Brief Summary
This article presents the long-term results of the PRECIS trial, a randomized phase II study investigating the efficacy and safety of whole-brain radiotherapy (WBRT) versus autologous stem-cell transplantation (ASCT) as consolidation treatment for patients with newly diagnosed primary CNS lymphoma. The study found that ASCT significantly reduced the risk of relapse compared to WBRT, with a higher 8-year event-free survival rate. While both treatments resulted in similar overall survival rates, WBRT was associated with significant neurotoxicity and cognitive impairment, leading the authors to conclude that ASCT is the preferred consolidation treatment for primary CNS lymphoma.
- ASCT significantly reduced the risk of relapse compared to WBRT.
- WBRT was associated with significant neurotoxicity and cognitive impairment.
Long-Term Outcomes of the PRECIS Trial
This chapter presents the long-term results of the PRECIS trial, a randomized phase II study investigating the efficacy and safety of whole-brain radiotherapy (WBRT) versus autologous stem-cell transplantation (ASCT) as consolidation treatment for patients with newly diagnosed primary CNS lymphoma. The study included 140 patients who were randomly assigned to receive either WBRT or ASCT after induction chemotherapy. The median follow-up was 98 months.
The study found that the 8-year event-free survival (EFS) from random assignment was significantly higher in the ASCT arm (67%) compared to the WBRT arm (39%). This indicates that ASCT was more effective in preventing relapses. The 8-year overall survival (OS) from random assignment was similar in both arms (69% for ASCT and 65% for WBRT). However, the authors noted that the similar OS rates were likely due to the successful salvage treatments with ASCT in the WBRT arm and the higher incidence of ASCT-related deaths in the ASCT arm.
Long-Term Complications
This chapter focuses on the long-term complications observed in the PRECIS trial, particularly neurocognitive impairment and other complications of special interest.
The study found that a significant decline in neurocognitive function, especially executive functions, was observed only after WBRT. This decline was not observed in the ASCT arm. The authors also noted that balance and cognition declined in a significantly higher proportion of patients in the WBRT arm compared to the ASCT arm.
Other complications of special interest included ischemic strokes, which were reported in seven patients after WBRT, and second solid cancers, which were reported in four patients after ASCT.
Discussion
This chapter discusses the implications of the long-term results of the PRECIS trial and compares them to previous studies.
The authors emphasize that the long-term analysis confirms the findings of the initial report, which showed a lower incidence of relapse after ASCT and a higher risk of cognitive impairment after WBRT. They also discuss the potential risks and benefits of using thiotepa-busulfan without cyclophosphamide for ASCT conditioning, as suggested by other studies.
The authors conclude that the long-term analysis of the PRECIS trial reinforces the recommendation to avoid conventional 40 Gy WBRT in first-line treatment for primary CNS lymphoma due to its neurotoxicity and suboptimal efficacy in reducing relapses. They advocate for ASCT consolidation as the preferred treatment option for better disease control.
Acknowledgement
This chapter acknowledges the contributions of the patients, their families, and the nursing staff involved in the PRECIS trial.
Data Sharing Statement
This chapter provides information about the study protocol and data sharing statement. It includes a link to access the protocol information and a statement about the availability of data sharing.
Authors' Disclosures of Potential Conflicts of Interest
This chapter lists the authors' disclosures of potential conflicts of interest, including any financial relationships or other affiliations that could be perceived as influencing their work.
References
This chapter provides a list of references cited in the article.
Appendix
This chapter includes supplementary figures and tables that provide additional information about the study design, patient characteristics, and results.
Metrics & Citations
This section provides information about the article's metrics, such as the number of citations and Altmetric score. It also includes options for downloading the article citation data.
Information
This section provides information about the article's publication details, including the journal, volume, issue, pages, PubMed ID, copyright information, and history.
Authors Affiliations
This section lists the authors' affiliations and provides links to their profiles.
Notes
This section provides contact information for the corresponding author.
Figures
This section provides links to the figures included in the article.
Other
This section includes options for sharing the article link and accessing the full text or PDF version. It also includes links to previous and next articles in the journal.