Mantle Cell Lymphoma
Real-World Data on Mantle Cell Lymphoma and Its Treatment
Given the ever‐changing mantle cell lymphoma (MCL) treatment landscape, real-world analyses can offer insights on changing patterns of care. To the extent that real-world studies include types of patients not typically enrolled in clinical trials, findings from these analyses may help to confirm or extend what is already known based on data from randomized clinical trials.
The Richard T. Silver Distinguished Professor of Hematology and Medical Oncology
“Real-world analyses largely provide confirmatory data that complement what is already known from prospective trials. That said, clinical trials of MCL may enroll patients who are younger and fitter than those encountered in the real world, so there is a role for both types of study.”
Real-world analyses largely provide confirmatory data that complement what is already known from prospective trials. That said, clinical trials of MCL may enroll patients who are younger and fitter than those encountered in the real world, so there is a role for both types of study. MCL is typically a disease of older and frailer people, unlike Hodgkin lymphoma, which usually affects younger and fitter individuals. Clinical trials might not entirely reflect the actual MCL patient population, and MCL is a disease state in which real-world data, if they are robust and include older patients, could be particularly helpful.
Now, sometimes we are limited by the nature of the data set that is available to work with, and such is the case in the analysis by Kabadi et al, which was conducted using a commercially insured population with younger individuals (aged <65 years) with MCL. The median age was 57 years in this study, compared with 68 years in the general MCL population. The majority of patients (63%) experienced 1 or more incident adverse event(s), and an increasing number of incident adverse events was linked to increased hospitalization risk. Among the treatments that fit the working definition of frontline therapy for MCL, R-CHOP was the most common, followed by rituximab monotherapy, then bendamustine-rituximab, and then, lastly, ibrutinib. The authors noted that the high frequency of first‐line rituximab monotherapy should be interpreted with caution and may reflect limitations of the claims‐based analysis. Further, the analysis spanned from November 2012 to January 2018, and my sense is that patterns had been changing during that period, to the extent that there would be less R-CHOP use and more bendamustine-rituximab use as frontline therapy in more recent years.
Further, Kabadi and colleagues noted that the stem cell transplantation rate of just 10% among patients receiving the 4 most common regimens was likely low due to underreporting in the database. Indeed, data from the Center for International Blood & Marrow Transplant Research (CIBMTR) indicate that, over a 10-year period between 2007 and 2017, there were 7144 autologous/allogeneic stem cell transplantations for MCL. If one were to extrapolate the annual incidence of MCL reported by Kabadi et al over 10 years, there would be some 33,000 incident MCL cases in the United States, and, with the 7144 transplants reported for MCL by the CIBMTR over the 10-year period, the rate of transplant in this younger population studied by Kabadi et al does seem low. Thus, real-world data have inherent limitations; one would not conclude, for instance, that a low rate of transplantation observed in the claims database reflected the true rate of transplantation. However, to the extent that these studies may shed light on patients not typically enrolled in clinical trials, they might have a role in confirming or extending what is known.
Center for International Blood & Marrow Transplant Research. Summary slides – HCT trends and survival data. https://www.cibmtr.org/ReferenceCenter/SlidesReports/SummarySlides/Pages/index.aspx. Accessed April 26, 2020.
Jeon YW, Yoon S, Min GJ, et al. Clinical outcomes for ibrutinib in relapsed or refractory mantle cell lymphoma in real-world experience. Cancer Med. 2019;8(16):6860-6870.
Kabadi SM, Near A, Wada K, Burudpakdee C. Treatment patterns, adverse events, healthcare resource use and costs among commercially insured patients with mantle cell lymphoma in the United States. Cancer Med. 2019;8(17):7174-7185.
Telford C, Kabadi SM, Abhyankar S, et al. Matching-adjusted indirect comparisons of the efficacy and safety of acalabrutinib versus other targeted therapies in relapsed/refractory mantle cell lymphoma. Clin Ther. 2019;41(11):2357-2379.e1.
Teras LR, DeSantis CE, Cerhan JR, Morton LM, Jemal A, Flowers CR. 2016 US lymphoid malignancy statistics by World Health Organization subtypes. CA Cancer J Clin. 2016;66(6):443‐459.
Wang ML, Blum KA, Martin P, et al. Long‐term follow‐up of MCL patients treated with single-agent ibrutinib: updated safety and efficacy results. Blood. 2015;126(6):739‐745.