ABSTRACT
The Intergroupe Francophone du Myélome conducted a randomized trial to compare bortezomib-thalidomide-dexamethasone (VTD) with bortezomib-cyclophosphamide-dexamethasone (VCD) as induction before high-dose therapy and autologous stem cell transplantation (ASCT) in patients with newly diagnosed multiple myeloma. Overall, a total of 340 patients were centrally randomly assigned to receive VTD or VCD. After 4 cycles, on an intent-to-treat basis, 66.3% of the patients in the VTD arm achieved at least a very good partial response (primary end point) vs 56.2% in the VCD arm (P = .05). In addition, the overall response rate was significantly higher in the VTD arm (92.3% vs 83.4% in the VCD arm; P = .01). Hematologic toxicity was higher in the VCD arm, with significantly increased rates of grade 3 and 4 anemia, thrombocytopenia, and neutropenia. On the other hand, the rate of peripheral neuropathy (PN) was significantly higher in the VTD arm. With the exception of hematologic adverse events and PN, other grade 3 or 4 toxicities were rare, with no significant differences between the VTD and VCD arms. Our data support the preferential use of VTD rather than VCD in preparation for ASCT. This trial was registered at www.clinicaltrials.gov as #NCT01564537 and at EudraCT as #2013-003174-27.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Multiple Myeloma/drug therapy , Adult , Aged , Anemia/chemically induced , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Bortezomib/administration & dosage , Bortezomib/adverse effects , Cyclophosphamide/administration & dosage , Cyclophosphamide/adverse effects , Dexamethasone/administration & dosage , Dexamethasone/adverse effects , Female , Humans , Male , Middle Aged , Neutropenia/chemically induced , Prospective Studies , Thalidomide/administration & dosage , Thalidomide/adverse effects , Thrombocytopenia/chemically inducedABSTRACT
BACKGROUND: Duloxetine is effective in the management of stress urinary incontinence (SUI) in women but has been poorly evaluated in the treatment of SUI following radical prostatectomy (RP). OBJECTIVE: To establish the superiority of duloxetine over placebo in SUI after RP. DESIGN, SETTING, AND PARTICIPANTS: We conducted a prospective, randomised, placebo-controlled, double-blind, monocentric superiority trial. After a placebo run-in period of 2 wk, patients with SUI after RP were randomised to receive either 80mg of duloxetine daily or matching placebo for 3 mo. MEASUREMENTS: The primary outcome measure was the relative variation in incontinence episodes frequency (IEF) at the end of study compared to baseline. Secondary outcomes included quality of life (QoL) measures (Incontinence Impact Questionnaire Short Form [IIQ-SF], Urogenital Distress Inventory Short Form [UDI-SF], Incontinence Quality of Life [I-QoL]), symptom scores (Urinary Symptom Profile [USP] questionnaire, International Consultation on Incontinence/World Health Organisation Short Form questionnaire [ICIQ-SF], the Beck Depression Inventory [BDI-II] questionnaire), 1-h pad test, and assessment of adverse events. RESULTS AND LIMITATIONS: Thirty-one patients were randomised to either the treatment (n=16) or control group (n=15). Reduction in IEF was significant with duloxetine compared to placebo (mean±standard deviation [SD] variation: -52.2%±38.6 [range: -100 to +46] vs +19.0%±43.5 [range: -53 to +104]; mean difference: 71.2%; 95% confidence interval [CI] for the difference: 41.0-101.4; p<0.0001). IIQ-SF total score, UDI-SF total score, SUI subscore of the USP questionnaire, and question 3 of the ICIQ-SF questionnaire showed improvement in the duloxetine group (p=0.006, p=0.02, p=0.0004, and p=0.003, respectively). Both treatments were well tolerated throughout the study period. CONCLUSIONS: Duloxetine is effective in the treatment of incontinence symptoms and improves QoL in patients with SUI after RP.
Subject(s)
Adrenergic Uptake Inhibitors/therapeutic use , Prostatectomy/adverse effects , Selective Serotonin Reuptake Inhibitors/therapeutic use , Thiophenes/therapeutic use , Urinary Incontinence/prevention & control , Adrenergic Uptake Inhibitors/adverse effects , Aged , Aged, 80 and over , Chi-Square Distribution , Double-Blind Method , Duloxetine Hydrochloride , Humans , Male , Middle Aged , Paris , Pilot Projects , Placebo Effect , Prospective Studies , Quality of Life , Selective Serotonin Reuptake Inhibitors/adverse effects , Surveys and Questionnaires , Thiophenes/adverse effects , Time Factors , Treatment Outcome , Urinary Incontinence/etiologyABSTRACT
Numerous infectious agents may induce acute pancreatitis. We report 6 cases of Salmonella-associated acute pancreatitis. Pathogenesis of this type of pancreatitis is related to multiple factors that may coexist in the same patient. The typical clinical picture consists in epigastric pain, nausea, vomiting, diarrhoea and fever. Imaging techniques often disclose minimal changes such as moderate swelling of a part or of the totality of pancreas. As outcome is usually good, conservative treatment and antibiotics may be sufficient to ensure recovery.
