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Consolidation Immunotherapy After Platinum-Based Chemoradiotherapy in Patients With Unresectable Stage III Non-Small Cell Lung Cancer—Cross-Sectional Study of Eligibility and Administration Rates
INTRODUCTION: The PACIFC trial demonstrated a significant benefit of durvalumab consolidation immunotherapy (CIT) after definitive platinum-based chemoradiotherapy (P-CRT) for survival in stage III non-small cell lung cancer (NSCLC). It is unknown how many patients are eligible in clinical practice...
Autores principales: | , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7736629/ https://www.ncbi.nlm.nih.gov/pubmed/33335856 http://dx.doi.org/10.3389/fonc.2020.586449 |
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author | Eichkorn, Tanja Bozorgmehr, Farastuk Regnery, Sebastian Dinges, Lisa A. Kudak, Andreas Bougatf, Nina Weber, Dorothea Christopoulos, Petros Muley, Thomas Kobinger, Sonja König, Laila Hörner-Rieber, Juliane Adeberg, Sebastian Heussel, Claus Peter Thomas, Michael Debus, Jürgen El Shafie, Rami A. |
author_facet | Eichkorn, Tanja Bozorgmehr, Farastuk Regnery, Sebastian Dinges, Lisa A. Kudak, Andreas Bougatf, Nina Weber, Dorothea Christopoulos, Petros Muley, Thomas Kobinger, Sonja König, Laila Hörner-Rieber, Juliane Adeberg, Sebastian Heussel, Claus Peter Thomas, Michael Debus, Jürgen El Shafie, Rami A. |
author_sort | Eichkorn, Tanja |
collection | PubMed |
description | INTRODUCTION: The PACIFC trial demonstrated a significant benefit of durvalumab consolidation immunotherapy (CIT) after definitive platinum-based chemoradiotherapy (P-CRT) for survival in stage III non-small cell lung cancer (NSCLC). It is unknown how many patients are eligible in clinical practice to receive CIT according to PACIFIC criteria compared to real administration rates and what influencing factors are. PATIENTS AND METHODS: We analyzed 442 patients with unresectable stage III NSCLC who received P-CRT between 2009 and 2019 regarding CIT eligibility rates according to PACIFIC criteria and administration rates since drug approval. RESULTS: Sixty-four percent of 437 patients were male, median age was 63 years [interquartile range (IQR): 57–69]. The most common histologic subtypes were adenocarcinoma (42.8%) and squamous cell carcinoma (41.1%), most tumors were in stage IIIB (56.8%). Mean PD-L1 tumor proportion score (TPS) was 29.8% (IQR: 1–60). The median total RT dose was 60 Gy (IQR: 60–66). Platinum component of P-CRT was evenly distributed between cisplatin (51.4%) and carboplatin (48.6%). 50.3% of patients were eligible for CIT according to PACIFIC criteria. Observed contraindications were progressive disease according to RECIST (32.4%), followed by a PD-L1 TPS < 1% (22.3%), pneumonitis CTCAE ≥ 2 (12.6%) and others (4.9%). One year after drug approval, 85.6% of patients who were eligible according to PACIFIC criteria actually received CIT. Time interval between chemotherapy start and radiation therapy start (OR 0.9, 95% CI: [0.9; 1.0] p = 0.009) and probably cisplatin as platinum-component of P-CRT (OR 1.5, 95% CI: [1.0; 2.4] p < 0.061) influence CIT eligibility. Highly positive PD-L1 TPS (≥50%; (OR 2.4, 95% CI: [1.3; 4.5] p = 0.004) was associated to a better chance for CIT eligibility. CONCLUSION: Eighty-five percent of potentially eligible patients received CIT one year after drug approval. Fifty percent of patients did not meet PACIFIC criteria for durvalumab eligibility, this was mainly caused by disease progression during platinum-based CRT, followed by therapy-related pneumonitis and PD-L1 TPS < 1% (in view of the EMA drug approval). |
format | Online Article Text |
id | pubmed-7736629 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-77366292020-12-16 Consolidation Immunotherapy After Platinum-Based Chemoradiotherapy in Patients With Unresectable Stage III Non-Small Cell Lung Cancer—Cross-Sectional Study of Eligibility and Administration Rates Eichkorn, Tanja Bozorgmehr, Farastuk Regnery, Sebastian Dinges, Lisa A. Kudak, Andreas Bougatf, Nina Weber, Dorothea Christopoulos, Petros Muley, Thomas Kobinger, Sonja König, Laila Hörner-Rieber, Juliane Adeberg, Sebastian Heussel, Claus Peter Thomas, Michael Debus, Jürgen El Shafie, Rami A. Front Oncol Oncology INTRODUCTION: The PACIFC trial demonstrated a significant benefit of durvalumab consolidation immunotherapy (CIT) after definitive platinum-based chemoradiotherapy (P-CRT) for survival in stage III non-small cell lung cancer (NSCLC). It is unknown how many patients are eligible in clinical practice to receive CIT according to PACIFIC criteria compared to real administration rates and what influencing factors are. PATIENTS AND METHODS: We analyzed 442 patients with unresectable stage III NSCLC who received P-CRT between 2009 and 2019 regarding CIT eligibility rates according to PACIFIC criteria and administration rates since drug approval. RESULTS: Sixty-four percent of 437 patients were male, median age was 63 years [interquartile range (IQR): 57–69]. The most common histologic subtypes were adenocarcinoma (42.8%) and squamous cell carcinoma (41.1%), most tumors were in stage IIIB (56.8%). Mean PD-L1 tumor proportion score (TPS) was 29.8% (IQR: 1–60). The median total RT dose was 60 Gy (IQR: 60–66). Platinum component of P-CRT was evenly distributed between cisplatin (51.4%) and carboplatin (48.6%). 50.3% of patients were eligible for CIT according to PACIFIC criteria. Observed contraindications were progressive disease according to RECIST (32.4%), followed by a PD-L1 TPS < 1% (22.3%), pneumonitis CTCAE ≥ 2 (12.6%) and others (4.9%). One year after drug approval, 85.6% of patients who were eligible according to PACIFIC criteria actually received CIT. Time interval between chemotherapy start and radiation therapy start (OR 0.9, 95% CI: [0.9; 1.0] p = 0.009) and probably cisplatin as platinum-component of P-CRT (OR 1.5, 95% CI: [1.0; 2.4] p < 0.061) influence CIT eligibility. Highly positive PD-L1 TPS (≥50%; (OR 2.4, 95% CI: [1.3; 4.5] p = 0.004) was associated to a better chance for CIT eligibility. CONCLUSION: Eighty-five percent of potentially eligible patients received CIT one year after drug approval. Fifty percent of patients did not meet PACIFIC criteria for durvalumab eligibility, this was mainly caused by disease progression during platinum-based CRT, followed by therapy-related pneumonitis and PD-L1 TPS < 1% (in view of the EMA drug approval). Frontiers Media S.A. 2020-12-01 /pmc/articles/PMC7736629/ /pubmed/33335856 http://dx.doi.org/10.3389/fonc.2020.586449 Text en Copyright © 2020 Eichkorn, Bozorgmehr, Regnery, Dinges, Kudak, Bougatf, Weber, Christopoulos, Muley, Kobinger, König, Hörner-Rieber, Adeberg, Heussel, Thomas, Debus and El Shafie http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Oncology Eichkorn, Tanja Bozorgmehr, Farastuk Regnery, Sebastian Dinges, Lisa A. Kudak, Andreas Bougatf, Nina Weber, Dorothea Christopoulos, Petros Muley, Thomas Kobinger, Sonja König, Laila Hörner-Rieber, Juliane Adeberg, Sebastian Heussel, Claus Peter Thomas, Michael Debus, Jürgen El Shafie, Rami A. Consolidation Immunotherapy After Platinum-Based Chemoradiotherapy in Patients With Unresectable Stage III Non-Small Cell Lung Cancer—Cross-Sectional Study of Eligibility and Administration Rates |
title | Consolidation Immunotherapy After Platinum-Based Chemoradiotherapy in Patients With Unresectable Stage III Non-Small Cell Lung Cancer—Cross-Sectional Study of Eligibility and Administration Rates |
title_full | Consolidation Immunotherapy After Platinum-Based Chemoradiotherapy in Patients With Unresectable Stage III Non-Small Cell Lung Cancer—Cross-Sectional Study of Eligibility and Administration Rates |
title_fullStr | Consolidation Immunotherapy After Platinum-Based Chemoradiotherapy in Patients With Unresectable Stage III Non-Small Cell Lung Cancer—Cross-Sectional Study of Eligibility and Administration Rates |
title_full_unstemmed | Consolidation Immunotherapy After Platinum-Based Chemoradiotherapy in Patients With Unresectable Stage III Non-Small Cell Lung Cancer—Cross-Sectional Study of Eligibility and Administration Rates |
title_short | Consolidation Immunotherapy After Platinum-Based Chemoradiotherapy in Patients With Unresectable Stage III Non-Small Cell Lung Cancer—Cross-Sectional Study of Eligibility and Administration Rates |
title_sort | consolidation immunotherapy after platinum-based chemoradiotherapy in patients with unresectable stage iii non-small cell lung cancer—cross-sectional study of eligibility and administration rates |
topic | Oncology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7736629/ https://www.ncbi.nlm.nih.gov/pubmed/33335856 http://dx.doi.org/10.3389/fonc.2020.586449 |
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