4.6 Review

Utilization of real-world data in assessing treatment effectiveness for diffuse large B-cell lymphoma

相关参考文献

注意:仅列出部分参考文献,下载原文获取全部文献信息。
Editorial Material Pharmacology & Pharmacy

Real-World Evidence in EU Medicines Regulation: Enabling Use and Establishing Value

Peter Arlett et al.

Summary: The vision is to enable and establish the use of real-world evidence by 2025 across various regulatory use cases, through collaboration with different stakeholders to support the development and use of better medicines for patients.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2022)

Article Oncology

Baseline Total Metabolic Tumor Volume is Prognostic for Refractoriness to Immunochemotherapy in DLBCL: Results From GOYA

Irene Canales Ruiz et al.

Summary: This article studied the risk factors for early treatment failure in patients with diffuse large B-cell lymphoma and found that total metabolic tumor volume is an important indicator in identifying patients at risk of early treatment failure.

CLINICAL LYMPHOMA MYELOMA & LEUKEMIA (2022)

Article Hematology

Site-Specific Survival of Extra Nodal Diffuse Large B-Cell Lymphoma and Comparison With Gastrointestinal Diffuse Large B-Cell Lymphoma

Varsha Gupta et al.

Summary: Based on the study, the site of presentation is an important prognostic factor for patients with EN-DLBCL, and histological and epidemiological characteristics have a significant impact on survival rates.

JOURNAL OF HEMATOLOGY (2022)

Article Oncology

Improved Efficacy of Tafasitamab plus Lenalidomide versus Systemic Therapies for Relapsed/Refractory DLBCL: RE-MIND2, an Observational Retrospective Matched Cohort Study

Grzegorz S. Nowakowski et al.

Summary: In this retrospective study, the combination of tafasitamab and lenalidomide showed a significant improvement in overall survival compared to other treatment regimens for relapsed/refractory diffuse large B-cell lymphoma.

CLINICAL CANCER RESEARCH (2022)

Article Hematology

Final results of a phase 1 study of loncastuximab tesirine in relapsed/refractory B-cell non-Hodgkin lymphoma

Mehdi Hamadani et al.

Summary: Loncastuximab tesirine, an antibody-drug conjugate, shows promising efficacy and safety in patients with relapsed or refractory B-cell non-Hodgkin lymphoma, especially for certain specific lymphoma subtypes. This study suggests that loncastuximab tesirine could be a valuable treatment option for these patients and warrants further investigation in phase 2 trials.
Article Oncology

Implementing Historical Controls in Oncology Trials

Olivier Collignon et al.

Summary: In oncology drug development, utilizing historical controls in single-arm trials can potentially accelerate development and reduce patient numbers, particularly in cases of high unmet clinical need with well-characterized disease courses and objective endpoints. Careful selection and pre-specification of historical data, matching patient characteristics with concurrent trial data, and innovative statistical methodologies are crucial for success. Early engagement with regulators is highly recommended for this approach.

ONCOLOGIST (2021)

Article Medicine, Research & Experimental

Indirect Treatment Comparison of Liso-Cel vs. Salvage Chemotherapy in Diffuse Large B-Cell Lymphoma: TRANSCEND vs. SCHOLAR-1

Gilles Salles et al.

Summary: This study compared the efficacy of liso-cel and salvage chemotherapy for patients with R/R LBCL using an unanchored MAIC methodology. The analyses showed significantly lower risk of mortality and higher rates of complete and objective response for patients treated with liso-cel compared to salvage chemotherapy, demonstrating favorable efficacy of liso-cel in the treatment of R/R LBCL patients.

ADVANCES IN THERAPY (2021)

Article Oncology

Transformed Lymphoma Is Associated with a Favorable Response to CAR-T-Cell Treatment in DLBCL Patients

Anna Nydegger et al.

Summary: This study suggests that patients with transformed/secondary lymphoma have a more favorable course after CAR-T-cell therapy compared to patients with de novo lymphoma.

CANCERS (2021)

Article Oncology

Rituximab plus gemcitabine and oxaliplatin (R-GemOx) in refractory/relapsed diffuse large B-cell lymphoma: a real-life study in patients ineligible for autologous stem-cell transplantation

Clarisse Cazelles et al.

Summary: The combination of R-GemOx shows efficacy and tolerability in R/R DLBCL patients who are ineligible for intensive treatment, with potential as a basis for new regimen combinations. However, further research and optimization are needed to improve outcomes.

LEUKEMIA & LYMPHOMA (2021)

Review Oncology

Diffuse large B-cell lymphoma: new targets and novel therapies

Bruce D. Cheson et al.

Summary: Newer, more effective and non-cytotoxic therapies are needed for patients with DLBCL and other B-cell malignancies. Approved treatments include various combinations of drugs, CAR-T cell products, and ongoing development of other therapies. Combinations of targeted therapies are expected to further improve the outcomes for patients.

BLOOD CANCER JOURNAL (2021)

Article Medicine, General & Internal

CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): checklist with explanation and elaboration

Linda Kwakkenbos et al.

Summary: Randomised controlled trials are increasingly conducted using cohorts or routinely collected data, and the CONSORT has introduced an extension to improve reporting quality in the long term. The extension, developed through a sequential approach including a Delphi survey, consensus meeting, and checklist piloting, includes modified items from the CONSORT 2010 statement and new items. Reporting items with explanations and examples are provided to highlight specific considerations in trials conducted using cohorts or routinely collected data.

BMJ-BRITISH MEDICAL JOURNAL (2021)

Article Hematology

Long-term outcomes from the phase II L-MIND study of tafasitamab (MOR208) plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma

Johannes Duell et al.

Summary: The combination therapy of Tafasitamab with lenalidomide showed good efficacy, long-term effectiveness, and well-defined safety profile in patients with relapsed/refractory DLBCL. The consistent efficacy results were observed across different subgroups of patients.

HAEMATOLOGICA (2021)

Article Oncology

Matching-adjusted indirect treatment comparison of liso-cel versus axi-cel in relapsed or refractory large B cell lymphoma

David G. Maloney et al.

Summary: This study used matching-adjusted indirect comparisons to evaluate the comparative efficacy and safety of lisocabtagene maraleucel versus axicabtagene ciloleucel in patients with relapsed or refractory large B cell lymphoma, finding that lisocabtagene maraleucel demonstrated comparable efficacy and a more favorable safety profile in this patient population.

JOURNAL OF HEMATOLOGY & ONCOLOGY (2021)

Review Health Care Sciences & Services

Single-arm oncology trials and the nature of external controls arms

Mustafa Hashmi et al.

Summary: This study reviewed the use of ECAs in single-arm trials, finding that ECAs derived from primary data collected by other trials or EHRs were more successful in achieving patient comparability and data quality comparability, often being submitted to regulatory authorities.

JOURNAL OF COMPARATIVE EFFECTIVENESS RESEARCH (2021)

Article Oncology

Shorter Diagnosis-to-Treatment Interval in Diffuse Large B-Cell Lymphoma is Associated With Inferior Overall Survival in a Large, Population-Based Registry

Danielle N. Blunt et al.

Summary: A study in Ontario, Canada found that in patients with diffuse large B-cell lymphoma (DLBCL), the length of time from diagnosis to treatment initiation (DTI) was associated with overall survival (OS), with shorter DTI indicating poorer survival. Increasing age, male sex, and the number of comorbidities were also linked to inferior survival outcomes. This suggests that DTI may serve as a surrogate marker for aggressive biology and that clinical trials with lengthy screening periods could create biases in patient selection.

JOURNAL OF THE NATIONAL COMPREHENSIVE CANCER NETWORK (2021)

Editorial Material Medicine, Research & Experimental

The Advantages and Challenges of Using Real-World Data for Patient Care

Yunn-Fang Ho et al.

CTS-CLINICAL AND TRANSLATIONAL SCIENCE (2020)

Article Oncology

Polatuzumab Vedotin in Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Laurie H. Sehn et al.

JOURNAL OF CLINICAL ONCOLOGY (2020)

Article Clinical Neurology

Leveraging real-world data to investigate multiple sclerosis disease behavior, prognosis, and treatment

Jeffrey A. Cohen et al.

MULTIPLE SCLEROSIS JOURNAL (2020)

Review Public, Environmental & Occupational Health

Trial designs using real-world data: The changing landscape of the regulatory approval process

Elodie Baumfeld Andre et al.

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY (2020)

Review Medicine, General & Internal

Reporting of Multi-Arm Parallel-Group Randomized Trials Extension of the CONSORT 2010 Statement

Edmund Juszczak et al.

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (2019)

Article Health Care Sciences & Services

Impact of missing data on bias and precision when estimating change in patient-reported outcomes from a clinical registry

Olawale F. Ayilara et al.

HEALTH AND QUALITY OF LIFE OUTCOMES (2019)

Article Oncology

Big Data in Cancer Research: Real-World Resources for Precision Oncology to Improve Cancer Care Delivery

Chiaojung Jillian Tsai et al.

SEMINARS IN RADIATION ONCOLOGY (2019)

Article Medicine, General & Internal

Tisagenlecleucel in Adult Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Stephen J. Schuster et al.

NEW ENGLAND JOURNAL OF MEDICINE (2019)

Review Obstetrics & Gynecology

A simplified guide to randomized controlled trials

Amar Bhide et al.

ACTA OBSTETRICIA ET GYNECOLOGICA SCANDINAVICA (2018)

Article Oncology

Real-world Data for Clinical Evidence Generation in Oncology

Sean Khozin et al.

JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE (2017)

Article Medicine, General & Internal

Axicabtagene Ciloleucel CAR T-Cell Therapy in Refractory Large B-Cell Lymphoma

S. S. Neelapu et al.

NEW ENGLAND JOURNAL OF MEDICINE (2017)

Article Medicine, General & Internal

Blinatumomab versus Chemotherapy for Advanced Acute Lymphoblastic Leukemia

Hagop Kantarjian et al.

NEW ENGLAND JOURNAL OF MEDICINE (2017)

Article Oncology

Real-world Data for Clinical Evidence Generation in Oncology

Sean Khozin et al.

JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE (2017)

Article Pharmacology & Pharmacy

When and How Can Real World Data Analyses Substitute for Randomized Controlled Trials?

Jessica M. Franklin et al.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2017)

Review Medicine, Research & Experimental

Rituximab in B-Cell Hematologic Malignancies: A Review of 20 Years of Clinical Experience

Gilles Salles et al.

ADVANCES IN THERAPY (2017)

Article Health Care Sciences & Services

Distinguishing Selection Bias and Confounding Bias in Comparative Effectiveness Research

Sebastien Haneuse

MEDICAL CARE (2016)

Article Education, Scientific Disciplines

Diffuse large B-cell lymphoma: R-CHOP failure-what to do?

Bertrand Coiffier et al.

HEMATOLOGY-AMERICAN SOCIETY OF HEMATOLOGY EDUCATION PROGRAM (2016)

Article Oncology

FDA Approval: Blinatumomab

Donna Przepiorka et al.

CLINICAL CANCER RESEARCH (2015)

Article Medical Informatics

Quantum of Effectiveness Evidence in FDA's Approval of Orphan Drugs: Update, July 2010 to June 2014

Frank J. Sasinowski et al.

THERAPEUTIC INNOVATION & REGULATORY SCIENCE (2015)

Editorial Material Oncology

Potential and Challenges of Patient-Generated Health Data for High-Quality Cancer Care

Arlene E. Chung et al.

JOURNAL OF ONCOLOGY PRACTICE (2015)

Article Mathematical & Computational Biology

Metrics for covariate balance in cohort studies of causal effects

Jessica M. Franklin et al.

STATISTICS IN MEDICINE (2014)

Article Mathematics, Interdisciplinary Applications

An Introduction to Propensity Score Methods for Reducing the Effects of Confounding in Observational Studies

Peter C. Austin

MULTIVARIATE BEHAVIORAL RESEARCH (2011)

Review Rheumatology

Registries in systemic sclerosis: a worldwide experience

Felice Galluccio et al.

RHEUMATOLOGY (2011)

Editorial Material Health Care Sciences & Services

Survivor treatment bias, treatment selection bias, and propensity scores in observational research

Peter C. Austin et al.

JOURNAL OF CLINICAL EPIDEMIOLOGY (2010)

Article Oncology

Salvage Regimens With Autologous Transplantation for Relapsed Large B-Cell Lymphoma in the Rituximab Era

Christian Gisselbrecht et al.

JOURNAL OF CLINICAL ONCOLOGY (2010)

Article Gastroenterology & Hepatology

Beyond randomized controlled trials: A critical comparison of trials with nonrandomized studies

Henrik Toft Sorensen et al.

HEPATOLOGY (2006)

Article Mathematical & Computational Biology

A comparison of propensity score methods: A case-study estimating the effectiveness of post-AMI statin use

PC Austin et al.

STATISTICS IN MEDICINE (2006)

Article Pharmacology & Pharmacy

Indications for propensity scores and review of their use in pharmacoepidemiology

RJ Glynn et al.

BASIC & CLINICAL PHARMACOLOGY & TOXICOLOGY (2006)

Review Health Care Sciences & Services

A review of uses of health care utilization databases for epidemiologic research on therapeutics

S Schneeweiss et al.

JOURNAL OF CLINICAL EPIDEMIOLOGY (2005)

Article Medicine, General & Internal

Practical clinical trials - Increasing the value of clinical research for decision making in clinical and health policy

SR Tunis et al.

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (2003)