PLYMOUTH MEETING, PA [September 5, 2024] — New research just-published online by JNCCN—Journal of the National Comprehensive Cancer Network finds that for many commonly used treatment regimens targeting metastatic gastrointestinal (GI) cancers, such as FOLFOX, FOLFIRI, or FOLFIRINOX, it is possible to administer 5-FU solely through continuous infusion, minus the bolus (quick-delivery via intravenous push) component, without negatively affecting patient outcomes.
The study reviewed results from 11,765 patients across 280 cancer clinics who were diagnosed with advanced colorectal, gastroesophageal, and pancreatic cancers between January 2011 and May 2022. According to the findings, there was no decrease in overall survival for the 13.7% of patients who did not receive a 5-FU bolus component as part of their treatment regimen. However, those patients did see a notable reduction in cytopenias, such as neutropenia (compromised immune system) or thrombocytopenia (bleeding problems).
“The true value of our findings lies in the empirical evidence they provide, which supports what many of us have long suspected,” said lead researcher Shun Yu, MD, NYU Langone Health. “The most significant benefit of this adjustment is that it makes the treatment more tolerable, potentially easing the chemotherapy experience for patients. For decades, the most effective treatment for gastrointestinal cancers was a combination of two forms of 5-fluorouracil: the 5-FU bolus injection, followed by the 5-FU continuous infusion. However, in the early 2000s, the standard of care evolved into multi-drug regimens after it was discovered that adding to the two-component 5-FU backbone significantly improved patient outcomes. While the value of the 5-FU bolus was well established in the older single drug regimens, its role in these newer multi-drug combinations was never thoroughly tested and was largely just assumed.”
The study points out that many practicing oncologists—particularly those who have been in practice longer or who specialize in GI cancers—have already begun to omit the bolus. Recent shortages of 5-FU have also highlighted the potential for reducing this bolus portion.
“This study offers solid evidence for not using a 5-FU bolus with FOLFOX/FOLFIRI/FOLFIRINOX regimens in advanced GI cancers,” commented Elena Gabriela Chiorean, MD, Fred Hutch Cancer Center, who was not involved in this research. “5-FU is a core component of treatment regimens for many gastrointestinal cancers and has traditionally been included as a bolus in addition to a 46-hour infusion in many multiagent chemotherapy regimens. However, there have been no clear evidence showing that bolus 5-FU confers additional efficacy when retained with 5-FU infusion in multi-agent regimens. The authors conducted a large retrospective cohort study to determine the safety and survival rates for patients with advanced colorectal, gastroesophageal and pancreatic cancers after multiagent 5-FU based chemotherapy with and without the 5-FU bolus from the start, adjusting for clinical factors such as age and comorbidities. This large study shows that omitting the bolus 5-FU has no detrimental effect on survival but reduces side effects and healthcare costs.”
A more detailed response from Dr. Chiorean, who is also a Member of the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Panel for Pancreatic Adenocarcinoma, will be publishing in the upcoming October 2024 issue of JNCCN.
Complimentary access is available to “Omission of 5-Fluorouracil Bolus from Multidrug Regimens for Advanced Gastrointestinal Cancers: A Multicenter Cohort Study.” To read the entire article, visit JNCCN.org.
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More than 25,000 oncologists and other cancer care professionals across the United States read JNCCN—Journal of the National Comprehensive Cancer Network. This peer-reviewed, indexed medical journal provides the latest information about innovation in translational medicine, and scientific studies related to oncology health services research, including quality care and value, bioethics, comparative and cost effectiveness, public policy, and interventional research on supportive care and survivorship. JNCCN features updates on the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®), review articles elaborating on guidelines recommendations, health services research, and case reports highlighting molecular insights in patient care. JNCCN is published by Harborside/BroadcastMed. Visit JNCCN.org. To inquire if you are eligible for a FREE subscription to JNCCN, visit NCCN.org/jnccn/subscribe. Follow JNCCN at x.com/JNCCN.
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Journal
Journal of the National Comprehensive Cancer Network
Subject of Research
People
Article Title
Omission of 5-Fluorouracil Bolus From Multidrug Regimens for Advanced Gastrointestinal Cancers: A Multicenter Cohort Study
Article Publication Date
5-Sep-2024
COI Statement
Dr. Oberstein has disclosed serving as a consultant or scientific advisor for Merck & Co., Inc., QED Therapeutics, AstraZeneca, Aravive, and Amal Therapeutics; and receiving grant/research support from Merck & Co., Inc., Genentech, Rafael Pharmaceuticals, Arcus Biosciences, Novartis, Zai Lab, and Amal Therapeutics. Dr. Berlin has disclosed receiving institutional grant/research support from 23andMe, AbbVie, Astellas Pharma, Atreca, Bayer, Bristol Myers Squibb/Celgene, Day One Biopharmaceuticals, Dragonfly Therapeutics, EMD Serono, HiberCell, I-MAB, Incendia Therapeutics, Incyte, Lilly & Co., Inc., Riboscience LLC, Sumitomo Dainippon Pharma, Totus Medicines, and Tyra Biosciences; and serving as a scientific advisor for Bayer, Bexion Pharmaceuticals, BioSapien, Bristol Myers Squibb/Celgene, Insmed Inc., Ipsen Biopharmaceuticals, MEKanistic Therapeutics, Merck & Co., Inc., Merus, Mirati Therapeutics, Oxford BioTherapeutics, and Regeneron Pharmaceuticals. The remaining authors have disclosed that they have not received any financial consideration from any person or organization to support the preparation, analysis, results, or discussion of this article.