R-CHOP with or without bevacizumab in patients with previously untreated diffuse large B-cell lymphoma: final MAIN study outcomes

Seymour, John F.; Pfreundschuh, Michael; Trněný, Marek; Sehn, Laurie H.; Catalano, John; Csinady, Eva; Moore, N.; Coiffier, Bertrand

doi:10.3324/haematol.2013.100818

Cited by 81 publications

(72 citation statements)

References 36 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…According to the inclusion criteria of each trial, patients were required to have adequate hepatic, renal and hematologic function. Underlying malignancies included colorectal cancer (11 trials) [14,[26][27][28][29][30][31][32][33][34][35], non-smallcell lung cancer (four trials) [36][37][38][39], breast cancer (nine trials) [40][41][42][43][44][45][46][47][48], gastric cancer (two trials) [49,50], renal-cell carcinoma (two trials) [51,52], ovarian cancer (four trials) [53][54][55][56], prostate cancer (one trial) [15], pancreatic cancer (one trial) [57], small-cell lung cancer (one trial) [58], melanoma (one trial) [59], malignant mesothelioma (one trial) [60], multiple myeloma (one trial) [61], glioblastoma (one trial) [62], lymphoma (one trial) [63] and cervical cancer (one trial) [64]. The quality of the 41 trials included was high: 20 trials had Jadad scores of 5.…”

Section: Search Resultsmentioning

confidence: 99%

Bevacizumab increases the risk of infections in cancer patients: A systematic review and pooled analysis of 41 randomized controlled trials

Zhang

et al. 2015

Critical Reviews in Oncology/Hematology

View full text Add to dashboard Cite

Section: Search Resultsmentioning

confidence: 99%

Bevacizumab increases the risk of infections in cancer patients: A systematic review and pooled analysis of 41 randomized controlled trials

Zhang

et al. 2015

Critical Reviews in Oncology/Hematology

View full text Add to dashboard Cite

“…Similarly, pertuzumab has not shown QTc effects 115, 116. Bevacizumab has been used alone or in combination with other TKI and other chemotherapeutic agents without causing QTc prolongation, despite its cardiotoxicity potential 166, 167, 168, 169…”

Section: Resultsmentioning

confidence: 99%

Incidence, Diagnosis, and Management of QT Prolongation Induced by Cancer Therapies: A Systematic Review

Porta‐Sánchez

Gilbert

Spears

et al. 2017

JAHA

154

142

View full text Add to dashboard Cite

BackgroundThe cardiovascular complications of cancer therapeutics are the focus of the burgeoning field of cardio‐oncology. A common challenge in this field is the impact of cancer drugs on cardiac repolarization (ie, QT prolongation) and the potential risk for the life‐threatening arrhythmia torsades de pointes. Although QT prolongation is not a perfect marker of arrhythmia risk, this has become a primary safety metric among oncologists. Cardiologists caring for patients receiving cancer treatment should become familiar with the drugs associated with QT prolongation, its incidence, and appropriate management strategies to provide meaningful consultation in this complex clinical scenario.Methods and ResultsIn this article, we performed a systematic review (using Preferred Reporting Items of Systematic Reviews and Meta‐Analyses (PRISMA) guidelines) of commonly used cancer drugs to determine the incidence of QT prolongation and clinically relevant arrhythmias. We calculated summary estimates of the incidence of all and clinically relevant QT prolongation as well as arrhythmias and sudden cardiac death. We then describe strategies to prevent, identify, and manage QT prolongation in patients receiving cancer therapy. We identified a total of 173 relevant publications. The weighted incidence of any corrected QT (QTc) prolongation in our systematic review in patients treated with conventional therapies (eg, anthracyclines) ranged from 0% to 22%, although QTc >500 ms, arrhythmias, or sudden cardiac death was extremely rare. The risk of QTc prolongation with targeted therapies (eg, small molecular tyrosine kinase inhibitors) ranged between 0% and 22.7% with severe prolongation (QTc >500 ms) reported in 0% to 5.2% of the patients. Arrhythmias and sudden cardiac death were rare.ConclusionsOur systematic review demonstrates that there is variability in the incidence of QTc prolongation of various cancer drugs; however, the clinical consequence, as defined by arrhythmias or sudden cardiac death, remains rare.

show abstract

“…One RCT [32] already mentioned a protocol change in their publication; therefore, 52 authors were emailed. The response rate was 23.1% (12/52).…”

Section: Resultsmentioning

confidence: 99%

Evidence of selective reporting bias in hematology journals: A systematic review

et al. 2017

View full text Add to dashboard Cite

IntroductionSelective reporting bias occurs when chance or selective outcome reporting rather than the intervention contributes to group differences. The prevailing concern about selective reporting bias is the possibility of results being modified towards specific conclusions. In this study, we evaluate randomized controlled trials (RCTs) published in hematology journals, a group in which selective outcome reporting has not yet been explored.MethodsOur primary goal was to examine discrepancies between the reported primary and secondary outcomes in registered and published RCTs concerning hematological malignancies reported in hematology journals with a high impact factor. The secondary goals were to address whether outcome reporting discrepancies favored statistically significant outcomes, whether a pattern existed between the funding source and likelihood of outcome reporting bias, and whether temporal trends were present in outcome reporting bias. For trials with major outcome discrepancies, we contacted trialists to determine reasons for these discrepancies. Trials published between January 1, 2010 and December 31, 2015 in Blood; British Journal of Haematology; American Journal of Hematology; Leukemia; and Haematologica were included.ResultsOf 499 RCTs screened, 109 RCTs were included. Our analysis revealed 118 major discrepancies and 629 total discrepancies. Among the 118 discrepancies, 30 (25.4%) primary outcomes were demoted, 47 (39.8%) primary outcomes were omitted, and 30 (25.4%) primary outcomes were added. Three (2.5%) secondary outcomes were upgraded to a primary outcome. The timing of assessment for a primary outcome changed eight (6.8%) times. Thirty-one major discrepancies were published with a P-value and twenty-five (80.6%) favored statistical significance. A majority of authors whom we contacted cited a pre-planned subgroup analysis as a reason for outcome changes.ConclusionOur results suggest that outcome changes occur frequently in hematology trials. Because RCTs ultimately underpin clinical judgment and guide policy implementation, selective reporting could pose a threat to medical decision making.

show abstract

R-CHOP with or without bevacizumab in patients with previously untreated diffuse large B-cell lymphoma: final MAIN study outcomes

Abstract: Methods

Cited by 81 publications

References 36 publications

Bevacizumab increases the risk of infections in cancer patients: A systematic review and pooled analysis of 41 randomized controlled trials

Bevacizumab increases the risk of infections in cancer patients: A systematic review and pooled analysis of 41 randomized controlled trials

Incidence, Diagnosis, and Management of QT Prolongation Induced by Cancer Therapies: A Systematic Review

Evidence of selective reporting bias in hematology journals: A systematic review

Contact Info

Product

Resources

About