@article{RiemerKrankeHelfetal.2021, author = {Riemer, Manuel and Kranke, Peter and Helf, Antonia and Mayer, Debora and Popp, Maria and Schlesinger, Tobias and Meybohm, Patrick and Weibel, Stephanie}, title = {Trial registration and selective outcome reporting in 585 clinical trials investigating drugs for prevention of postoperative nausea and vomiting}, series = {BMC Anesthesiology}, volume = {21}, journal = {BMC Anesthesiology}, doi = {10.1186/s12871-021-01464-w}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-265518}, year = {2021}, abstract = {Background: Selective outcome reporting in clinical trials introduces bias in the body of evidence distorting clinical decision making. Trial registration aims to prevent this bias and is suggested by the International Committee of Medical Journal Editors (ICMJE) since 2004. Methods: The 585 randomized controlled trials (RCTs) published between 1965 and 2017 that were included in a recently published Cochrane review on antiemetic drugs for prevention of postoperative nausea and vomiting were selected. In a retrospective study, we assessed trial registration and selective outcome reporting by comparing study publications with their registered protocols according to the 'Cochrane Risk of bias' assessment tool 1.0. Results: In the Cochrane review, the first study which referred to a registered trial protocol was published in 2004. Of all 585 trials included in the Cochrane review, 334 RCTs were published in 2004 or later, of which only 22\% (75/334) were registered. Among the registered trials, 36\% (27/75) were pro- and 64\% (48/75) were retrospectively registered. 41\% (11/27) of the prospectively registered trials were free of selective outcome reporting bias, 22\% (6/27) were incompletely registered and assessed as unclear risk, and 37\% (10/27) were assessed as high risk. Major outcome discrepancies between registered and published high risk trials were a change from the registered primary to a published secondary outcome (32\%), a new primary outcome (26\%), and different outcome assessment times (26\%). Among trials with high risk of selective outcome reporting 80\% favoured at least one statistically significant result. Registered trials were assessed more often as 'overall low risk of bias' compared to non-registered trials (64\% vs 28\%). Conclusions: In 2017, 13 years after the ICMJE declared prospective protocol registration a necessity for reliable clinical studies, the frequency and quality of trial registration in the field of PONV is very poor. Selective outcome reporting reduces trustworthiness in findings of clinical trials. Investigators and clinicians should be aware that only following a properly registered protocol and transparently reporting of predefined outcomes, regardless of the direction and significance of the result, will ultimately strengthen the body of evidence in the field of PONV research in the future.}, language = {en} } @article{LiebersDuellFitzgeraldetal.2021, author = {Liebers, Nora and Duell, Johannes and Fitzgerald, Donnacha and Kerkhoff, Andrea and Noerenberg, Daniel and Kaebisch, Eva and Acker, Fabian and Fuhrmann, Stephan and Leng, Corinna and Welslau, Manfred and Chemnitz, Jens and Middeke, Jan-Moritz and Weber, Thomas and Holtick, Udo and Trappe, Ralf and Pfannes, Roald and Liersch, Ruediger and Spoer, Christian and Fuxius, Stefan and Gebauer, Niklas and Caill{\´e}, L{\´e}andra and Geer, Thomas and Koenecke, Christian and Keller, Ulrich and Claus, Rainer and Mougiakakos, Dimitrios and Mayer, Stephanie and Huettmann, Andreas and Pott, Christiane and Trummer, Arne and Wulf, Gerald and Brunnberg, Uta and Bullinger, Lars and Hess, Georg and Mueller-Tidow, Carsten and Glass, Bertram and Lenz, Georg and Dreger, Peter and Dietrich, Sascha}, title = {Polatuzumab vedotin as a salvage and bridging treatment in relapsed or refractory large B-cell lymphomas}, series = {Blood Advances}, volume = {5}, journal = {Blood Advances}, doi = {10.1182/bloodadvances.2020004155}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-369173}, pages = {2707-2716}, year = {2021}, abstract = {The antibody-drug conjugate polatuzumab vedotin (pola) has recently been approved in combination with bendamustine and rituximab (pola-BR) for patients with refractory or relapsed (r/r) large B-cell lymphoma (LBCL). To investigate the efficacy of pola-BR in a real-world setting, we retrospectively analyzed 105 patients with LBCL who were treated in 26 German centers under the national compassionate use program. Fifty-four patients received pola as a salvage treatment and 51 patients were treated with pola with the intention to bridge to chimeric antigen receptor (CAR) T-cell therapy (n = 41) or allogeneic hematopoietic cell transplantation (n = 10). Notably, patients in the salvage and bridging cohort had received a median of 3 prior treatment lines. In the salvage cohort, the best overall response rate was 48.1\%. The 6-month progression-free survival and overall survival (OS) was 27.7\% and 49.6\%, respectively. In the bridging cohort, 51.2\% of patients could be successfully bridged with pola to the intended CAR T-cell therapy. The combination of pola bridging and successful CAR T-cell therapy resulted in a 6-month OS of 77.9\% calculated from pola initiation. Pola vedotin-rituximab without a chemotherapy backbone demonstrated encouraging overall response rates up to 40\%, highlighting both an appropriate alternative for patients unsuitable for chemotherapy and a new treatment option for bridging before leukapheresis in patients intended for CAR T-cell therapy. Furthermore, 7 of 12 patients with previous failure of CAR T-cell therapy responded to a pola-containing regimen. These findings suggest that pola may serve as effective salvage and bridging treatment of r/r LBCL patients.}, language = {en} }