Real-world data is helping to fine-tune care decisions for multiple myeloma patients
Two poster sessions at ASCO 2024 from the research teams at COTA, Hackensack University Medical Center, and the Georgetown Lombardi Comprehensive Cancer Center
Patients with newly diagnosed multiple myeloma (NDMM) face a long care journey filled with complex decisions about their treatment.
Currently, widely used care pathways generally recommend stem cell transplantation, for those eligible for the procedure, followed by a period of maintenance therapy.? However, this pathway could bring risks for some patients, including increased likelihood of secondary malignancies from lenalidomide, the most common therapy used for ongoing maintenance.
Researchers and clinicians both agree that standards of care should be regularly reviewed and optimized based on the latest evidence to ensure that existing recommendations remain relevant.?
Fortunately, we now have more tools than ever to re-examine established care patterns and help refine clinical approaches that help patients live longer and have a higher quality of life during treatment.
Real-world data (RWD) is at the core of these efforts.? By curating a large volume of rich, comprehensive information from a variety of high-value data sources, we can gain unprecedented insights into actual patients and treatment protocols in both the community oncology clinics and academic medical centers.?
At the 2024 ASCO Annual Meeting taking place May 31-June 4 in Chicago, COTA will be presenting two abstracts that leverage RWD to examine the effectiveness and outcomes of current strategies for treating multiple myeloma in newly diagnosed individuals.
This research adds significantly to the conversation around standards of care for the challenging disease while showcasing the potential for using real-world insights to guide decision-making in cancer care and beyond.
In this study, a team of researchers from COTA , Hackensack University Medical Center, and the Georgetown Lombardi Comprehensive Cancer Center examined whether maintenance therapy after a stem cell transplant impacted outcomes including time to next treatment and overall survival.
After analyzing data from 1,928 patients, half of whom received maintenance therapy and half of whom did not, they found that maintenance therapy after stem cell transplant did not, in fact, improve outcomes.
The study found that despite having a shorter time to the first treatment immediately following stem cell transplant (35.9 vs. 51.0 months), patients who did not receive maintenance therapy had a significantly longer time to the second treatment or death (21.6 vs. 11.7 months). Additionally, patients who did not receive maintenance therapy survived for a median of 126.3 months compared to 108.8 months for those who did.
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The study demonstrates that RWD can uncover nuances in treatment patterns and outcomes that may not be available via other research modalities.? It also emphasizes the importance of personalizing cancer care decisions based on the patient’s priorities for living a high-quality life.?
Multiple myeloma patients eligible for stem cell transplants can have a single transplantation (a course of high-dose chemotherapy followed by infusion of stem cells) or tandem transplantation— two rounds of chemo and stem cells in a row.?
The single version, followed by maintenance therapy as described above, is widely accepted as the current standard of care.? However, evidence is starting to show that the tandem transplantation may have benefits, both in progression-free survival and overall survival.
To better understand tandem transplantation outcomes, researchers from Hackensack University Medical Center, and the Georgetown Lombardi Comprehensive Cancer Center worked with COTA to examine the RWD of 1,117 patients.
The study compared patients receiving single transplant with maintenance therapy against those receiving tandem transplantation without maintenance. The results showed that patients who received tandem transplant without maintenance therapy had comparable time to next treatment immediately following transplant (52.7 vs. 51.0 months), but significantly longer duration of time between the subsequent line of therapy or death (33.9 months vs. 11.8 months).
The differences held true even though the tandem group had a much higher baseline burden of high-risk cytogenetic abnormalities (HRCAs), which may be why these patients received more aggressive treatment to begin with.
Median overall survival as a primary outcome was more difficult to judge, the team noted, since it requires follow-up for a length of time that exceeded the scope of this study.
However, the research does provide valuable perspectives into the effectiveness of tandem transplantation and gives clinicians additional material to consider when working with patients on treatment decisions.
COTA will be presenting these abstracts at ASCO 2024 from May 31 - June 4 in Chicago.?
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Ex-FDA biostatistician specializing in oncology/hematology clinical trial designs and RWD research.
6 个月We worked on these two abstracts for a while now and am excited to see them being presented at #ASCO2024. The findings surprised us at first so we did a triple check of our work and additional sensitivity analyses. Someone described them as ground breaking and practice changing in multiple myeloma patients! Such studies are infeasible in a clinical trial setting for various reasons and using RWD is the next best alternative to add to our understanding.
Strategy Advisor| Innovation and Transformation I Clinical Development and Digital Health| Board Member| SpeakerI Ex Genentech, Roche, JnJ, Bayer
6 个月This research puts into question the SOC practices during maintenance therapy in MM patients. We need similar RWD research in other cancers as well to avoid unnecessary therapies that may not necessarily lead to better patient outcomes but put a heavy toxicity/quality of life and financial burden on patients and healthcare.
Executive Director of Business Development at Culinary Depot/Founder of the Hope Organization
6 个月It's inspiring to see COTA and partners using real-world data to tackle multiple myeloma treatment strategies. This approach could significantly impact patient outcomes and set new benchmarks in oncology care. Looking forward to the insights from these abstracts at .