Broad scale sampling methods for microplastic monitoring in the open ocean waters remain a challenge in oceanography. A large number of samples is required to understand the distribution, abundance ...and fate of microplastic particles in the environment. Despite more than a decade of widespread study, there is currently no established time series of microplastic measurements and the research community is yet to establish a standardised set of methods that will allow data to be collected in a quick, affordable and interoperable way. We present a sampling technique involving the connection of a custom-built microplastic sampling device to the pump-underway ship intake system of a research vessel (RV) as an unexploited opportunity for oceanic monitoring needs concerning microplastic abundance and distribution. The method is cost effective, highly versatile and accurate, and is able to sample particles down to 50μm from opportunity platforms, thus contributing to an emerging area of study, and in particular helping to increase the monitoring reporting of data, and thereby serving as a valuable aid for the implementation of the Marine Strategy Framework Directive (MSFD). Sampling was performed during three consecutive oceanographic cruises in the subtropical NE Atlantic over a year, sampling subsurface waters (4 m depth) during navigation and while on coastal and oceanic stations. Microplastic particles were found in all stations and transects sampled. Fibres (64.42%) were predominant over fragments (35.58%), with the concentration values falling within the ranges of data reported for other areas of the Atlantic.
Summary Background Mantle-cell lymphoma is an aggressive B-cell lymphoma with a poor prognosis. Both ibrutinib and temsirolimus have shown single-agent activity in patients with relapsed or ...refractory mantle-cell lymphoma. We undertook a phase 3 study to assess the efficacy and safety of ibrutinib versus temsirolimus in relapsed or refractory mantle-cell lymphoma. Methods This randomised, open-label, multicentre, phase 3 clinical trial enrolled patients with relapsed or refractory mantle-cell lymphoma confirmed by central pathology in 21 countries who had received one or more rituximab-containing treatments. Patients were stratified by previous therapy and simplified mantle-cell lymphoma international prognostic index score, and were randomly assigned with a computer-generated randomisation schedule to receive daily oral ibrutinib 560 mg or intravenous temsirolimus (175 mg on days 1, 8, and 15 of cycle 1; 75 mg on days 1, 8, and 15 of subsequent 21-day cycles). Randomisation was balanced by using randomly permuted blocks. The primary efficacy endpoint was progression-free survival assessed by a masked independent review committee with the primary hypothesis that ibrutinib compared with temsirolimus significantly improves progression-free survival. The analysis followed the intention-to-treat principle. The trial is ongoing and is registered with ClinicalTrials.gov (number NCT01646021 ) and with the EU Clinical Trials Register, EudraCT (number 2012-000601-74). Findings Between Dec 10, 2012, and Nov 26, 2013, 280 patients were randomised to ibrutinib (n=139) or temsirolimus (n=141). Primary efficacy analysis showed significant improvement in progression-free survival (p<0·0001) for patients treated with ibrutinib versus temsirolimus (hazard ratio 0·43 95% CI 0·32–0·58; median progression-free survival 14·6 months 95% CI 10·4–not estimable vs 6·2 months 4·2–7·9, respectively). Ibrutinib was better tolerated than temsirolimus, with grade 3 or higher treatment-emergent adverse events reported for 94 (68%) versus 121 (87%) patients, and fewer discontinuations of study medication due to adverse events for ibrutinib versus temsirolimus (9 6% vs 36 26%). Interpretation Ibrutinib treatment resulted in significant improvement in progression-free survival and better tolerability versus temsirolimus in patients with relapsed or refractory mantle-cell lymphoma. These data lend further support to the positive benefit–risk ratio for ibrutinib in relapsed or refractory mantle-cell lymphoma. Funding Janssen Research & Development, LLC.
Romidepsin is a structurally unique, potent class 1 selective histone deacetylase inhibitor. The primary objective of this international, pivotal, single-arm, phase II trial was to confirm the ...efficacy of romidepsin in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
Patients who were refractory to at least one prior systemic therapy or for whom at least one prior systemic therapy failed received romidepsin at 14 mg/m(2) as a 4-hour intravenous infusion on days 1, 8, and 15 every 28 days. The primary end point was the rate of complete response/unconfirmed complete response (CR/CRu) as assessed by an independent review committee.
Of the 131 patients enrolled, 130 had histologically confirmed PTCL by central review. The median number of prior systemic therapies was two (range, one to eight). The objective response rate was 25% (33 of 130), including 15% (19 of 130) with CR/CRu. Patient characteristics, prior stem-cell transplantation, number or type of prior therapies, or response to last prior therapy did not have an impact on response rate. The median duration of response was 17 months, with the longest response ongoing at 34+ months. Of the 19 patients who achieved CR/CRu, 17 (89%) had not experienced disease progression at a median follow-up of 13.4 months. The most common grade ≥ 3 adverse events were thrombocytopenia (24%), neutropenia (20%), and infections (all types, 19%).
Single-agent romidepsin induced complete and durable responses with manageable toxicity in patients with relapsed or refractory PTCL across all major PTCL subtypes, regardless of the number or type of prior therapies. Results led to US Food and Drug Administration approval of romidepsin in this indication.
Manta nets are commonly used for microplastics sampling although a number of limitations have emerged. In this study we compare the manta net to an innovative microplastic sampler, referred to as ...MuMi, registered as utility model. The results highlight the large variability that can exist in the outcomes of the different studies due to the lack of harmonization between methods and the differing factors such as sampling mesh size, representativeness or reproducibility of the sampling volumes. Control over the filtered volume is an issue to be improved in trawl sampling methods, while in the MuMi sampler the control over the sampling depth could be improved. Still, MuMi represents a highly advantageous sampling system in terms of ease of operation, lower cost, smaller microplastics target size and greater precision, all while maintaining the representativeness of the collected samples.
•Comparison of the Manta net Vs a filtering device (MuMi) for microplastic sampling.•The abundance of microplastics varies up to two orders of magnitude.•The microplastic sampler measures accurately the filtered volume.•Reduced risk of contamination, and sample processing time are MuMi's advantages.•MuMi's 50 μm mesh contributed up to 64 % of the total microplastics collected.
Behavioral activation (BA) and acceptance and commitment therapy (ACT) are considered particularly useful treatments when dealing with emotional problems of cancer survivors. The efficacy of these ...two treatments, applied on a group basis, were evaluated and compared.
An analysis was carried out of pre-post treatment changes in the emotional state and patterns of activation/avoidance of 52 cancer patients, with anxiety and/or depression, randomly assigned to three groups (BA/ACT/waiting list control).
Both therapies were superior to no treatment in all the variables evaluated. Significant differences were found between the two treatments in favor of ACT in social impairment and avoidance/rumination.
BA and ACT, applied on a group basis, are efficacious in the treatment of those emotional difficulties most prevalent in cancer survivors. Results suggest that activation and avoidance are the mechanisms responsible for the changes.
Summary Background Patients with follicular lymphoma can have long survival times, but disease progression typically occurs 3–5 years after initial treatment. We assessed the potential benefit of 2 ...years of rituximab maintenance after first-line treatment in patients with follicular lymphoma receiving a rituximab plus chemotherapy regimen. Methods The randomised, open-label PRIMA study was undertaken in 223 centres in 25 countries. 1217 patients with previously untreated follicular lymphoma needing systemic therapy received one of three non-randomised immunochemotherapy induction regimens used in routine practice. 1019 patients achieving a complete or partial response were then randomly assigned to receive 2 years of rituximab maintenance therapy (375 mg/m2 every 8 weeks) or observation. Treatment was assigned equally by centralised block randomisation, stratified by induction regimen, response, region, and centre. Neither the participants nor those giving the interventions, assessing outcomes, and analysing data were masked to group assignments. The primary endpoint was progression-free survival (PFS). Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov , number NCT00140582. Findings 505 patients were assigned to rituximab maintenance and 513 to observation (one patient died during randomisation). With a median follow-up of 36 months (IQR 30–42), PFS was 74·9% (95% CI 70·9–78·9) in the rituximab maintenance group (130 patients progressed) and 57·6% (53·2–62·0) in the observation group (218 progressed; hazard ratio HR 0·55, 95% CI 0·44–0·68, p<0·0001). 2 years after randomisation, 361 patients (71·5%) in the rituximab maintenance group were in complete or unconfirmed complete response versus 268 (52·2%) in the observation group (p=0·0001). Overall survival did not differ significantly between groups (HR 0·87, 95% CI 0·51–1·47). Grade 3 and 4 adverse events were recorded in 121 patients (24%) in the rituximab maintenance group and 84 (17%) in the observation group (risk ratio 1·46, 95% CI 1·14–1·87; p=0·0026). Infections (grades 2–4) were the most common adverse event, occurring in 197 (39%) and 123 (24%) patients, respectively (risk ratio 1·62, 95% CI 1·35–1·96; p<0·0001). Interpretation 2 years of rituximab maintenance therapy after immunochemotherapy as first-line treatment for follicular lymphoma significantly improves PFS. Funding Groupe d'Etude des Lymphomes de l'Adulte (GELA) and F Hoffmann-La Roche.
We designed a phase 1-2 study to evaluate the safety and the efficacy of increasing doses of bendamustine (160 mg/m2, 180 mg/m2, and 200 mg/m2 given on days −7 and −6) coupled with fixed doses of ...etoposide, cytarabine, and melphalan (BeEAM regimen) as the conditioning regimen to autologous stem cell transplantation for resistant/relapsed lymphoma patients. Forty-three patients (median age, 47 years) with non-Hodgkin (n = 28) or Hodgkin (n = 15) lymphoma were consecutively treated. Nine patients entered the phase 1 study; no patients experienced a dose-limiting toxicity. Thirty-four additional patients were then treated in the phase 2. A median number of 6 × 106 CD34+ cells/kg (range, 2.4-15.5) were reinfused. All patients engrafted, with a median time to absolute neutrophil count > 0.5 × 109/L of 10 days. The 100-day transplantation-related mortality was 0%. After a median follow-up of 18 months, 35 of 43 patients (81%) are in complete remission, whereas 6 of 43 relapsed and 2 of 43 did not respond. Disease type (non-Hodgkin lymphomas vs Hodgkin disease) and disease status at transplantation (chemosensitive vs chemoresistant) significantly influenced DFS (P = .01; P = .007). Remarkably, 4 of 43 (9%) patients achieved the first complete remission after receiving the high-dose therapy with autologous stem cell transplantation. In conclusion, the new BeEAM regimen is safe and effective for heavily pretreated lymphoma patients. The study was registered at European Medicines Agency (EudraCT number 2008-002736-15).
Abstract
Background
Human papillomavirus (HPV) is one of the most common sexually transmitted infections and can be prevented by vaccination. The purpose of this study is to gain a better ...understanding, by analysing interview responses of adolescents and parents, of how adolescent sexual behaviour is approached in families, how widespread knowledge about HPV is in Andalusia, the autonomous region with the lowest vaccination rate in Spain, as well as to learn more about the interviewees’ position regarding vaccination.
Methods
A qualitative study by means of 15 focus groups of adolescents (
N
= 137, aged 14–17 years) and five focus groups of parents with children of those ages (
N
= 37) was conducted in the provinces of Granada, Seville and Jaén (Andalusia, Spain). The audio data were transcribed verbatim, coded and analysed thematically using NVIVO-10 software.
Results
There were three major results: (1) There is a lack of communication between adolescents and parents regarding sexual behaviour; (2) In both groups, scarce knowledge about HPV and vaccination was found; (3) Parents mistrust vaccination due to a lack of qualified and verified information about its benefits.
Conclusions
Healthy adolescent sexual behaviour is aided by communication within the family. Families need more information based on the evidence about HPV and vaccination. Health professionals are a key element in this process.
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