Difference between revisions of "Staging page"
Jump to navigation
Jump to search
m |
m |
||
| Line 3: | Line 3: | ||
[[#top|Back to Top]] | [[#top|Back to Top]] | ||
</div> | </div> | ||
| − | {{#lst:Section editor transclusions| | + | {{#lst:Section editor transclusions|tcl}} |
| − | '' | + | <big>'''Note: these studies were specific to ALCL or had ALCL subgroups; regimens used in [[Peripheral_T-cell_lymphoma|PTCL, NOS]] are also often used in this condition. Certain regimens have been moved to dedicated pages: |
| + | *'''[[Anaplastic large cell lymphoma, pediatric|Pediatric ALCL]] | ||
| + | </big> | ||
{| class="wikitable" style="float:right; margin-right: 5px;" | {| class="wikitable" style="float:right; margin-right: 5px;" | ||
|- | |- | ||
| Line 10: | Line 12: | ||
<div style="background-color: #deebf6; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Variant |limit=10000|format=sum}} [[Tutorial#Variants|variants]] on this page</b></font></div> | <div style="background-color: #deebf6; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Variant |limit=10000|format=sum}} [[Tutorial#Variants|variants]] on this page</b></font></div> | ||
|} | |} | ||
| − | {{TOC limit|limit= | + | {{TOC limit|limit=3}} |
| − | = | + | =Guidelines= |
| − | == | + | ==[http://www.esmo.org/ ESMO]== |
| + | *'''2015:''' d'Amore et al. [https://www.esmo.org/Guidelines/Haematological-Malignancies/Peripheral-T-Cell-Lymphomas Peripheral T-cell lymphomas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up] | ||
| + | =Untreated= | ||
| + | ==BV-CHP {{#subobject:6964de|Regimen=1}}== | ||
| + | BV-CHP: '''<u>B</u>'''rentuximab '''<u>V</u>'''edotin, '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>P</u>'''rednisone | ||
<div class="toccolours" style="background-color:#eeeeee"> | <div class="toccolours" style="background-color:#eeeeee"> | ||
| − | === | + | ===Regimen {{#subobject:985a91|Variant=1}}=== |
| + | {| class="wikitable" style="color:white; background-color:#404040" | ||
| + | |<small>'''FDA-recommended dose'''</small> | ||
| + | |- | ||
| + | |} | ||
| + | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
| + | !style="width: 20%"|Study | ||
| + | !style="width: 20%"|Years of enrollment | ||
| + | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
| + | !style="width: 20%"|Comparator | ||
| + | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
| + | |- | ||
| + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6436818/ Horwitz et al. 2018 (ECHELON-2)] | ||
| + | |2013-2016 | ||
| + | |style="background-color:#1a9851"|Phase 3 (E-RT-switch-ooc) | ||
| + | |[[#CHOP|CHOP]] | ||
| + | | style="background-color:#1a9850" |Superior OS<br>Median OS: NYR vs NYR<br>(HR 0.66, 95% CI 0.46-0.95) | ||
| + | |- | ||
| + | |} | ||
| + | <div class="toccolours" style="background-color:#b3e2cd"> | ||
| + | ====Antibody-drug conjugate therapy==== | ||
| + | *[[Brentuximab vedotin (Adcetris)]] 1.8 mg/kg (maximum dose of 180 mg) IV once on day 1 | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
| − | *[[ | + | *[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 |
| − | + | *[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | |
| − | + | ====Glucocorticoid therapy==== | |
| − | + | *[[Prednisone (Sterapred)]] 100 mg PO once per day on days 1 to 5 | |
| − | * | + | '''21-day cycle for 6 to 8 cycles''' |
| − | + | </div></div> | |
| − | + | ===References=== | |
| − | + | # '''ECHELON-2:''' Horwitz S, O'Connor OA, Pro B, Illidge T, Fanale M, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Feldman T, Lennard A, Belada D, Illés Á, Tobinai K, Tsukasaki K, Yeh SP, Shustov A, Hüttmann A, Savage KJ, Yuen S, Iyer S, Zinzani PL, Hua Z, Little M, Rao S, Woolery J, Manley T, Trümper L; ECHELON-2 Study Group. Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomised, phase 3 trial. Lancet. 2019 Jan 19;393(10168):229-240. Epub 2018 Dec 4. Erratum in: Lancet. 2019 Jan 19;393(10168):228. [https://doi.org/10.1016/S0140-6736(18)32984-2 link to original article] '''contains dosing details in abstract''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6436818/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30522922 PubMed] NCT01777152 | |
| − | + | ==CHOEP-14 {{#subobject:c516ab|Regimen=1}}== | |
| − | *[[ | + | CHOEP-14: '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>E</u>'''toposide, '''<u>P</u>'''rednisone every '''<u>14</u>''' days |
| − | + | <br>CHOPE | |
| − | + | <br>VACOP | |
| − | + | ===Example orders=== | |
| − | + | *[[Example orders for CHOEP in lymphoma]] | |
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | === | ||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
<div class="toccolours" style="background-color:#eeeeee"> | <div class="toccolours" style="background-color:#eeeeee"> | ||
| − | === | + | ===Regimen {{#subobject:f61648|Variant=1}}=== |
| + | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
| + | !style="width: 17%"|Study | ||
| + | !style="width: 15%"|Years of enrollment | ||
| + | !style="width: 17%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
| + | !style="width: 17%"|Comparator | ||
| + | !style="width: 17%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
| + | !style="width: 17%"|[[Levels_of_Evidence#Toxicity|Comparative Toxicity]] | ||
| + | |- | ||
| + | |[http://www.bloodjournal.org/content/104/3/626.long Pfreundschuh et al. 2004 (NHL-B1)] | ||
| + | |1993-2000 | ||
| + | | style="background-color:#91cf61" |Phase 3, <20 pts in this subgroup (E-esc) | ||
| + | |1. [[#CHOEP-21|CHOEP-21]]<br>2. [[#CHOP|CHOP-21]]<br> 3. [[#CHOP-14_99|CHOP-14]] | ||
| + | |Not reported by subgroup | ||
| + | |Not reported by subgroup | ||
| + | |} | ||
| + | ''This regimen was used in 16 ALCL patients in the NHL-B1 trial. The authors did not report a subgroup analysis for this minority population.'' | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
| − | *[[ | + | *[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 |
| − | + | *[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | |
| − | * | + | *[[Vincristine (Oncovin)]] 2 mg IV once on day 1 |
| − | * | + | *[[Etoposide (Vepesid)]] 100 mg/m<sup>2</sup> IV once per day on days 1 to 3 |
| − | * | + | ====Glucocorticoid therapy==== |
| − | + | *[[Prednisone (Sterapred)]] 100 mg PO once per day on days 1 to 5 | |
| − | + | ====Supportive therapy==== | |
| − | + | *[[Filgrastim (Neupogen)]] by the following criteria: | |
| − | * | + | **Patients less than 75 kg: 300 mcg SC once per day on days 4 to 13 |
| − | *[[ | + | **Patients at least 75 kg: 480 mcg SC once per day on days 4 to 13 |
| − | ** | + | '''14-day cycle for 6 cycles''', next cycle to start as long as WBC count is greater than 2.5 x 10<sup>9</sup>/L and platelets greater than 80 x 10<sup>9</sup>/L |
| − | + | </div> | |
| − | ** | + | <div class="toccolours" style="background-color:#cbd5e7"> |
| − | + | ====Subsequent treatment==== | |
| − | + | *Patients with initial bulky disease (mass conglomerate at least 7.5 cm): [[#Radiation_therapy_88|RT]] x 36 Gy to extranodal sites of disease when possible | |
| − | + | </div></div> | |
| − | + | ===References=== | |
| − | + | # '''NHL-B1:''' Pfreundschuh M, Trümper L, Kloess M, Schmits R, Feller AC, Rudolph C, Reiser M, Hossfeld DK, Metzner B, Hasenclever D, Schmitz N, Glass B, Rübe C, Loeffler M; German High-Grade Non-Hodgkin's Lymphoma Study Group. Two-weekly or 3-weekly CHOP chemotherapy with or without etoposide for the treatment of young patients with good-prognosis (normal LDH) aggressive lymphomas: results of the NHL-B1 trial of the DSHNHL. Blood. 2004 Aug 1;104(3):626-33. Epub 2004 Feb 24. [http://www.bloodjournal.org/content/104/3/626.long link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/14982884 PubMed] | |
| − | + | ==CHOEP-21 {{#subobject:c621ab|Regimen=1}}== | |
| − | + | CHOEP-21: '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>E</u>'''toposide, '''<u>P</u>'''rednisone every '''<u>21</u>''' days | |
| − | + | <br>CHOPE | |
| − | + | <br>VACOP | |
| − | + | ===Example orders=== | |
| − | * | + | *[[Example orders for CHOEP in lymphoma]] |
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | === | ||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
<div class="toccolours" style="background-color:#eeeeee"> | <div class="toccolours" style="background-color:#eeeeee"> | ||
| − | === | + | ===Regimen {{#subobject:fan248|Variant=1}}=== |
| + | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
| + | !style="width: 17%"|Study | ||
| + | !style="width: 15%"|Years of enrollment | ||
| + | !style="width: 17%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
| + | !style="width: 17%"|Comparator | ||
| + | !style="width: 17%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
| + | !style="width: 17%"|[[Levels_of_Evidence#Toxicity|Comparative Toxicity]] | ||
| + | |- | ||
| + | |[http://www.bloodjournal.org/content/104/3/626.long Pfreundschuh et al. 2004 (NHL-B1)] | ||
| + | |1993-2000 | ||
| + | |style="background-color:#1a9851"|Phase 3 (E-esc) | ||
| + | |1. [[#CHOEP-14|CHOEP-14]]<br>2. [[#CHOP|CHOP-21]]<br>3. [[#CHOP-14_99|CHOP-14]] | ||
| + | |Not reported by subgroup | ||
| + | |Not reported by subgroup | ||
| + | |} | ||
| + | ''This regimen was used in 20 ALCL patients in the NHL-B1 trial. The authors did not report a subgroup analysis for this minority population.'' | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
| − | *[[ | + | *[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 |
| − | + | *[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | |
| − | + | *[[Vincristine (Oncovin)]] 2 mg IV once on day 1 | |
| − | + | *[[Etoposide (Vepesid)]] 100 mg/m<sup>2</sup> IV once per day on days 1 to 3 | |
| − | * | + | ====Glucocorticoid therapy==== |
| − | + | *[[Prednisone (Sterapred)]] 100 mg PO once per day on days 1 to 5 | |
| − | + | ====Supportive therapy==== | |
| − | + | *[[Filgrastim (Neupogen)]] is by discretion of ordering physician | |
| − | + | '''21-day cycle for 6 cycles''', next cycle to start as long as WBC count is greater than 2.5 x 10<sup>9</sup>/L and platelets greater than 80 x 10<sup>9</sup>/L | |
| − | *[[ | + | </div> |
| − | + | <div class="toccolours" style="background-color:#cbd5e7"> | |
| − | + | ====Subsequent treatment==== | |
| − | + | *Patients with initial bulky disease (mass conglomerate at least 7.5 cm): [[#Radiation_therapy_88|RT]] x 36 Gy to extranodal sites of disease when possible | |
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | *[[ | ||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | *[[ | ||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | ====Supportive | ||
| − | *[[ | ||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | <div class="toccolours" style="background-color:# | ||
| − | |||
| − | ==== | ||
| − | * | ||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
</div></div> | </div></div> | ||
===References=== | ===References=== | ||
| − | # ''' | + | # '''NHL-B1:''' Pfreundschuh M, Trümper L, Kloess M, Schmits R, Feller AC, Rudolph C, Reiser M, Hossfeld DK, Metzner B, Hasenclever D, Schmitz N, Glass B, Rübe C, Loeffler M; German High-Grade Non-Hodgkin's Lymphoma Study Group. Two-weekly or 3-weekly CHOP chemotherapy with or without etoposide for the treatment of young patients with good-prognosis (normal LDH) aggressive lymphomas: results of the NHL-B1 trial of the DSHNHL. Blood. 2004 Aug 1;104(3):626-33. Epub 2004 Feb 24. [http://www.bloodjournal.org/content/104/3/626.long link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/14982884 PubMed] |
| − | # ''' | + | ==CHOP {{#subobject:4ca454|Regimen=1}}== |
| − | + | CHOP: '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''rednisone | |
| + | <br>CHOP-21 | ||
| + | <br>ACOP | ||
| + | <br>CAVP | ||
| + | <br>COPA | ||
| + | <br>VACP | ||
| + | <br>VCAP | ||
<div class="toccolours" style="background-color:#eeeeee"> | <div class="toccolours" style="background-color:#eeeeee"> | ||
| − | === | + | ===Regimen variant #1, capped vincristine {{#subobject:9e662b|Variant=1}}=== |
| + | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
| + | !style="width: 20%"|Study | ||
| + | !style="width: 20%"|Years of enrollment | ||
| + | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
| + | !style="width: 20%"|Comparator | ||
| + | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
| + | |- | ||
| + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6436818/ Horwitz et al. 2018 (ECHELON-2)] | ||
| + | |2013-2016 | ||
| + | |style="background-color:#1a9851"|Phase 3 (C) | ||
| + | |[[#BV-CHP|BV-CHP]] | ||
| + | | style="background-color:#d73027" |Inferior OS | ||
| + | |- | ||
| + | |} | ||
| + | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
| − | *[[ | + | *[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 |
| − | + | *[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | |
| − | + | *[[Vincristine (Oncovin)]] 1.4 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 1 | |
| − | *[[ | + | ====Glucocorticoid therapy==== |
| − | + | *[[Prednisone (Sterapred)]] 100 mg PO once per day on days 1 to 5 | |
| − | + | '''21-day cycle for 6 to 8 cycles''' | |
| − | + | </div></div><br> | |
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | *[[ | ||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | ==== | ||
| − | *[[ | ||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
<div class="toccolours" style="background-color:#eeeeee"> | <div class="toccolours" style="background-color:#eeeeee"> | ||
| − | === | + | ===Regimen variant #2, flat-dose vincristine {{#subobject:9e770b|Variant=1}}=== |
| + | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
| + | !style="width: 17%"|Study | ||
| + | !style="width: 15%"|Years of enrollment | ||
| + | !style="width: 17%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
| + | !style="width: 17%"|Comparator | ||
| + | !style="width: 17%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
| + | !style="width: 17%"|[[Levels_of_Evidence#Toxicity|Comparative Toxicity]] | ||
| + | |- | ||
| + | |[http://www.bloodjournal.org/content/104/3/626.long Pfreundschuh et al. 2004 (NHL-B1)] | ||
| + | |1993-2000 | ||
| + | |style="background-color:#91cf61"|Phase 3, <20 pts in arm (C) | ||
| + | |1. [[#CHOEP-21|CHOEP-21]]<br>2. [[#CHOP-14_99|CHOP-14]] | ||
| + | |Not reported by subgroup | ||
| + | |Not reported by subgroup | ||
| + | |} | ||
| + | ''This regimen was used in 14 ALCL patients in NHL-B1. The authors did not report a subgroup analysis for this minority population.'' | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
| − | *[[ | + | *[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 |
| − | + | *[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | |
| − | + | *[[Vincristine (Oncovin)]] 2 mg IV once on day 1 | |
| − | *[[ | + | ====Glucocorticoid therapy==== |
| − | + | *[[Prednisone (Sterapred)]] 100 mg PO once per day on days 1 to 5 | |
| − | * | + | ====Supportive therapy==== |
| − | * | + | *At the discretion of ordering physician: [[Filgrastim (Neupogen)]] 300 mcg (for patients less than 75 kg) or 480 mcg (for patients at least 75 kg) SC once per day on days 4 to 13 |
| − | * | + | '''21-day cycle for 6 cycles''' |
| − | + | </div></div> | |
| − | + | ===References=== | |
| − | + | # '''NHL-B1:''' Pfreundschuh M, Trümper L, Kloess M, Schmits R, Feller AC, Rudolph C, Reiser M, Hossfeld DK, Metzner B, Hasenclever D, Schmitz N, Glass B, Rübe C, Loeffler M; German High-Grade Non-Hodgkin's Lymphoma Study Group. Two-weekly or 3-weekly CHOP chemotherapy with or without etoposide for the treatment of young patients with good-prognosis (normal LDH) aggressive lymphomas: results of the NHL-B1 trial of the DSHNHL. Blood. 2004 Aug 1;104(3):626-33. Epub 2004 Feb 24. [http://www.bloodjournal.org/content/104/3/626.long link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/14982884 PubMed] | |
| − | + | # '''ECHELON-2:''' Horwitz S, O'Connor OA, Pro B, Illidge T, Fanale M, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Feldman T, Lennard A, Belada D, Illés Á, Tobinai K, Tsukasaki K, Yeh SP, Shustov A, Hüttmann A, Savage KJ, Yuen S, Iyer S, Zinzani PL, Hua Z, Little M, Rao S, Woolery J, Manley T, Trümper L; ECHELON-2 Study Group. Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomised, phase 3 trial. Lancet. 2019 Jan 19;393(10168):229-240. Epub 2018 Dec 4. Erratum in: Lancet. 2019 Jan 19;393(10168):228. [https://doi.org/10.1016/S0140-6736(18)32984-2 link to original article] '''contains dosing details in abstract''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6436818/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30522922 PubMed] NCT01777152 | |
| − | + | ==DA-EPOCH {{#subobject:6c5911|Regimen=1}}== | |
| − | + | DA-EPOCH: '''<u>D</u>'''ose '''<u>A</u>'''djusted '''<u>E</u>'''toposide, '''<u>P</u>'''rednisone, '''<u>O</u>'''ncovin (Vincristine), '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin) | |
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
<div class="toccolours" style="background-color:#eeeeee"> | <div class="toccolours" style="background-color:#eeeeee"> | ||
| − | === | + | ===Regimen {{#subobject:659929|Variant=1}}=== |
| + | {| class="wikitable" style="width: 40%; text-align:center;" | ||
| + | !style="width: 25%"|Study | ||
| + | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
| + | |- | ||
| + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4697904/ Dunleavy et al. 2016 (NCI 93-C-0133<sub>ALCL</sub>)] | ||
| + | |style="background-color:#91cf61"|Phase 2 | ||
| + | |- | ||
| + | |} | ||
| + | ''Note: this should be considered a substudy under the master protocol NCI 93-C-0133.'' | ||
| + | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
| − | *[[ | + | *[[Etoposide (Vepesid)]] 50 mg/m<sup>2</sup>/day IV continuous infusion over 96 hours, started on day 1 (total dose per cycle: 200 mg/m<sup>2</sup>) |
| − | + | *[[Vincristine (Oncovin)]] 0.4 mg/m<sup>2</sup>/day IV continuous infusion over 96 hours, started on day 1 (total dose per cycle: 1.6 mg/m<sup>2</sup>) | |
| − | + | *[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV over 2 hours once on day 5 | |
| − | + | *[[Doxorubicin (Adriamycin)]] 10 mg/m<sup>2</sup>/day IV continuous infusion over 96 hours, started on day 1 (total dose per cycle: 40 mg/m<sup>2</sup>) | |
| − | + | ====Glucocorticoid therapy==== | |
| − | + | *[[Prednisone (Sterapred)]] 60 mg/m<sup>2</sup> PO twice per day on days 1 to 5 | |
| − | + | ====Supportive therapy==== | |
| − | + | *[[Filgrastim (Neupogen)]] 300 mcg SC once per day, starting on day 6 and continuing until ANC greater than 5000/uL past nadir | |
| − | + | *[[Trimethoprim-Sulfamethoxazole (Bactrim DS)]] 160/800 mg (or equivalent if allergic) PO once per day on 3 days per week | |
| − | + | *[[Omeprazole (Prilosec)]] 20 mg (or equivalent) PO once per day | |
| − | + | *[[Docusate (Colace)]] (dose not specified) and [[Sennosides (Senna)]] 2 tablets PO twice per day as needed for constipation | |
| − | + | *Lactulose 20 g PO every 6 hours as needed for constipation | |
| − | *[[ | + | *Hepatitis B surface antigen positive patients: received daily [[:Category:Antivirals|antiviral]] therapy until 8 weeks after completion of chemotherapy |
| − | + | '''21-day cycle for 6 to 8 cycles''' | |
| − | + | ====Dose modifications==== | |
| − | + | *Start cycle 1 as described above. | |
| − | + | *Obtain CBCs twice per week for nadir measurements. | |
| − | + | *If nadir ANC greater than 500/uL, increase etoposide, doxorubicin, and cyclophosphamide by one level (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 x 10<sup>9</sup>/L, decrease etoposide, doxorubicin, and cyclophosphamide by 20% compared to the previous cycle. | |
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | *[[ | ||
| − | |||
| − | |||
| − | * | ||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | ==== | ||
| − | *[[ | ||
| − | |||
| − | |||
| − | * | ||
| − | |||
| − | * | ||
| − | * | ||
| − | |||
| − | * | ||
| − | * | ||
| − | |||
| − | |||
| − | ==== | ||
| − | * | ||
| − | * | ||
| − | * | ||
| − | |||
| − | |||
| − | * | ||
| − | |||
| − | * | ||
| − | |||
| − | |||
| − | |||
| − | |||
</div></div> | </div></div> | ||
===References=== | ===References=== | ||
| − | # ''' | + | # '''NCI 93-C-0133:''' Dunleavy K, Pittaluga S, Shovlin M, Roschewski M, Lai C, Steinberg SM, Jaffe ES, Wilson WH. Phase II trial of dose-adjusted EPOCH in untreated systemic anaplastic large cell lymphoma. Haematologica. 2016 Jan;101(1):e27-9. [http://www.haematologica.org/content/101/1/e27.long link to original article] '''refers to protocol in [https://doi.org/10.1056/NEJMoa1214561 Dunleavy et al. 2013]''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4697904/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26518748 PubMed] NCT00001337 |
| − | + | =Relapsed or refractory, salvage therapy= | |
| − | == | + | ==Brentuximab vedotin monotherapy {{#subobject:e32d67|Regimen=1}}== |
<div class="toccolours" style="background-color:#eeeeee"> | <div class="toccolours" style="background-color:#eeeeee"> | ||
| − | === | + | ===Regimen variant #1, 16 cycles {{#subobject:46fbc9|Variant=1}}=== |
| − | + | {| class="wikitable" style="width: 60%; text-align:center;" | |
| − | + | !style="width: 33%"|Study | |
| − | + | !style="width: 33%"|Years of enrollment | |
| − | + | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | |
| − | + | |- | |
| − | + | |[https://doi.org/10.1200/jco.2011.38.0402 Pro et al. 2012 (SG035-0004)] | |
| − | + | |2009-2010 | |
| − | + | |style="background-color:#91cf61"|Phase 2 (RT) | |
| − | + | |- | |
| − | + | |} | |
| − | + | <div class="toccolours" style="background-color:#b3e2cd"> | |
| − | = | + | ====Antibody-drug conjugate therapy==== |
| − | + | *[[Brentuximab vedotin (Adcetris)]] 1.8 mg/kg IV over 30 minutes once on day 1 | |
| − | + | '''21-day cycle for up to 16 infusions''' | |
| − | + | </div></div><br> | |
| − | == | ||
| − | |||
| − | |||
| − | |||
| − | |||
| − | = | ||
| − | |||
| − | |||
| − | |||
| − | |||
| − | = | ||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | = | ||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | *[[ | ||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
<div class="toccolours" style="background-color:#eeeeee"> | <div class="toccolours" style="background-color:#eeeeee"> | ||
| − | === | + | ===Regimen variant #2, bridge to transplant {{#subobject:48bjc9|Variant=1}}=== |
| − | + | {| class="wikitable" style="width: 40%; text-align:center;" | |
| − | + | !style="width: 25%"|Study | |
| − | + | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] | |
| − | + | |- | |
| − | + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3659993/ Gibb et al. 2012] | |
| − | + | |style="background-color:#91cf61"|Named Patient Programme | |
| − | + | |- | |
| − | + | |} | |
| − | + | <div class="toccolours" style="background-color:#b3e2cd"> | |
| − | + | ====Antibody-drug conjugate therapy==== | |
| − | + | *[[Brentuximab vedotin (Adcetris)]] 1.8 mg/kg IV over 30 minutes once on day 1 | |
| − | + | '''21-day cycles until transplant''' | |
| − | + | </div></div><br> | |
| − | |||
| − | |||
| − | |||
| − | |||
| − | == | ||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | ==== | ||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | *[[ | ||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
<div class="toccolours" style="background-color:#eeeeee"> | <div class="toccolours" style="background-color:#eeeeee"> | ||
| − | === | + | ===Regimen variant #3, indefinite {{#subobject:46nz3b|Variant=1}}=== |
| − | == | + | {| class="wikitable" style="width: 40%; text-align:center;" |
| − | + | !style="width: 25%"|Study | |
| − | + | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] | |
| − | + | |- | |
| − | + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3731651/ Gopal et al. 2012 (SGN35-006)] | |
| − | + | |style="background-color:#ffffbe"|Phase 2, <20 pts in subgroup | |
| − | + | |- | |
| − | + | |} | |
| − | + | ''Note: SGN35-006 is a re-treatment trial; all patients were previously exposed to brentuximab vedotin. Patients who had received the 1.2 mg/kg dose on a prior trial also received that dose at re-treatment.'' | |
| − | + | <div class="toccolours" style="background-color:#b3e2cd"> | |
| − | + | ====Antibody-drug conjugate therapy==== | |
| − | + | *[[Brentuximab vedotin (Adcetris)]] 1.8 mg/kg IV over 30 minutes once on day 1 | |
| − | + | '''21-day cycles''' | |
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | ==== | ||
| − | |||
| − | |||
| − | *[[ | ||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
</div></div> | </div></div> | ||
===References=== | ===References=== | ||
| − | # ''' | + | # '''SGN35-006:''' Gopal AK, Ramchandren R, O'Connor OA, Berryman RB, Advani RH, Chen R, Smith SE, Cooper M, Rothe A, Matous JV, Grove LE, Zain J. Safety and efficacy of brentuximab vedotin for Hodgkin lymphoma recurring after allogeneic stem cell transplantation. Blood. 2012 Jul 19;120(3):560-8. Epub 2012 Apr 17. [http://www.bloodjournal.org/content/120/3/560.long link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3731651/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/22510871 PubMed] NCT01026233 |
| − | == | + | ## '''Update:''' Bartlett NL, Chen R, Fanale MA, Brice P, Gopal A, Smith SE, Advani R, Matous JV, Ramchandren R, Rosenblatt JD, Huebner D, Levine P, Grove L, Forero-Torres A. Retreatment with brentuximab vedotin in patients with CD30-positive hematologic malignancies. J Hematol Oncol. 2014 Mar 19;7:24. [http://jhoonline.biomedcentral.com/articles/10.1186/1756-8722-7-24 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3994656/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/24642247 PubMed] |
| + | # '''SG035-0004:''' 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. [https://doi.org/10.1200/jco.2011.38.0402 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/22614995 PubMed] NCT00866047 | ||
| + | <!-- ## '''Update: Abstract:''' Barbara Pro, MD, Ranjana Advani, MD, Pauline Brice, MD, Nancy L. Bartlett, MD, Joseph D. Rosenblatt, MD, Tim Illidge, Jeffrey Matous, MD, Radhakrishnan Ramchandern, MD, Michelle A. Fanale, MD, Joseph M. Connors, MD, Yinghui Wang, MS, Dirk Huebner, MD, Dana A. Kennedy, PharmD, BCOP and Andrei R. Shustov, MD. Four-Year Survival Data from an Ongoing Pivotal Phase 2 Study of Brentuximab Vedotin in Patients with Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma. ASH Annual Meeting 2014, Abstract 3095 [https://ash.confex.com/ash/2014/webprogram/Paper67039.html link to abstract] --> | ||
| + | ## '''Update:''' Pro B, Advani R, Brice P, Bartlett NL, Rosenblatt JD, Illidge T, Matous J, Ramchandren R, Fanale M, Connors JM, Fenton K, Huebner D, Pinelli JM, Kennedy DA, Shustov A. Five-year results of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma. Blood. 2017 Dec 21;130(25):2709-2717. Epub 2017 Oct 3. [https://doi.org/10.1182/blood-2017-05-780049 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc5746164/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/28974506 PubMed] | ||
| + | # Gibb A, Jones C, Bloor A, Kulkarni S, Illidge T, Linton K, Radford J. Brentuximab vedotin in refractory CD30+ lymphomas: a bridge to allogeneic transplantation in approximately one quarter of patients treated on a Named Patient Programme at a single UK center. Haematologica. 2013 Apr;98(4):611-4. Epub 2012 Oct 12. [http://www.haematologica.org/content/98/4/611.long link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3659993/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/23065511 PubMed] | ||
| + | # '''Retrospective:''' Gopal AK, Bartlett NL, Forero-Torres A, Younes A, Chen R, Friedberg JW, Matous JV, Shustov AR, Smith SE, Zain J, O'Meara MM, Fanale MA. Brentuximab vedotin in patients aged 60 years or older with relapsed or refractory CD30-positive lymphomas: a retrospective evaluation of safety and efficacy. Leuk Lymphoma. 2014 Oct;55(10):2328-34. Epub 2014 Feb 24. [http://www.tandfonline.com/doi/full/10.3109/10428194.2013.876496 link to original article] [https://pubmed.ncbi.nlm.nih.gov/24359243 PubMed] | ||
| + | ==DHAP {{#subobject:5a2988|Regimen=1}}== | ||
| + | DHAP: '''<u>D</u>'''examethasone, '''<u>H</u>'''igh-dose '''<u>A</u>'''ra-C (cytarabine), '''<u>P</u>'''latinol (cisplatin) | ||
<div class="toccolours" style="background-color:#eeeeee"> | <div class="toccolours" style="background-color:#eeeeee"> | ||
| − | === | + | ===Regimen {{#subobject:d2a377|Variant=1}}=== |
| − | == | + | {| class="wikitable sortable" style="width: 100%; text-align:center;" |
| − | + | !style="width: 20%"|Study | |
| − | + | !style="width: 20%"|Years of enrollment | |
| − | + | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | |
| − | + | !style="width: 20%"|Comparator | |
| − | + | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | |
| − | + | |- | |
| − | + | |[https://doi.org/10.1200/jco.2013.53.9593 Crump et al. 2014 (NCIC-CTG LY.12)] | |
| − | + | |2003-2011 | |
| − | + | |style="background-color:#91cf61"|Phase 3, <20 in this arm (C) | |
| − | + | |[[Anaplastic_large_cell_lymphoma#GDP|GDP]] | |
| − | = | + | |style="background-color:#eeee01"|Non-inferior ORR |
| − | + | |- | |
| − | + | |} | |
| − | + | <div class="toccolours" style="background-color:#b3e2cd"> | |
| − | = | + | ====Chemotherapy==== |
| − | + | *[[Cytarabine (Ara-C)]] 2000 mg/m<sup>2</sup> IV over 3 hours every 12 hours on day 2 (total dose per cycle: 4000 mg/m<sup>2</sup>) | |
| − | + | *[[Cisplatin (Platinol)]] 100 mg/m<sup>2</sup> IV continuous infusion over 24 hours, started on day 1 | |
| − | + | ====Glucocorticoid therapy==== | |
| − | + | *[[Dexamethasone (Decadron)]] 40 mg PO once per day on days 1 to 4 | |
| − | = | + | '''21-day cycle for up to 3 cycles''' |
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | = | ||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | = | ||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | = | ||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | <div class="toccolours" style="background-color:# | ||
| − | |||
| − | ====Chemotherapy | ||
| − | *[[ | ||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | *[[ | ||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | ==== | ||
| − | *[[ | ||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
</div></div> | </div></div> | ||
===References=== | ===References=== | ||
| − | # ''' | + | <!-- Presented in part at the Annual Meeting of the American Society of Hematology, Atlanta, GA, December 7-10, 2013, and the International Conference on Malignant Lymphoma, Lugano, Switzerland, June 19-22, 2013. --> |
| − | = | + | # '''NCIC-CTG LY.12:''' Crump M, Kuruvilla J, Couban S, MacDonald DA, Kukreti V, Kouroukis CT, Rubinger M, Buckstein R, Imrie KR, Federico M, Di Renzo N, Howson-Jan K, Baetz T, Kaizer L, Voralia M, Olney HJ, Turner AR, Sussman J, Hay AE, Djurfeldt MS, Meyer RM, Chen BE, Shepherd LE. Randomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG LY.12. J Clin Oncol. 2014 Nov 1;32(31):3490-6. Epub 2014 Sep 29. [https://doi.org/10.1200/jco.2013.53.9593 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/25267740 PubMed] NCT00078949 |
| − | == | + | ==GDP {{#subobject:21f926|Regimen=1}}== |
| + | GDP: '''<u>G</u>'''emcitabine, '''<u>D</u>'''examethasone, '''<u>P</u>'''latinol (Cisplatin) | ||
<div class="toccolours" style="background-color:#eeeeee"> | <div class="toccolours" style="background-color:#eeeeee"> | ||
| − | === | + | ===Regimen {{#subobject:ce43d5|Variant=1}}=== |
| + | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
| + | !style="width: 20%"|Study | ||
| + | !style="width: 20%"|Years of enrollment | ||
| + | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
| + | !style="width: 20%"|Comparator | ||
| + | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
| + | |- | ||
| + | |[https://doi.org/10.1200/jco.2013.53.9593 Crump et al. 2014 (NCIC-CTG LY.12)] | ||
| + | |2003-2011 | ||
| + | |style="background-color:#91cf61"|Phase 3, <20 pts in this arm (E-switch-ic) | ||
| + | |[[#DHAP|DHAP]] | ||
| + | |style="background-color:#eeee01"|Non-inferior ORR | ||
| + | |- | ||
| + | |} | ||
| + | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
| − | *[[ | + | *[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once per day on days 1 & 8 |
| − | + | *[[Cisplatin (Platinol)]] 75 mg/m<sup>2</sup> IV once on day 1 | |
| − | + | ====Glucocorticoid therapy==== | |
| − | + | *[[Dexamethasone (Decadron)]] 40 mg PO once per day on days 1 to 4 | |
| − | + | '''21-day cycle for up to 3 cycles''' | |
| − | |||
| − | |||
| − | |||
| − | |||
| − | *[[ | ||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | ==== | ||
| − | *[[ | ||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
</div></div> | </div></div> | ||
===References=== | ===References=== | ||
| − | # ''' | + | <!-- Presented in part at the Annual Meeting of the American Society of Hematology, Atlanta, GA, December 7-10, 2013, and the International Conference on Malignant Lymphoma, Lugano, Switzerland, June 19-22, 2013. --> |
| − | # ''' | + | # '''NCIC-CTG LY.12:''' Crump M, Kuruvilla J, Couban S, MacDonald DA, Kukreti V, Kouroukis CT, Rubinger M, Buckstein R, Imrie KR, Federico M, Di Renzo N, Howson-Jan K, Baetz T, Kaizer L, Voralia M, Olney HJ, Turner AR, Sussman J, Hay AE, Djurfeldt MS, Meyer RM, Chen BE, Shepherd LE. Randomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG LY.12. J Clin Oncol. 2014 Nov 1;32(31):3490-6. Epub 2014 Sep 29. [https://doi.org/10.1200/jco.2013.53.9593 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/25267740 PubMed] NCT00078949 |
| − | + | =Consolidation after salvage therapy= | |
| − | + | ==FluBuCy, then allo HSCT {{#subobject:84acb0|Regimen=1}}== | |
| − | + | FluBuCy: '''<u>Flu</u>'''darabine, '''<u>Bu</u>'''sulfan, '''<u>Cy</u>'''clophosphamide | |
<div class="toccolours" style="background-color:#eeeeee"> | <div class="toccolours" style="background-color:#eeeeee"> | ||
| − | === | + | ===Regimen {{#subobject:bfe434|Variant=1}}=== |
| − | + | {| class="wikitable" style="width: 40%; text-align:center;" | |
| − | + | !style="width: 25%"|Study | |
| − | + | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] | |
| − | + | |- | |
| − | + | |[https://doi.org/10.1016/S1470-2045(14)70161-5 Glass et al. 2014 (DSHNHL R3)] | |
| − | + | | style="background-color:#91cf61" |Phase 2 | |
| − | + | |- | |
| − | + | |} | |
| − | + | {{#lst:Allogeneic HSCT|bfe434}} | |
| − | + | ====Immunotherapy==== | |
| − | + | *[[Allogeneic stem cells]] | |
| − | + | '''Stem cells transfused on day 0''' | |
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | = | ||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | ==== | ||
| − | |||
| − | *[[ | ||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
</div></div> | </div></div> | ||
===References=== | ===References=== | ||
| − | # ''' | + | <!-- # Glass B, rabbits Kamp J, Wulf G, Dreger P, Pfreundschuh M, Gramatzki M Silling G, Wilhelm C, Zeis M, Görlitz A, Pfeiffer S, Hilgers R, Truemper L, Schmitz N. High-dose chemotherapy Followed by allogeneic stem cell transplantation in relapsed and refractory high-risk aggressive non-Hodgkin's lymphoma: Results of a prospective study of the German high-grade non-Hodgkin's lymphoma study group. J Clin Oncol 30, 2012 (suppl; abstr 8004) --> |
| + | # '''DSHNHL R3:''' Glass B, Hasenkamp J, Wulf G, Dreger P, Pfreundschuh M, Gramatzki M, Silling G, Wilhelm C, Zeis M, Görlitz A, Pfeiffer S, Hilgers R, Truemper L, Schmitz N; German High-Grade Lymphoma Study Group. Rituximab after lymphoma-directed conditioning and allogeneic stem-cell transplantation for relapsed and refractory aggressive non-Hodgkin lymphoma (DSHNHL R3): an open-label, randomised, phase 2 trial. Lancet Oncol. 2014 Jun;15(7):757-66. Epub 2014 May 11. [https://doi.org/10.1016/S1470-2045(14)70161-5 link to original article] [http://www.dshnhl.org/app/download/9495510598/Studienprotokoll+DSHNHL+alloFBC+final+vollst.pdf link to original protocol (in German)] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/24827808 PubMed] NCT00785330 | ||
| + | [[Category:Anaplastic large cell lymphoma regimens]] | ||
[[Category:Disease-specific pages]] | [[Category:Disease-specific pages]] | ||
| − | [[Category: | + | [[Category:T-cell lymphomas]] |
| − | |||
Revision as of 11:21, 29 October 2022
Section editor transclusions Note: these studies were specific to ALCL or had ALCL subgroups; regimens used in PTCL, NOS are also often used in this condition. Certain regimens have been moved to dedicated pages:
0 regimens on this page
0 variants on this page
|
Guidelines
ESMO
- 2015: d'Amore et al. Peripheral T-cell lymphomas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up
Untreated
BV-CHP
BV-CHP: Brentuximab Vedotin, Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Prednisone
Regimen
| FDA-recommended dose |
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Horwitz et al. 2018 (ECHELON-2) | 2013-2016 | Phase 3 (E-RT-switch-ooc) | CHOP | Superior OS Median OS: NYR vs NYR (HR 0.66, 95% CI 0.46-0.95) |
Antibody-drug conjugate therapy
- Brentuximab vedotin (Adcetris) 1.8 mg/kg (maximum dose of 180 mg) IV once on day 1
Chemotherapy
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
Glucocorticoid therapy
- Prednisone (Sterapred) 100 mg PO once per day on days 1 to 5
21-day cycle for 6 to 8 cycles
References
- ECHELON-2: Horwitz S, O'Connor OA, Pro B, Illidge T, Fanale M, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Feldman T, Lennard A, Belada D, Illés Á, Tobinai K, Tsukasaki K, Yeh SP, Shustov A, Hüttmann A, Savage KJ, Yuen S, Iyer S, Zinzani PL, Hua Z, Little M, Rao S, Woolery J, Manley T, Trümper L; ECHELON-2 Study Group. Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomised, phase 3 trial. Lancet. 2019 Jan 19;393(10168):229-240. Epub 2018 Dec 4. Erratum in: Lancet. 2019 Jan 19;393(10168):228. link to original article contains dosing details in abstract link to PMC article PubMed NCT01777152
CHOEP-14
CHOEP-14: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Etoposide, Prednisone every 14 days
CHOPE
VACOP
Example orders
Regimen
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy | Comparative Toxicity |
|---|---|---|---|---|---|
| Pfreundschuh et al. 2004 (NHL-B1) | 1993-2000 | Phase 3, <20 pts in this subgroup (E-esc) | 1. CHOEP-21 2. CHOP-21 3. CHOP-14 |
Not reported by subgroup | Not reported by subgroup |
This regimen was used in 16 ALCL patients in the NHL-B1 trial. The authors did not report a subgroup analysis for this minority population.
Chemotherapy
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Vincristine (Oncovin) 2 mg IV once on day 1
- Etoposide (Vepesid) 100 mg/m2 IV once per day on days 1 to 3
Glucocorticoid therapy
- Prednisone (Sterapred) 100 mg PO once per day on days 1 to 5
Supportive therapy
- Filgrastim (Neupogen) by the following criteria:
- Patients less than 75 kg: 300 mcg SC once per day on days 4 to 13
- Patients at least 75 kg: 480 mcg SC once per day on days 4 to 13
14-day cycle for 6 cycles, next cycle to start as long as WBC count is greater than 2.5 x 109/L and platelets greater than 80 x 109/L
Subsequent treatment
- Patients with initial bulky disease (mass conglomerate at least 7.5 cm): RT x 36 Gy to extranodal sites of disease when possible
References
- NHL-B1: Pfreundschuh M, Trümper L, Kloess M, Schmits R, Feller AC, Rudolph C, Reiser M, Hossfeld DK, Metzner B, Hasenclever D, Schmitz N, Glass B, Rübe C, Loeffler M; German High-Grade Non-Hodgkin's Lymphoma Study Group. Two-weekly or 3-weekly CHOP chemotherapy with or without etoposide for the treatment of young patients with good-prognosis (normal LDH) aggressive lymphomas: results of the NHL-B1 trial of the DSHNHL. Blood. 2004 Aug 1;104(3):626-33. Epub 2004 Feb 24. link to original article contains dosing details in manuscript PubMed
CHOEP-21
CHOEP-21: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Etoposide, Prednisone every 21 days
CHOPE
VACOP
Example orders
Regimen
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy | Comparative Toxicity |
|---|---|---|---|---|---|
| Pfreundschuh et al. 2004 (NHL-B1) | 1993-2000 | Phase 3 (E-esc) | 1. CHOEP-14 2. CHOP-21 3. CHOP-14 |
Not reported by subgroup | Not reported by subgroup |
This regimen was used in 20 ALCL patients in the NHL-B1 trial. The authors did not report a subgroup analysis for this minority population.
Chemotherapy
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Vincristine (Oncovin) 2 mg IV once on day 1
- Etoposide (Vepesid) 100 mg/m2 IV once per day on days 1 to 3
Glucocorticoid therapy
- Prednisone (Sterapred) 100 mg PO once per day on days 1 to 5
Supportive therapy
- Filgrastim (Neupogen) is by discretion of ordering physician
21-day cycle for 6 cycles, next cycle to start as long as WBC count is greater than 2.5 x 109/L and platelets greater than 80 x 109/L
Subsequent treatment
- Patients with initial bulky disease (mass conglomerate at least 7.5 cm): RT x 36 Gy to extranodal sites of disease when possible
References
- NHL-B1: Pfreundschuh M, Trümper L, Kloess M, Schmits R, Feller AC, Rudolph C, Reiser M, Hossfeld DK, Metzner B, Hasenclever D, Schmitz N, Glass B, Rübe C, Loeffler M; German High-Grade Non-Hodgkin's Lymphoma Study Group. Two-weekly or 3-weekly CHOP chemotherapy with or without etoposide for the treatment of young patients with good-prognosis (normal LDH) aggressive lymphomas: results of the NHL-B1 trial of the DSHNHL. Blood. 2004 Aug 1;104(3):626-33. Epub 2004 Feb 24. link to original article contains dosing details in manuscript PubMed
CHOP
CHOP: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Prednisone
CHOP-21
ACOP
CAVP
COPA
VACP
VCAP
Regimen variant #1, capped vincristine
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Horwitz et al. 2018 (ECHELON-2) | 2013-2016 | Phase 3 (C) | BV-CHP | Inferior OS |
Chemotherapy
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg) IV once on day 1
Glucocorticoid therapy
- Prednisone (Sterapred) 100 mg PO once per day on days 1 to 5
21-day cycle for 6 to 8 cycles
Regimen variant #2, flat-dose vincristine
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy | Comparative Toxicity |
|---|---|---|---|---|---|
| Pfreundschuh et al. 2004 (NHL-B1) | 1993-2000 | Phase 3, <20 pts in arm (C) | 1. CHOEP-21 2. CHOP-14 |
Not reported by subgroup | Not reported by subgroup |
This regimen was used in 14 ALCL patients in NHL-B1. The authors did not report a subgroup analysis for this minority population.
Chemotherapy
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Vincristine (Oncovin) 2 mg IV once on day 1
Glucocorticoid therapy
- Prednisone (Sterapred) 100 mg PO once per day on days 1 to 5
Supportive therapy
- At the discretion of ordering physician: Filgrastim (Neupogen) 300 mcg (for patients less than 75 kg) or 480 mcg (for patients at least 75 kg) SC once per day on days 4 to 13
21-day cycle for 6 cycles
References
- NHL-B1: Pfreundschuh M, Trümper L, Kloess M, Schmits R, Feller AC, Rudolph C, Reiser M, Hossfeld DK, Metzner B, Hasenclever D, Schmitz N, Glass B, Rübe C, Loeffler M; German High-Grade Non-Hodgkin's Lymphoma Study Group. Two-weekly or 3-weekly CHOP chemotherapy with or without etoposide for the treatment of young patients with good-prognosis (normal LDH) aggressive lymphomas: results of the NHL-B1 trial of the DSHNHL. Blood. 2004 Aug 1;104(3):626-33. Epub 2004 Feb 24. link to original article contains dosing details in manuscript PubMed
- ECHELON-2: Horwitz S, O'Connor OA, Pro B, Illidge T, Fanale M, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Feldman T, Lennard A, Belada D, Illés Á, Tobinai K, Tsukasaki K, Yeh SP, Shustov A, Hüttmann A, Savage KJ, Yuen S, Iyer S, Zinzani PL, Hua Z, Little M, Rao S, Woolery J, Manley T, Trümper L; ECHELON-2 Study Group. Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomised, phase 3 trial. Lancet. 2019 Jan 19;393(10168):229-240. Epub 2018 Dec 4. Erratum in: Lancet. 2019 Jan 19;393(10168):228. link to original article contains dosing details in abstract link to PMC article PubMed NCT01777152
DA-EPOCH
DA-EPOCH: Dose Adjusted Etoposide, Prednisone, Oncovin (Vincristine), Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin)
Regimen
| Study | Evidence |
|---|---|
| Dunleavy et al. 2016 (NCI 93-C-0133ALCL) | Phase 2 |
Note: this should be considered a substudy under the master protocol NCI 93-C-0133.
Chemotherapy
- Etoposide (Vepesid) 50 mg/m2/day IV continuous infusion over 96 hours, started on day 1 (total dose per cycle: 200 mg/m2)
- Vincristine (Oncovin) 0.4 mg/m2/day IV continuous infusion over 96 hours, started on day 1 (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 over 96 hours, started on day 1 (total dose per cycle: 40 mg/m2)
Glucocorticoid therapy
- Prednisone (Sterapred) 60 mg/m2 PO twice per day on days 1 to 5
Supportive therapy
- Filgrastim (Neupogen) 300 mcg SC once per day, starting on day 6 and continuing until ANC greater than 5000/uL past nadir
- Trimethoprim-Sulfamethoxazole (Bactrim DS) 160/800 mg (or equivalent if allergic) PO once per day on 3 days per week
- Omeprazole (Prilosec) 20 mg (or equivalent) PO once per day
- Docusate (Colace) (dose not specified) and Sennosides (Senna) 2 tablets PO twice per day as needed for constipation
- Lactulose 20 g PO every 6 hours as needed for constipation
- Hepatitis B surface antigen positive patients: received daily antiviral therapy until 8 weeks after completion of chemotherapy
21-day cycle for 6 to 8 cycles
Dose modifications
- Start cycle 1 as described above.
- Obtain CBCs twice per week for nadir measurements.
- If nadir ANC greater than 500/uL, increase etoposide, doxorubicin, and cyclophosphamide by one level (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 x 109/L, decrease etoposide, doxorubicin, and cyclophosphamide by 20% compared to the previous cycle.
References
- NCI 93-C-0133: Dunleavy K, Pittaluga S, Shovlin M, Roschewski M, Lai C, Steinberg SM, Jaffe ES, Wilson WH. Phase II trial of dose-adjusted EPOCH in untreated systemic anaplastic large cell lymphoma. Haematologica. 2016 Jan;101(1):e27-9. link to original article refers to protocol in Dunleavy et al. 2013 link to PMC article PubMed NCT00001337
Relapsed or refractory, salvage therapy
Brentuximab vedotin monotherapy
Regimen variant #1, 16 cycles
| Study | Years of enrollment | Evidence |
|---|---|---|
| Pro et al. 2012 (SG035-0004) | 2009-2010 | Phase 2 (RT) |
Antibody-drug conjugate therapy
- Brentuximab vedotin (Adcetris) 1.8 mg/kg IV over 30 minutes once on day 1
21-day cycle for up to 16 infusions
Regimen variant #2, bridge to transplant
| Study | Evidence |
|---|---|
| Gibb et al. 2012 | Named Patient Programme |
Antibody-drug conjugate therapy
- Brentuximab vedotin (Adcetris) 1.8 mg/kg IV over 30 minutes once on day 1
21-day cycles until transplant
Regimen variant #3, indefinite
| Study | Evidence |
|---|---|
| Gopal et al. 2012 (SGN35-006) | Phase 2, <20 pts in subgroup |
Note: SGN35-006 is a re-treatment trial; all patients were previously exposed to brentuximab vedotin. Patients who had received the 1.2 mg/kg dose on a prior trial also received that dose at re-treatment.
Antibody-drug conjugate therapy
- Brentuximab vedotin (Adcetris) 1.8 mg/kg IV over 30 minutes once on day 1
21-day cycles
References
- SGN35-006: Gopal AK, Ramchandren R, O'Connor OA, Berryman RB, Advani RH, Chen R, Smith SE, Cooper M, Rothe A, Matous JV, Grove LE, Zain J. Safety and efficacy of brentuximab vedotin for Hodgkin lymphoma recurring after allogeneic stem cell transplantation. Blood. 2012 Jul 19;120(3):560-8. Epub 2012 Apr 17. link to original article contains dosing details in manuscript link to PMC article PubMed NCT01026233
- Update: Bartlett NL, Chen R, Fanale MA, Brice P, Gopal A, Smith SE, Advani R, Matous JV, Ramchandren R, Rosenblatt JD, Huebner D, Levine P, Grove L, Forero-Torres A. Retreatment with brentuximab vedotin in patients with CD30-positive hematologic malignancies. J Hematol Oncol. 2014 Mar 19;7:24. link to original article contains dosing details in manuscript link to PMC article PubMed
- SG035-0004: 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 dosing details in manuscript PubMed NCT00866047
- Update: Pro B, Advani R, Brice P, Bartlett NL, Rosenblatt JD, Illidge T, Matous J, Ramchandren R, Fanale M, Connors JM, Fenton K, Huebner D, Pinelli JM, Kennedy DA, Shustov A. Five-year results of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma. Blood. 2017 Dec 21;130(25):2709-2717. Epub 2017 Oct 3. link to original article link to PMC article PubMed
- Gibb A, Jones C, Bloor A, Kulkarni S, Illidge T, Linton K, Radford J. Brentuximab vedotin in refractory CD30+ lymphomas: a bridge to allogeneic transplantation in approximately one quarter of patients treated on a Named Patient Programme at a single UK center. Haematologica. 2013 Apr;98(4):611-4. Epub 2012 Oct 12. link to original article contains dosing details in manuscript link to PMC article PubMed
- Retrospective: Gopal AK, Bartlett NL, Forero-Torres A, Younes A, Chen R, Friedberg JW, Matous JV, Shustov AR, Smith SE, Zain J, O'Meara MM, Fanale MA. Brentuximab vedotin in patients aged 60 years or older with relapsed or refractory CD30-positive lymphomas: a retrospective evaluation of safety and efficacy. Leuk Lymphoma. 2014 Oct;55(10):2328-34. Epub 2014 Feb 24. link to original article PubMed
DHAP
DHAP: Dexamethasone, High-dose Ara-C (cytarabine), Platinol (cisplatin)
Regimen
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Crump et al. 2014 (NCIC-CTG LY.12) | 2003-2011 | Phase 3, <20 in this arm (C) | GDP | Non-inferior ORR |
Chemotherapy
- Cytarabine (Ara-C) 2000 mg/m2 IV over 3 hours every 12 hours on day 2 (total dose per cycle: 4000 mg/m2)
- Cisplatin (Platinol) 100 mg/m2 IV continuous infusion over 24 hours, started on day 1
Glucocorticoid therapy
- Dexamethasone (Decadron) 40 mg PO once per day on days 1 to 4
21-day cycle for up to 3 cycles
References
- NCIC-CTG LY.12: Crump M, Kuruvilla J, Couban S, MacDonald DA, Kukreti V, Kouroukis CT, Rubinger M, Buckstein R, Imrie KR, Federico M, Di Renzo N, Howson-Jan K, Baetz T, Kaizer L, Voralia M, Olney HJ, Turner AR, Sussman J, Hay AE, Djurfeldt MS, Meyer RM, Chen BE, Shepherd LE. Randomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG LY.12. J Clin Oncol. 2014 Nov 1;32(31):3490-6. Epub 2014 Sep 29. link to original article contains dosing details in manuscript PubMed NCT00078949
GDP
GDP: Gemcitabine, Dexamethasone, Platinol (Cisplatin)
Regimen
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Crump et al. 2014 (NCIC-CTG LY.12) | 2003-2011 | Phase 3, <20 pts in this arm (E-switch-ic) | DHAP | Non-inferior ORR |
Chemotherapy
- Gemcitabine (Gemzar) 1000 mg/m2 IV once per day on days 1 & 8
- Cisplatin (Platinol) 75 mg/m2 IV once on day 1
Glucocorticoid therapy
- Dexamethasone (Decadron) 40 mg PO once per day on days 1 to 4
21-day cycle for up to 3 cycles
References
- NCIC-CTG LY.12: Crump M, Kuruvilla J, Couban S, MacDonald DA, Kukreti V, Kouroukis CT, Rubinger M, Buckstein R, Imrie KR, Federico M, Di Renzo N, Howson-Jan K, Baetz T, Kaizer L, Voralia M, Olney HJ, Turner AR, Sussman J, Hay AE, Djurfeldt MS, Meyer RM, Chen BE, Shepherd LE. Randomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG LY.12. J Clin Oncol. 2014 Nov 1;32(31):3490-6. Epub 2014 Sep 29. link to original article contains dosing details in manuscript PubMed NCT00078949
Consolidation after salvage therapy
FluBuCy, then allo HSCT
FluBuCy: Fludarabine, Busulfan, Cyclophosphamide
Regimen
| Study | Evidence |
|---|---|
| Glass et al. 2014 (DSHNHL R3) | Phase 2 |
Chemotherapy
- Fludarabine (Fludara) 25 mg/m2/day IV on days -8 to -4
- Busulfan (Myleran) 4 mg/kg/day PO on days -6 to -4
- Cyclophosphamide (Cytoxan) 60 mg/kg/day IV on days -3 and -2
Immunotherapy
- Allogeneic stem cells transfused on day 0
GVHD prophylaxis
- Antithymocyte globulin, rabbit ATG (Thymoglobulin) 2 mg/kg IV from day -3 to -1 (unclear if this is a total dose or a daily dose)
- Option also to use ATG-Fresenius S at a higher dose of 10 mg/kg
- Tacrolimus (Prograf) 8 to 12 mcg/L (route/frequency not specified) starting on day -1, tapered from day +100 in absence of GVHD
- Mycophenolate mofetil (CellCept) 1000 mg (route not specified) twice per day from day +1 to +28
One course
Immunotherapy
Stem cells transfused on day 0
References
- DSHNHL R3: Glass B, Hasenkamp J, Wulf G, Dreger P, Pfreundschuh M, Gramatzki M, Silling G, Wilhelm C, Zeis M, Görlitz A, Pfeiffer S, Hilgers R, Truemper L, Schmitz N; German High-Grade Lymphoma Study Group. Rituximab after lymphoma-directed conditioning and allogeneic stem-cell transplantation for relapsed and refractory aggressive non-Hodgkin lymphoma (DSHNHL R3): an open-label, randomised, phase 2 trial. Lancet Oncol. 2014 Jun;15(7):757-66. Epub 2014 May 11. link to original article link to original protocol (in German) contains dosing details in manuscript PubMed NCT00785330