Plain Language Summary
What is this summary about?
This plain language summary describes the first results obtained from the ROMEI study. In this study, researchers want to learn how doctors in Italy use ruxolitinib to treat people with myelofibrosis, a rare type of blood cancer. It also looks at how ruxolitinib affects the symptoms and overall health of participants.
What are the key takeaways?
Out of 306 participants, 57% received the expected dose of ruxolitinib, based on their blood test results. Conversely, 43% started with a lower dose than expected, even though their blood test results would have allowed a higher dose. Before the start of the study, people who received the expected dose of ruxolitinib (the ‘AsEx group’) were generally younger and showed better blood test results than participants who received a lower-than-expected dose (the ‘LtEx group’).
During the first 12 months of the treatment, participants in the AsEx group were treated with ruxolitinib for a longer time with fewer interruptions compared to participants in the LtEx group. They also felt better sooner and had a greater, faster reduction in the size of their spleen. Fewer people in the AsEx group died compared to the LtEx group.
What were the main conclusions reported by the researchers?
Patients who received the expected dose of ruxolitinib showed greater improvements in their health compared to those who received a lower dose. Some physicians started with lower doses for older or more frail patients. However, in this study, starting at a lower dose did not show additional advantages.
What do the results mean and why does it matter?
These results show how important it is to start ruxolitinib at the right dose, based on each person’s blood test results. Starting at the right dose can help people with myelofibrosis get the best possible results from treatment, such as faster relief from symptoms, reduction of spleen size, and possibly a longer life.
KEYWORDS: Myelofibrosis, Hematopoietic stem cells, Anemia, spleen, Platelet count, Ruxolitinib, quality of life
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Disclosure statement
Massimo Breccia received honoraria for lectures and consultancy from Novartis, Pfizer, Incyte, BMS/Celgene, AbbVie, AOP, and GSK; Paola Guglielmelli received honoraria for lectures and consultancy from Novartis, AOP, BMS, GSK, and Incyte; Chiara Castiglioni is a Novartis employee; Francesca Palandri received honoraria for consultancy from AbbVie, Amgen, AOP, BMS Celgene, Novartis, CTI, GSK, Grifols, Karyopharm, Morphosis, Sierra Oncology, and Sobi; Francesco Passamonti received honoraria during the last two years for lectures from Novartis, Bristol-Myers Squibb, Abbvie, GSK, AOP Orphan, Jazz, Menarini Stemline and for advisory boards from Novartis, Bristol-Myers Squibb/ Celgene, GSK, Abbvie, Keros, Takeda, Sumitomo. 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.
Editorial support was provided by Alessandra Rossi, PhD, on behalf of Helyx Srl, and was funded by Novartis Farma, Italy.
Patient reviewers on this PLSP have received honorarium from Future Oncology for their review work but have no other relevant financial relationships to disclose.
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Funding
The ROMEI study was sponsored by Novartis Farma S.p.A, Italy. Chiara Castiglioni, a Novartis employee, contributed to the preparation of this PLSP and was involved in the decision to publish. The sponsor was involved in the study design, data collection and analysis. All authors met the criteria for authorship as recommended by the ICMJE.