticoid therapy==== | ||
− | *[[Prednisone (Sterapred)]] | + | *[[Prednisone (Sterapred)]] 30 mg/m<sup>2</sup> PO twice per day on days 1 to 5, then tapered over 3 days |
− | ====Supportive | + | ====Supportive therapy==== |
− | *[[Folinic acid | + | *[[Leucovorin (Folinic acid)]] 15 mg/m<sup>2</sup> PO every 6 hours until MTX level less than 0.15, beginning 24 hours after the start of the HD-MTX infusion |
− | + | ====CNS therapy, prophylaxis==== | |
− | ====CNS prophylaxis==== | + | *[[Methotrexate (MTX)]] 8 to 15 mg (dose varies with age) IT once per day on days 2 & 6 |
− | *[[Methotrexate (MTX)]] (dose | + | *[[Hydrocortisone (Cortef)]] 8 to 15 mg (dose varies with age) IT once per day on days 2 & 6 |
− | + | '''16- to 21-day cycle for 2 cycles (see note)''' | |
− | ''' | + | </div></div> |
− | |||
− | |||
− | |||
− | |||
===References=== | ===References=== | ||
− | # '''FAB/LMB96:''' Patte C, Auperin A, Gerrard M, Michon J, Pinkerton R, Sposto R, Weston C, Raphael M, Perkins SL, McCarthy K, Cairo MS; FAB/LMB96 International Study Committee. Results of the randomized international FAB/LMB96 trial for intermediate risk B-cell non-Hodgkin lymphoma in children and adolescents: it is possible to reduce treatment for the early responding patients. Blood. 2007 Apr 1;109(7):2773-80. [https://doi.org/10.1182/blood-2006-07-036673 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc1852229/ link to PMC article] ''' | + | # '''FAB/LMB96:''' Patte C, Auperin A, Gerrard M, Michon J, Pinkerton R, Sposto R, Weston C, Raphael M, Perkins SL, McCarthy K, Cairo MS; FAB/LMB96 International Study Committee. Results of the randomized international FAB/LMB96 trial for intermediate risk B-cell non-Hodgkin lymphoma in children and adolescents: it is possible to reduce treatment for the early responding patients. Blood. 2007 Apr 1;109(7):2773-80. [https://doi.org/10.1182/blood-2006-07-036673 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc1852229/ link to PMC article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/17132719/ PubMed] [https://clinicaltrials.gov/study/NCT00002757 NCT00002757] |
− | # '''Inter-B-NHL Ritux 2010:''' Minard-Colin V, Aupérin A, Pillon M, Burke GAA, Barkauskas DA, Wheatley K, Delgado RF, Alexander S, Uyttebroeck A, Bollard CM, Zsiros J, Csoka M, Kazanowska B, Chiang AK, Miles RR, Wotherspoon A, Adamson PC, Vassal G, Patte C, Gross TG; European Intergroup for Childhood Non-Hodgkin Lymphoma; Children’s Oncology Group. Rituximab for High-Risk, Mature B-Cell Non-Hodgkin's Lymphoma in Children. N Engl J Med. 2020 Jun 4;382(23):2207-2219. [https://doi.org/10.1056/nejmoa1915315 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7720281/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/32492302/ PubMed] NCT01516580 | + | # '''Inter-B-NHL Ritux 2010:''' Minard-Colin V, Aupérin A, Pillon M, Burke GAA, Barkauskas DA, Wheatley K, Delgado RF, Alexander S, Uyttebroeck A, Bollard CM, Zsiros J, Csoka M, Kazanowska B, Chiang AK, Miles RR, Wotherspoon A, Adamson PC, Vassal G, Patte C, Gross TG; European Intergroup for Childhood Non-Hodgkin Lymphoma; Children’s Oncology Group. Rituximab for High-Risk, Mature B-Cell Non-Hodgkin's Lymphoma in Children. N Engl J Med. 2020 Jun 4;382(23):2207-2219. [https://doi.org/10.1056/nejmoa1915315 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7720281/ link to PMC article] '''dosing details in supplement have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/32492302/ PubMed] [https://clinicaltrials.gov/study/NCT01516580 NCT01516580] |
==R-COPADM {{#subobject:bac173|Regimen=1}}== | ==R-COPADM {{#subobject:bac173|Regimen=1}}== | ||
− | |||
R-COPADM: '''<u>R</u>'''ituximab, '''<u>C</u>'''yclophosphamide, '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''rednisone, '''<u>AD</u>'''riamycin (Doxorubicin), '''<u>M</u>'''ethotrexate | R-COPADM: '''<u>R</u>'''ituximab, '''<u>C</u>'''yclophosphamide, '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''rednisone, '''<u>AD</u>'''riamycin (Doxorubicin), '''<u>M</u>'''ethotrexate | ||
− | === | + | <div class="toccolours" style="background-color:#eeeeee"> |
+ | ===Regimen {{#subobject:avdc15|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
Line 105: | Line 141: | ||
| style="background-color:#1a9851" |Phase 3 (E-RT-esc) | | style="background-color:#1a9851" |Phase 3 (E-RT-esc) | ||
|[[#COPADM|COPADM]] | |[[#COPADM|COPADM]] | ||
− | | style="background-color:#1a9850" |Superior OS<br>OS36: 95.1% vs 87.3%<br>(HR 0.36, 95% CI 0.16-0.82) | + | | style="background-color:#1a9850" |Superior OS (secondary endpoint)<br>OS36: 95.1% vs 87.3%<br>(HR 0.36, 95% CI 0.16-0.82)<br><br>Superior EFS (primary endpoint)<br>EFS36: 93.9% vs 82.3%<br>(HR 0.32, 95% CI 0.15-0.66) |
|- | |- | ||
|} | |} | ||
− | ''Note: | + | ''Note: Cycle 2 should start as soon as peripheral blood counts have recovered (ANC approximately 1000/uL and platelets approximately 100 x 10<sup>9</sup>/L), which is usually days 18 to 21.'' |
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
====Preceding treatment==== | ====Preceding treatment==== | ||
− | *[[#CVP|COP | + | *Inter-B-NHL Ritux 2010, high-risk: [[#CVP|COP]] pre-phase |
+ | </div> | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Targeted therapy==== | ====Targeted therapy==== | ||
*[[Rituximab (Rituxan)]] 375 mg/m<sup>2</sup> IV once per day on days -2 & 1 | *[[Rituximab (Rituxan)]] 375 mg/m<sup>2</sup> IV once per day on days -2 & 1 | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | *[[Cyclophosphamide (Cytoxan)]] 250 mg/m<sup>2</sup> IV | + | *[[Cyclophosphamide (Cytoxan)]] 250 mg/m<sup>2</sup> IV over 15 minutes every 12 hours on days 2 to 4 (total dose: 1500 mg/m<sup>2</sup>) |
− | *[[Vincristine (Oncovin)]] 2 mg/m<sup>2</sup> IV once on day 1 | + | *[[Vincristine (Oncovin)]] 2 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 1 |
− | *[[Doxorubicin (Adriamycin)]] 60 mg/m<sup>2</sup> IV once on day 2 | + | *[[Doxorubicin (Adriamycin)]] 60 mg/m<sup>2</sup> IV over 60 minutes once on day 2 |
*[[Methotrexate (MTX)]] 3000 mg/m<sup>2</sup> IV over 3 hours once on day 1 | *[[Methotrexate (MTX)]] 3000 mg/m<sup>2</sup> IV over 3 hours once on day 1 | ||
====Glucocorticoid therapy==== | ====Glucocorticoid therapy==== | ||
− | *[[Prednisone (Sterapred)]] | + | *[[Prednisone (Sterapred)]] 30 mg/m<sup>2</sup> PO twice per day on days 1 to 5, then tapered over 3 days |
− | ====Supportive | + | ====Supportive therapy==== |
− | *[[Folinic acid | + | *[[Leucovorin (Folinic acid)]] 15 mg/m<sup>2</sup> PO every 6 hours until MTX level less than 0.15, beginning 24 hours after the start of the HD-MTX infusion |
− | + | ====CNS therapy, prophylaxis==== | |
− | ====CNS prophylaxis==== | + | *[[Methotrexate (MTX)]] 8 to 15 mg (dose varies with age) IT once per day on days 2 & 6 |
− | *[[Methotrexate (MTX)]] (dose | + | *[[Hydrocortisone (Cortef)]] 8 to 15 mg (dose varies with age) IT once per day on days 2 & 6 |
− | + | '''16- to 21-day cycle for 2 cycles (see note)''' | |
− | ''' | + | </div></div> |
− | |||
− | |||
− | |||
− | |||
===References=== | ===References=== | ||
− | # '''Inter-B-NHL Ritux 2010:''' Minard-Colin V, Aupérin A, Pillon M, Burke GAA, Barkauskas DA, Wheatley K, Delgado RF, Alexander S, Uyttebroeck A, Bollard CM, Zsiros J, Csoka M, Kazanowska B, Chiang AK, Miles RR, Wotherspoon A, Adamson PC, Vassal G, Patte C, Gross TG; European Intergroup for Childhood Non-Hodgkin Lymphoma; Children’s Oncology Group. Rituximab for High-Risk, Mature B-Cell Non-Hodgkin's Lymphoma in Children. N Engl J Med. 2020 Jun 4;382(23):2207-2219. [https://doi.org/10.1056/nejmoa1915315 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7720281/ link to PMC article] ''' | + | # '''Inter-B-NHL Ritux 2010:''' Minard-Colin V, Aupérin A, Pillon M, Burke GAA, Barkauskas DA, Wheatley K, Delgado RF, Alexander S, Uyttebroeck A, Bollard CM, Zsiros J, Csoka M, Kazanowska B, Chiang AK, Miles RR, Wotherspoon A, Adamson PC, Vassal G, Patte C, Gross TG; European Intergroup for Childhood Non-Hodgkin Lymphoma; Children’s Oncology Group. Rituximab for High-Risk, Mature B-Cell Non-Hodgkin's Lymphoma in Children. N Engl J Med. 2020 Jun 4;382(23):2207-2219. [https://doi.org/10.1056/nejmoa1915315 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7720281/ link to PMC article] '''dosing details in supplement have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/32492302/ PubMed] [https://clinicaltrials.gov/study/NCT01516580 NCT01516580] |
− | |||
[[Category:Non-Hodgkin lymphoma regimens]] | [[Category:Non-Hodgkin lymphoma regimens]] | ||
[[Category:Disease-specific pages]] | [[Category:Disease-specific pages]] | ||
[[Category:Lymphomas]] | [[Category:Lymphomas]] | ||
[[Category:Pediatric hematologic neoplasms]] | [[Category:Pediatric hematologic neoplasms]] |
Latest revision as of 17:14, 17 July 2024
Section editor | |
---|---|
David Noyd, MD, MPH University of Washington Seattle, WA, USA |
This page contains studies that were specific to pediatric populations, who are generally treated based on risk-stratification, not on the underlying histology. See individual trials for inclusion criteria.
3 regimens on this page
3 variants on this page
|
Guidelines
Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.
NCCN
Untreated, pre-phase
CVP
CVP: Cyclophosphamide, Vincristine, Prednisone
COP: Cyclophosphamide, Oncovin (Vincristine), Prednisone
Regimen
Study | Dates of enrollment | Evidence |
---|---|---|
Patte et al. 2007 (FAB/LMB96) | 1996-2001 | Non-randomized part of phase 3 RCT |
Chemotherapy
- Cyclophosphamide (Cytoxan) 300 mg/m2 IV once on day 1
- Vincristine (Oncovin) 1 mg/m2 IV once on day 1
Glucocorticoid therapy
- Prednisone (Sterapred) 60 mg/m2/day IV or PO on days 1 to 7
CNS therapy, prophylaxis
- Methotrexate (MTX) (dose not specified) IT once on day 1
7-day course
Subsequent treatment
- COPADM induction
References
- FAB/LMB96: Patte C, Auperin A, Gerrard M, Michon J, Pinkerton R, Sposto R, Weston C, Raphael M, Perkins SL, McCarthy K, Cairo MS; FAB/LMB96 International Study Committee. Results of the randomized international FAB/LMB96 trial for intermediate risk B-cell non-Hodgkin lymphoma in children and adolescents: it is possible to reduce treatment for the early responding patients. Blood. 2007 Apr 1;109(7):2773-80. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors PubMed NCT00002757
Untreated, induction
COPADM
COPADM: Cyclophosphamide, Oncovin (Vincristine), Prednisone, ADriamycin (Doxorubicin), Methotrexate
Regimen variant #1
Study | Dates of enrollment | Evidence |
---|---|---|
Patte et al. 2007 (FAB/LMB96) | 1996-2001 | Non-randomized part of phase 3 RCT |
Note: It is not clear from Patte et al. 2007 whether the cyclophosphamide was fractionated.
Preceding treatment
- COP pre-phase
Chemotherapy
- Cyclophosphamide (Cytoxan) 250 mg/m2 IV twice per day on days 2 to 4 (total dose: 1500 mg/m2)
- Vincristine (Oncovin) 2 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 60 mg/m2 IV once on day 2
- Methotrexate (MTX) 3000 mg/m2 IV over 3 hours once on day 1
Glucocorticoid therapy
- Prednisone (Sterapred) 60 mg/m2/day IV or PO on days 1 to 7
Supportive therapy
CNS therapy, prophylaxis
- Methotrexate (MTX) (dose not specified) IT once per day on days 2 & 6
One course
Regimen variant #2
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Minard-Colin et al. 2020 (Inter-B-NHL Ritux 2010) | 2011-2015 | Phase 3 (C) | R-COPADM | Inferior OS |
Note: Cycle 2 should start as soon as peripheral blood counts have recovered (ANC approximately 1000/uL and platelets approximately 100 x 109/L), which is usually days 18 to 21. The main difference between this and the above variant is the capped vincristine and the tapering of the steroids.
Preceding treatment
- Inter-B-NHL Ritux 2010, high-risk: COP pre-phase
Chemotherapy
- Cyclophosphamide (Cytoxan) 250 mg/m2 IV over 15 minutes every 12 hours on days 2 to 4 (total dose: 1500 mg/m2)
- Vincristine (Oncovin) 2 mg/m2 (maximum dose of 2 mg) IV once on day 1
- Doxorubicin (Adriamycin) 60 mg/m2 IV over 60 minutes once on day 2
- Methotrexate (MTX) 3000 mg/m2 IV over 3 hours once on day 1
Glucocorticoid therapy
- Prednisone (Sterapred) 30 mg/m2 PO twice per day on days 1 to 5, then tapered over 3 days
Supportive therapy
- Leucovorin (Folinic acid) 15 mg/m2 PO every 6 hours until MTX level less than 0.15, beginning 24 hours after the start of the HD-MTX infusion
CNS therapy, prophylaxis
- Methotrexate (MTX) 8 to 15 mg (dose varies with age) IT once per day on days 2 & 6
- Hydrocortisone (Cortef) 8 to 15 mg (dose varies with age) IT once per day on days 2 & 6
16- to 21-day cycle for 2 cycles (see note)
References
- FAB/LMB96: Patte C, Auperin A, Gerrard M, Michon J, Pinkerton R, Sposto R, Weston C, Raphael M, Perkins SL, McCarthy K, Cairo MS; FAB/LMB96 International Study Committee. Results of the randomized international FAB/LMB96 trial for intermediate risk B-cell non-Hodgkin lymphoma in children and adolescents: it is possible to reduce treatment for the early responding patients. Blood. 2007 Apr 1;109(7):2773-80. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors PubMed NCT00002757
- Inter-B-NHL Ritux 2010: Minard-Colin V, Aupérin A, Pillon M, Burke GAA, Barkauskas DA, Wheatley K, Delgado RF, Alexander S, Uyttebroeck A, Bollard CM, Zsiros J, Csoka M, Kazanowska B, Chiang AK, Miles RR, Wotherspoon A, Adamson PC, Vassal G, Patte C, Gross TG; European Intergroup for Childhood Non-Hodgkin Lymphoma; Children’s Oncology Group. Rituximab for High-Risk, Mature B-Cell Non-Hodgkin's Lymphoma in Children. N Engl J Med. 2020 Jun 4;382(23):2207-2219. link to original article link to PMC article dosing details in supplement have been reviewed by our editors PubMed NCT01516580
R-COPADM
R-COPADM: Rituximab, Cyclophosphamide, Oncovin (Vincristine), Prednisone, ADriamycin (Doxorubicin), Methotrexate
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Minard-Colin et al. 2020 (Inter-B-NHL Ritux 2010) | 2011-2015 | Phase 3 (E-RT-esc) | COPADM | Superior OS (secondary endpoint) OS36: 95.1% vs 87.3% (HR 0.36, 95% CI 0.16-0.82) Superior EFS (primary endpoint) EFS36: 93.9% vs 82.3% (HR 0.32, 95% CI 0.15-0.66) |
Note: Cycle 2 should start as soon as peripheral blood counts have recovered (ANC approximately 1000/uL and platelets approximately 100 x 109/L), which is usually days 18 to 21.
Preceding treatment
- Inter-B-NHL Ritux 2010, high-risk: COP pre-phase
Targeted therapy
- Rituximab (Rituxan) 375 mg/m2 IV once per day on days -2 & 1
Chemotherapy
- Cyclophosphamide (Cytoxan) 250 mg/m2 IV over 15 minutes every 12 hours on days 2 to 4 (total dose: 1500 mg/m2)
- Vincristine (Oncovin) 2 mg/m2 (maximum dose of 2 mg) IV once on day 1
- Doxorubicin (Adriamycin) 60 mg/m2 IV over 60 minutes once on day 2
- Methotrexate (MTX) 3000 mg/m2 IV over 3 hours once on day 1
Glucocorticoid therapy
- Prednisone (Sterapred) 30 mg/m2 PO twice per day on days 1 to 5, then tapered over 3 days
Supportive therapy
- Leucovorin (Folinic acid) 15 mg/m2 PO every 6 hours until MTX level less than 0.15, beginning 24 hours after the start of the HD-MTX infusion
CNS therapy, prophylaxis
- Methotrexate (MTX) 8 to 15 mg (dose varies with age) IT once per day on days 2 & 6
- Hydrocortisone (Cortef) 8 to 15 mg (dose varies with age) IT once per day on days 2 & 6
16- to 21-day cycle for 2 cycles (see note)
References
- Inter-B-NHL Ritux 2010: Minard-Colin V, Aupérin A, Pillon M, Burke GAA, Barkauskas DA, Wheatley K, Delgado RF, Alexander S, Uyttebroeck A, Bollard CM, Zsiros J, Csoka M, Kazanowska B, Chiang AK, Miles RR, Wotherspoon A, Adamson PC, Vassal G, Patte C, Gross TG; European Intergroup for Childhood Non-Hodgkin Lymphoma; Children’s Oncology Group. Rituximab for High-Risk, Mature B-Cell Non-Hodgkin's Lymphoma in Children. N Engl J Med. 2020 Jun 4;382(23):2207-2219. link to original article link to PMC article dosing details in supplement have been reviewed by our editors PubMed NCT01516580