Association of Extended Dosing Intervals or Delays in Pembrolizumab-based Regimens With Survival Outcomes in Advanced Non-small-cell Lung Cancer
Copyright © 2020 Elsevier Inc. All rights reserved..
BACKGROUND: Besides modeling/simulation-based analysis, no post-approval studies have evaluated the optimal administration frequency of pembrolizumab in non-small-cell lung cancer (NSCLC).
PATIENTS AND METHODS: We performed a multicenter retrospective cohort study to evaluate the association between survival outcomes and treatment extensions/delays of pembrolizumab-based regimens in patients with advanced NSCLC. Those who had received at least 4 cycles in routine practice were divided into 2 groups: nonstandard (Non-Std, ≥ 2 cycles at intervals > 3 weeks + 3 days) and standard (Std, all cycles every 3 weeks or 1 cycle > 3 weeks + 3 days).
RESULTS: Among 150 patients, 92 (61%) were eligible for the study (Non-Std, 27; Std, 65). The reasons for patients with extensions/delays in the Non-Std group included: immune-related adverse events (irAEs) (33%), non-irAE-related medical issues (26%), and patient-physician preference (41%). The Non-Std group was more likely to have a higher programmed death-ligand 1 tumor proportion score, a higher number of treatment cycles, and pembrolizumab monotherapy. Univariate and 6-month landmark analyses showed longer median overall survival and progression-free survival in the Non-Std group compared with the Std group. After multivariable adjustment for confounding factors, there was no significant difference in overall survival (hazard ratio, 1.2; 95% confidence interval, 0.3-4.8; P = .824) or progression-free survival (hazard ratio, 2.6; 95% confidence interval, 0.7-9.6; P = .157) between the 2 groups.
CONCLUSION: Our study shows that a significant proportion of patients with advanced NSCLC receive pembrolizumab-based regimens with extended intervals or delays in routine clinical practice and with similar outcomes to those receiving treatment at label-specified 3-week intervals. Given the durability of benefit seen and the potential for cost reduction and decreased infusion frequency in these patients, this requires validation in prospective trials.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:22 |
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| Enthalten in: |
Clinical lung cancer - 22(2021), 3 vom: 15. Mai, Seite e379-e389 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Sehgal, Kartik [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 29.12.2021 Date Revised 29.12.2021 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.cllc.2020.05.028 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 100 | 1 | |a Sehgal, Kartik |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Association of Extended Dosing Intervals or Delays in Pembrolizumab-based Regimens With Survival Outcomes in Advanced Non-small-cell Lung Cancer |
| 264 | 1 | |c 2021 | |
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| 500 | |a Date Completed 29.12.2021 | ||
| 500 | |a Date Revised 29.12.2021 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2020 Elsevier Inc. All rights reserved. | ||
| 520 | |a BACKGROUND: Besides modeling/simulation-based analysis, no post-approval studies have evaluated the optimal administration frequency of pembrolizumab in non-small-cell lung cancer (NSCLC) | ||
| 520 | |a PATIENTS AND METHODS: We performed a multicenter retrospective cohort study to evaluate the association between survival outcomes and treatment extensions/delays of pembrolizumab-based regimens in patients with advanced NSCLC. Those who had received at least 4 cycles in routine practice were divided into 2 groups: nonstandard (Non-Std, ≥ 2 cycles at intervals > 3 weeks + 3 days) and standard (Std, all cycles every 3 weeks or 1 cycle > 3 weeks + 3 days) | ||
| 520 | |a RESULTS: Among 150 patients, 92 (61%) were eligible for the study (Non-Std, 27; Std, 65). The reasons for patients with extensions/delays in the Non-Std group included: immune-related adverse events (irAEs) (33%), non-irAE-related medical issues (26%), and patient-physician preference (41%). The Non-Std group was more likely to have a higher programmed death-ligand 1 tumor proportion score, a higher number of treatment cycles, and pembrolizumab monotherapy. Univariate and 6-month landmark analyses showed longer median overall survival and progression-free survival in the Non-Std group compared with the Std group. After multivariable adjustment for confounding factors, there was no significant difference in overall survival (hazard ratio, 1.2; 95% confidence interval, 0.3-4.8; P = .824) or progression-free survival (hazard ratio, 2.6; 95% confidence interval, 0.7-9.6; P = .157) between the 2 groups | ||
| 520 | |a CONCLUSION: Our study shows that a significant proportion of patients with advanced NSCLC receive pembrolizumab-based regimens with extended intervals or delays in routine clinical practice and with similar outcomes to those receiving treatment at label-specified 3-week intervals. Given the durability of benefit seen and the potential for cost reduction and decreased infusion frequency in these patients, this requires validation in prospective trials | ||
| 650 | 4 | |a Comparative Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Research Support, N.I.H., Extramural | |
| 650 | 4 | |a Extended-interval dosing | |
| 650 | 4 | |a Immune-related adverse event | |
| 650 | 4 | |a Patient-physician preference | |
| 650 | 4 | |a Real-world outcomes | |
| 650 | 4 | |a Treatment delays | |
| 650 | 7 | |a Antibodies, Monoclonal, Humanized |2 NLM | |
| 650 | 7 | |a Antineoplastic Agents, Immunological |2 NLM | |
| 650 | 7 | |a pembrolizumab |2 NLM | |
| 650 | 7 | |a DPT0O3T46P |2 NLM | |
| 700 | 1 | |a Bulumulle, Anushi |e verfasserin |4 aut | |
| 700 | 1 | |a Brody, Heather |e verfasserin |4 aut | |
| 700 | 1 | |a Gill, Ritu R |e verfasserin |4 aut | |
| 700 | 1 | |a Macherla, Shravanti |e verfasserin |4 aut | |
| 700 | 1 | |a Qilleri, Aleksandra |e verfasserin |4 aut | |
| 700 | 1 | |a McDonald, Danielle C |e verfasserin |4 aut | |
| 700 | 1 | |a Cherry, Cynthia R |e verfasserin |4 aut | |
| 700 | 1 | |a Shea, Meghan |e verfasserin |4 aut | |
| 700 | 1 | |a Huberman, Mark S |e verfasserin |4 aut | |
| 700 | 1 | |a VanderLaan, Paul A |e verfasserin |4 aut | |
| 700 | 1 | |a Weiss, Glen J |e verfasserin |4 aut | |
| 700 | 1 | |a Walker, Paul R |e verfasserin |4 aut | |
| 700 | 1 | |a Costa, Daniel B |e verfasserin |4 aut | |
| 700 | 1 | |a Rangachari, Deepa |e verfasserin |4 aut | |
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