Lisocabtagene Maraleucel (Liso-cel) in Patients with Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL) Treated As Outpatients or Inpatients in the Community/Nonuniversity Setting: Patient-Reported Outcomes/Health-Related Quality of Life from the Outreach Study

Linhares, Yuliya; Liu, Fei‐Fei; Freytes, Cesar; Cherry, Mohamad; Shi, Ling; Liao, Weiqi; Braverman, Julia; Espinola, Ricardo; Vedal, Min; Mattar, Bassam

doi:10.1182/blood-2022-159645

Cited by 2 publications

(7 citation statements)

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“…In the reviewed studies, the choice of outpatient administration was at the investigator's discretion, taking into account patient disease characteristics, clinical status, and logistical considerations, such as the availability of caregiver support and the ability to remain within a short distance from the treatment site for 30 days after infusion [32,[34][35][36][37][38][39][42][43][44][64][65][66][67]. Typically, patients receiving CAR-T therapy in the outpatient setting are closely monitored by a multidisciplinary CAR-T therapy team and adhere to standard operating procedures for outpatient AE monitoring and management [32,[34][35][36][37][38]66,67].…”

Section: Discussionmentioning

confidence: 99%

“…2022) reported QoL assessments in patients treated with CAR-T therapy at multiple time points, including pre-treatment (baseline), on day of infusion, on several dates after infusion (days 29, 50, 90, 180, 270, 365, 545, and 730/end of study), and at disease progression and assessed the least squares (LS) mean change from the baseline for visits with ≥10 patients. Both the outpatient and inpatient groups exhibited comparable meaningful improvements in various aspects of QoL, including global health status/QoL, fatigue, pain, assessed by EORTC-QLQ-C30, and the EuroQol 5-Level 5-Dimension questionnaire (EQ-5D-5L) visual analog scale (VAS) scores (Table 8) [38].…”

Section: Efficacy: Response and Survival Outcomesmentioning

confidence: 98%

“…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]. Five studies reported data on AEs, including CRS and neurologic toxicity [37,39,42,53,67].…”

Section: Study Characteristicsmentioning

confidence: 99%

“…The modified Downs and Black checklist with 27 items assessed eight non-randomized single-arm trials. Table S5 highlights one study of good quality (score, [15][16][17], five of fair quality (score, [12][13][14], and two of poor quality (score < 11) [38,39,42,46,49,51,67]. The NOS criteria were used to assess the quality of double-arm and single-arm observational studies.…”

Section: Quality Assessmentmentioning

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: Discussionmentioning

confidence: 99%

Section: Efficacy: Response and Survival Outcomesmentioning

confidence: 98%

Section: Study Characteristicsmentioning

confidence: 99%

Section: Study Characteristicsmentioning

confidence: 99%

Section: Quality Assessmentmentioning

confidence: 99%

See 3 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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Comparing 2-day vs 3-day flu-CY lymphodepleting regimens for CD19 CAR T-cell therapy in patients with non-hodgkin’s lymphoma

Frame,

Geer,

Kasha

et al. 2024

Front. Immunol.

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IntroductionLymphodepleting chemotherapy (LDC) is critical to CAR T-cell expansion and efficacy. Despite this, there is not a consensus in the literature regarding the optimal LDC regimen, including dose and frequency.MethodsWe retrospectively reviewed consecutive patients at a single institution that received LDC prior to treatment with the CD19 directed CAR T-cell products axicabtagene ciloleucel and tisagenlecleucel. Patients treated at our center received fludarabine 30 mg/m2 and cyclophosphamide 500 mg/m2 for 3 consecutive days prior to May 2019. After this timepoint patients routinely received fludarabine 40 mg/m2 and cyclophosphamide 500 mg/m2 for 2 consecutive days. Clinical data from each cohort were obtained from the electronic medical record and compared for differences in CAR T-cell efficacy and toxicity.ResultsFrom June 2018 to August 2023, LDC was given to 92 patients prior to CD19 directed CAR T-cell therapy for relapsed non-Hodgkin’s lymphoma. Twenty-eight patients received a 3-day regimen, and 64 patients received a 2-day regimen. In the total cohort, 75% of patients received axicabtagene ciloleucel and 25% received tisagenlecleucel. The overall response rates in both the 2-day regimen group and the 3-day regimen group were similar (69% vs 75%, p= 0.21) as were the complete response rates (50% vs 54%, p=0.82). There were no significant differences between the 2-day and 3-day regimens for grade 2–4 cytokine release syndrome (55% vs 50%, p=0.82), grade 2–4 immune effector cell associated-neurotoxicity syndrome (42% vs 29%, p=0.25), or time to resolution of neutropenia or thrombocytopenia. The rate of prolonged platelet recovery lasting greater than 60 days was higher with the 3-day regimen (9% vs 27%, p=0.026).DiscussionAs the number of patients eligible for CAR T-cell therapy continues to increase, optimizing each component of therapy is necessary. We show that a 2-day regimen of LDC with fludarabine and cyclophosphamide is feasible without significant impact on CAR T-cell efficacy or toxicity. Prospective studies are necessary to further determine the most effective LDC regimen.

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Lisocabtagene Maraleucel (Liso-cel) in Patients with Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL) Treated As Outpatients or Inpatients in the Community/Nonuniversity Setting: Patient-Reported Outcomes/Health-Related Quality of Life from the Outreach Study

Cited by 2 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

Comparing 2-day vs 3-day flu-CY lymphodepleting regimens for CD19 CAR T-cell therapy in patients with non-hodgkin’s lymphoma

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