ORCID Profile
0000-0002-8904-3802
Current Organisations
University of Amsterdam
,
Amsterdam UMC Locatie AMC Divisie 1
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Publisher: American Association for Cancer Research (AACR)
Date: 15-05-2023
DOI: 10.1158/1078-0432.C.6516061.V2
Abstract: AbstractPurpose: Older patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) may be considered ineligible for curative-intent therapy including high-dose chemotherapy with autologous stem-cell transplantation (HDT-ASCT). Here, we report outcomes of a preplanned subgroup analysis of patients ≥65 years in ZUMA-7. Patients and Methods: Patients with LBCL refractory to or relapsed ≤12 months after first-line chemoimmunotherapy were randomized 1:1 to axicabtagene ciloleucel [axi-cel autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy] or standard of care (SOC 2–3 cycles of chemoimmunotherapy followed by HDT-ASCT). The primary endpoint was event-free survival (EFS). Secondary endpoints included safety and patient-reported outcomes (PROs). Results: Fifty-one and 58 patients aged ≥65 years were randomized to axi-cel and SOC, respectively. Median EFS was greater with axi-cel versus SOC (21.5 vs. 2.5 months median follow-up: 24.3 months HR, 0.276 descriptive i P /i 0.0001). Objective response rate was higher with axi-cel versus SOC (88% vs. 52% OR, 8.81 descriptive i P /i 0.0001 complete response rate: 75% vs. 33%). Grade ≥3 adverse events occurred in 94% of axi-cel and 82% of SOC patients. No grade 5 cytokine release syndrome or neurologic events occurred. In the quality-of-life analysis, the mean change in PRO scores from baseline at days 100 and 150 favored axi-cel for EORTC QLQ-C30 Global Health, Physical Functioning, and EQ-5D-5L visual analog scale (descriptive i P /i 0.05). CAR T-cell expansion and baseline serum inflammatory profile were comparable in patients ≥65 and years. Conclusions: Axi-cel is an effective second-line curative-intent therapy with a manageable safety profile and improved PROs for patients ≥65 years with R/R LBCL. /
Publisher: American Association for Cancer Research (AACR)
Date: 31-03-2023
DOI: 10.1158/1078-0432.C.6516061.V1
Abstract: AbstractPurpose: Older patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) may be considered ineligible for curative-intent therapy including high-dose chemotherapy with autologous stem-cell transplantation (HDT-ASCT). Here, we report outcomes of a preplanned subgroup analysis of patients ≥65 years in ZUMA-7. Patients and Methods: Patients with LBCL refractory to or relapsed ≤12 months after first-line chemoimmunotherapy were randomized 1:1 to axicabtagene ciloleucel [axi-cel autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy] or standard of care (SOC 2–3 cycles of chemoimmunotherapy followed by HDT-ASCT). The primary endpoint was event-free survival (EFS). Secondary endpoints included safety and patient-reported outcomes (PROs). Results: Fifty-one and 58 patients aged ≥65 years were randomized to axi-cel and SOC, respectively. Median EFS was greater with axi-cel versus SOC (21.5 vs. 2.5 months median follow-up: 24.3 months HR, 0.276 descriptive i P /i 0.0001). Objective response rate was higher with axi-cel versus SOC (88% vs. 52% OR, 8.81 descriptive i P /i 0.0001 complete response rate: 75% vs. 33%). Grade ≥3 adverse events occurred in 94% of axi-cel and 82% of SOC patients. No grade 5 cytokine release syndrome or neurologic events occurred. In the quality-of-life analysis, the mean change in PRO scores from baseline at days 100 and 150 favored axi-cel for EORTC QLQ-C30 Global Health, Physical Functioning, and EQ-5D-5L visual analog scale (descriptive i P /i 0.05). CAR T-cell expansion and baseline serum inflammatory profile were comparable in patients ≥65 and years. Conclusions: Axi-cel is an effective second-line curative-intent therapy with a manageable safety profile and improved PROs for patients ≥65 years with R/R LBCL. /
Publisher: American Association for Cancer Research (AACR)
Date: 15-05-2023
DOI: 10.1158/1078-0432.22820209.V1
Abstract: Tabulated data supporting ZUMA-7 elderly analysisSupplementary Table S1. Patient-reported outcomes instrumentsSupplementary Table S2. Axi-cel delivery and administration timeSupplementary Table S3. Summary of efficacy and safety outcomes in patients ≥65 years versus all patients in ZUMA-7Supplementary Table S4. Serious adverse events in at least 3 patients in patients ≥65 yearsSupplementary Table S5. Summary of cytopenias present on or after 90 days from initiation of definitive therapy on protocol in patients ≥65 yearsSupplementary Table S6. Deaths in axi-cel and SOC arms for patients ≥65 years (safety analysis set)Supplementary Table S7. Summary of serum analytes in patients years versus ≥65 years in the axi-cel arm (N = 170)Supplementary Table S8. Most common adverse events, cytokine release syndrome, and neurologic events in patients ≥70 yearsSupplementary Table S9. Deaths in axi-cel and SOC arms for patients ≥70 years Supplementary Table S10. Baseline characteristics for quality-of-life analysis in patients ≥65 yearsSupplementary Table S11. Mixed model with repeated measures estimated difference in change from baseline forprespecified patient-reported outcomes measures (quality-of-life analysis set) in patients ≥65 years
Publisher: American Association for Cancer Research (AACR)
Date: 31-03-2023
DOI: 10.1158/1078-0432.22437817
Abstract: CAR T-cell levels in patients ≥65 years
Publisher: American Association for Cancer Research (AACR)
Date: 15-05-2023
DOI: 10.1158/1078-0432.C.6516061
Abstract: AbstractPurpose: Older patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) may be considered ineligible for curative-intent therapy including high-dose chemotherapy with autologous stem-cell transplantation (HDT-ASCT). Here, we report outcomes of a preplanned subgroup analysis of patients ≥65 years in ZUMA-7. Patients and Methods: Patients with LBCL refractory to or relapsed ≤12 months after first-line chemoimmunotherapy were randomized 1:1 to axicabtagene ciloleucel [axi-cel autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy] or standard of care (SOC 2–3 cycles of chemoimmunotherapy followed by HDT-ASCT). The primary endpoint was event-free survival (EFS). Secondary endpoints included safety and patient-reported outcomes (PROs). Results: Fifty-one and 58 patients aged ≥65 years were randomized to axi-cel and SOC, respectively. Median EFS was greater with axi-cel versus SOC (21.5 vs. 2.5 months median follow-up: 24.3 months HR, 0.276 descriptive i P /i 0.0001). Objective response rate was higher with axi-cel versus SOC (88% vs. 52% OR, 8.81 descriptive i P /i 0.0001 complete response rate: 75% vs. 33%). Grade ≥3 adverse events occurred in 94% of axi-cel and 82% of SOC patients. No grade 5 cytokine release syndrome or neurologic events occurred. In the quality-of-life analysis, the mean change in PRO scores from baseline at days 100 and 150 favored axi-cel for EORTC QLQ-C30 Global Health, Physical Functioning, and EQ-5D-5L visual analog scale (descriptive i P /i 0.05). CAR T-cell expansion and baseline serum inflammatory profile were comparable in patients ≥65 and years. Conclusions: Axi-cel is an effective second-line curative-intent therapy with a manageable safety profile and improved PROs for patients ≥65 years with R/R LBCL. /
Publisher: American Association for Cancer Research (AACR)
Date: 31-03-2023
DOI: 10.1158/1078-0432.22437826.V1
Abstract: Overall survival (interim) and progression-free survival in patients ≥70 years
Publisher: American Association for Cancer Research (AACR)
Date: 15-05-2023
DOI: 10.1158/1078-0432.22820209
Abstract: Tabulated data supporting ZUMA-7 elderly analysisSupplementary Table S1. Patient-reported outcomes instrumentsSupplementary Table S2. Axi-cel delivery and administration timeSupplementary Table S3. Summary of efficacy and safety outcomes in patients ≥65 years versus all patients in ZUMA-7Supplementary Table S4. Serious adverse events in at least 3 patients in patients ≥65 yearsSupplementary Table S5. Summary of cytopenias present on or after 90 days from initiation of definitive therapy on protocol in patients ≥65 yearsSupplementary Table S6. Deaths in axi-cel and SOC arms for patients ≥65 years (safety analysis set)Supplementary Table S7. Summary of serum analytes in patients years versus ≥65 years in the axi-cel arm (N = 170)Supplementary Table S8. Most common adverse events, cytokine release syndrome, and neurologic events in patients ≥70 yearsSupplementary Table S9. Deaths in axi-cel and SOC arms for patients ≥70 years Supplementary Table S10. Baseline characteristics for quality-of-life analysis in patients ≥65 yearsSupplementary Table S11. Mixed model with repeated measures estimated difference in change from baseline forprespecified patient-reported outcomes measures (quality-of-life analysis set) in patients ≥65 years
Publisher: American Association for Cancer Research (AACR)
Date: 31-03-2023
DOI: 10.1158/1078-0432.22437820
Abstract: Mixed model with repeated measures for change from baseline for prespecified patient-reported outcomes endpoints in patients ≥65 years
Publisher: American Association for Cancer Research (AACR)
Date: 15-05-2023
DOI: 10.1158/1078-0432.22820215
Abstract: Mixed model with repeated measures for change from baseline for prespecified patient-reported outcomes endpoints in patients ≥65 years
Publisher: American Association for Cancer Research (AACR)
Date: 31-03-2023
DOI: 10.1158/1078-0432.22437823.V1
Abstract: Sensitivity analysis of interim overall survival in patients ≥65 years
Publisher: American Association for Cancer Research (AACR)
Date: 15-05-2023
DOI: 10.1158/1078-0432.22820212
Abstract: CAR T-cell levels in patients ≥65 years
Publisher: American Association for Cancer Research (AACR)
Date: 15-05-2023
DOI: 10.1158/1078-0432.22820218
Abstract: Sensitivity analysis of interim overall survival in patients ≥65 years
Publisher: American Association for Cancer Research (AACR)
Date: 31-03-2023
DOI: 10.1158/1078-0432.22437823
Abstract: Sensitivity analysis of interim overall survival in patients ≥65 years
Publisher: American Association for Cancer Research (AACR)
Date: 31-03-2023
DOI: 10.1158/1078-0432.22437826
Abstract: Overall survival (interim) and progression-free survival in patients ≥70 years
Publisher: American Association for Cancer Research (AACR)
Date: 15-05-2023
DOI: 10.1158/1078-0432.22820215.V1
Abstract: Mixed model with repeated measures for change from baseline for prespecified patient-reported outcomes endpoints in patients ≥65 years
Publisher: American Association for Cancer Research (AACR)
Date: 15-05-2023
DOI: 10.1158/1078-0432.22820224.V1
Abstract: Event-free survival per central review and objective response rate in patients ≥70 years
Publisher: American Association for Cancer Research (AACR)
Date: 31-03-2023
DOI: 10.1158/1078-0432.22437817.V1
Abstract: CAR T-cell levels in patients ≥65 years
Publisher: American Association for Cancer Research (AACR)
Date: 31-03-2023
DOI: 10.1158/1078-0432.22437829.V1
Abstract: Event-free survival per central review and objective response rate in patients ≥70 years
Publisher: American Association for Cancer Research (AACR)
Date: 15-05-2023
DOI: 10.1158/1078-0432.22820212.V1
Abstract: CAR T-cell levels in patients ≥65 years
Publisher: American Association for Cancer Research (AACR)
Date: 31-03-2023
DOI: 10.1158/1078-0432.22437829
Abstract: Event-free survival per central review and objective response rate in patients ≥70 years
Publisher: American Association for Cancer Research (AACR)
Date: 31-03-2023
DOI: 10.1158/1078-0432.22437820.V1
Abstract: Mixed model with repeated measures for change from baseline for prespecified patient-reported outcomes endpoints in patients ≥65 years
Publisher: American Association for Cancer Research (AACR)
Date: 15-05-2023
DOI: 10.1158/1078-0432.22820218.V1
Abstract: Sensitivity analysis of interim overall survival in patients ≥65 years
Publisher: American Association for Cancer Research (AACR)
Date: 15-05-2023
DOI: 10.1158/1078-0432.22820224
Abstract: Event-free survival per central review and objective response rate in patients ≥70 years
Publisher: American Association for Cancer Research (AACR)
Date: 31-03-2023
DOI: 10.1158/1078-0432.CCR-22-3136
Abstract: Older patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) may be considered ineligible for curative-intent therapy including high-dose chemotherapy with autologous stem-cell transplantation (HDT-ASCT). Here, we report outcomes of a preplanned subgroup analysis of patients ≥65 years in ZUMA-7. Patients with LBCL refractory to or relapsed ≤12 months after first-line chemoimmunotherapy were randomized 1:1 to axicabtagene ciloleucel [axi-cel autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy] or standard of care (SOC 2–3 cycles of chemoimmunotherapy followed by HDT-ASCT). The primary endpoint was event-free survival (EFS). Secondary endpoints included safety and patient-reported outcomes (PROs). Fifty-one and 58 patients aged ≥65 years were randomized to axi-cel and SOC, respectively. Median EFS was greater with axi-cel versus SOC (21.5 vs. 2.5 months median follow-up: 24.3 months HR, 0.276 descriptive P & 0.0001). Objective response rate was higher with axi-cel versus SOC (88% vs. 52% OR, 8.81 descriptive P & 0.0001 complete response rate: 75% vs. 33%). Grade ≥3 adverse events occurred in 94% of axi-cel and 82% of SOC patients. No grade 5 cytokine release syndrome or neurologic events occurred. In the quality-of-life analysis, the mean change in PRO scores from baseline at days 100 and 150 favored axi-cel for EORTC QLQ-C30 Global Health, Physical Functioning, and EQ-5D-5L visual analog scale (descriptive P & 0.05). CAR T-cell expansion and baseline serum inflammatory profile were comparable in patients ≥65 and & years. Axi-cel is an effective second-line curative-intent therapy with a manageable safety profile and improved PROs for patients ≥65 years with R/R LBCL.
Publisher: American Association for Cancer Research (AACR)
Date: 15-05-2023
DOI: 10.1158/1078-0432.22820221.V1
Abstract: Overall survival (interim) and progression-free survival in patients ≥70 years
Publisher: American Association for Cancer Research (AACR)
Date: 31-03-2023
DOI: 10.1158/1078-0432.22437814
Abstract: Tabulated data supporting ZUMA-7 elderly analysis Supplementary Table S1. Patient-reported outcomes instruments Supplementary Table S2. Axi-cel delivery and administration time Supplementary Table S3. Summary of efficacy and safety outcomes in patients ≥65 years versus all patients in ZUMA-7 Supplementary Table S4. Serious adverse events in at least 3 patients in patients ≥65 years Supplementary Table S5. Summary of cytopenias present on or after 90 days from initiation of definitive therapy on protocol in patients ≥65 years Supplementary Table S6. Deaths in axi-cel and SOC arms for patients ≥65 years (safety analysis set) Supplementary Table S7. Summary of serum analytes in patients years versus ≥65 years in the axi-cel arm (N = 170) Supplementary Table S8. Most common adverse events, cytokine release syndrome, and neurologic events in patients ≥70 years Supplementary Table S9. Deaths in axi-cel and SOC arms for patients ≥70 years Supplementary Table S10. Baseline characteristics for quality-of-life analysis in patients ≥65 years Supplementary Table S11. Mixed model with repeated measures estimated difference in change from baseline for prespecified patient-reported outcomes measures (quality-of-life analysis set) in patients ≥65 years
Publisher: American Association for Cancer Research (AACR)
Date: 31-03-2023
DOI: 10.1158/1078-0432.22437814.V1
Abstract: Tabulated data supporting ZUMA-7 elderly analysis Supplementary Table S1. Patient-reported outcomes instruments Supplementary Table S2. Axi-cel delivery and administration time Supplementary Table S3. Summary of efficacy and safety outcomes in patients ≥65 years versus all patients in ZUMA-7 Supplementary Table S4. Serious adverse events in at least 3 patients in patients ≥65 years Supplementary Table S5. Summary of cytopenias present on or after 90 days from initiation of definitive therapy on protocol in patients ≥65 years Supplementary Table S6. Deaths in axi-cel and SOC arms for patients ≥65 years (safety analysis set) Supplementary Table S7. Summary of serum analytes in patients years versus ≥65 years in the axi-cel arm (N = 170) Supplementary Table S8. Most common adverse events, cytokine release syndrome, and neurologic events in patients ≥70 years Supplementary Table S9. Deaths in axi-cel and SOC arms for patients ≥70 years Supplementary Table S10. Baseline characteristics for quality-of-life analysis in patients ≥65 years Supplementary Table S11. Mixed model with repeated measures estimated difference in change from baseline for prespecified patient-reported outcomes measures (quality-of-life analysis set) in patients ≥65 years
Publisher: American Association for Cancer Research (AACR)
Date: 15-05-2023
DOI: 10.1158/1078-0432.22820221
Abstract: Overall survival (interim) and progression-free survival in patients ≥70 years
No related grants have been discovered for Marie José Kersten.