engleski

Gem-(R)CHOP versus (R)CHOP: a randomized phase II study of gemcitabine combined with (R)CHOP in unutreated aggressive non-Hodgkin’s lymphoma – EORTC lymphoma group protocol 20021 (EudraCT number 2004-004635-54)

Despite recent improvements, many patients with aggressive non-Hodgkin’s lymphoma (NHL) ultimately succumb to their disease. Therefore, improvements in front-line chemotherapy of aggressive NHL are needed. Gemcitabine is active in lymphoma. We performed a randomized phase II trial of the addition of gemcitabine to standard CHOP chemotherapy with or without rituximab ((R)CHOP). The trial was also designed to determine the maximal tolerated dose (MTD) of gemcitabine in this combination. Patients with previously untreated aggressive NHL were randomized to receive either 8 cycles of (R)CHOP given every 3 weeks or (R)CHOP combined with gemcitabine (Gem-(R)CHOP). Twenty-five patients were enrolled in the trial before early closure. Twelve were randomized to Gem-(R)CHOP and 13 to (R)CHOP. MTD of gemcitabine was 800 mg/m2 given on days 1 and 8 ; dose limiting toxicity was hematologic. Five patients (42%) treated with Gem-(R)CHOP achieved CR in comparison to 10 (77%) treated with (R)CHOP. Median time to treatment failure was 1.5 years for Gem-(R)CHOP and 3.1 years for (R)CHOP. Three patients receiving Gem-(R)CHOP had serious pulmonary toxicity, as compared to none receiving (R)CHOP. One patient died of pneumonitis. In this group of patients, addition of gemcitabine did not seem to improve outcomes. Gem-(R)CHOP in previously untreated patients with aggressive NHL occasionally results in severe, potentially fatal, pulmonary toxicity.

antineoplastic protocols; gemcitabine; lymphoma; large B-cell; lymphoma large-cell; anaplastic; lymphoma non-Hodgkin; lymphoma; T-cell; peripheral

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