Thoracic Oncology

Hi everyone,

I'd love to hear what everyone is doing for tarlatamab monitoring right now. It's an ever-evolving process for us at the moment. 

Outpatient administration + monitoring for C1D1+D8 is reserved for our ECOG 0-1, lower disease burden, no active CNS disease. We administer at 5PM on a Wednesday and monitor until 11PM in our outpatient infusion center. The patient returns to the infusion center the next morning at 7AM and stays until ~3PM for observation and vital sign monitoring. We try to manage Grade 1 CRS in the outpatient setting if we can.

All other patients are admitted for 24 hours of inpatient monitoring for C1D1+D8.

Thanks in advance for sharing.

Lia

We're still admitting patients for the first 2 doses as our initial patient experiences after FDA approval had significantly higher rates of ICANS than was reported in trials, so we were hesitant to shift towards outpatient monitoring. That said - the emerging 6-8h data from the DeLLphi-300 & 304 trials are certainly encouraging. We haven't met yet as a group but I anticipate we may do so in the next ~6mo to determine which patients best qualify for this approach. Hopefully there will be some labeling changes which support this as well. 

-Kevin

Hi everyone,

I'd love to hear what everyone is doing for tarlatamab monitoring right now. It's an ever-evolving process for us at the moment. 

Outpatient administration + monitoring for C1D1+D8 is reserved for our ECOG 0-1, lower disease burden, no active CNS disease. We administer at 5PM on a Wednesday and monitor until 11PM in our outpatient infusion center. The patient returns to the infusion center the next morning at 7AM and stays until ~3PM for observation and vital sign monitoring. We try to manage Grade 1 CRS in the outpatient setting if we can.

All other patients are admitted for 24 hours of inpatient monitoring for C1D1+D8.

Thanks in advance for sharing.

Lia

I can echo what Kevin's team is doing for our group here at Hopkins. We struggle with solid tumor bed space inpatient so the sooner we can get our patients treated in the outpatient setting, the better. One of the issues has been the inability to expand our OETC (think of it as urgent care for oncology) hours to 24/7 given staffing challenges of APPs. Once we can get staffing for 24/7 OETC, we will likely treat these patients in the outpatient infusion clinic with monitoring in OETC (if still 22 hrs post) or in infusion with transfer to OETC if a labeling change shortens the required monitoring. We have not seen any cases of ICANs yet but we have had some CRS and have had to administer tocilizumab. Our biggest struggle has been the education of ALL of the solid tumor attendings and residents as luck would have it, most of our CRS events have occurred on the weekend or in the middle of the night when our inpatient clinical pharmacy specialists for MedOnc are off. 

We're still admitting patients for the first 2 doses as our initial patient experiences after FDA approval had significantly higher rates of ICANS than was reported in trials, so we were hesitant to shift towards outpatient monitoring. That said - the emerging 6-8h data from the DeLLphi-300 & 304 trials are certainly encouraging. We haven't met yet as a group but I anticipate we may do so in the next ~6mo to determine which patients best qualify for this approach. Hopefully there will be some labeling changes which support this as well. 

-Kevin

Hi everyone,

I'd love to hear what everyone is doing for tarlatamab monitoring right now. It's an ever-evolving process for us at the moment. 

Outpatient administration + monitoring for C1D1+D8 is reserved for our ECOG 0-1, lower disease burden, no active CNS disease. We administer at 5PM on a Wednesday and monitor until 11PM in our outpatient infusion center. The patient returns to the infusion center the next morning at 7AM and stays until ~3PM for observation and vital sign monitoring. We try to manage Grade 1 CRS in the outpatient setting if we can.

All other patients are admitted for 24 hours of inpatient monitoring for C1D1+D8.

Thanks in advance for sharing.

Lia

We have a project to help facilitate outpatient administration of tarlatamab that mimics some of the workflows Lia described in UVA. Patients receive tarlatamab and then after infusion are eligible to go home. A clinic nurse will perform a phone assessment to screen for CRS/ICANS after infusion. 

Patients are educated to call the clinic immediately to confirm CRS/ICAN s/sx. Patients are given APAP, dexamethasone as take-home prescriptions and triage will educate patients when to take these medications.

If they have s/sx during clinic hours, they can come to our triage clinic to receive dexamethasone. If after hours, they must go to a specific ED within our health system. (Patients are only eligible to receive outpatient tarlatamab if they live within 30 minutes of our ED). 

But, with the traffic restrictions and Seattle being kind of a tough place to drive through, we haven't had too many patients on an outpatient protocol.

I can echo what Kevin's team is doing for our group here at Hopkins. We struggle with solid tumor bed space inpatient so the sooner we can get our patients treated in the outpatient setting, the better. One of the issues has been the inability to expand our OETC (think of it as urgent care for oncology) hours to 24/7 given staffing challenges of APPs. Once we can get staffing for 24/7 OETC, we will likely treat these patients in the outpatient infusion clinic with monitoring in OETC (if still 22 hrs post) or in infusion with transfer to OETC if a labeling change shortens the required monitoring. We have not seen any cases of ICANs yet but we have had some CRS and have had to administer tocilizumab. Our biggest struggle has been the education of ALL of the solid tumor attendings and residents as luck would have it, most of our CRS events have occurred on the weekend or in the middle of the night when our inpatient clinical pharmacy specialists for MedOnc are off. 

We're still admitting patients for the first 2 doses as our initial patient experiences after FDA approval had significantly higher rates of ICANS than was reported in trials, so we were hesitant to shift towards outpatient monitoring. That said - the emerging 6-8h data from the DeLLphi-300 & 304 trials are certainly encouraging. We haven't met yet as a group but I anticipate we may do so in the next ~6mo to determine which patients best qualify for this approach. Hopefully there will be some labeling changes which support this as well. 

-Kevin

Hi everyone,

I'd love to hear what everyone is doing for tarlatamab monitoring right now. It's an ever-evolving process for us at the moment. 

Outpatient administration + monitoring for C1D1+D8 is reserved for our ECOG 0-1, lower disease burden, no active CNS disease. We administer at 5PM on a Wednesday and monitor until 11PM in our outpatient infusion center. The patient returns to the infusion center the next morning at 7AM and stays until ~3PM for observation and vital sign monitoring. We try to manage Grade 1 CRS in the outpatient setting if we can.

All other patients are admitted for 24 hours of inpatient monitoring for C1D1+D8.

Thanks in advance for sharing.

Lia

Hi all,

I am curious how your outpatient tarlatamab processes have been going more recently? We are hoping to implement a process here soon at Duke. We were planning to closely mirror the DeLLphi-300 substudy, including a clinic visit on day 2/day 9 and nurse phone call on day 3/day 10 with patients staying local to Duke for the first 48-72 hours. Has anyone else implemented a process similar to this or made modifications to your processes described previously? Our infusion center is only open 8-8, so one of our struggles is timing of tarla administration to avoid overnight CRS given the average onset of 10-16 hours post-dose. Our thought is to administer first thing in the morning to maintain the 6-8hr observation period as well. Patients will be instructed to take dex and tylenol if CRS symptoms develop and given a wallet card. We will try to manage Gr1 CRS outpatient, but otherwise want to be very cautious with monitoring as we get this rolling.

Thank you in advance!

We have a project to help facilitate outpatient administration of tarlatamab that mimics some of the workflows Lia described in UVA. Patients receive tarlatamab and then after infusion are eligible to go home. A clinic nurse will perform a phone assessment to screen for CRS/ICANS after infusion. 

Patients are educated to call the clinic immediately to confirm CRS/ICAN s/sx. Patients are given APAP, dexamethasone as take-home prescriptions and triage will educate patients when to take these medications.

If they have s/sx during clinic hours, they can come to our triage clinic to receive dexamethasone. If after hours, they must go to a specific ED within our health system. (Patients are only eligible to receive outpatient tarlatamab if they live within 30 minutes of our ED). 

But, with the traffic restrictions and Seattle being kind of a tough place to drive through, we haven't had too many patients on an outpatient protocol.

I can echo what Kevin's team is doing for our group here at Hopkins. We struggle with solid tumor bed space inpatient so the sooner we can get our patients treated in the outpatient setting, the better. One of the issues has been the inability to expand our OETC (think of it as urgent care for oncology) hours to 24/7 given staffing challenges of APPs. Once we can get staffing for 24/7 OETC, we will likely treat these patients in the outpatient infusion clinic with monitoring in OETC (if still 22 hrs post) or in infusion with transfer to OETC if a labeling change shortens the required monitoring. We have not seen any cases of ICANs yet but we have had some CRS and have had to administer tocilizumab. Our biggest struggle has been the education of ALL of the solid tumor attendings and residents as luck would have it, most of our CRS events have occurred on the weekend or in the middle of the night when our inpatient clinical pharmacy specialists for MedOnc are off. 

We're still admitting patients for the first 2 doses as our initial patient experiences after FDA approval had significantly higher rates of ICANS than was reported in trials, so we were hesitant to shift towards outpatient monitoring. That said - the emerging 6-8h data from the DeLLphi-300 & 304 trials are certainly encouraging. We haven't met yet as a group but I anticipate we may do so in the next ~6mo to determine which patients best qualify for this approach. Hopefully there will be some labeling changes which support this as well. 

-Kevin

Hi everyone,

I'd love to hear what everyone is doing for tarlatamab monitoring right now. It's an ever-evolving process for us at the moment. 

Outpatient administration + monitoring for C1D1+D8 is reserved for our ECOG 0-1, lower disease burden, no active CNS disease. We administer at 5PM on a Wednesday and monitor until 11PM in our outpatient infusion center. The patient returns to the infusion center the next morning at 7AM and stays until ~3PM for observation and vital sign monitoring. We try to manage Grade 1 CRS in the outpatient setting if we can.

All other patients are admitted for 24 hours of inpatient monitoring for C1D1+D8.

Thanks in advance for sharing.

Lia