Purpose: Additional targeted therapeutics are needed for the treatment of lymphoma. Abexinostat is an oral pan-histone deacetylase inhibitor (HDACi) displaying potent activity in preclinical models. We conducted a multicenter phase I/II study (N ¼ 55) with single-agent abexinostat in relapsed/refractory lymphoma.Experimental Design: In phase I, 25 heavily pretreated patients with any lymphoma subtype received oral abexinostat ranging from 30 to 60 mg/m 2 twice daily 5 days/week for 3 weeks or 7 days/week given every other week. Phase II evaluated abexinostat at the maximum tolerated dose in 30 patients with relapsed/ refractory follicular lymphoma or mantle cell lymphoma.Results: The recommended phase II dose was 45 mg/m 2 twice daily (90 mg/m 2 total), 7 days/week given every other week. Of the 30 follicular lymphoma and mantle cell lymphoma patients enrolled in phase II, 25 (14 follicular lymphoma, 11 mantle cell lymphoma) were response-evaluable. Tumor size was reduced in 86% of follicular lymphoma patients with an investigatorassessed ORR of 64.3% for evaluable patients [intent-to-treat (ITT) ORR 56.3%]. Median duration of response was not reached, and median progression-free survival (PFS) was 20.5 months (1.2-22.3þ). Of responding follicular lymphoma patients, 89% were on study/drug >8 months. In mantle cell lymphoma, the ORR was 27.3% for evaluable patients (ITT ORR 21.4%), and median PFS was 3.9 months (range, 0.1-11.5). Grade 3-4 treatment-related adverse events (phase II) with !10% incidence were thrombocytopenia (20%), fatigue (16.7%), and neutropenia (13.3%) with rare QTc prolongation and no deaths.Conclusions: The pan-HDACi, abexinostat, was overall well tolerated and had significant clinical activity in follicular lymphoma, including highly durable responses in this multiply relapsed patient population.
Objectives To establish values of fetal left brachiocephalic vein (LBCV) dimensions during normal pregnancy and determine whether routine assessment of the LBCV may help in identifying fetuses with congenital abnormalities of this vessel. Methods
Duplex kidneys are one of the most common major congenital abnormalities of the urinary tract. The antenatal diagnosis of duplex kidney and its associated ureterocele is infrequent. We report on our experience with the prenatal diagnosis of duplex kidneys in seven fetuses over the past 24 months. In all fetuses, the sagittal length of the duplex kidney was above the 95th centile for gestational age. A 'cyst-like' structure in the upper pole of the duplex kidney and a ureterocele in the urinary bladder were present in all of the seven fetuses. An ipsilateral dilated ureter was seen in six of seven fetuses. Postnatal confirmation of renal duplication anomalies was obtained in all neonates. Increased familiarity of the prenatal sonographer with duplex kidney will allow for its antenatal diagnosis and thus early postnatal treatment.
Three-dimensional transvaginal sonography provides visualization and evaluation of the uterine cavity with similar or better accuracy than standard hysterosalpingography in the office setting, with lower cost and morbidity.
No abstract
To define the feasibility of assessing the right subcalavian artery (RSA) in 1 st and 2 nd trimester ultrasonographic assessment of routine population and the association of ARSA with chromosomal, cardiac and extracardiac anomalies. Methods: RSA was prospectively evaluated since July 2009 in all routine patients booked in our fetal medicine Unit. We included 11-14 weeks assessment, pre-invasive US evaluation in patients that declined 1 st trimester screening at booking and opted directly for fetal karyotyping due to maternal age ≥ 35 y and routine anomaly scan. All patients referred for increased NT, amniocentesis, cardiac or extracardiac abnormalities were excluded. Results: We have assessed 4068 routine patients, 3036 in the 1 st and 3152 in the 2 nd trimester; 2281 patients were assessed in both 1 st and 2 nd trimesters. RSA assessment was feasible in 2529 1 st trimester exams (83%). Feasibility in the first trimester was related to the CRL/BMI ratio. In the 2 nd trimester the feasibility was higher reaching 98%. The overall feasibility in our series was 91.1% (3709 feasible cases, considering both 1 st and 2 nd trimester evaluation). An ARSA was found in 49 fetuses (overall incidence 1.32% of the feasible cases) where 28 were detected in the 1 st and 19 in the 2 nd trimester. Nine of the 2 nd trimester ARSA have been misdiagnosed in the 1 st trimester assessment. Fetal echocardiography always confirmed the initial diagnosis, when an ARSA was detected in the screening scan (no false positive cases). Of the 49 ARSA, 39 were euploid with no other findings; the remaining 10 cases included 5 aneuploidies, 1 genetic syndrome, 1 22q11 microdeletion, 1 cardiac and 2 extracardiac abnormalities. Conclusions: The feasibility of RSA assessment in a routine population depends on gestational age and maternal BMI, with more than 80% feasible cases in the first trimester. A high rate of ARSA are associated with genetic or structural, abnormalities.
Oral poster abstracts 286 patients (74.8%) the three vessel flow and the ''V'' sign were imaged, the outflow tracts and the crossing of the great vessels in 294 cases (76.9%) and the aortic arch in 160 patients (41.8%). Our group included three cases with major cardiac anomalies, confirmed at 20 weeks scan, but suspected from the first trimester examination. The 20 minutes examination time was sufficient in all cases. The evaluation was limited by early gestational age, increased maternal abdominal adipose tissue or uterine pathology (leiomyomas and uterine scar) in which cases a transvaginal examination was helpful. Conclusions: Even though the diagnosis of cardiac anomaly was not made during the first trimester scan, it helped in selecting suspicious cases. The examination time is not significantly increased and the procedure was accessible to second level sonographers. OP28.05Early fetal echocardiography in daily routine practice M. Krapp, A. Ludwig, P. Kreiselmaier Center for Prenatal Medicine, Endokrinologikum Hamburg, Hamburg, GermanyObjectives: Fetal echocardiography is already part of a detailed ultrasound scan between 11 and 14 weeks of gestation. The objective of this study was, to examine which planes and malformations can be visualized under clinical conditions with a limited investigation time interval. Methods: In a retrospective study all fetuses with a crown-rump length between 45 and 84 mm were included. The fetal echocardiographies were carried out by one examiner (M.K.) using a Philips i.u.22 ultrasound devise with a 9-4 MHz transabdominal and a 7-4 MHz transvaginal probe. The examination was performed during the normal first trimester scan within a limit time interval of maximal 30 min. When possible, the 4-chamber view (CV),pulmonary veins, left and right ventricular outflow tract, 3-vessel view (3-VV) and the aortic arch were visualized by B-mode, color Doppler and power Doppler sonography. Results: 426 pregnancies were enrolled in the study. The 4 CV, pulmonary veins, left and right ventricular outflow tract, 3-VV and the aortic arch were visualized in 96%, 23%, 97%, 97%, 98% and 72% of cases, respectively. During that time interval eleven atrioventricular septal defects, three aortic stenosis, one absent pulmonary valve syndrome and one interrupted aortic arch were diagnosed. Conclusion: The standard planes of fetal echocardiography can be displayed in the first trimester even in clinical routine. High end ultrasound equipment with specially fitted settings enables us to visualize even pulmonary veins in almost a quarter of the cases. With further technical improvements fetal echocardiography may be established as standard examination during the first trimester. OP28.06Fetal cardiac axis in the first and early second trimester of pregnancy
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