INDYGO: intraoperative PDT for newly diagnosed GBM, 2-years follow-up (Conference Presentation)

Background and Objective Glioblastoma (GBM) is a malignant brain tumor with a median overall survival of approximately 15 months with the current standard of care (SOC). Although it is a rare neoplastic disease with low prevalence (0.3/10,000 persons), it remains the most frequent primary malignant brain tumor in adults. Currently, there is still no therapeutic option to prevent GBM recurrence and total resection is rarely feasible because of tumor cells infiltrating the surrounding brain. Thus, adjuvant therapies to improve local control are highly expected. 5-ALA photodynamic therapies have been reported with promising results. We present here an ongoing clinical trial (INDYGO) to evaluate 5-ALA PDT delivered intraoperatively to treat newly diagnosed GBM. Materials and Methods Our group has introduced a specific light applicator to deliver PDT in the surgical cavity early after maximal resection. 5-ALA PDT is delivered in combination with the SOC recommended by the current guidelines and enabling to simultaneously investigate the potential synergistic effects. Results and Discussion Between May 2017 and June 2018 ten patients have been enrolled. Currently, therapy has been delivered without significant toxicity or adverse event and are fulfilling the primary endpoint of this feasibility study. Secondary endpoints still being under investigation are progression-free survival, overall survival and patients' quality of life. Conclusions Finally, after the feasibility and the absence of adverse effects, multicentric, parallel-group, randomized controlled trial (RCT) is planned to assess the efficacy of 5-ALA PDT for the treatment of newly diagnosed GBM.