(PA-014) Outpatient Step-up Dosing of Teclistamab (TEC): An Implementation Process Shifting from the Academic Inpatient (IP) to Community Outpatient (OP) Setting

Step-up dosing (SUD) of TEC can mitigate severity of cytokine release syndrome (CRS). In trials, patients (pts) are admitted for 24-48hr monitoring after each SUD, but bed capacity may limit in the real world. Outpatient (OP) SUD experience is growing but mostly at experienced academic centres, leaving access gaps in the community. We present a structured approach to shift TEC SUD from the IP to OP setting, and from academic to community centres.

Methods:   

To start, we formed a TEC Working Group (providers, nurse educator, pharmacists, project manager) adapting TEC SUD protocols from IP trials to the OP setting. We then tested protocols in a pilot cohort of 13 pts at our academic centre, reviewing pts in sequence for logistics and safety (treatment metrics, toxicity management, resource use).  Safety concerns/inefficiencies led to process modifications and re-testing in subsequent pts. Learnings were collated in a Handbook for community implementation. 

Results:   

All 13 pilot pts were triple-drug refractory, median 3 prior lines, median age 67 (54-82), non-frail (ECOG 0-2, Rockwood frailty score < 6).  Various SUD schedules were used, most MWF. During the 3 SUD period, pts were seen daily until 48hrs post-SUD3.  CRS occurred in 6 pts (46%; all grade 1), onset 1-2 days after SUD2 only. In the OP setting, we mandated tocilizumab (TOCI) for CRS grade 1 (fever only): 5 pts received TOCI, defervescing in 1.5-4.1hrs, enabling 4 to go home same day. Two were admitted for monitoring but discharged next day without intervention. Grade 1 ICANS occurred in 2 pts, 1 received steroid x 1. 6/13 (46%) had SUD delays (mostly SUD3).  OP chair time was 3hrs 27mins, with 1hr monitoring post-dose. 85% required additional supports on daily visits (fluids, transfusions, imaging).

Selected pilot learnings include:  Simple fitness assessment can guide OP selection; daily visits during SUD period safely captures most toxicity events and supports additional care; Mon/Wed/Mon SUD schedule best avoids weekend CRS intervention and is flexible for SUD3 delays; CRS can be treated as an OP using a 4-hr holding space to monitor CRS resolution after TOCI; preemptive TOCI for grade 1 CRS may reduce severity and leads to efficient TOCI use (38% received 1 dose).

The TEC Working Group then compiled pilot learnings into a practical Handbook with 3 sections: TEC OP Logistics (selection, resources, training), Patient Resources (alert card, home monitoring, education), and Management Guide (e.g. OP treatment of CRS). The Handbook is now undergoing implementation at a partner community site, with 3 others planned.  Evaluation of caregiver burden is ongoing.

Conclusions:   

Here we demonstrate a structured process for using academic expertise to shift a complex IP-based treatment into the OP community setting, promoting capacity and access closer to home.  Though our Implementation Science pilot focuses on TEC in myeloma, processes can be applied to other complex therapies across cancer types.