Randomized, Double-Blind, Pharmacokinetic Equivalence Trial Comparing DRL-Rituximab With MabThera in Patients With Diffuse Large B-Cell Lymphoma

Viswabandya, Auro; Shah, Sandip; Mukhopadhyay, A.; Nagarkar, Rajnish; Batra, Sonica Sachdeva; López-Lázaro, Luis; Kankanwadi, Suresh; Srivastava, Alok

doi:10.1200/jgo.19.00248

Cited by 21 publications

(33 citation statements)

References 21 publications

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“…Mortality from cancer remains high in limited-resource settings, and it is projected that the burden from cancer will grow in low- and middle-income countries [ 39 , 40 ]. There is an urgent need to improve knowledge among providers to prevent, screen, diagnose, and treat cancers, and therefore, more research is needed in low-resource settings to create the evidence base on optimal education interventions [ 41 , 42 ].…”

Section: Discussionmentioning

confidence: 99%

The Effectiveness of mHealth and eHealth Tools in Improving Provider Knowledge, Confidence, and Behaviors Related to Cancer Detection, Treatment, and Survivorship Care: a Systematic Review

2021

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Mobile health (mHealth) and eHealth interventions have demonstrated potential to improve cancer care delivery and disease management by increasing access to health information and health management skills. However, there is a need to better understand the overall impact of these interventions in improving cancer care and to identify best practices to support intervention adoption. Overall, this review intended to systematically catalogue the recent body of cancer-based mHealth and eHealth education and training interventions and assess the effectiveness of these interventions in increasing health care professionals’ knowledge, confidence, and behaviors related to the delivery of care along the cancer continuum. Our initial search yielded 135 articles, and our full review included 23 articles. We abstracted descriptive data for each of the 23 studies, including an overview of interventions (i.e., intended intervention recipients, location of delivery, topic of focus), study methods (i.e., design, sampling approach, sample size), and outcome measures. Almost all the studies reported knowledge gain as an outcome of the education interventions, whereas only half assessed provider confidence or behavior change. We conclude that there is some evidence that mHealth and eHealth interventions lead to improvements in cancer care delivery, but this is not a consistent finding across the studies reviewed. Our findings also identify gaps that should be addressed in future research, offer guidance on the utility of mHealth and eHealth interventions, and provide a roadmap for addressing these gaps. Supplementary Information The online version contains supplementary material available at 10.1007/s13187-021-01961-z.

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Section: Discussionmentioning

confidence: 99%

The Effectiveness of mHealth and eHealth Tools in Improving Provider Knowledge, Confidence, and Behaviors Related to Cancer Detection, Treatment, and Survivorship Care: a Systematic Review

2021

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“…Eight biosimilars of rituximab have been approved by a regulatory health authority with preclinical and clinical information. 69 – 82 From all these biosimilars, only four were approved after conducting a comparative trial in DLBCL patients.…”

Section: Rituximab Biosimilarsmentioning

confidence: 99%

“…The efficacy (defined by a non-inferiority response rate), safety, and immunogenicity profiles were similar. 75 …”

Section: Rituximab Biosimilarsmentioning

confidence: 99%

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Rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in diffuse large B-cell lymphoma

Candelaria

Dueñas‐González

2021

Therapeutic Advances in Hematology

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Background: Diffuse large B-cell lymphoma (DLBCL) is the most frequent non-Hodgkin lymphoma worldwide. The current standard of care is chemoimmunotherapy with an R-CHOP regimen. We aim to review the role of this regimen after two decades of being the standard of care. Methods: A comprehensive literature review of DLBCL, including the epidemiology, trials defining R-CHOP as the standard of care, as well as dose intensification and dose reduction schemes. Additionally, we briefly review the development of rituximab biosimilars and the addition of targeted drugs to R-CHOP in clinical trials. Discussion: R-CHOP cures approximately 70% of DLBCL patients. Dose-dense regimens do not show a benefit in response and increase toxicity. Dose reduction, particularly in elderly patients or with comorbidities, may be a treatment option. DLBCL constitutes a group of diseases that activate different biological pathways. Matching specific treatments to a defined genetic alteration is under development. Rituximab biosimilars have become available to a broader population, particularly in developing countries, where access to treatment is limited because of economic resources. Conclusion: DLBCL landscape is heterogeneous. R-CHOP immunochemotherapy has been a standard of care for two decades and cures approximately 70% of cases. Molecular characterization of patients is evolving and may have critical therapeutic implications.

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“…Other rituximab biosimilars have been developed (eg, MK-8808, BI 695500), but the manufacturers have since terminated development and are no longer listing the rituximab biosimilars as part of their product pipeline. 56-59…”

Section: Rituximab Biosimilar Use In Non-hodgkin Lymphomamentioning

confidence: 99%

A Clinical Review of Biosimilars Approved in Oncology

Ngo

Chen

2020

Ann Pharmacother

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Objective: To summarize and review the clinical data of Food and Drug Administration (FDA)-approved biosimilars for use in treatment of cancer and the current challenges health care institutions face when implementing a newly approved biosimilar. Data Sources: A literature search of the following databases was performed between January 1, 2012, and December 31, 2019: PubMed, Google, and ClinicalTrials.gov. Search terms included the words biosimilar, bevacizumab, rituximab, and/or trastuzumab. Study Selection and Data Extraction: Only primary literature on biosimilars with an ongoing or completed phase 3 trial and/or FDA approval were included in the final analysis. Primary literature consisted of peer-reviewed publications, published abstracts, and any results posted on the ClinicalTrials.gov database. Data Synthesis: Clinical trials of FDA-approved biosimilars for bevacizumab, rituximab, and trastuzumab showed no significant differences with respect to efficacy, safety, and pharmacokinetics when compared with their reference products. Relevance to Patient Care and Clinical Practice: The anticipated growth of biologics in oncology and the recent introduction of biosimilars over the past few years have placed a lot of emphasis on biosimilars as a significant source of cost savings for the health care system. Our article compiles and analyzes existing data on biosimilar efficacy, safety, and financial impact. Conclusions: The major concerns of biosimilars revolve around their long-term efficacy and safety. Even with many questions to be answered, biosimilars have the potential for significant cost savings in the US health care system.

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Randomized, Double-Blind, Pharmacokinetic Equivalence Trial Comparing DRL-Rituximab With MabThera in Patients With Diffuse Large B-Cell Lymphoma

Cited by 21 publications

References 21 publications

The Effectiveness of mHealth and eHealth Tools in Improving Provider Knowledge, Confidence, and Behaviors Related to Cancer Detection, Treatment, and Survivorship Care: a Systematic Review

The Effectiveness of mHealth and eHealth Tools in Improving Provider Knowledge, Confidence, and Behaviors Related to Cancer Detection, Treatment, and Survivorship Care: a Systematic Review

Rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in diffuse large B-cell lymphoma

A Clinical Review of Biosimilars Approved in Oncology

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