Diagnostic accuracy of metabolic evaluation in RCSF increases both with the number of urines collected and the time passing after a stone event. Urines collected at weekends differ from those of the week only by their lower volumes. Abnormalities of RF for calcium nephrolithiasis can be detected in 85.3% of RCSF, and HC is the most common RF both in male and female RCSF.
BackgroundAdding bevacizumab to chemotherapy improves response rates and progression-free survival (PFS) in metastatic breast cancer (mBC). We aimed to demonstrate decreased toxicity with metronomic chemotherapy/bevacizumab compared with paclitaxel/bevacizumab.MethodsThis multicenter, randomized phase III trial compared bevacizumab with either paclitaxel (arm A) or daily oral capecitabine-cyclophosphamide (arm B) as first-line treatment in patients with HER2-negative advanced breast cancer. The primary endpoint was the incidence of selected grade 3–5 adverse events (AE) including: febrile neutropenia, infection, sensory/motor neuropathy, and mucositis. Secondary endpoints included objective response rate, disease control rate, PFS, overall survival (OS), quality of life (QoL), and pharmacoeconomics. The study was registered prospectively with ClinicalTrials.gov, number NCT01131195 on May 25, 2010.ResultsBetween September 2010 and December 2012, 147 patients were included at 22 centers. The incidence of primary endpoint-defining AEs was similar in arm A (25 % [18/71]; 95 % CI 15–35 %) and arm B (24 % [16/68]; 95 % CI 13–34 %; P = 0.96). Objective response rates were 58 % (42/73; 95 % CI 0.46–0.69) and 50 % (37/74; 95 % CI 0.39–0.61) in arms A and B, respectively (P = 0.45). Median PFS was 10.3 months (95 % CI 8.7–11.3) in arm A and 8.5 months (95 % CI 6.5–11.9) in arm B (P = 0.90). Other secondary efficacy endpoints were not significantly different between study arms. The only statistically significant differences in QoL were less hair loss and less numbness in arm B. Treatment costs between the two arms were equivalent.ConclusionThis trial failed to meet its primary endpoint of a reduced rate of prespecified grade 3–5 AEs with metronomic bevacizumab, cyclophosphamide and capecitabine.Electronic supplementary materialThe online version of this article (doi:10.1186/s12885-016-2823-y) contains supplementary material, which is available to authorized users.
Abstracturines collected and the time passing after a stone event. Urines collected at weekends diÂer from those Background. Metabolic evaluation in recurrent idiopathic calcium renal stone-formers (RCSF ) was ana-of the week only by their lower volumes. Abnormalities of RF for calcium nephrolithiasis can be detected in lysed with respect to the following questions: (1 ) do three 24-h urines provide more diagnostic accuracy in 85.3% of RCSF, and HC is the most common RF both in male and female RCSF. the metabolic evaluation of RCSF than 1 or 2 urines?; ( 2) does time after stone event influence the diagnostic yield?; (3) is urine composition at weekends diÂerent Key words: hypercalciuria; hyperoxaluria; hypocitratufrom that at mid-week?; (4 ) what are the prevalences ria; idiopathic calcium nephrolithiasis; low urine of the most important risk factors (RF ) of idiopathic volume; metabolic evaluation calcium nephrolithiasis, i.e. low volume (LV ), hypercalciuria (HC ), hyperoxaluria ( HO), hyperuricosuria ( HU ), hypocitraturia (Hypo-Cit), and hypomagnesiuria ( Hypo-Mg)?; and (5 ) do male RCSF diÂer from Introduction females with respect to urinary RFs? Methods. Seventy-five RCSF (59 men, 16 women)Renal stone formation is a common disorder: up to collected three 24-h urines ( U1-3) while on free-choice 15% of the population will develop kidney stones over diet. To account for possible variations in lifestyle and a lifetime [1]. About 80% of all stones that are formed diet, U1 and U3 had to be collected midweek and U2 contain calcium, mainly in the form of calcium oxalate at a weekend.[2]. Since renal stone formation is the ultimate conResults. When considering all three urines together sequence of increased urinary supersaturation with ( U1+U2+U3 ), the number of RF abnormalities/ calcium salts and most therapeutic approaches focus patient was 2.8±0.1, higher than numbers of any on reducing supersaturation [3 ], metabolic evaluation combination of two urines or of any single urine (P= in clinical practice has primarily to consider risk factors 0.0001 for all comparisons). The number of RF abnorof increased urinary supersaturation. malities also rose with time after stone event, fromThe question whether all patients with nephrolithi-0.8±0.1 (range 0-4) in U1 to 1.1±0.1 (range 0-4) in asis, in particular those with a first renal colic, should U3 (P=0.011 vs U1). Whereas all other RF did not undergo thorough metabolic evaluation, has been change between collections, urine volume was lower in addressed by several authors. A meta-analysis of six U2 (1793±90 ml ) than in U1 ( 2071±97 ml, P=0.0001 large retrospective studies [4 ] concluded that, given vs U2) and U3 (1946±97 ml, P=0.046 vs U2). At the relatively low morbidity associated with a first least 1 abnormality was found in 85.3% of all RCSF, stone episode and the rather high risk of side-eÂects and multiple abnormalities occurred in 47%. The most with so-called specific therapy, single stone-formers frequent RF was HC ( 39%), followed by HO and LV should not un...
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