Summary:superior to G-CSF alone based on mean CD34 ؉ cell yield per pheresis, adequate CD34 ؉ cell collections can be achieved with G-CSF alone in most MM patients The best method for peripheral blood progenitor cell (PBPC) mobilization in patients with multiple myeloma with less toxicity and with simplification of the procedure. (MM) remains controversial. We report the results of two different methods of PBPC collection for autologous Keywords: multiple myeloma; PBPC mobilization; GM-CSF; G-CSF transplantation in 40 patients with stage II or III MM. In group I (n = 18), HD-CY, 4 g/m 2 i.v., was administered followed by GM-CSF, 8 g/kg/day s.c., until the end of collection, starting the leukaphereses after hemaPeripheral blood progenitor cells (PBPC) are increasingly tological recovery (Ͼ1 × 10 9 /l WBC). In group II used for hemopoietic autologous rescue afer high-dose ther-(n = 22), G-CSF, 10 g/kg/day s.c., was used alone until apy (HDT) in multiple myeloma (MM). 1-7 The use of perthe last day of collection, starting consecutive aphereses ipheral blood as the source of hematopoietic stem cells has on the 5th day. A minimum of two aphereses were perreplaced the bone marrow due to the rapidity of the formed to collect at least 2 × 10 6 /kg CD34 + cells. Both engraftment and the difficulties in harvesting bone marrow patient groups were comparable for age, sex and clinical cells in most MM patients due to osteoporosis or to preprognostic features as well as previous therapies. In vious irradiation. Another potential advantage for the use group I, the median yields per pheresis were: MNC 1. 47 of PBPC is the lower percentage of tumor cell contami-(1.38-2.32) × 10 8 /kg, CFU-GM 0.82 (0.18-13.2) × 10 4 /kg nation when compared with bone marrow, as recently conand CD34 + cells 1.98 (0.96-6.96) × 10 6 /kg. In group II firmed by molecular methods, 8 although this point is conthese results were: MNC 2.44 (2.06-3.6 × 10 8 /kg) troversial because several recent reports have suggested that (P = 0.03), CFU-GM 0.75 (0.16-7.8) × 10 4 /kg and CD34 + plasma cells may be recruited into the peripheral blood after 1.05 (0.32-3.4) × 10 6 /kg (P = 0.02). The median number mobilizing therapy. 9,10 HDT followed by autologous PBPC of aphereses performed in each group was 5 (4-12) with in MM may induce about 40-60% of complete responses a median of 5.24 ± 2.51 in group I and 3 (2-6) with a in previously untreated patients or in first partial response median of 3.1 (±0.91) in group II (P = NS). Hospitalizafter current induction chemotherapy 1-7,11-13 and some ation for PBPC mobilization was required in all patients investigators have found an advantage regarding response in group I and the treatment-related toxicity was rate, duration of response and progression-free survival greater in this group: 12 patients (66%) developed fever when compared with conventional treatment. 11,12 requiring antibiotics during the neutropenic periodIn spite of the expansion of this strategy, the optimum after HD-CY and six (33%) patients required transsche...

This study illustrates the usability and examines the reliability of the WSP tool as a method for signal detection in electronic health records. When the events are uncommon the success of this method may depend on the reporting time accurately reflecting the true event onset time. The study has shown that further work is required to define the censoring periods. The addition of a control group is not required but may enhance causal inference by showing that other causes than the exposure may lead to a signal.

dard chemotherapy have a median survival ranging from Among the 248 patients evaluable for response 125 24 to 36 months with less than 5% of patients surviving at (51%) had a CR and 100 had a PR (40%). The median 10 years. 1-3 The response rates to most conventional duration of progression-free survival (PFS) and overall chemotherapy regimens are usually between 40 and 60%, survival (OS) after transplantation was 23 and 35and only 5 to 10% of these responses consist of complete months, respectively. Univariate analysis showed that remissions (CR).

Patients from groups BA and BB presented with a significantly higher number of adverse prognostic factors, reflecting that we were dealing with high tumor MM cases, as compared with patients from group AA. The number of mononuclear cells, CD34+ cells and CFU-GM cells collected in patients with non-reversible renal insufficiency was similar to those harvested in MM patients with normal renal function. Moreover, neutrophil and platelet engraftments were identical in patients with and without renal failure (days +11 and +12, respectively). By contrast, transplant-related mortality (TRM) was significantly higher in group BB patients (29%) than in groups BA (4.1%) and AA (3.3%). In multivariate analysis only three variables showed independent influence on TRM: poor performance status (ECOG 3), hemoglobin <9.5 g/dl and serum creatinine > or =5 mg/dl. The response to high dose therapy was independent of renal function. Interestingly, 43% of patients from group BB showed an improvement in renal function (creatinine < 2 mg/dl) after transplant. The three-year overall survival from transplantation was 56, 49 and 61% for the BB, BA and AA groups, respectively, with a statistically significant difference favoring group AA (P<0.01). PFS did not differ significantly between the three groups of patients. In multivariate analysis the only unfavorable independent prognostic factors for overall survival were poor performance status either at diagnosis or at transplant, high beta(2)-microglobulin levels, and no response to transplant. According to these results, ASCT is an attractive alternative for MM patients with renal insufficiency, and it should not constitute a criterion for exclusion from transplant unless patients display poor performance status and very high creatinine levels (>5 mg/dl).

No abstract