Abstract
What is this summary about?
This is a summary describing the results from a phase 3 clinical trial called SUNLIGHT. The study looked at treatment with orally administered trifluridine/tipiracil plus intravenously administered bevacizumab in people with metastatic colorectal cancer (mCRC) that is refractory to treatment.
This study included people whose cancer had grown or spread beyond its original location after no more than two previous treatments. People in the study received either the combination of trifluridine/tipiracil plus bevacizumab or they received trifluridine/tipiracil alone. The aims of the study were to see how long people lived after treatment with trifluridine/tipiracil plus bevacizumab compared with trifluridine/tipiracil alone and to find out how well the combination of trifluridine/tipiracil plus bevacizumab worked at slowing down the spread of the cancer. Researchers also looked at side effects from taking the medicines and at how treatment affected people's physical functioning.
What are the key takeaways?
People in the combination group lived longer (a median of 10.8 months) than people who received trifluridine/tipiracil alone (7.5 months). In addition, the time it took for the cancer to worsen was longer for those who received the combination treatment (a median of 5.6 months) compared with those who received trifluridine/tipiracil alone (2.4 months). People's physical functioning took longer to worsen with combination therapy (a median of 9.3 months) than it did with trifluridine/tipiracil alone (6.3 months), as measured by the impact of treatment on people's ability to carry out daily living activities. The most common side effects in both treatment groups were low levels of white blood cells, known as neutrophils (neutropenia), nausea, and low levels of healthy red blood cells (anemia).
What were the main conclusions reported by the researchers?
The results from the study suggest that treatment with oral trifluridine/tipiracil plus intravenous (IV) bevacizumab could help people with refractory mCRC live longer and maintain good physical functioning, and it could slow the worsening of their cancer.
Clinical Trial Registration: NCT04737187 (SUNLIGHT) (ClinicalTrials.gov)
This is an abstract of the Plain Language Summary of Publication article.
To read the full Plain Language Summary of this article, click here to view the PDF.
Link to original article here
Financial disclosure
This study was sponsored by Servier and Taiho Oncology, Inc. GWP has been an expert witness for Amgen, AstraZeneca, Bayer, Bristol Myers Squibb, Daiichi Sankyo, Hoffmann-La Roche, Merck KGaA, MSD, Novartis, Pierre Fabre, and Servier and has received consulting fees from Bayer. JT has received consulting fees from Amgen, Astellas, Bristol Myers Squibb, Merck, MSD, Novartis, Pierre Fabre, and Servier. MW has received consulting fees from Amgen, Array BioPharma, AstraZeneca, Bayer, Bristol Myers Squibb, Genentech, Incyte, Mirati Therapeutics, Nouscom, PsiOxus Therapeutics, Taiho Oncology, Inc., and Xenthera. FC has received a research grant from Amgen, Bayer, AstraZeneca, Hoffmann-La Roche, and Merck KGaA and has received consulting fees from Bayer, Hoffmann-La Roche, Merck KGaA, Pfizer, Pierre Fabre, and Servier. EVC has received consulting fees from AbbVie, ALX Oncology, Amgen, Array BioPharma, Astellas, AstraZeneca, Bayer, BeiGene, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Eli Lilly and Company, Hoffmann-La Roche, GlaxoSmithKline, Incyte, Ipsen, Merck, Mirati Therapeutics, Nordic Pharma, Novartis, Pfizer, Pierre Fabre, Seattle Genetics, Servier, Taiho Pharmaceutical Co., Takeda Oncology, Terumo, and Zymeworks. EE has received speaker fees from Amgen, Merck, Organon, Pierre Fabre, Sanofi Aventis, and Servier and has received consulting fees from Bayer, Hoffmann-La Roche, and Novartis. GL has received consultancy fees from Danone and funding for an educational workshop from Servier. DPM has received honoraria for lectures from Amgen, AstraZeneca, Bristol Myers Squibb, Lilly Deutschland, Merck, Pierre Fabre., Seagen, Servier, and Taiho Pharmaceutical Co., consultancy fees from Amgen, Onkowissen, Pierre Fabre, and Takeda Oncology, grants from Amgen and Servier, funds toward travel from Amgen and Servier, and funding as a member of an endpoint review committee from Servier. JT has received consultancy fees from Array BioPharma, AstraZeneca, Bayer, Boehringer Ingelheim, Chugai Pharmaceutical, Daiichi Sankyo, Eli Lilly and Company, Hoffmann-La Roche, Genentech, HalioDX SAS, Hutchinson MediPharma, Ikena Oncology, Inspirna, IQVIA, Menarini, Merck Serono, Merus, MSD, NeoPhore, Novartis, Ona Therapeutics, Orion Biotechnology, Peptomyc, Pfizer, Pierre Fabre, Samsung Bioepis, Sanofi, Scandion Oncology, Scorpion Therapeutics, Seattle Genetics, Servier, SOTIO Biotech, Taiho Pharmaceutical Co., Tessa Therapeutics, and TheraMyc, has received support for an educational collaboration from Imedex /HMP, Medscape Education, MJH Life Sciences, PeerView Institute for Medical Education, and Physicians Education Resource (PER), and has stock in Oniria Therapeutics. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Writing disclosure
Medical writing assistance on an early version of the original manuscript was provided by Fiona Bolland, PhD, CMPP, of Envision Pharma Group, funded by Taiho Oncology, Inc. Medical writing assistance for this plain language summary was provided by Lisa Moore, PhD, CMPP, and Farhana Burnett, PhD, CMPP, of Envision Pharma Group, funded by Taiho Oncology, Inc.
Acknowledgments
The authors thank the patients in this study, their families, the investigators, and the site personnel for their contributions to this study. We thank the Envision the Patient team, of Envision Pharma Group, for reviewing the use of patient-friendly language in this PLSP, and for organizing and providing feedback from a patient reviewer.
Competing interests disclosure
The authors have no competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript.