In comparison with a single ASCT as up-front therapy for newly diagnosed MM, double ASCT effected superior CR or nCR rate, RFS, and EFS, but failed to significantly prolong overall survival. Benefits offered by double ASCT were particularly evident among patients who failed at least nCR after one autotransplantation.
Deep vein thrombosis of upper limb is a common complication of CVC in patients with cancer. In these patients the risk factors for CVC-related thrombosis are not completely defined. The purpose of this study was to identify the risk factors for CVC-related thrombosis in patients included in a randomized, double-blind, placebo-controlled study aimed at assessing the efficacy and safety of enoxaparin for the prophylaxis of CVC-related thrombosis. CVC-related thrombosis was screened by mandatory venography after 6 weeks of study treatment. A number of patient baseline characteristics were assessed as potential risk factors for CVC-related deep vein thrombosis. Crude associations between risk factors and clinical outcomes were assessed by chi(2) test or Fisher's exact test. Multiple logistic regression analysis was used to identify independent risk factors. A CVC-related thrombosis was found in 50 out of 310 patients (16.1%). At multiple logistic regression analysis, CVC tip misplaced in the upper half of superior vena cava (OR 4.05, 95%CI 1.64-10.02), left-sided CVC insertion (OR 2.29, 95%CI 1.01-5.51) and chest radiotherapy (OR 7.01, 95%CI 1.42-34.66) were independent risk factors for thrombosis. In addition to these risk factors, the presence of distant metastases (OR 9.36, 95%CI 1.53-57.05) increased the risk of thrombosis in patients who received placebo. An inadequate position of the CVC tip, left-sided CVC insertion and chest radiotherapy are independent risk factors for CVC-related thrombosis in cancer patients. Patients with distant metastases have an increased risk for thrombosis in absence of antithrombotic prophylaxis.
BackgroundA central venous catheter (CVC) currently represents the most frequently adopted intravenous line for patients undergoing infusional chemotherapy and/or high-dose chemotherapy with hematopoietic stem-cell transplantation and parenteral nutrition.CVC insertion represents a risk for pneumothorax, nerve or arterial punctures. The aim of this prospective observational study was to explore the safety and efficacy of CVC insertion under ultrasound (US) guidance and to confirm its utility in clinical practice in cancer patients.MethodsConsecutive adult patients attending the oncology-hematology department were eligible if they had solid or hematologic malignancies and required CVC insertion. Four types of possible complication were defined a priore: mechanical, thrombotic, infection and malfunctioning.The patient was placed in Trendelenburg's position, a 7.5 MHZ puncturing US probe was placed in the supraclavicular site and a 16-gauge needle was advanced under real-time US guidance into the last portion of internal jugular vein. The Seldinger technique was used to place the catheter, which was advanced into the superior vena cava until insertion into right atrium. Within two hours after each procedure, an upright chest X-ray and ultrasound scanning were carried out to confirm the CVC position and to rule out a pneumotorax. CVC-related infections, symptomatic vein thrombosis and malfunctioning were recorded.ResultsFrom December 2000 to January 2009, 1,978 CVC insertional procedures were applied to 1,660 consecutive patients. The procedure was performed 580 times in patients with hematologic malignancies and 1,398 times those with solid tumors. A single-needle puncture of the vein was performed on 1,948 of 1,978 procedures (98.48%); only eighteen attempts among 1,978 failed (0.9%).No pneumotorax, no major bleeding, and no nerve puncture were reported; four cases (0.2%) showed self-limiting hematomas. The mean lifespan of CVC was 189.7 +/- 18.6 days (range 7-701). Symptomatic deep-vein thrombosis of the upper limbs developed in 48 patients (2.42%). Catheter-related infections occurred in 197 (9.96%) of the catheters inserted. They were successfully treated with antibiotics and only in 48 (2.9%) patients definitive CVC removal was required for infection and/or thrombosis or malfunctioning.ConclusionsThis study represents the largest published series of consecutive patients with cancer undergoing CVC insertion under US guidance; this procedure allowed the completion of the therapeutic program for 1,930/1,978 (97.6%) of the catheters inserted. The absence of pneumotorax and other major complications indicates that US guidance should be mandatory for CVC insertion in patients with cancer.
A subanalysis of the GIMEMA-MMY-3006 trial was performed to characterize treatment-emergent peripheral neuropathy (PN) in patients randomized to thalidomide-dexamethasone (TD) or bortezomib-TD (VTD) before and after double autologous transplantation (ASCT) for multiple myeloma (MM). A total of 236 patients randomized to VTD and 238 to TD were stratified according to the emergence of grade 2 PN. Gene expression profiles (GEP) of CD1381 plasma cells were analyzed in 120 VTD-treated patients. The incidence of grade 2 PN was 35% in the VTD arm and 10% in the TD arm (P < 0.001). PN resolved in 88 and 95% of patients in VTD and TD groups, respectively. Rates of complete/near complete response, progression-free and overall survival were not adversely affected by emergence of grade 2 PN. Baseline characteristics were not risk factors for PN, while GEP analysis revealed the deregulated expression of genes implicated in cytoskeleton rearrangement, neurogenesis, and axonal guidance. In conclusion, in comparison with TD, incorporation of VTD into ASCT was associated with a higher incidence of PN which, however, was reversible in most of the patients and did not adversely affect their outcomes nor their ability to subsequently receive ASCT. GEP analysis suggests an interaction between myeloma genetic profiles and development of VTDinduced PN.
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