Rituximab-Based Regimen for Children with B-Cell Lymphoma

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Source: NEJM. June 2020. doi: 10.1056/NEJMoa1915315" /> </div> </figure> </div> <p>The results from a recent study establish a new standard for treating children and young adults newly diagnosed with fast-growing forms of B-cell non-Hodgkin lymphoma, including Burkitt lymphoma.</p> <p>In the study, adding the drug <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="4a7e6621-fd2f-4abf-8b29-6f366b39f368" href="/about-cancer/treatment/drugs/rituximab">rituximab (Rituxan, Truxima)</a> to standard chemotherapy <a href="https://pubmed.ncbi.nlm.nih.gov/32492302/">improved the overall cure rate in these patients from approximately 87% to 95%</a>.</p> <p>The new treatment regimen “is a remarkably effective therapy for a group of children who have a very <a class="definition" data-glossary-id="CDR0000046053" href="/Common/PopUps/popDefinition.aspx?id=CDR0000046053&version=Patient&language=en">aggressive</a> form of lymphoma,” said Malcolm Smith, M.D., Ph.D., of NCI’s <a href="https://ctep.cancer.gov/">Cancer Therapy Evaluation Program</a>, who was not involved in the study.</p> <p>“To achieve 95% survival for these patients is an outstanding result and a very important accomplishment,” Dr. Smith added.</p> <p>Findings from the international study, which was led by the NCI-supported <a class="definition" data-glossary-id="CDR0000689414" href="/Common/PopUps/popDefinition.aspx?id=CDR0000689414&version=Patient&language=en">Children’s Oncology Group</a> and the European Intergroup for Childhood Non-Hodgkin Lymphoma, were published June 4 in the <em>New England Journal of Medicine</em>.</p> <h2>Moving the Needle on Survival Rates</h2> <p>Childhood non-Hodgkin lymphoma is a disease in which cancer cells form in the <a class="definition" data-glossary-id="CDR0000793442" href="/Common/PopUps/popDefinition.aspx?id=CDR0000793442&version=Patient&language=en">lymph system</a>, which is part of the body’s <a class="definition" data-glossary-id="CDR0000046356" href="/Common/PopUps/popDefinition.aspx?id=CDR0000046356&version=Patient&language=en">immune system</a>. B-cell non-Hodgkin lymphoma begins in white blood cells called <a class="definition" data-glossary-id="CDR0000044953" href="/Common/PopUps/popDefinition.aspx?id=CDR0000044953&version=Patient&language=en">B lymphocytes</a>. In children, B-cell non-Hodgkin lymphoma is often a very aggressive, fast-growing disease, and most cases are Burkitt lymphoma, said Thomas Gross, M.D., Ph.D., of Children’s Hospital Colorado, one of the lead authors on the new study.</p> <p>The development of <a class="definition" data-glossary-id="CDR0000796903" href="/Common/PopUps/popDefinition.aspx?id=CDR0000796903&version=Patient&language=en">intensive chemotherapy</a> regimens for pediatric Burkitt lymphoma, which use high doses of cancer drugs given over several months, increased the cure rate for these relatively rare cancers from about 30% in the 1970s to 85% in the 1990s for children with the most serious cases, Dr. Gross said.</p> <p>“But to get those kinds of improvements we had to really intensify the chemotherapy,” and any further intensifying could lead to more treatment-related deaths, he continued. So, to further improve treatment outcomes, researchers needed to find and test less-toxic drugs that could be given in addition to chemotherapy.</p> <p>Rituximab—a type of <a class="definition" data-glossary-id="CDR0000045729" href="/Common/PopUps/popDefinition.aspx?id=CDR0000045729&version=Patient&language=en">immunotherapy</a> that targets cancerous B cells as well as normal B cells—was a good candidate because earlier studies showed that adding this drug to chemotherapy helped adults with B-cell lymphoma live longer, Dr. Gross explained.</p> <h2>Benefits of Adding Rituximab Are Clear</h2> <p>To enroll enough children with B-cell lymphomas in the type of large clinical trial needed to rigorously test the potential benefit of adding rituximab to chemotherapy, Dr. Gross and his colleagues forged a collaboration involving a dozen countries in North America, Europe, Asia, New Zealand, and Australia.</p> <p>Patients ranging from 2 to 17 years old were randomly assigned to receive either the standard regimen of intensive chemotherapy or the same chemotherapy regimen plus six doses of rituximab given over the course of treatment.</p> <p>Researchers had originally planned to enroll about 600 patients in the study. However, it was stopped early, after enrolling only 328 patients, because a preplanned interim analysis of patient data showed such a clear benefit for rituximab. Halting the trial meant that the <a class="definition" data-glossary-id="CDR0000045858" href="/Common/PopUps/popDefinition.aspx?id=CDR0000045858&version=Patient&language=en">randomized</a> part of the trial was stopped and all children who were not receiving rituximab were allowed to receive it, Dr. Smith said.</p> <p>Of the 328 patients randomly assigned to chemotherapy only or to chemotherapy plus rituximab, 287—or nearly 90%—had Burkitt lymphoma. Three years after starting treatment, the <a class="definition" data-glossary-id="CDR0000655269" href="/Common/PopUps/popDefinition.aspx?id=CDR0000655269&version=Patient&language=en">event-free survival</a> rate was 82% with chemotherapy alone and 94% with chemotherapy plus rituximab. Event-free survival means that these patients had not seen any sign of their cancer’s return or progression, developed a second cancer, or died from any cause.</p> <p>The percentage of patients still living after 3 years (<a class="definition" data-glossary-id="CDR0000655245" href="/Common/PopUps/popDefinition.aspx?id=CDR0000655245&version=Patient&language=en">overall survival</a>) was 87% with chemotherapy alone and 95% with rituximab plus chemotherapy. Children with aggressive B-cell lymphoma who survive for 3 years without the disease coming back are generally considered cured, Dr. Smith said.</p> <h2>Most Side Effects Are Temporary</h2> <p>Severe side effects, such as infections and <a class="definition" data-glossary-id="CDR0000415543" href="/Common/PopUps/popDefinition.aspx?id=CDR0000415543&version=Patient&language=en">febrile neutropenia</a>, occurred in 24% of patients in the chemotherapy-only group and 33% of patients in the rituximab–chemotherapy group.</p> <p>Three patients in each group died from treatment-related effects. However, Dr. Smith said, “most children were able to tolerate the treatment, and most of the side effects were reversible.”</p> <p>“Children who received rituximab had more infections during treatment, but we were able to treat them successfully,” Dr. Gross said. “Because rituximab attacks normal B cells as well as tumor B cells, it will be important to follow these children long term to make sure that their immune systems return to normal function.”</p> <p>Results from the Childhood Cancer Survivor Study published last year show that the intensive chemotherapy regimen used to cure children with aggressive B-cell non-Hodgkin lymphoma <a href="https://pubmed.ncbi.nlm.nih.gov/31283408/">does not have many long-term effects that would affect a person’s quality of life</a>, Dr. Gross noted. </p> <h2>Challenges for Treatment in Low- and Middle-Income Countries</h2> <p>Despite the high cure rate achieved by adding rituximab to chemotherapy, Dr. Gross said, “we still need to find treatments for the 5% of patients who aren’t cured with this therapy,” because once the disease comes back there are no good treatment options.</p> <p>In addition, he noted, only about 10% of all children worldwide who have Burkitt lymphoma and other aggressive B-cell lymphomas live in countries that have sufficient resources to allow them to get potentially curative treatments and the <a class="definition" data-glossary-id="CDR0000046609" href="/Common/PopUps/popDefinition.aspx?id=CDR0000046609&version=Patient&language=en">supportive care</a> needed to manage severe side effects of intensive chemotherapy. Burkitt lymphoma has been linked to infection with the <a class="definition" data-glossary-id="CDR0000045684" href="/Common/PopUps/popDefinition.aspx?id=CDR0000045684&version=Patient&language=en">Epstein-Barr virus</a>, particularly in Africa, where this virus causes most cases of the disease.</p> <p>Cure rates for children with aggressive B-cell lymphomas are markedly lower in low- and middle-income countries (LMICs) than in high-income countries like the United States, said Monika Metzger, M.D., of the Department of Global Pediatric Medicine at St. Jude Children’s Research Hospital. </p> <p>In Central America, for example, inadequate supportive care results in more patients dying from treatment-related complications, while others die due to abandonment of therapy or from disease that comes back because the intensive therapy needed for a cure could not be administered, she said. </p> <p>“It is conceivable that the addition of rituximab could allow for a reduction of [toxic] chemotherapy” in children with non-Hodgkin lymphoma, the study authors wrote. But more data are needed before that possibility can be explored.</p> <p>“Trials in LMICs, where very intensive chemotherapy is not tolerated and more than 10% of patients die from toxicity, could provide an opportunity to examine which patients can be cured with less intense chemotherapy when rituximab is added,” Dr. Metzger said.</p> <p>Unfortunately, she noted, rituximab is either not readily available or unaffordable in many LMICs. “This needs to change, so that all children with an otherwise highly curable cancer have access to a potential cure,” she concluded.</p> </div> </div> <footer class="article-footer"> <div id='cgov-blog-post-pagination' class='clearfix'> <div class='blog-post-older'> <a href="/news-events/cancer-currents-blog/2020/covid-19-cancer-clinical-trials">< Older Post</a> <p><i>Responding to Coronavirus, Cancer Researchers Reimagine Clinical Trials</i></p> </div> <div class='blog-post-newer'> <a href="/news-events/cancer-currents-blog/2020/fda-pembrolizumab-tmb-approval-genomic-testing">Newer Post ></a> <p><i>A New FDA Approval Furthers the Role of Genomics in Cancer Care</i></p> </div> </div> <div id="blog-cards"> <h2 class="recommended-content__header">Recommended From NCI</h2> <div id="nvcgSlLayoutFeatureA" class="row flex-columns"> <div class="slot-item equalheight large-4 columns card gutter blog-feature"> <div class="feature-card cgvBlogPost"> <a href="/news-events/cancer-currents-blog/2019/lowy-ccdi-symposium-childhood-cancer"> <div class="image-hover"> <img loading="lazy" src="/sites/g/files/xnrzdm211/files/styles/cgov_featured/public/cgov_image/media_image/2019-08/Doug-Lowy-CCDI-Symposium-compressed.jpg?h=8b86396b&itok=ZvHfXIiV" width="425" height="319" alt="NCI Acting Director Douglas Lowy, M.D., speaking at the Childhood Cancer Data Initiative Symposium in Washington, DC." /> </div> <h3>Symposium Supports Childhood Cancer Data Initiative</h3> </a> </div> </div> <div class="slot-item equalheight large-4 columns card gutter blog-feature"> <div class="feature-card cgvBlogPost"> <a href="/news-events/cancer-currents-blog/2019/car-t-cell-childhood-cancers"> <div class="image-hover"> <img loading="lazy" src="/sites/g/files/xnrzdm211/files/styles/cgov_featured/public/cgov_image/media_image/100/700/2/files/Medulloblastoma%20%28Article%29.jpg?h=216590b8&itok=6VnrSDtr" width="425" height="319" alt="" /> </div> <h3>CAR T-Cell Study Suggests Promise for Childhood Cancers</h3> </a> </div> </div> </div> <div> <div id="nvcgSlPublicUse"> <div class="slot-item only-SI"> <div class="public-use"> <div id="block-ncids-trans-public-use"> <p><em>If you would like to reproduce some or all of this content, see <a href="/policies/copyright-reuse">Reuse of NCI Information</a> for guidance about copyright and permissions. 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