TY  - JOUR
A1  - Röllig, C.
A1  - Kramer, M.
A1  - Gabrecht, M.
A1  - Hänel, M.
A1  - Herbst, R.
A1  - Kaiser, U.
A1  - Schmitz, N.
A1  - Kullmer, J.
A1  - Fetscher, S.
A1  - Link, H.
A1  - Mantovani-Löffler, L.
A1  - Krümpelmann, U.
A1  - Neuhaus, T.
A1  - Heits, F.
A1  - Einsele, H.
A1  - Ritter, B.
A1  - Bornhäuser, M.
A1  - Schetelig, J.
A1  - Thiede, C.
A1  - Mohr, B.
A1  - Schaich, M.
A1  - Platzbecker, U.
A1  - Schäfer-Eckart, K.
A1  - Krämer, A.
A1  - Berdel, W. E.
A1  - Serve, H.
A1  - Ehninger, G.
A1  - Schuler, U. S.
T1  - Intermediate-dose cytarabine plus mitoxantrone versus standard-dose cytarabine plus daunorubicin for acute myeloid leukemia in elderly patients
JF  - Annals of Oncology
N2  - Background: The combination of intermediate-dose cytarabine plus mitoxantrone (IMA) can induce high complete remission rates with acceptable toxicity in elderly patients with acute myeloid leukemia (AML). We present the final results of a randomized-controlled trial comparing IMA with the standard 7+3 induction regimen consisting of continuous infusion cytarabine plus daunorubicin (DA). 

Patients and methods: Patients with newly diagnosed AML>60 years were randomized to receive either intermediate-dose cytarabine (1000 mg/m(2) twice daily on days 1, 3, 5, 7) plus mitoxantrone (10 mg/m(2) days 1-3) (IMA) or standard induction therapy with cytarabine (100 mg/m(2) continuously days 1-7) plus daunorubicin (45 mg/m(2) days 3-5) (DA). Patients in complete remission after DA received intermediate-dose cytarabine plus amsacrine as consolidation treatment, whereas patients after IMA were consolidated with standard-dose cytarabine plus mitoxantrone. 

Results: Between February 2005 and October 2009, 485 patients were randomized; 241 for treatment arm DA and 244 for IMA; 76% of patients were >65 years. The complete response rate after DA was 39% [95% confidence interval (95% CI): 33-45] versus 55% (95% CI: 49-61) after IMA (odds ratio 1.89, P = 0.001). The 6-week early-death rate was 14% in both arms. Relapse-free survival curves were superimposable in the first year, but separated afterwards, resulting in 3-year relapse-free survival rates of 29% versus 14% in the DA versus IMA arms, respectively (P = 0.042). The median overall survival was 10 months in both arms (P = 0.513). 

Conclusion: The dose escalation of cytarabine in induction therapy lead to improved remission rates in the elderly AML patients. This did not translate into a survival advantage, most likely due to differences in consolidation treatment. Thus, effective consolidation strategies need to be further explored. In combination with an effective consolidation strategy, the use of intermediate-dose cytarabine in induction may improve curative treatment for elderly AML patients.
KW  - acute myeloid leukemia
KW  - cytarabine dose
KW  - elderly
Y1  - 2018
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-226473
VL  - 29
IS  - 4
ER  - 
TY  - JOUR
A1  - Wilhelm, M.
A1  - Smetak, M.
A1  - Reimer, P.
A1  - Geissinger, E.
A1  - Ruediger, T.
A1  - Metzner, B.
A1  - Schmitz, N.
A1  - Engert, A.
A1  - Schaefer-Eckart, K.
A1  - Birkmann, J.
T1  - First-line therapy of peripheral T-cell lymphoma: extension and long-term follow-up of a study investigating the role of autologous stem cell transplantation
JF  - Blood Cancer Journal
N2  - Current guidelines recommend consolidation with autologous stem cell transplantation (autoSCT) after induction chemotherapy for most patients with peripheral T-cell lymphoma (PTCL). This assumption is based on five prospective phase II studies, three of which included <50 patients with limited follow-up. Here we present the final analysis of the prospective German study. The treatment regimen consisted of four to six cycles of CHOP chemotherapy followed by mobilizing therapy and stem cell collection. Patients in complete remission (CR) or partial remission (PR) underwent myeloablative chemo(radio)therapy and autoSCT. From January 2001 to July 2010, 111 patients were enrolled in the study. The main subgroups were PTCL not specified (n=42) and angioimmunoblastic T-cell lymphoma (n=37). Seventy-five (68%) of the 111 patients received transplantation. The main reason for not receiving autoSCT was progressive disease. In an intent-to-treat analysis, the complete response rate after myeloablative therapy was 59%. The estimated 5-year overall survival, disease-free survival and progression-free survival rates were 44%, 54% and 39%, respectively. The results of this study confirm that upfront autoSCT can result in long-term remissions in patients with all major subtypes of PTCL and therefore should be part of first-line therapy whenever possible.
KW  - Chemotherapy
Y1  - 2016
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-164506
VL  - 6
ER  -