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Purpose: The aim of the study was to evaluate whether glycosylated granulocyte colony - stimulating factor (G-CSF) (lenograstim) offers a benefit over non glycosylated G-CSF (filgrastim) in clinically relevant end points after high-dose chemotherapy (HDC) and autol- ogous peripheral blood stem cell transplantation (PBS CT). Methods: We retrospectively analyzed the outcome of 261 patients treated with either lenograstim (n 68) or filgrastim (n 193). Time to blood cell recov- ery, toxicities, and infectious complications were analyzed in a total of 469 G-CSF treatment cycles. Results: Mean time to leukocyte recovery was 10.7 days (SD ± 0.9) (lenograstim) and 10.8 days (SD ± 0.6) (filgrastim), respectively. Likewise, time to thrombocyte engraftment, febrile days, duration of therapeutic antibiotic treatment, severity of non-hematological toxicities, duration of in- hospital stay, and duration of G-CSF treatment were similar in both groups. Owing to the physicochemical and pharmaco kinetic properties of lenograstim, the required dose until leukocyte recovery was significantly smaller as compared to filgrastim (38.5 vs 54.0 pg/kg of body weight). Conclusions: Collectively, our data indicate that both G-CSF preparations are equally effective in hastening leukocyte recovery in the setting of high-dose chemotherapy followed by autologous PBSCT. [ABSTRACT FROM AUTHOR]

Hemolytic uremic syndrome (HUS) has been described following the administration of multiple antineoplastic agents, most notably mitomycin C. More recently, several cases of gemcitabine-induced HUS have been observed with the overall incidence of gemcitabine-induced HUS estimated at 0.015-0.25%. We here report on four patients who developed HUS following gemcitabine therapy at our institution within the last year (incidence 1.4%). All these patients had advanced-stage disease, were heavily pretreated, and received prolonged gemcitabine application, suggesting that in this subgroup of patients HUS may be more frequently encountered than documented so far. [ABSTRACT FROM AUTHOR]

Schütt P, Ebeling P, Buttkereit U, Brandhorst D, Opalka B, Hoiczyk M, Flasshove M, Hense J, Bojko P, Metz K, Moritz T, Seeber S, Nowrousian MR. Thalidomide in combination with vincristine, epirubicin and dexamethasone (VED) for previously untreated patients with multiple myeloma.Eur J Haematol 2005: 74: 40–46.©Blackwell Munksgaard 2005.The present study aimed to evaluate the side-effects and efficacy of thalidomide in combination with an anthracycline-containing chemotherapy regimen in previously untreated myeloma patients. Thalidomide (400 mg/d) was combined with bolus injections of vincristine and epirubicin and oral dexamethasone (VED). Chemotherapy cycles were repeated every 3 wk until no further reduction in myeloma protein was observed, whereas the treatment with thalidomidewas continued until disease progression. Thirty-one patients were enrolled, 12 patients were exclusively treated with thalidomide in combination with VED and 19 patients additionally received high-dose melphalan, for consolidation. Adverse events and response to therapy were assessed prior to treatment with high-dose chemotherapy. Response to thalidomide combined with VED was complete remission in six patients (19%), partial remission in 19 patients (61%), stable disease in five patients (16%), and progressive disease in one patient (3.2%). Grade 3 and 4 adverse events consisted of leukocytopenia in 10 patients (32%), and thrombocytopenia and anemia in one patient each (3.2%). Neutropenic infections grade 3 and 4 occurred in seven (23%) and three patients (9.7%), respectively, including two patients (6.5%) who died from septic shock. Deep vein thrombosis occurred in eight patients (26%), constipation in 20 patients (65%), and polyneuropathy in 20 patients (65%). The probability of event-free survival and overall survival in the whole group of patients at 36 months were 26 and 62%, respectively. In conclusion, the combination of thalidomide with VED appears to be highly effective in previously untreated patients with multiple myeloma, but it is associated with a high rate of thrombotic events, polyneuropathy, and neutropenic infections. [ABSTRACT FROM AUTHOR]

Summary:The purpose of this prospective trial was to study a combined-modality treatment including local consolidation by surgery or radiotherapy and high-dose chemotherapy (HDC) followed by peripheral-blood stem-cell (PBSC) transplantation. In all, 48 patients with oligometastatic breast cancer amenable to local treatment after induction chemotherapy with epirubicin and cyclophosphamide or paclitaxel and cisplatin, depending on prior adjuvant chemotherapy, were enrolled. The median follow-up was 41 months (range, 7-85 months). PBSC were collected in 47 patients, and 40 received one or two courses of HDC. Local therapy was given in 37 patients. No treatment-related deaths occurred. Of 47 evaluable patients, 36 (75%of intention-to-treat population) had no evidence of disease or complete remission after completion of therapy. Six patients (12.5%) had partial response, two patients (4%) no change, and three patients (6%) progressive disease. The median time to progression and overall survival was 17.5 (95%confidence interval (CI), 14-21 months) and 42.2 months (95%CI, 33-52 months), respectively, and 27%of patients were progression free after 5 years. In conclusion, patients with oligometastatic breast cancer can be treated safely with this combined modality protocol with promising relapse-free survivals.Bone Marrow Transplantation (2004) 34, 637-643. doi:10.1038/sj.bmt.1704613 Published online 9 August 2004 [ABSTRACT FROM AUTHOR]

Summary:We retrospectively analyzed the outcome of 67 patients with breast (n=24), ovarian (n=11) or testicular cancer (n=32) treated for relapse after high-dose chemotherapy (HDC) and peripheral blood stem cell (PBSC) transplantation. Treatment, survival and toxicity were analyzed. Patients with breast, ovarian or testicular cancer received a mean of 5.9 (range 1-24), 5.1 (1-13) and 4.6 (1-13) regimens for relapse after HDC. Overall response at the end of the observation period was 20.8% for patients with breast cancer (three complete (CR) and two partial responses (PR)), 45.5% (one CR, four PR) for ovarian and 9.4% (three PR) for testicular cancer patients. The mean overall-survival (OAS) from first relapse was 28 (range 3-44), 17 (2-24) and 10 (1-28) months, respectively. Leukocytopenia grade 3/4 occurred in 27-63% of patients, and thrombocytopenia grade 3/4 was observed in 58-88%, respectively. Nonhematological grade 3/4 toxicities were below 20%. In conclusion, patients with relapse after HDC usually have a poor outcome but long-term survivors are observed. Hematological toxicity is common, while other severe side effects are less frequent.Bone Marrow Transplantation (2003) 31, 995-1000. doi:10.1038/sj.bmt.1704047 [ABSTRACT FROM AUTHOR]

Summary:We report three patients with relapsed ovarian cancer who developed femoral head necrosis requiring endoprosthetic hip surgery 16-35 months after high-dose chemotherapy (HDC) with treosulfan (47 and 56?g/m2 body-surface area (BSA)) given as 3-25?h infusions and followed by autologous peripheral blood stem cell (PBSC) transplantation. One woman received two courses of single agent treosulfan while the other two patients received one course of high-dose treosulfan either preceded or followed by high-dose carboplatin, etoposide and cyclophosphamide. A total of 30 women with ovarian cancer were treated with HDC at our unit and 21 of them received treosulfan-containing regimens. Femoral head necrosis was not observed in patients either receiving conditioning regimens without treosulfan (n=9) or when the total treosulfan dose was given over 3 consecutive days (n=3) or in patients with a diagnosis other than ovarian cancer and treated with high-dose treosulfan (n=10). We conclude that women with relapsed ovarian cancer receiving HDC with excessive single-dose treosulfan might be at an increased risk of developing bone necrosis.Bone Marrow Transplantation (2003) 31, 487-491. doi:10.1038/sj.bmt.1703886 [ABSTRACT FROM AUTHOR]

The purpose of this investigation was to study thrombopoietin (TPO) and Flt3 ligand (FL) serum levels in the course of peripheral blood stem cell (PBSC) mobilization and high-dose chemotherapy (HDC) and to correlate the values with stem cell yield and engraftment. Thirty-nine patients were included. PBSC were mobilized by chemotherapy followed by two body surface area-dependent doses of glycosylated recombinant human granulocyte colony-stimulating factor (rhu-G-CSF, lenograstim). PBSC could be harvested in 35 patients and 30 received a total of 62 courses of HDC (1–3 per patient). Fifty-six were analyzed and TPO and FL serum levels were measured at the start of PBSC mobilization, at the first PBSC collection, on the day of PBSC infusion, and until engraftment. Mean baseline TPO and FL serum levels were 173 pg/ml and 192 pg/ml and increased to 493 and 323 pg/ml at the start of PBSC collection. Maximum values were 2279 pg/ml TPO after HDC 1 and 2375 pg/ml after HDC 2, while the mean maximum serum levels for FL were 1181 and 1236 pg/ml after HDC 1 and 2 and PBSC transfusion, respectively. FL serum levels at the start of PBSC mobilization correlated with the total yield of CD34+ cells (17.61±18.8×106/kg body weight, r=0.81), while TPO serum levels on days 11–13 after PBSC infusion were inversely correlated with the amount of transfused CD34+61+62+ cells (r=–0.88 and –0.79 for HDC 1 and 2). There was no strong correlation between TPO or FL serum levels and WBC and platelet engraftment. In conclusion, chemotherapy followed by glycosylated rhu-G-CSF induced elevated serum levels of TPO and to a lower degree of FL at the start of PBSC collection. The maximum increase was 13.7-fold for TPO and 6.4-fold for FL after PBSC infusion indicating endogenous release which should be considered if the clinical use of these cytokines is intended in this setting. [ABSTRACT FROM AUTHOR]