Long-term follow-up of lenalidomide in relapsed/refractory mantle cell lymphoma: subset analysis of the NHL-003 study.

BACKGROUND: Mantle cell lymphoma (MCL) is an uncommon type of non-Hodgkin lymphoma with poor overall prognosis, requiring the development of new therapies. Lenalidomide is an immunomodulatory agent demonstrating antitumor and antiproliferative effects in MCL. We report results from a long-term subset analysis of 57 patients with relapsed/refractory MCL from the NHL-003 phase II multicenter study of single-agent lenalidomide in patients with aggressive lymphoma DESIGN: Lenalidomide was administered orally 25 mg daily on days 1-21 every 28 days until progressive disease (PD) or intolerability. The primary end point was overall response rate (ORR). RESULTS: Fifty-seven patients with relapsed/refractory, advanced-stage MCL had a median of three prior therapies. The ORR was 35% [complete response (CR)/CR unconfirmed (CRu) 12%], with a median duration of response (DOR) of 16.3 months (not yet reached in patients with CR/CRu) by blinded independent central review. The median time to first response was 1.9 months. Median progression-free survival was 8.8 months, and overall survival had not yet been reached. The most common grade 3/4 adverse events (AEs) were neutropenia (46%), thrombocytopenia (30%), and anemia (13%). CONCLUSIONS: These results show the activity of lenalidomide in heavily pretreated, relapsed/refractory MCL. Responders had a durable response with manageable side-effects. Clinical trial number posted on www.clinicaltrials.gov NCT00413036

Thrombolysis using tissue plasminogen activator: Experience from a critical care setting

To describe the experience of thrombolysis using tissue plasminogen activator (tPA) in critically ill children admitted to the pediatric intensive care unit (PICU), retrospective review of medical records of all children (1 month–16 years), who were admitted in PICU since January 2014 to December 2017 and received systemic tPA for thrombolysis was done. Data was collected on a structured proforma and included thrombus location, tPA dose and duration, outcome (resolution, survival) and complications (bleeding). Total 9 patients (7 males, 2 females) received systemic tPA therapy for thrombolysis with mean age of 74.64 ± 69.58 months. Two patients had thrombus in femoral artery, 3 in IVC and 4 had intra-cardiac thrombosis. Median number of doses was 2 with a range of 1–5 doses. Complete resolution of the clot was noted in all except one patient. A standard starting dose of 0.01 mg/kg/h was used in all patients. Only one patient developed melena after TPA therapy which self-resolved. Systemic tPA therapy was very safe in pediatric critically ill patients and was effective for thrombolysis and did not show any adverse effects in children with varying underlying diagnosis

Review and “Vote Count” Analysis of OTL-Effect Studies

In the fourth chapter an overview is given of 51 primary studies, conducted during the last twenty years. Schematic summary descriptions are put together in a large summary table. Although quantitative meta-analysis of these studies was beyond the scope of this review study, some basic summary tables were produced to provide an overall orientation on how OTL had been researched and what can be concluded about its effectiveness. It is concluded that the vote count measure of OTL, (i.e. the percentage of effect sizes that were statistically significant and positive) established in this study, and which was 44 %, is of comparable size to other effectiveness enhancing conditions like achievement orientation, learning time and parental involvement, but dramatically higher than vote count measures for variables like cooperation and educational leadership. What should be considered is that vote counting is a rather crude procedure and that comparison of quantitative effect sizes is more informative