Results from Outreach: A Phase 2 Study of Lisocabtagene Maraleucel (Liso-cel) Administered As Outpatient (Outpt) or Inpatient (Inpt) Treatment in the Community/Nonuniversity Setting in Patients (Pts) with Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL)

Linhares, Yuliya; Freytes, Cesar; Cherry, Mohamad; Bachier, Carlos; Maris, Michael; Hoda, Daanish; Varela, Juan Carlos; Bellomo, Courtney; Cross, Scott J.; Essell, James; Fanning, Suzanne R.; Terebelo, Howard R.; Yimer, Habte; Courtright, Jay; Sharman, Jeff P.; Vedal, Min; Mailley, Connor; Espinola, Ricardo; Mattar, Bassam

doi:10.1182/blood-2022-159595

Cited by 4 publications

(20 citation statements)

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“…Only one retrospective study did not report the specific location where it was conducted [68]. Eleven studies reported data on CAR-T administration in both outpatient and inpatient settings [26,[32][33][34][35][36][37][38][39][40][41][42][43][44][52][53][54]58,61,62,[64][65][66][67][68]. These publications were based on 5 clinical trials, namely OUTREACH [32][33][34][35][36][37][38], ELARA [66,67], PILOT [39][40][41], TRANSCEND NHL 001 [42][43][44], and TRANSFORM [64,65], where the choice of site of care for patients treated with CAR-T therapies was determined at the investigator's discretion, taking into consideration the perspectives of multiple stakeholders including healthcare providers, patients, and caregivers.…”

Section: Study Characteristicsmentioning

confidence: 99%

“…Nine of the shortlisted studies reported efficacy outcomes including response rates and survival outcomes [36,37,39,42,47,55,57,60,63,67]. Only one clinical trial reported QoL in the patient groups of interest [38].…”

Section: Study Characteristicsmentioning

confidence: 99%

“…Only one clinical trial reported QoL in the patient groups of interest [38]. Five studies reported data on AEs, including CRS and neurologic toxicity [37,39,42,53,67]. Seven studies reported costs/reimbursement amounts associated with the administration of CAR-T in both settings [26,41,52,53,62,65,67].…”

Section: Study Characteristicsmentioning

confidence: 99%

“…Seven studies reported costs/reimbursement amounts associated with the administration of CAR-T in both settings [26,41,52,53,62,65,67]. Ten studies reported data on HCRU [26,37,39,41,[52][53][54]62,67,68] in both settings while a further seven studies reported HCRU among patients who received CAR-T only in the outpatient setting [26,37,39,41,46,[52][53][54][55]57,59,60,[62][63][64]67,68]. The distribution of age, sex, performance status, number of prior treatment lines, and other patient characteristics varied across the studies.…”

Section: Study Characteristicsmentioning

confidence: 99%

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The Impact of Outpatient versus Inpatient Administration of CAR-T Therapies on Clinical, Economic, and Humanistic Outcomes in Patients with Hematological Cancer: A Systematic Literature Review

Hansen,

Liu,

Ranjan

et al. 2023

Cancers

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Although chimeric antigen receptor (CAR)-T cell therapies are typically administered in the inpatient setting, outpatient administration is rapidly expanding. However, there is limited summarized evidence comparing outcomes between outpatient and inpatient administration. This systematic literature review aims to compare the safety, efficacy, quality of life (QoL), costs, and healthcare resource utilization (HCRU) outcomes in patients with hematological cancer who are administered CAR-T therapy in an outpatient versus an inpatient setting. Publications (2016 or later) that reported the outcomes of interest in patients treated with a CAR-T therapy in both outpatient and inpatient settings, or only the outpatient setting, were reviewed. In total, 38 publications based on 21 studies were included. Safety findings suggested the comparable frequency of adverse events in the two settings. Eleven studies that reported data in both settings showed comparable response rates (80–82% in outpatient and 72–80% in inpatient). Improvements in the QoL were observed in both settings while costs associated with CAR-T therapy were lower in the outpatient setting. Although unplanned hospitalizations were higher in the outpatient cohort, overall HCRU was lower. Outpatient administration of CAR-T therapy appears to have comparable outcomes in safety, efficacy, and QoL to inpatient administration while reducing the economic burden.

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Section: Study Characteristicsmentioning

confidence: 99%

Section: Study Characteristicsmentioning

confidence: 99%

Section: Study Characteristicsmentioning

confidence: 99%

Section: Study Characteristicsmentioning

confidence: 99%

See 2 more Smart Citations

The Impact of Outpatient versus Inpatient Administration of CAR-T Therapies on Clinical, Economic, and Humanistic Outcomes in Patients with Hematological Cancer: A Systematic Literature Review

Hansen,

Liu,

Ranjan

et al. 2023

Cancers

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show abstract

“… 19–26 Even among those outpatients who required admission, the median hospital length of stay was approximately 10 days shorter, as compared to patients who received inpatient cell infusion. 22 …”

Section: Introductionmentioning

confidence: 99%

Outpatient CAR T-Cell Therapy as Standard of Care: Current Perspectives and Considerations

Gatwood,

Mahmoudjafari,

Baer

et al. 2024

Clinical Hematology International

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Chimeric antigen receptor T-cell therapy (CAR-T) has altered the treatment landscape of several hematologic malignancies. Until recently, most CAR-T infusions have been administered in the inpatient setting, due to their toxicity profile. However, the advent of new product constructs, as well as improved detection and management of adverse effects, have greatly increased the safety in administering these therapies. CAR-T indications continue to expand, and inpatient administration is associated with increased healthcare resource utilization and overall cost. Therefore, transitioning CAR-T administration to the outpatient setting has been of great interest in an effort to improve access, reduce financial burden, and improve patient satisfaction. Establishment of a successful outpatient CAR-T requires several components, including a multidisciplinary cellular therapy team and an outpatient center with appropriate clinical space and personnel. Additionally, clear criteria for outpatient administration eligibility and for inpatient admission with pathways for prompt toxicity evaluation and admission, and toxicity management guidelines should be implemented. Education about CAR-T therapy and its associated toxicities is imperative for all clinical staff, as well as patients and their caregivers. Finally, rigorous financial planning and close collaboration with payers to ensure equitable access, while effectively managing cost, are essential to program success and sustainability. This review provides a summary of currently published experiences, as well as expert opinion regarding implementation of an outpatient CAR-T program.

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Mobilizing CARs: Benefits, drawbacks, and directions for outpatient CAR T-cell therapy

Woo,

Nguyen,

Liu

et al. 2024

Seminars in Hematology

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Results from Outreach: A Phase 2 Study of Lisocabtagene Maraleucel (Liso-cel) Administered As Outpatient (Outpt) or Inpatient (Inpt) Treatment in the Community/Nonuniversity Setting in Patients (Pts) with Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL)

Cited by 4 publications

References 0 publications

The Impact of Outpatient versus Inpatient Administration of CAR-T Therapies on Clinical, Economic, and Humanistic Outcomes in Patients with Hematological Cancer: A Systematic Literature Review

The Impact of Outpatient versus Inpatient Administration of CAR-T Therapies on Clinical, Economic, and Humanistic Outcomes in Patients with Hematological Cancer: A Systematic Literature Review

Outpatient CAR T-Cell Therapy as Standard of Care: Current Perspectives and Considerations

Mobilizing CARs: Benefits, drawbacks, and directions for outpatient CAR T-cell therapy

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