Speaker: Andreas Engert, MD, Professor/Senior Consultant, First Department of Internal Medicine, University of Cologne, Cologne, Germany

Combination therapy with the chemotherapeutic agent fludarabine phosphate (Fludara®, Berlex) and the monoclonal antibody alemtuzumab (Campath®, Berlex) (FluCam) was safe and effective in eradicating both detectable minimal residual disease and in improving overall survival in heavily pre-treated patients with relapsed or refractory chronic lympho-cytic leukemia (CLL).

Because monoclonal antibodies such as alemtuzumab act synergistically with fludarabine both in vitro and in vivo, a phase 2 study was performed to evaluate a new FluCam combination regimen in 37 patients with relapsed or refractory disease. Apcalis Oral Jelly

Patients received FluCam after a short period of an alem-tuzumab dose escalation. The doses were increased from 3 to 10 to 30 mg during the first 14 days. The FluCam regimen consisted of IV fludarabine 30 mg/m2 for 15 to 30 minutes on days one to three; IV alemtuzumab 30 mg over four hours on day one; and IV alemtuzumab for two hours on days two and three. The FluCam regimen was repeated every 28 days for a maximum of six cycles.

Four-color flow cytometry was used to measure minimal residual disease. Staging of patients was performed at entry, at day 0 (zero) of the third and fifth cycles (if given), and at one month after the end of treatment. Follow-up staging was undertaken every 12 months until disease progression occurred. The overall response rate was 83%, with 11 complete responses (CRs) (30.5%), 19 partial responses (PRs) (52.8%), one patient with stable disease, and five patients with progressive disease (13.9%). Disease resolved in all sites, particularly in the blood, bone marrow, and spleen.

The lymphocytosis that had been present at the baseline examination resolved rapidly during the first two treatment cycles. By the third month of follow-up, 16 of 34 patients for whom data were available (44%) had achieved immunophenotypic responses in the peripheral blood, indicative of eradication of minimal residual disease.
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Notably, seven patients who had active autoimmune hemo-lytic anemia (AIHA) and/or autoimmune thrombocytopenia (AITP) upon entering the trial were successfully treated with FluCam. FluCam also benefited nine other patients with transfusion-dependent thrombocytopenia or anemia caused by bone marrow infiltration prior to therapy.

The overall survival rate was longest in patients who achieved CRs. The median survival rate has not yet been reached in these individuals.

Yttrium 90 Ibritumomab Tiuxetan plus Rituximab for Untreated Low-Grade Follicular Lymphoma

Speaker: John W. Sweetenham, MD, Hematologist/Oncolo-gist, Hematology/Oncology, Arizona Cancer Center, Tucson, Arizona

First-line yttrium 90 (Y) ibritumomab tiuxetan (Zevalin®, Biogen Idec) therapy with rituximab (Rituxan®, Biogen Idec/Genentech) produced a 100% response rate in a small population of patients with low-grade follicular lymphoma.

To evaluate the efficacy and safety profile of Y ibritumomab tiuxetan delivered before rituximab maintenance therapy in patients with low-grade follicular lymphoma, researchers enrolled 10 patients in a small study. On the first day, the patients were given an initial infusion of rituximab 250 mg/m2, followed by an imaging dose of indium 111 (In) ibritumomab tiuxetan 5 millicuries (mCi). One week later, the patients received an injection of Y ibritumomab tiuxetan 0.3 or 0.4 mCi/mg, depending on their platelet counts. They were then given a second infusion of rituximab 250 mg/m2. Rituximab maintenance therapy at 375 mg/m2 was scheduled four times at six-month intervals over two years.

Of the 10 patients who received the Y ibritumomab tiuxetan induction, eight were evaluable for their responses and for the safety of the therapy. Five patients achieved CRs, and three patients achieved PRs. Toxicities were primarily hematologi-cal. Grade 3 cytopenia was reported in three patients.

Tositumomab/Iodine 131 Tositumomab in Relapsed or Refractory Non-Hodgkin’s Lymphoma

Speaker: Stephanie A. Gregory, MD, Professor of Medicine, Hematology, Rush University Medical Center, and Director of Hematology, Rush-Presbyterian-St.Luke’s Medical Center/ Rush Cancer Institute, Chicago, Illinois

Tositumomab plus iodine 131 (I) tositumomab (Bexxar®, Corixia/GlaxoSmithKline) has been found to be a safe and effective treatment in elderly patients with relapsed or refractory low-grade, follicular, and transformed non-Hodgkin’s lymphoma (NHL).

Data from 995 patients who were enrolled in five core clinical trials and an expanded access program were evaluated to establish the efficacy and safety of the tositumomab combination (the Bexxar® Therapeutic Regimen) as a function of age. (NHL is generally diagnosed in patients whose median age is 60 years.)

Three patient age groups were analyzed: group 1, 60 years of age or younger (586 patients); group 2, ages 60 to 70 years or younger (250 patients); and group 3, older than 70 years of age (159 patients).

Substantial overall response rates were observed in each patient group: 66% in group 1, 50% in group 2, and 53% in group 3. Approximately 50% of these responses were complete responses (CRs); 37% for the group 1 patients, 23% for the group 2 patients, and 23% for patients in group 3.
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The median duration for patients achieving CRs in all three age groups was 32.3 months; the median duration for those older than 70 years of age was 36.4 months. Generally, patients younger than 60 years of age had somewhat more favorable responses, but patients older than age 60 had poorer prognostic factors on presentation, with high International Prognostic Index scores and transformed histological features.

In all age groups, the clinical outcome following the combination treatment was superior to that reported after previous therapy.