21 research outputs found

    Effect of sampling effort and sampling frequency on the composition of the planktonic crustacean assemblage: a case study of the river Danube

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    Although numerous studies have focused on the seasonal dynamics of riverine zooplankton, little is known about its short-term variation. In order to examine the effects of sampling frequency and sampling effort, microcrustacean samples were collected at daily intervals between 13 June and 21 July of 2007 in a parapotamal side arm of the river Danube, Hungary. Samples were also taken at biweekly intervals from November 2006 to May 2008. After presenting the community dynamics, the effect of sampling effort was evaluated with two different methods; the minimal sample size was also estimated. We introduced a single index (potential dynamic information loss; to determine the potential loss of information when sampling frequency is reduced. The formula was calculated for the total abundance, densities of the dominant taxa, adult/larva ratios of copepods and for two different diversity measures. Results suggest that abundances may experience notable fluctuations even within 1 week, as do diversities and adult/larva ratios

    Maintenance Rituximab Every 2 Months for 2 Years Is Effective and Well Tolerated In Patients with Follicular Lymphoma with Both Standard or Rapid Infusion: Updated Results From the Phase IIIb MAXIMA Study

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    Abstract Abstract 3945 Background: MAXIMA is a Phase IIIb study evaluating the safety of rituximab (Rituxan®, MabThera®) maintenance therapy given at either a standard infusion rate or as a rapid infusion in patients with treatment-naïve or previously treated follicular lymphoma (FL) responding to induction treatment. The study also aims at confirming the effectiveness of rituximab maintenance therapy with respect to improvement of progression-free survival and overall survival, and the rate of conversion from partial response (PR) to complete response/unconfirmed complete response (CR/CRu) whilst on maintenance. Data are described here at a median follow-up of 28.8 months. Methods: Patients from 211 centers in 24 countries who achieved a CR/CRu or PR following induction therapy with 8 cycles of a rituximab-containing regimen, received maintenance treatment with rituximab (375 mg/m2) every 2 months for a maximum of 2 years. Rituximab could be administered at a standard infusion rate (&gt;90 minutes) or as a rapid infusion (≤90 minutes), depending on the standard practice at each center. Results: A total of 545 patients responding to induction treatment were enrolled. Median age of the patients was 57 years (range 29–86), with 11.7% over 70 years. 395 (72.5%) patients were previously untreated. 381 (69.9%) patients entered the study in CR/CRu after induction and 164 (30.1%) in PR. Of the 381 patients with post-induction CR/CRu, 353 (92.7%) remained in CR/CRu during maintenance (progressive disease 7.1%; missing 0.3%). Of the 164 patients achieving PR during induction, 11 patients (6.7%) converted to CR/CRu during maintenance. The full course of maintenance therapy was completed by 407 patients (74.7%). For the 137 patients who did not complete rituximab maintenance, reasons for premature discontinuation were disease progression (58 patients), treatment toxicity which was low (16 patients), voluntary pt withdrawal (11 pts), death (5 pts) and other reasons (47 pts) accounted for the remainder. Rituximab maintenance every 2 months for 2 years was very well tolerated. In the safety population of 534 patients, a total of 52 infusion-related adverse events (AEs) occurred in 31 patients (5.8%), with hypotension (5 patients), pyrexia (3 patients), hypertension (3 patients), headaches (3 patients), insomnia (2 patients) and erythema (3 patients) being the most commonly reported side effects. No differences in infusion-related AEs were observed by infusion schedule, with AEs occurring with 0.9% of standard infusions and 0.5% of rapid infusions (Table).The majority of infusion-related AEs were Grade 1 (42/52). One infusion-related serious adverse event (SAE), a Grade 4 cerebrovascular accident, was reported. Other AEs were observed in 336 patients (62.9%), with the majority of these being Grade 1–2. Grade 3, 4 and 5 AEs occurred in 86 (16.1%), 30 (5.6%) and 9 patients (1.7%), respectively. Rituximab-related AEs were rare being reported in 57 patients (10.7%) and accounting for only 6.1% (105/1721) of all AEs. The most common rituximab-related AEs were infections, occurring in 22 patients (4.1%). Two Grade 5 rituximab-related AEs were reported; 1 liver disorder and 1 cerebral hemorrhage. A total of 141 SAEs occurred in 104 patients; of these, only 19 events in 15 patients were deemed to be related to rituximab. The most common rituximab-related AE was pneumonia with 3 events reported. Conclusions: Maintenance rituximab was well tolerated with little rituximab-related toxicity. Treatment was associated with few infusion-related AEs, and there was no apparent difference in tolerability when rituximab was administered as a standard or rapid infusion. This study provides additional support for the use of rituximab maintenance every 2 months for 2 years following rituximab-containing induction therapy for patients with newly diagnosed or previously treated FL. Disclosures: Foá: Roche: Membership on an entity's Board of Directors or advisory committees. Off Label Use: Rituximab is broadly approved for the treatment of FL however the specific use and therapeutic lines may represent some off-label use. van Hazel:Roche: Membership on an entity's Board of Directors or advisory committees. </jats:sec

    Maintenance with rituximab is safe and not associated with severe or uncommon infections in patients with follicular lymphoma: results from the phase IIIb MAXIMA study.

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    Previous randomized trials have demonstrated that rituximab maintenance (R-maintenance) can prolong time to progressive disease in patients with follicular lymphoma (FL). The phase IIIb MAXIMA study (NCT00430352) was a large prospective evaluation of R-maintenance in a daily care setting. The primary objective was safety. Secondary objectives included progression-free survival, overall survival, time to next lymphoma treatment, and partial response (PR) to complete response/unconfirmed (CR/CRu) conversion rate. Patients (n = 545) with first-line or relapsed FL who responded to 8 cycles of rituximab-based induction received R-maintenance every 2 months for 2 years. At study entry, 380 patients had CR or CRu, and 165 had PR. The median age was 57.0 years. The most common non-hematologic adverse events (AEs, excluding infusion-related reactions) were cough (9.9 % of patients), fatigue (7.5 %), nasopharyngitis (7.1 %), back pain (6.5 %), diarrhea (6.9 %), arthralgia (6.0 %), headache and hypertension (5.2 % each), and pyrexia (5.1 %). The majority of AEs were grade 1 or 2. Grade 3, 4, and 5 infections occurred in 21 (3.9 %), 2 (0.4 %), and 1 (0.2 %) patient, respectively. Fifty-one hematologic AEs occurred in 6.6 % (n = 35) of patients. Grade 3/4 prolonged neutropenia and hypogammaglobulinemia occurred in 13 (2.4 %) and 5 (0.9 %) patients, respectively. All cases of prolonged neutropenia or hypogammaglobulinemia were manageable and resolved. Fast infusion did not alter the safety profile. Efficacy was comparable with results from previous trials. R-maintenance is safe in a daily care setting for patients with first-line or relapsed FL

    Maintenance with rituximab is safe and not associated with severe or uncommon infections in patients with follicular lymphoma: results from the phase IIIb MAXIMA study

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    Previous randomized trials have demonstrated that rituximab maintenance (R-maintenance) can prolong time to progressive disease in patients with follicular lymphoma (FL). The phase IIIb MAXIMA study (NCT00430352) was a large prospective evaluation of R-maintenance in a daily care setting. The primary objective was safety. Secondary objectives included progression-free survival, overall survival, time to next lymphoma treatment, and partial response (PR) to complete response/unconfirmed (CR/CRu) conversion rate. Patients (n = 545) with first-line or relapsed FL who responded to 8 cycles of rituximab-based induction received R-maintenance every 2 months for 2 years. At study entry, 380 patients had CR or CRu, and 165 had PR. The median age was 57.0 years. The most common non-hematologic adverse events (AEs, excluding infusion-related reactions) were cough (9.9 % of patients), fatigue (7.5 %), nasopharyngitis (7.1 %), back pain (6.5 %), diarrhea (6.9 %), arthralgia (6.0 %), headache and hypertension (5.2 % each), and pyrexia (5.1 %). The majority of AEs were grade 1 or 2. Grade 3, 4, and 5 infections occurred in 21 (3.9 %), 2 (0.4 %), and 1 (0.2 %) patient, respectively. Fifty-one hematologic AEs occurred in 6.6 % (n = 35) of patients. Grade 3/4 prolonged neutropenia and hypogammaglobulinemia occurred in 13 (2.4 %) and 5 (0.9 %) patients, respectively. All cases of prolonged neutropenia or hypogammaglobulinemia were manageable and resolved. Fast infusion did not alter the safety profile. Efficacy was comparable with results from previous trials. R-maintenance is safe in a daily care setting for patients with first-line or relapsed FL. © 2014 Springer-Verlag Berlin Heidelberg
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