Skip to main content
Erschienen in: International Journal of Hematology 2/2012

01.08.2012 | Progress in Hematology

Clinical studies of acute myeloid leukemia in the Japan Adult Leukemia Study Group

verfasst von: Shuichi Miyawaki

Erschienen in: International Journal of Hematology | Ausgabe 2/2012

Einloggen, um Zugang zu erhalten

Abstract

Acute myeloid leukemia (AML) is the most common adult leukemia in Japan. The treatment for AML consists of induction, consolidation, and maintenance therapies. To improve outcomes in the treatment of AML, the Japan Adult Leukemia Study Group has conducted six studies in AML patients aged 15–64 years since 1987. In AML201 study, IDR (12 mg/m2/day for 3 days) or DNR (50 mg/m2/day for 5 days) in combination with Ara-C (100 mg/m2/day continuous infusion for 7 days) was established as the standard induction therapy, and four courses of combination chemotherapy using non-cross-resistant agents for non-core binding factor (CBF) AML or three courses of high-dose Ara-C for CBF AML was established as the standard consolidation therapy. The AML97 study showed that allo-HSCT from an HLA-identical sibling donor reduced relapse incidence and improved disease-free survival (DFS), but did not significantly impact overall survival (OS) in poor or intermediate risk patients. Despite these studies by JALSG, only about one-third of AML patients remain free of disease for more than 7 years. The JALSG is now conducting the AML209 study to adapt individual therapies according to genetic alterations.
Literatur
1.
Zurück zum Zitat Bishop JF, Matthews JP, Young GA, Szer J, Gillett A, Joshua D, et al. A randomized study of high-dose cytarabine in induction in acute myeloid leukemia. Blood. 1996;87:1710–7.PubMed Bishop JF, Matthews JP, Young GA, Szer J, Gillett A, Joshua D, et al. A randomized study of high-dose cytarabine in induction in acute myeloid leukemia. Blood. 1996;87:1710–7.PubMed
2.
Zurück zum Zitat Weick JK, Kopecky KJ, Appelbaum FR, Head DR, Kingsbury LL, Balcerzak SP, et al. A randomized investigation of high-dose versus standard-dose cytosine arabinoside with daunorubicin in patients with previously untreated acute myeloid leukemia: a Southwest Oncology Group study. Blood. 1996;88:2841–51.PubMed Weick JK, Kopecky KJ, Appelbaum FR, Head DR, Kingsbury LL, Balcerzak SP, et al. A randomized investigation of high-dose versus standard-dose cytosine arabinoside with daunorubicin in patients with previously untreated acute myeloid leukemia: a Southwest Oncology Group study. Blood. 1996;88:2841–51.PubMed
3.
Zurück zum Zitat Berman E, Heller G, Santorsa J, McKenzie S, Gee T, Kempin S, et al. Results of randomized trial comparing idarubicin and cytosine arabinoside with daunorubicin and cytosine arabinoside in adult patients with newly diagnosed acute myelogenous leukemia. Blood. 1991;77:1666–74.PubMed Berman E, Heller G, Santorsa J, McKenzie S, Gee T, Kempin S, et al. Results of randomized trial comparing idarubicin and cytosine arabinoside with daunorubicin and cytosine arabinoside in adult patients with newly diagnosed acute myelogenous leukemia. Blood. 1991;77:1666–74.PubMed
4.
Zurück zum Zitat Wiernik PH, Banks PL, Case DC Jr, Arlin ZA, Periman PO, Todd MB, et al. Cytarabine idarubicin or daunorubicin as induction and consolidation therapy for previously untreated adult patients with acute myeloid leukemia. Blood. 1992;79:313–9.PubMed Wiernik PH, Banks PL, Case DC Jr, Arlin ZA, Periman PO, Todd MB, et al. Cytarabine idarubicin or daunorubicin as induction and consolidation therapy for previously untreated adult patients with acute myeloid leukemia. Blood. 1992;79:313–9.PubMed
5.
Zurück zum Zitat Vogler WR, Velez-Garcia E, Weiner RS, Flaum MA, Bartolucci AA, Omura GA, et al. A phase III trial comparing idarubicin and daunorubicin with in acute myeloid leukemia: a Southeastern Cancer Study Group study. J Clin Oncol. 1992;10:1103–8.PubMed Vogler WR, Velez-Garcia E, Weiner RS, Flaum MA, Bartolucci AA, Omura GA, et al. A phase III trial comparing idarubicin and daunorubicin with in acute myeloid leukemia: a Southeastern Cancer Study Group study. J Clin Oncol. 1992;10:1103–8.PubMed
6.
Zurück zum Zitat The AML collaborative Group. A systematic collaborative overview of randomized trials comparing idarubicin with daunorubicin (or other anthracyclines) as induction for acute myeloid leukemia. Br J Haematol. 1998;103:100–9.CrossRef The AML collaborative Group. A systematic collaborative overview of randomized trials comparing idarubicin with daunorubicin (or other anthracyclines) as induction for acute myeloid leukemia. Br J Haematol. 1998;103:100–9.CrossRef
7.
Zurück zum Zitat Ohtake S, Miyawaki S, Kiyoi H, Miyazaki Y, Okumura H, Matsuda S, et al. Randomized trial of response-oriented individualized versus fixed-schedule induction chemotherapy with idarubicin and cytarabine in adult acute myeloid leukemia: the JALSG AML95 study. Int J Hematol. 2010;91:276–83.PubMedCrossRef Ohtake S, Miyawaki S, Kiyoi H, Miyazaki Y, Okumura H, Matsuda S, et al. Randomized trial of response-oriented individualized versus fixed-schedule induction chemotherapy with idarubicin and cytarabine in adult acute myeloid leukemia: the JALSG AML95 study. Int J Hematol. 2010;91:276–83.PubMedCrossRef
8.
Zurück zum Zitat Miyawaki S, Sakamaki H, Ohtake S, Emi N, Yagasaki F, Mitani K, Matsuda S, et al. A randomized, postremission comparison of four courses of standard-dose consolidation therapy without maintenance therapy versus three courses of standard-dose consolidation with maintenance therapy in adults with acute myeloid leukemia. Cancer. 2005;104:2726–34.PubMedCrossRef Miyawaki S, Sakamaki H, Ohtake S, Emi N, Yagasaki F, Mitani K, Matsuda S, et al. A randomized, postremission comparison of four courses of standard-dose consolidation therapy without maintenance therapy versus three courses of standard-dose consolidation with maintenance therapy in adults with acute myeloid leukemia. Cancer. 2005;104:2726–34.PubMedCrossRef
9.
Zurück zum Zitat Ohno R, Kobayashi T, Tanimoto M, Hiraoka A, Imai K, Asou N, et al. Randomized study of individualized induction therapy with or without vincristine, and of maintenance intensification therapy between 4 or 12 courses in adult acute myeloid leukemia: AML-87 Study of the Japan Adult Leukemia Study Group. Cancer. 1993;71:3888–95.PubMedCrossRef Ohno R, Kobayashi T, Tanimoto M, Hiraoka A, Imai K, Asou N, et al. Randomized study of individualized induction therapy with or without vincristine, and of maintenance intensification therapy between 4 or 12 courses in adult acute myeloid leukemia: AML-87 Study of the Japan Adult Leukemia Study Group. Cancer. 1993;71:3888–95.PubMedCrossRef
10.
Zurück zum Zitat Kobayashi T, Miyawaki S, Tanimoto M, Kuriyama K, Murakami H, Yoshida M, et al. Randomized trials between behenoyl cytarabine and cytarabine in combination induction and consolidation therapy, and with or without ubenimex after maintenance/intensification therapy in adult acute myeloid leukemia. J Clin Oncol. 1996;14:204–13.PubMed Kobayashi T, Miyawaki S, Tanimoto M, Kuriyama K, Murakami H, Yoshida M, et al. Randomized trials between behenoyl cytarabine and cytarabine in combination induction and consolidation therapy, and with or without ubenimex after maintenance/intensification therapy in adult acute myeloid leukemia. J Clin Oncol. 1996;14:204–13.PubMed
11.
Zurück zum Zitat Miyawaki S, Tanimoto M, Kobayashi T, Kuriyama K, Murakami H, Yoshida M, et al. No beneficial effect from addition of etoposide to daunorubicin, cytarabine, and 6-mercaptopurine in individualized induction therapy of adult acute myeloid leukemia: the JALSG-AML92 study. Int J Hematol. 1999;70:97–104.PubMed Miyawaki S, Tanimoto M, Kobayashi T, Kuriyama K, Murakami H, Yoshida M, et al. No beneficial effect from addition of etoposide to daunorubicin, cytarabine, and 6-mercaptopurine in individualized induction therapy of adult acute myeloid leukemia: the JALSG-AML92 study. Int J Hematol. 1999;70:97–104.PubMed
12.
Zurück zum Zitat Ohtake S, Miyawaki S, Fujita H, Kiyoi H, Shinagawa K, Usui N, et al. Randomized study of induction therapy comparing standard-dose idarubicin with high-dose daunorubicin in adult patients with previously untreated acute myeloid leukemia: the JALSGAML201 Study. Blood. 2011;117:1613–8.CrossRef Ohtake S, Miyawaki S, Fujita H, Kiyoi H, Shinagawa K, Usui N, et al. Randomized study of induction therapy comparing standard-dose idarubicin with high-dose daunorubicin in adult patients with previously untreated acute myeloid leukemia: the JALSGAML201 Study. Blood. 2011;117:1613–8.CrossRef
13.
Zurück zum Zitat Fernandez HF, Sun Z, Yao X, et al. Anthracycline dose intensification in acute myeloid leukemia. N Engl J Med. 2009;361:1249–59.PubMedCrossRef Fernandez HF, Sun Z, Yao X, et al. Anthracycline dose intensification in acute myeloid leukemia. N Engl J Med. 2009;361:1249–59.PubMedCrossRef
14.
Zurück zum Zitat Usui N, Takeshita A, Nakaseko C, Dobashi N, Fujita Hi, Kiyoi H, et al. Phase I trial of gemtuzumab ozogamicin in intensive combination chemotherapy for relapsed or refractory adult acute myeloid leukemia (AML): Japan Adult Leukemia Study Group (JALSG)-AML206 study. Cancer Sci. 2011;102:1358–65.PubMedCrossRef Usui N, Takeshita A, Nakaseko C, Dobashi N, Fujita Hi, Kiyoi H, et al. Phase I trial of gemtuzumab ozogamicin in intensive combination chemotherapy for relapsed or refractory adult acute myeloid leukemia (AML): Japan Adult Leukemia Study Group (JALSG)-AML206 study. Cancer Sci. 2011;102:1358–65.PubMedCrossRef
15.
Zurück zum Zitat Castaigne S, Pautas C, Terré C, Raffoux E, Bordessoule D, Bastie JN, et al. Effect of gemtuzumab ozogamicin on survival of adult patients with de novo acute myeloid leukaemia (ALFA-0701): a randomised, open-label, phase 3 study. Lancet. 2012;379:1508–16.PubMedCrossRef Castaigne S, Pautas C, Terré C, Raffoux E, Bordessoule D, Bastie JN, et al. Effect of gemtuzumab ozogamicin on survival of adult patients with de novo acute myeloid leukaemia (ALFA-0701): a randomised, open-label, phase 3 study. Lancet. 2012;379:1508–16.PubMedCrossRef
16.
Zurück zum Zitat Mayer RJ, Davis RB, Schiffer CA, Berg DT, Powell BL, Schulman P, et al. Intensive postremission chemotherapy in adults with acute myeloid leukemia. N Engl J Med. 1994;331(14):896–903.PubMedCrossRef Mayer RJ, Davis RB, Schiffer CA, Berg DT, Powell BL, Schulman P, et al. Intensive postremission chemotherapy in adults with acute myeloid leukemia. N Engl J Med. 1994;331(14):896–903.PubMedCrossRef
17.
Zurück zum Zitat Miyawaki S, Ohtake S, Fujisawa S, Kiyoi H, Shinagawa K, Usui N, Sakura T, et al. A randomized comparison of 4 courses of standard-dose multiagent chemotherapy versus 3 courses of high-dose cytarabine alone in postremission therapy for acute myeloid leukemia in adults: the JALSG AML201 Study. Blood. 2011;117:2366–72.PubMedCrossRef Miyawaki S, Ohtake S, Fujisawa S, Kiyoi H, Shinagawa K, Usui N, Sakura T, et al. A randomized comparison of 4 courses of standard-dose multiagent chemotherapy versus 3 courses of high-dose cytarabine alone in postremission therapy for acute myeloid leukemia in adults: the JALSG AML201 Study. Blood. 2011;117:2366–72.PubMedCrossRef
18.
Zurück zum Zitat Cassileth PA, Harrington DP, Appelbaum FR, et al. Chemotherapy compared with autologous or allogeneic bone marrow transplantation in the management of acute myeloid leukemia in first remission. N Engl J Med. 1998;339(23):1649–56.PubMedCrossRef Cassileth PA, Harrington DP, Appelbaum FR, et al. Chemotherapy compared with autologous or allogeneic bone marrow transplantation in the management of acute myeloid leukemia in first remission. N Engl J Med. 1998;339(23):1649–56.PubMedCrossRef
19.
Zurück zum Zitat Harousseau JL, Cahn JY, Pignon B, et al. Comparison of autologous bone marrow transplantation and intensive chemotherapy as postremission therapy in adult acute myeloid leukemia. The Groupe Ouest Est Leucemies Aigues Myeloblastiques (GOELAM). Blood. 1997;90:2978–86.PubMed Harousseau JL, Cahn JY, Pignon B, et al. Comparison of autologous bone marrow transplantation and intensive chemotherapy as postremission therapy in adult acute myeloid leukemia. The Groupe Ouest Est Leucemies Aigues Myeloblastiques (GOELAM). Blood. 1997;90:2978–86.PubMed
20.
Zurück zum Zitat Burnett AK, Wheatley K, Goldstone AH, et al. The value of allogeneic bone marrow transplant in patients with acute myeloid leukaemia at differing risk of relapse: results of the UK MRC AML 10 trial. Br J Haematol. 2002;118:385–400.PubMedCrossRef Burnett AK, Wheatley K, Goldstone AH, et al. The value of allogeneic bone marrow transplant in patients with acute myeloid leukaemia at differing risk of relapse: results of the UK MRC AML 10 trial. Br J Haematol. 2002;118:385–400.PubMedCrossRef
21.
Zurück zum Zitat Keating S, de Witte T, Suciu S, et al. The influence of HLA matched sibling donor availability on treatment outcome for patients with AML: an analysis of the AML 8A study of the EORTC Leukaemia Cooperative Group and GIMEMA. European Organization for Research and Treatment of Cancer. Gruppo Italiano Malattie Ematologiche Maligne dell’Adulto. Br J Haematol. 1998;102(5):1344–53.PubMedCrossRef Keating S, de Witte T, Suciu S, et al. The influence of HLA matched sibling donor availability on treatment outcome for patients with AML: an analysis of the AML 8A study of the EORTC Leukaemia Cooperative Group and GIMEMA. European Organization for Research and Treatment of Cancer. Gruppo Italiano Malattie Ematologiche Maligne dell’Adulto. Br J Haematol. 1998;102(5):1344–53.PubMedCrossRef
22.
Zurück zum Zitat Sakamaki H, Miyawaki S, Ohtake S, Emi N, Yagasaki F, Mitani K, et al. Allogeneic stem cell transplantation versus chemotherapy as post-remission therapy for intermediate or poor risk adult acute myeloid leukemia: results of the JALSG AML97 study. Int J Hematol. 2010;91:284–92.PubMedCrossRef Sakamaki H, Miyawaki S, Ohtake S, Emi N, Yagasaki F, Mitani K, et al. Allogeneic stem cell transplantation versus chemotherapy as post-remission therapy for intermediate or poor risk adult acute myeloid leukemia: results of the JALSG AML97 study. Int J Hematol. 2010;91:284–92.PubMedCrossRef
23.
Zurück zum Zitat Estey E, Plunkett W, Gandhi V, Rios MB, Kantarjian H, Keating MJ. Fludarabine and arabinosylcytosine therapy of refractory and relapsed acute myelogenous leukemia. Leuk Lymphoma. 1993;9:343–50.PubMedCrossRef Estey E, Plunkett W, Gandhi V, Rios MB, Kantarjian H, Keating MJ. Fludarabine and arabinosylcytosine therapy of refractory and relapsed acute myelogenous leukemia. Leuk Lymphoma. 1993;9:343–50.PubMedCrossRef
24.
Zurück zum Zitat Miyawaki S, Kawai Y, Takeshita A, Komatsu N, Usui N, Arai Y, et al. Phase I trial of FLAGM with high doses of cytosine arabinoside for relapsed, refractory acute myeloid leukemia: study of the Japan Adult Leukemia Study Group (JALSG). Int J Hematol. 2007;86:343–7.PubMedCrossRef Miyawaki S, Kawai Y, Takeshita A, Komatsu N, Usui N, Arai Y, et al. Phase I trial of FLAGM with high doses of cytosine arabinoside for relapsed, refractory acute myeloid leukemia: study of the Japan Adult Leukemia Study Group (JALSG). Int J Hematol. 2007;86:343–7.PubMedCrossRef
25.
Zurück zum Zitat Hatsumi N, Miyawaki S, Yamauchi T, Takeshita A, Komatsu N, Usui N, et al. Phase II Study of FLAGM (fludarabine + high-dose cytarabine + granulocyte colony-stimulating factor + mitoxantrone) for relapsed or refractory acute myeloid leukemia: Recommendable salvage therapy for subsequent stem cell transplantation. Leuk Lymphoma. 2012 Submitted. Hatsumi N, Miyawaki S, Yamauchi T, Takeshita A, Komatsu N, Usui N, et al. Phase II Study of FLAGM (fludarabine + high-dose cytarabine + granulocyte colony-stimulating factor + mitoxantrone) for relapsed or refractory acute myeloid leukemia: Recommendable salvage therapy for subsequent stem cell transplantation. Leuk Lymphoma. 2012 Submitted.
26.
Zurück zum Zitat Slovak ML, Kopecky KJ, Cassileth PA, Harrington DH, Theil KS, Mohamed A, et al. Karyotypic analysis predicts outcome of preremission and postremission therapy in adult acute myeloid leukemia: a Southwest Oncology Group/Eastern Cooperative Oncology Group study. Blood. 2000;96:4075–83.PubMed Slovak ML, Kopecky KJ, Cassileth PA, Harrington DH, Theil KS, Mohamed A, et al. Karyotypic analysis predicts outcome of preremission and postremission therapy in adult acute myeloid leukemia: a Southwest Oncology Group/Eastern Cooperative Oncology Group study. Blood. 2000;96:4075–83.PubMed
27.
Zurück zum Zitat Grimwade D, Walker H, Oliver F, Wheatley K, Harrison C, Harrison G, et al. The importance of diagnostic cytogenetics on outcome in AML: analysis of 1,612 patients entered into the MRC AML 10 trial. The Medical Research Council Adult and Children’s Leukaemia Working Parties. Blood. 1998;92:2322–33.PubMed Grimwade D, Walker H, Oliver F, Wheatley K, Harrison C, Harrison G, et al. The importance of diagnostic cytogenetics on outcome in AML: analysis of 1,612 patients entered into the MRC AML 10 trial. The Medical Research Council Adult and Children’s Leukaemia Working Parties. Blood. 1998;92:2322–33.PubMed
28.
Zurück zum Zitat Schlenk RF, Döhner K, Krauter J, Fröhling S, Corbacioglu A, Bullinger L, et al. Mutations and treatment outcome in cytogenetically normal acute myeloid leukemia. N Engl J Med. 2008;358:1909–18.PubMedCrossRef Schlenk RF, Döhner K, Krauter J, Fröhling S, Corbacioglu A, Bullinger L, et al. Mutations and treatment outcome in cytogenetically normal acute myeloid leukemia. N Engl J Med. 2008;358:1909–18.PubMedCrossRef
29.
Zurück zum Zitat Kiyoi H, Naoe T, Nakano Y, et al. Prognostic implication of FLT3 and N-RAS gene mutations in acute myeloid leukemia. Blood. 1999;93:3074–80.PubMed Kiyoi H, Naoe T, Nakano Y, et al. Prognostic implication of FLT3 and N-RAS gene mutations in acute myeloid leukemia. Blood. 1999;93:3074–80.PubMed
30.
Zurück zum Zitat Döhner H, Estey EH, Amadori S, Appelbaum FR, Büchner T, Burnett AK, Dombret H, et al. Diagnosis and management of acute myeloid leukemia in adults: recommendations from an international expert panel, on behalf of the European LeukemiaNet. Blood. 2010;115:453–74.PubMedCrossRef Döhner H, Estey EH, Amadori S, Appelbaum FR, Büchner T, Burnett AK, Dombret H, et al. Diagnosis and management of acute myeloid leukemia in adults: recommendations from an international expert panel, on behalf of the European LeukemiaNet. Blood. 2010;115:453–74.PubMedCrossRef
31.
Zurück zum Zitat Kuriyama K, Tomonaga M, Kobayashi T, et al. Trial to extract prognostic factors prior to the start of induction chemotherapy for adult AML. In: Hiddeman W, Buchner T, Worman B, et al., editors. Acute leukemias VII: experimental approaches and novel therapies. New York: Springer; 1998. p. 901–905. Kuriyama K, Tomonaga M, Kobayashi T, et al. Trial to extract prognostic factors prior to the start of induction chemotherapy for adult AML. In: Hiddeman W, Buchner T, Worman B, et al., editors. Acute leukemias VII: experimental approaches and novel therapies. New York: Springer; 1998. p. 901–905.
32.
Zurück zum Zitat Miyazaki Y, Nishida K, Kuriyama K, Taniwaki M, Sakamaki H, Miyawaki S, et al. A new scoring system to predict the prognosis of patients with acute myeloid leukemia. study from the Japan Adult Leukemia Study Group. Blood. 2005;106:667a. Abstract 2373. Miyazaki Y, Nishida K, Kuriyama K, Taniwaki M, Sakamaki H, Miyawaki S, et al. A new scoring system to predict the prognosis of patients with acute myeloid leukemia. study from the Japan Adult Leukemia Study Group. Blood. 2005;106:667a. Abstract 2373.
Metadaten
Titel
Clinical studies of acute myeloid leukemia in the Japan Adult Leukemia Study Group
verfasst von
Shuichi Miyawaki
Publikationsdatum
01.08.2012
Verlag
Springer Japan
Erschienen in
International Journal of Hematology / Ausgabe 2/2012
Print ISSN: 0925-5710
Elektronische ISSN: 1865-3774
DOI
https://doi.org/10.1007/s12185-012-1150-6

Weitere Artikel der Ausgabe 2/2012

International Journal of Hematology 2/2012 Zur Ausgabe

Erhöhtes Risiko fürs Herz unter Checkpointhemmer-Therapie

28.05.2024 Nebenwirkungen der Krebstherapie Nachrichten

Kardiotoxische Nebenwirkungen einer Therapie mit Immuncheckpointhemmern mögen selten sein – wenn sie aber auftreten, wird es für Patienten oft lebensgefährlich. Voruntersuchung und Monitoring sind daher obligat.

Costims – das nächste heiße Ding in der Krebstherapie?

28.05.2024 Onkologische Immuntherapie Nachrichten

„Kalte“ Tumoren werden heiß – CD28-kostimulatorische Antikörper sollen dies ermöglichen. Am besten könnten diese in Kombination mit BiTEs und Checkpointhemmern wirken. Erste klinische Studien laufen bereits.

Perioperative Checkpointhemmer-Therapie verbessert NSCLC-Prognose

28.05.2024 NSCLC Nachrichten

Eine perioperative Therapie mit Nivolumab reduziert das Risiko für Rezidive und Todesfälle bei operablem NSCLC im Vergleich zu einer alleinigen neoadjuvanten Chemotherapie um über 40%. Darauf deuten die Resultate der Phase-3-Studie CheckMate 77T.

Positiver FIT: Die Ursache liegt nicht immer im Dickdarm

27.05.2024 Blut im Stuhl Nachrichten

Immunchemischer Stuhltest positiv, Koloskopie negativ – in solchen Fällen kann die Blutungsquelle auch weiter proximal sitzen. Ein Forschungsteam hat nachgesehen, wie häufig und in welchen Lokalisationen das der Fall ist.

Update Onkologie

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.