Difference between revisions of "Acute promyelocytic leukemia - null regimens"
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| − | The purpose of this page is to provide references to "null therapy" such as placebo and observation. | + | The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the [[Acute promyelocytic leukemia|main APL page]] for regimens that include active anticancer treatment. |
{{TOC limit|limit=3}} | {{TOC limit|limit=3}} | ||
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==Observation== | ==Observation== | ||
| − | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen=== | ===Regimen=== | ||
{| 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 41: | Line 41: | ||
|2. [[Acute_promyelocytic_leukemia#ATRA.2C_Mercaptopurine.2C_Methotrexate|ATRA, 6-MP, MTX]]<br> 3. [[Acute_promyelocytic_leukemia#Mercaptopurine_.26_Methotrexate|6-MP & MTX]] | |2. [[Acute_promyelocytic_leukemia#ATRA.2C_Mercaptopurine.2C_Methotrexate|ATRA, 6-MP, MTX]]<br> 3. [[Acute_promyelocytic_leukemia#Mercaptopurine_.26_Methotrexate|6-MP & MTX]] | ||
| style="background-color:#d73027" |Inferior 2-year relapse rate | | style="background-color:#d73027" |Inferior 2-year relapse rate | ||
| + | |- | ||
| + | |[http://www.ncbi.nlm.nih.gov/pmc/articles/pmc4064464/ Coutre et al. 2014 (SWOG S0521)] | ||
| + | |2007-06 to 2010-05 | ||
| + | | style="background-color:#1a9851" |Phase 3 (C) | ||
| + | |[[Acute_promyelocytic_leukemia#ATRA.2C_Mercaptopurine.2C_Methotrexate|ATRA, 6-MP, MTX]] | ||
| + | | style="background-color:#ffffbf" |Inconclusive whether non-inferior DFS36 (primary endpoint) | ||
|- | |- | ||
|} | |} | ||
''No further treatment given after consolidation. Note that this arm was dropped from AIDA 0493 from February 1997.'' | ''No further treatment given after consolidation. Note that this arm was dropped from AIDA 0493 from February 1997.'' | ||
| + | <div class="toccolours" style="background-color:#cbd5e8"> | ||
====Preceding treatment==== | ====Preceding treatment==== | ||
*EAPLG APL 93: [[Acute_promyelocytic_leukemia#Cytarabine_.26_Daunorubicin|Cytarabine & daunorubicin]] consolidation | *EAPLG APL 93: [[Acute_promyelocytic_leukemia#Cytarabine_.26_Daunorubicin|Cytarabine & daunorubicin]] consolidation | ||
*GIMEMA AIDA 0493 & LAP 0389: [[Acute_promyelocytic_leukemia#Cytarabine_.26_Idarubicin.2C_then_Etoposide_.26_Mitoxantrone.2C_then_Cytarabine.2C_Idarubicin.2C_Thioguanine|Cytarabine & idarubicin, then etoposide & mitoxantrone, then cytarabine, idarubicin, thioguanine]] consolidation | *GIMEMA AIDA 0493 & LAP 0389: [[Acute_promyelocytic_leukemia#Cytarabine_.26_Idarubicin.2C_then_Etoposide_.26_Mitoxantrone.2C_then_Cytarabine.2C_Idarubicin.2C_Thioguanine|Cytarabine & idarubicin, then etoposide & mitoxantrone, then cytarabine, idarubicin, thioguanine]] consolidation | ||
| − | + | </div></div> | |
===References=== | ===References=== | ||
| − | # '''GIMEMA AIDA 0493:''' Mandelli F, Diverio D, Avvisati G, Luciano A, Barbui T, Bernasconi C, Broccia G, Cerri R, Falda M, Fioritoni G, Leoni F, Liso V, Petti MC, Rodeghiero F, Saglio G, Vegna ML, Visani G, Jehn U, Willemze R, Muus P, Pelicci PG, Biondi A, Lo Coco F; Gruppo Italiano-Malattie Ematologiche Maligne dell'Adulto; Associazione Italiana di Ematologia ed Oncologia Pediatrica Cooperative Groups. Molecular remission in PML/RAR alpha-positive acute promyelocytic leukemia by combined all-trans retinoic acid and idarubicin (AIDA) therapy. Blood. 1997 Aug 1;90(3):1014-21. [http://www.bloodjournal.org/content/90/3/1014.long link to original article] | + | # '''GIMEMA AIDA 0493:''' Mandelli F, Diverio D, Avvisati G, Luciano A, Barbui T, Bernasconi C, Broccia G, Cerri R, Falda M, Fioritoni G, Leoni F, Liso V, Petti MC, Rodeghiero F, Saglio G, Vegna ML, Visani G, Jehn U, Willemze R, Muus P, Pelicci PG, Biondi A, Lo Coco F; Gruppo Italiano-Malattie Ematologiche Maligne dell'Adulto; Associazione Italiana di Ematologia ed Oncologia Pediatrica Cooperative Groups. Molecular remission in PML/RAR alpha-positive acute promyelocytic leukemia by combined all-trans retinoic acid and idarubicin (AIDA) therapy. Blood. 1997 Aug 1;90(3):1014-21. [http://www.bloodjournal.org/content/90/3/1014.long link to original article] [https://pubmed.ncbi.nlm.nih.gov/9242531/ PubMed] |
| − | ## '''Update:''' Avvisati G, Lo-Coco F, Paoloni FP, Petti MC, Diverio D, Vignetti M, Latagliata R, Specchia G, Baccarani M, Di Bona E, Fioritoni G, Marmont F, Rambaldi A, Di Raimondo F, Kropp MG, Pizzolo G, Pogliani EM, Rossi G, Cantore N, Nobile F, Gabbas A, Ferrara F, Fazi P, Amadori S, Mandelli F; GIMEMA; AIEOP; EORTC. AIDA 0493 protocol for newly diagnosed acute promyelocytic leukemia: very long-term results and role of maintenance. Blood. 2011 May 5;117(18):4716-25. Epub 2011 Mar 8. [http://www.bloodjournal.org/content/117/18/4716.long link to original article] | + | ## '''Update:''' Avvisati G, Lo-Coco F, Paoloni FP, Petti MC, Diverio D, Vignetti M, Latagliata R, Specchia G, Baccarani M, Di Bona E, Fioritoni G, Marmont F, Rambaldi A, Di Raimondo F, Kropp MG, Pizzolo G, Pogliani EM, Rossi G, Cantore N, Nobile F, Gabbas A, Ferrara F, Fazi P, Amadori S, Mandelli F; GIMEMA; AIEOP; EORTC. AIDA 0493 protocol for newly diagnosed acute promyelocytic leukemia: very long-term results and role of maintenance. Blood. 2011 May 5;117(18):4716-25. Epub 2011 Mar 8. [http://www.bloodjournal.org/content/117/18/4716.long link to original article] [https://pubmed.ncbi.nlm.nih.gov/21385856/ PubMed] |
| − | # '''EAPLG APL 93:''' Fenaux P, Chastang C, Chevret S, Sanz M, Dombret H, Archimbaud E, Fey M, Rayon C, Huguet F, Sotto JJ, Gardin C, Makhoul PC, Travade P, Solary E, Fegueux N, Bordessoule D, Miguel JS, Link H, Desablens B, Stamatoullas A, Deconinck E, Maloisel F, Castaigne S, Preudhomme C, Degos L. A randomized comparison of all transretinoic acid (ATRA) followed by chemotherapy and ATRA plus chemotherapy and the role of maintenance therapy in newly diagnosed acute promyelocytic leukemia; European APL Group. Blood. 1999 Aug 15;94(4):1192-200. [http://www.bloodjournal.org/content/94/4/1192.long link to original article] [https://pubmed.ncbi.nlm.nih.gov/10438706 PubMed] | + | # '''EAPLG APL 93:''' Fenaux P, Chastang C, Chevret S, Sanz M, Dombret H, Archimbaud E, Fey M, Rayon C, Huguet F, Sotto JJ, Gardin C, Makhoul PC, Travade P, Solary E, Fegueux N, Bordessoule D, Miguel JS, Link H, Desablens B, Stamatoullas A, Deconinck E, Maloisel F, Castaigne S, Preudhomme C, Degos L. A randomized comparison of all transretinoic acid (ATRA) followed by chemotherapy and ATRA plus chemotherapy and the role of maintenance therapy in newly diagnosed acute promyelocytic leukemia; European APL Group. Blood. 1999 Aug 15;94(4):1192-200. [http://www.bloodjournal.org/content/94/4/1192.long link to original article] [https://pubmed.ncbi.nlm.nih.gov/10438706/ PubMed] |
| − | ## '''Update:''' Adès L, Guerci A, Raffoux E, Sanz M, Chevallier P, Lapusan S, Recher C, Thomas X, Rayon C, Castaigne S, Tournilhac O, de Botton S, Ifrah N, Cahn JY, Solary E, Gardin C, Fegeux N, Bordessoule D, Ferrant A, Meyer-Monard S, Vey N, Dombret H, Degos L, Chevret S, Fenaux P; European APL Group. Very long-term outcome of acute promyelocytic leukemia after treatment with all-trans retinoic acid and chemotherapy: the European APL Group experience. Blood. 2010 Mar 4;115(9):1690-6. Epub 2009 Dec 17. [http://www.bloodjournal.org/content/115/9/1690.long link to original article] [https://pubmed.ncbi.nlm.nih.gov/20018913 PubMed] | + | ## '''Update:''' Adès L, Guerci A, Raffoux E, Sanz M, Chevallier P, Lapusan S, Recher C, Thomas X, Rayon C, Castaigne S, Tournilhac O, de Botton S, Ifrah N, Cahn JY, Solary E, Gardin C, Fegeux N, Bordessoule D, Ferrant A, Meyer-Monard S, Vey N, Dombret H, Degos L, Chevret S, Fenaux P; European APL Group. Very long-term outcome of acute promyelocytic leukemia after treatment with all-trans retinoic acid and chemotherapy: the European APL Group experience. Blood. 2010 Mar 4;115(9):1690-6. Epub 2009 Dec 17. [http://www.bloodjournal.org/content/115/9/1690.long link to original article] [https://pubmed.ncbi.nlm.nih.gov/20018913/ PubMed] |
| − | # '''GIMEMA LAP 0389:''' Avvisati G, Petti MC, Lo-Coco F, Vegna ML, Amadori S, Baccarani M, Cantore N, Di Bona E, Ferrara F, Fioritoni G, Gallo E, Invernizzi R, Lazzarino M, Liso V, Mariani G, Ricciuti F, Selleri C, Sica S, Veneri D, Mandelli F; GIMEMA. Induction therapy with idarubicin alone significantly influences event-free survival duration in patients with newly diagnosed hypergranular acute promyelocytic leukemia: final results of the GIMEMA randomized study LAP 0389 with 7 years of minimal follow-up. Blood. 2002 Nov 1;100(9):3141-6. [http://www.bloodjournal.org/content/100/9/3141.long link to original article] ''' | + | # '''GIMEMA LAP 0389:''' Avvisati G, Petti MC, Lo-Coco F, Vegna ML, Amadori S, Baccarani M, Cantore N, Di Bona E, Ferrara F, Fioritoni G, Gallo E, Invernizzi R, Lazzarino M, Liso V, Mariani G, Ricciuti F, Selleri C, Sica S, Veneri D, Mandelli F; GIMEMA. Induction therapy with idarubicin alone significantly influences event-free survival duration in patients with newly diagnosed hypergranular acute promyelocytic leukemia: final results of the GIMEMA randomized study LAP 0389 with 7 years of minimal follow-up. Blood. 2002 Nov 1;100(9):3141-6. [http://www.bloodjournal.org/content/100/9/3141.long link to original article] [https://pubmed.ncbi.nlm.nih.gov/12384411/ PubMed] |
| + | #'''SWOG S0521:''' Coutre SE, Othus M, Powell B, Willman CL, Stock W, Paietta E, Levitan D, Wetzler M, Attar EC, Altman JK, Gore SD, Maher T, Kopecky KJ, Tallman MS, Larson RA, Appelbaum FR. Arsenic trioxide during consolidation for patients with previously untreated low/intermediate risk acute promyelocytic leukaemia may eliminate the need for maintenance therapy. Br J Haematol. 2014 May;165(4):497-503. Epub 2014 Feb 14. [https://doi.org/10.1111/bjh.12775 link to original article] [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc4064464/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/24528179/ PubMed] [https://clinicaltrials.gov/study/NCT00492856 NCT00492856] | ||
[[Category:Acute promyelocytic leukemia regimens]] | [[Category:Acute promyelocytic leukemia regimens]] | ||
Revision as of 23:40, 27 May 2024
The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main APL page for regimens that include active anticancer treatment.
Maintenance after upfront therapy
Observation
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Avvisati et al. 2002 (GIMEMA LAP 0389) | 1989-1993 | Phase 3 (C) | 6-MP & MTX | Did not meet primary endpoint of EFS |
| Mandelli et al. 1997 (GIMEMA AIDA 0493) | 1993-1996 | Phase 3 (C) | 1. ATRA | Did not meet primary endpoint of molecular DFS |
| 2. ATRA, 6-MP, MTX | Did not meet primary endpoint of molecular DFS | |||
| 3. 6-MP & MTX | Did not meet primary endpoint of molecular DFS | |||
| Fenaux et al. 1999 (EAPLG APL 93) | 1993-1996 | Phase 3 (C) | 1. ATRA | Seems to have inferior 2-year relapse rate |
| 2. ATRA, 6-MP, MTX 3. 6-MP & MTX |
Inferior 2-year relapse rate | |||
| Coutre et al. 2014 (SWOG S0521) | 2007-06 to 2010-05 | Phase 3 (C) | ATRA, 6-MP, MTX | Inconclusive whether non-inferior DFS36 (primary endpoint) |
No further treatment given after consolidation. Note that this arm was dropped from AIDA 0493 from February 1997.
Preceding treatment
- EAPLG APL 93: Cytarabine & daunorubicin consolidation
- GIMEMA AIDA 0493 & LAP 0389: Cytarabine & idarubicin, then etoposide & mitoxantrone, then cytarabine, idarubicin, thioguanine consolidation
References
- GIMEMA AIDA 0493: Mandelli F, Diverio D, Avvisati G, Luciano A, Barbui T, Bernasconi C, Broccia G, Cerri R, Falda M, Fioritoni G, Leoni F, Liso V, Petti MC, Rodeghiero F, Saglio G, Vegna ML, Visani G, Jehn U, Willemze R, Muus P, Pelicci PG, Biondi A, Lo Coco F; Gruppo Italiano-Malattie Ematologiche Maligne dell'Adulto; Associazione Italiana di Ematologia ed Oncologia Pediatrica Cooperative Groups. Molecular remission in PML/RAR alpha-positive acute promyelocytic leukemia by combined all-trans retinoic acid and idarubicin (AIDA) therapy. Blood. 1997 Aug 1;90(3):1014-21. link to original article PubMed
- Update: Avvisati G, Lo-Coco F, Paoloni FP, Petti MC, Diverio D, Vignetti M, Latagliata R, Specchia G, Baccarani M, Di Bona E, Fioritoni G, Marmont F, Rambaldi A, Di Raimondo F, Kropp MG, Pizzolo G, Pogliani EM, Rossi G, Cantore N, Nobile F, Gabbas A, Ferrara F, Fazi P, Amadori S, Mandelli F; GIMEMA; AIEOP; EORTC. AIDA 0493 protocol for newly diagnosed acute promyelocytic leukemia: very long-term results and role of maintenance. Blood. 2011 May 5;117(18):4716-25. Epub 2011 Mar 8. link to original article PubMed
- EAPLG APL 93: Fenaux P, Chastang C, Chevret S, Sanz M, Dombret H, Archimbaud E, Fey M, Rayon C, Huguet F, Sotto JJ, Gardin C, Makhoul PC, Travade P, Solary E, Fegueux N, Bordessoule D, Miguel JS, Link H, Desablens B, Stamatoullas A, Deconinck E, Maloisel F, Castaigne S, Preudhomme C, Degos L. A randomized comparison of all transretinoic acid (ATRA) followed by chemotherapy and ATRA plus chemotherapy and the role of maintenance therapy in newly diagnosed acute promyelocytic leukemia; European APL Group. Blood. 1999 Aug 15;94(4):1192-200. link to original article PubMed
- Update: Adès L, Guerci A, Raffoux E, Sanz M, Chevallier P, Lapusan S, Recher C, Thomas X, Rayon C, Castaigne S, Tournilhac O, de Botton S, Ifrah N, Cahn JY, Solary E, Gardin C, Fegeux N, Bordessoule D, Ferrant A, Meyer-Monard S, Vey N, Dombret H, Degos L, Chevret S, Fenaux P; European APL Group. Very long-term outcome of acute promyelocytic leukemia after treatment with all-trans retinoic acid and chemotherapy: the European APL Group experience. Blood. 2010 Mar 4;115(9):1690-6. Epub 2009 Dec 17. link to original article PubMed
- GIMEMA LAP 0389: Avvisati G, Petti MC, Lo-Coco F, Vegna ML, Amadori S, Baccarani M, Cantore N, Di Bona E, Ferrara F, Fioritoni G, Gallo E, Invernizzi R, Lazzarino M, Liso V, Mariani G, Ricciuti F, Selleri C, Sica S, Veneri D, Mandelli F; GIMEMA. Induction therapy with idarubicin alone significantly influences event-free survival duration in patients with newly diagnosed hypergranular acute promyelocytic leukemia: final results of the GIMEMA randomized study LAP 0389 with 7 years of minimal follow-up. Blood. 2002 Nov 1;100(9):3141-6. link to original article PubMed
- SWOG S0521: Coutre SE, Othus M, Powell B, Willman CL, Stock W, Paietta E, Levitan D, Wetzler M, Attar EC, Altman JK, Gore SD, Maher T, Kopecky KJ, Tallman MS, Larson RA, Appelbaum FR. Arsenic trioxide during consolidation for patients with previously untreated low/intermediate risk acute promyelocytic leukaemia may eliminate the need for maintenance therapy. Br J Haematol. 2014 May;165(4):497-503. Epub 2014 Feb 14. link to original article link to PMC article PubMed NCT00492856