The human recombinant G-CSF filgrastim has been widely used for the mobilization of CD34+ stem cells of healthy donors (HD). In 2008, the G-CSF biosimilar XM02 (Ratiograstim, Tevagrastim and Biograstim) was approved by the European Medicines Agency (EMA) for the mobilization of PBSC. However, there is limited experience in the application of biosimilar G-CSF for the mobilization of PBSC especially in HD. Therefore, we investigated in two cohorts (n=22), the efficacy and safety of PBSC mobilization by either biosimilar G-CSF or reference G-CSF. We observed a similar yield of CD34+ stem cells as well as CD3+ T-cells and nucleated cells in both groups and a safe engraftment in all patients with similar reconstitution of hematopoiesis in all hosts. In summary, we found a comparable efficacy and safety of biosimilar G-CSF when compared with reference G-CSF.
Between July 2011 and September 2013, 25 patients were included in this analysis. The median number of previous treatments was 1 (range 1-2). Twenty-two patients (88%) responded after at least two cycles of RBP (one sCR, five nCR, eight VGPR and eight PR). The median time to first haematological response was 28 days, and median time to best response was 56 days. Due to increased haematological toxicity a dose reduction in most patients required in subsequent cycles of therapy. The median progression-free and overall survival was 22 and 38 months, respectively. In conclusion RBP is a highly effective therapy for patients with relapsed/refractory MM. In contrast to our phase 1 study, dose reduction was necessary in many patients because of haematological toxicity.
VEGF inhibition in gastric cancer has a proven benefit in the second line setting.Pazopanib, an oral tyrosine kinase inhibitor, selectively inhibits VEGFR-1, -2 and -3, c-kit and PDGF-R resulting in inhibition of angiogenesis. This open-label randomized phase II trial (2:1
Background: Myelopathy due to epidural spinal cord compression is rare in patients with malignant lymphoma and most of these patients are diagnosed with high-grade lymphoma. An epidural growth of low-grade lymphoma is even more unusual. Due to this low incidence, therapeutic experience for this entity is limited. Patients and Methods: We report the outcome of 3 consecutive patients with primary spinal epidural follicular lymphoma (FL). Due to the clinical disorders of the patients and despite the localized disease, we used an intensive multimodal therapy concept consisting of spinal decompression, systemic (immuno)chemotherapy and local irradiation. All patients improved in their medical condition; 2 achieved a complete remission, 1 of these with long-term remission. Conclusions: In contrast to the established irradiation therapy for early-stage FL, an intensive multimodal therapy concept should be initiated in patients with primary spinal epidural FL. With this approach, a fast improvement of the symptoms and long-term disease-free survival is possible.
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