KEY TAKEAWAYS
- The INDYGO trial aimed to provide patients with updated exploratory analyses on OS, PFS, and HRQOL.
- The study concluded that intraoperative PDT alongside surgical excision and standard adjuvant therapy improved outcomes.
Despite optimal multimodal management, glioblastoma, a form of brain cancer, remains incurable. An interim analysis from the open-label INDYGO pilot trial demonstrated promising outcomes, including a 12-month progression-free survival (PFS) rate of 60% (median 17.1 months) and a 12-month overall survival (OS) rate of 80% (median 23.1 months).
Iulia Peciu-Florianu and the team aimed to present updated exploratory analyses on OS, PFS, and health-related quality of life (HRQOL) for individuals undergoing intraoperative photodynamic therapy (PDT) with 5-aminolevulinic acid hydrochloride (5-ALA HCl).
The study included 10 patients from May 2017 to April 2021 and employed a standardized therapeutic approach. This approach comprised 5-ALA HCl fluorescence-guided surgery (FGS), followed by intraoperative PDT using a single 200 J/cm2 light dose.
Following surgery, patients underwent adjuvant therapy following the Stupp protocol and were monitored every 3 months with clinical assessments and cerebral MRI scans until disease progression or death. The procedure’s safety and toxicity within the first 4 weeks post-PDT were evaluated. Data on relapse, HRQOL, and survival were collected and analyzed prospectively.
The results revealed that as of the November 1st, 2023 cut-off, the median follow-up period was 23 months (ranging from 9.7 to 71.4 months). No unacceptable or unexpected toxicities were observed, and there were no treatment-related deaths throughout the study. The Kaplan-Meier analysis estimated a median OS of 23.4 months. The actuarial 12-month progress PFS rate was 60%, while the actuarial rates for 12-month, 24-month, and 5-year OS were 80%, 50%, and 40%, respectively. About 4 patients were still alive at the time of analysis, with one being recurrence-free.
The study concluded that at the 5-year follow-up, intraoperative PDT combined with surgical maximal excision as initial therapy, along with standard adjuvant treatment, indicated an extended time to recurrence and improved overall survival in many patients. Moreover, the maintenance of QOL was observed without any severe side effects.
The trial was sponsored by the University Hospital, Lille.
Source: https://link.springer.com/article/10.1007/s11060-024-04693-4
Clinical Trial: https://clinicaltrials.gov/study/NCT03048240
Peciu-Florianu, I., Vannod-Michel, Q., Vauleon, E., et al. (2024) “Long-term follow-up of patients with newly diagnosed glioblastoma treated by intraoperative photodynamic therapy: an update from the INDYGO trial (NCT03048240).” J Neurooncol (2024). https://doi.org/10.1007/s11060-024-04693-4
