Estimating COVID-19 risk in elderly GBM patients

Interesting recent findings and recommendations from the following two publications:-
"The publication by Tabrizi et al provides a quantitative framework for estimating COVID-19 risk in elderly GBM patients, allowing for personalization of therapeutic choices."

"The overall results demonstrated that in low– and medium–COVID-19 risk scenarios, hypofractionated chemoradiotherapy over 3 weeks yielded the most favorable results, irrespective of MGMT methylation status. For sicker patients for whom single-modality treatment may be contemplated, as expected, MGMT methylation status guides therapeutic selection in the model. For patients with MGMT methylation, temozolomide produced less risk and more favorable survival compared with radiation therapy. In contrast in the MGMT-unmethylated patients, radiation therapy alone was found to be superior to temozolomide."

"In a separate publication, Bernhardt and colleagues assembled a 16-person multidisciplinary expert team to propose practical management strategies to be considered in the context of this pandemic."

"Chemotherapy: Withholding temozolomide from GBM patients with unmethylated MGMT is considered reasonable. Temozolomide monotherapy for elderly GBM patients with methylated tumors is considered a good option. This is recommended only if radiotherapy is unavailable or treatment completion would be put at risk. For elderly patients with unmethylated GBM, temozolomide may be withheld in favor of radiotherapy alone. Given the significant toxicities (including pulmonary fibrosis) and infection risk posed by PCV chemotherapy, consideration should be given to dropping the vincristine, or switching to temozolomide, as feasible."

"Clinical trials: Access to these has started to become more limited, especially where long-distance travel is required. Further, trials that require substantial interactions for endpoints such as cognition, or for multiple blood draws, are becoming more difficult to conduct, and some have, in-fact, been put on hold. However, as and where available, clinical trials should still be offered."

https://www.practiceupdate.com/c/100594/2/1/?elsca1=emc_enews_daily-digest&elsca2=email&elsca3=practiceupdate_onc&elsca4=oncology&elsca5=newsletter&rid=NDQ3MTgxOTYwMzc4S0&lid=10332481

Is it possible to make an emergency application to the FDA for Paxalisib to be used in the treatment of GBM patients with unmethylated MGMT because of the present COVID-19 risk, based on our GBM trial results to date ?

Regards.