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12th Congress of the European Hematology ... - Haematologica

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12 th <strong>Congress</strong> <strong>of</strong> <strong>the</strong> <strong>European</strong> <strong>Hematology</strong> Association<br />

Therapy <strong>of</strong> non-Hodgkin's lymphoma<br />

0297<br />

QUALITY OF LIFE IN PATIENTS WITH NON-HODGKINS-LYMPHOMA DURING<br />

MAINTENANCE THERAPY WITH THE ANTI-CD20 ANTIBODY RITUXIMAB<br />

M. Witzens-Harig, 1 M. Reiz,1 C. Heiss, 2 A. Benner, 2 M. Hensel, 1<br />

K. Neben, 1 P. Dreger, 1 A. Krämer, 1 A.D. Ho 1<br />

1 University <strong>of</strong> Heidelberg Hospital, HEIDELBERG; 2 German Cancer Research<br />

Center, HEIDELBERG, Germany<br />

The introduction <strong>of</strong> rituximab into <strong>the</strong> treatment <strong>of</strong> malignant lymphomas<br />

<strong>of</strong> <strong>the</strong> B-cell lineage has had a major impact on <strong>the</strong> management<br />

<strong>of</strong> <strong>the</strong>se diseases. In diffuse large B-cell lymphomas (DLBCLs) and follicular<br />

lymphomas (FLs) several multicenter prospective randomized trials<br />

consistently demonstrated an improved outcome when rituximab<br />

was added to chemo<strong>the</strong>rapy. In addition, prolonged exposure to rituximab<br />

as maintenance <strong>the</strong>rapy has been benefical in patients with FL and<br />

mantle cell lymphoma (MCL). For patients, <strong>the</strong> effect <strong>of</strong> any prolonged<br />

antitumor <strong>the</strong>rapy on <strong>the</strong> quality <strong>of</strong> life (QoL) is a very important question.<br />

However, so far <strong>the</strong> question whe<strong>the</strong>r rituximab maintenance <strong>the</strong>rapy<br />

may impair QoL in patients with Non-Hodgkins-lymphoma<br />

remains unanswered. To investigate this subject , we have performed a<br />

prospective randomized trial <strong>of</strong> rituximab maintenance <strong>the</strong>rapy (8 cycles<br />

rituximab 375 mg/m 2 every 3 months) versus observation in patients<br />

with CD20 + B-cell Non-Hodgkins-Lymphoma in our institution.<br />

Between July 2002 and December 2005, 106 patients (pts) were included<br />

into <strong>the</strong> trial. QoL was assessed with <strong>the</strong> standardized questionnaires<br />

EORTC-QLQ-C30 and EuroQol-5D. After statistical analysis with <strong>the</strong><br />

Wilcoxon signed-rank test, we found no significant differences <strong>of</strong> <strong>the</strong><br />

QoL between <strong>the</strong> rituximab treatment group and <strong>the</strong> observation group.<br />

We conclude that rituximab maintenance <strong>the</strong>rapy is safe and does not<br />

impair quality <strong>of</strong> life in this patient population.<br />

0298<br />

RITUXIMAB MAINTENENANCE THERAPY IN CD20+ B-CELL NON-HODGKIN-LYMPHOMA<br />

FIRST RESULTS OF A MULTICENTER PROSPECTIVE RANDOMISED PHASE II STUDY<br />

M. Witzens-Harig, 1 M. Hensel, 1 J. Schmier, 1 K. Neben, 1 A. Benner, 2<br />

P. Dreger, 1 C. Kuhn, 3 I. Schmidt-Wolf, 4 A. Krämer, 1 A.D. Ho1 1 University <strong>of</strong> Heidelberg Hospital, HEIDELBERG; 2 German Cancer Research<br />

Center, HEIDELBERG; 3 University <strong>of</strong> Heidelberg, Mannheim, MANNHEIM;<br />

4 University <strong>of</strong> Bonn, BONN, Germany<br />

Clinical and pharmacokinetic data suggest that <strong>the</strong> effect <strong>of</strong> rituximab<br />

could be improved by prolonged exposure to <strong>the</strong> drug. To test for this<br />

hypo<strong>the</strong>sis we performed a prospective randomized trial <strong>of</strong> rituximab<br />

maintenance <strong>the</strong>rapy in patients with CD20 + B-cell Non-Hodgkins-Lymphoma.<br />

After completion <strong>of</strong> standard treatment patients were randomized<br />

to ei<strong>the</strong>r observation or maintenance <strong>the</strong>rapy with rituximab (375<br />

mg/m 2 ) every 3 months for 2 years. Patients after first line <strong>the</strong>rapy as well<br />

as relapse patients were included in <strong>the</strong> study. Patients with aggressive<br />

lymphoma were enrolled if <strong>the</strong>y had achieved a complete response (CR)<br />

after initial treatment. Patients with aggressive lymphoma with residual<br />

tumor mass were examined with positrone emission tomography (PET)<br />

and qualified for randomization if PET showed no signs <strong>of</strong> tumor activity.<br />

Patients with indolent lymphoma qualified for <strong>the</strong> study if at least<br />

a partial response (PR) was achieved. After recruitment <strong>of</strong> 172 patients<br />

a planed interim analysis was performed. Complete data sets <strong>of</strong> 162<br />

patients (pts) with CD20 + B-cell Non-Hodgkins-Lymphoma were evaluable<br />

for analysis. Histological subtypes included diffuse large cell lymphoma<br />

(69 pts), follicular lymphoma (41 pts), mantle cell lymphoma (18<br />

pts), primary mediastinal lymphoma (15 pts), marginal zone lymphoma<br />

(9 pts), Burkitt’s lymphoma (3 pts), immunocytoma (2 pts), primary<br />

intestinal lymphoma (1 pt), hairy cell leukemia (1 pt), chronic lymphocytic<br />

leukemia (1 pt) and unclassified B-cell lymphoma (2 pts). The interim<br />

analysis showed that event free survival was significantly prolonged<br />

in <strong>the</strong> rituximab maintenance group compared to <strong>the</strong> observation group<br />

(p

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