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.
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