We present the results of a phase 2 study using thalidomide, dexamethasone, and pegylated liposomal doxorubicin (ThaDD) in the treatment of 50 patients older than 65 years with newly diagnosed multiple myeloma. Thalidomide 100 mg was administered orally at bedtime continuously, dexamethasone 40 mg was administered orally on days 1 to 4 and 9 to 12, and pegylated liposomal doxorubicin 40 mg/m 2 was administered intravenously on day 1 over the 28-day cycle. Response was assessed according to the EBMT criteria. Seventeen (34%) patients achieved CR, 7 (14%) nCR, 5 (10%) VGPR, 15 (30%) PR, and 5 (10%) MR, resulting in an ORR of 98%. Only 1 patient (2%) presented progressive disease. Time to progression (TTP), event-free survival (EFS), and overall survival (OS) projected at 3 years were 60%, 57%, and 74%, respectively, and these parameters were significantly higher in those patients achieving a response of at least VGPR versus those who did not. Grade 3 and 4 nonhematologic adverse events were constipation (10%), fatigue (6%), tremors (4%), mucositis (4%), and palmar-plantar erythrodysesthesia (2%). Grade 3 and 4 neutropenia occurred in 12% of patients. Grade 3 and 4 infections and thromboembolic accidents were observed in 22% and 14% of patients, respectively. In the treatment of elderly patients with newly diagnosed multiple myeloma, ThaDD is a very effective regimen with manageable toxicity.
Procalcitonin (PCT) is a a marker of bacterial infection. Its prognostic role in the critically-ill patient, however, is still object of debate. Aim of this study was to evaluate the capacity of admission PCT (apct) in assessing the prognosis of the critically-ill patient regardless the presence of bacterial infection. A single-cohort, single-center retrospective study was performed evaluating critically-ill patients admitted to a stepdown care unit. Age, sex, Simplified Acute Physiology Score II (SAPS-II), shock, troponin-I, aPCT, serum creatinine, cultures and clinical endpoints (in-hospital mortality or Intensive Care Unit (ICU) transfer) were collected. Time free from adverse event (TF-AE) was defined as the time between hospitalization and occurrence of one of the clinical endpoints, and calculated with Kaplan-Meier curves. We engineered a new predictive model (POCS) adopting aPCT, age and shock. We enrolled 1063 subjects: 450 reached the composite outcome of death or ICU transfer. aPCT was significantly higher in this group, where it predicted TF-AE both in septic and non-septic patients. aPCT and POCS showed a good prognostic performance in the whole sample, both in septic and non-septic patients. aPCT showed a good prognostic accuracy, adding informations on the rapidity of clinical deterioration. pocS model reached a performance similar to SApS-ii. Procalcitonin (PCT) is a pro-hormone of human calcitonin synthesized by the parafollicular C cells of the thyroid and involved in calcium homeostasis. PCT is produced in large quantities by different cell types in patients affected by bacterial infections 1. Several studies have shown low-to moderately-elevated PCT levels also among critically-ill patients without evidence of infection (trauma, major surgery, multi-organ failure and myocardial infarction) 2,3. Clinically, PCT represents a quantitative biomarker which is currently used to help predicting the probability of bacterial infections 4 and guide the duration of antibiotic therapy 5. PCT demonstrated not only a diagnostic, but also an elevated prognostic value in septic patients. A recent meta-analysis concluded that increased PCT concentrations and absence of PCT clearance were strongly associated with all-cause mortality in septic patients 6. Clinical and pathophysiological data suggest a role of PCT in prognostic evaluation of critically-ill patients regardless the presence of a bacterial infection 7 , but large and conclusive data are still lacking. Main objective of the present study was to assess the prognostic value of PCT, evaluated as a single assay at the admission (aPCT) within the first 12 hours, in critically-ill patients regardless of the presence of bacterial infection. We also engineered a new predictive model, named "Procalcitonin and Other Clinical Score" (POCS), adopting both clinical and laboratoristic variables (aPCT, age and shock), to improve the prediction of outcomes and compared its performances with other validated prognostic markers, as Troponin I (TnI) 8 and the Simplified ...
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