Pegargiminase Plus First-Line Chemotherapy in Patients With Nonepithelioid Pleural Mesothelioma Article Swipe
Peter W. Szlosarek
,
Ben Creelan
,
Thomas Sarkodie
,
Luke Nolan
,
Paul Taylor
,
Olga Olevsky
,
Federica Grosso
,
Diego Cortinovis
,
Meenali Chitnis
,
Amy Roy
,
D. Gilligan
,
Hedy L. Kindler
,
Dionysis Papadatos-Pastos
,
Giovanni Luca Ceresoli
,
Aaron S. Mansfield
,
Anne S. Tsao
,
Kenneth J. O’Byrne
,
Anna K. Nowak
,
Jeremy Steele
,
Michael Sheaff
,
Chiung‐Fang Shiu
,
Chih‐Ling Kuo
,
Amanda Johnston
,
John S. Bomalaski
,
Marjorie G. Zauderer
,
Dean A. Fennell
,
Igor I. Rybkin
,
Christian Rolfo
,
Melanie Mackean
,
Nicola Steele
,
K. Franks
,
P. Nicholas Shaw
,
Michael Lind
,
Sunil Upadhyay
,
Thomas John
,
Christos S. Karapetis
,
Ratnesh Kumar Srivastav
,
Manlio Mencoboni
,
Antonio Chella
,
Nicoletta Zilembo
,
Filippo de Marinis
,
Giulia Maria Stella
,
Inn‐Wen Chong
,
Chin‐Chou Wang
·
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1001/jamaoncol.2023.6789
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1001/jamaoncol.2023.6789
Importance Arginine deprivation using ADI-PEG20 (pegargiminase) combined with chemotherapy is untested in a randomized study among patients with cancer. ATOMIC-Meso (ADI-PEG20 Targeting of Malignancies Induces Cytotoxicity-Mesothelioma) is a pivotal trial comparing standard first-line chemotherapy plus pegargiminase or placebo in patients with nonepithelioid pleural mesothelioma. Objective To determine the effect of pegargiminase-based chemotherapy on survival in nonepithelioid pleural mesothelioma, an arginine-auxotrophic tumor. Design, Setting, and Participants This was a phase 2-3, double-blind randomized clinical trial conducted at 43 centers in 5 countries that included patients with chemotherapy-naive nonepithelioid pleural mesothelioma from August 1, 2017, to August 15, 2021, with at least 12 months’ follow-up. Final follow-up was on August 15, 2022. Data analysis was performed from March 2018 to June 2023. Intervention Patients were randomly assigned (1:1) to receive weekly intramuscular pegargiminase (36.8 mg/m 2 ) or placebo. All patients received intravenous pemetrexed (500 mg/m 2 ) and platinum (75-mg/m 2 cisplatin or carboplatin area under the curve 5) chemotherapy every 3 weeks up to 6 cycles. Pegargiminase or placebo was continued until progression, toxicity, or 24 months. Main Outcomes and Measures The primary end point was overall survival, and secondary end points were progression-free survival and safety. Response rate by blinded independent central review was assessed in the phase 2 portion only. Results Among 249 randomized patients (mean [SD] age, 69.5 [7.9] years; 43 female individuals [17.3%] and 206 male individuals [82.7%]), all were included in the analysis. The median overall survival was 9.3 months (95% CI, 7.9-11.8 months) with pegargiminase-chemotherapy as compared with 7.7 months (95% CI, 6.1-9.5 months) with placebo-chemotherapy (hazard ratio [HR] for death, 0.71; 95% CI, 0.55-0.93; P = .02). The median progression-free survival was 6.2 months (95% CI, 5.8-7.4 months) with pegargiminase-chemotherapy as compared with 5.6 months (95% CI, 4.1-5.9 months) with placebo-chemotherapy (HR, 0.65; 95% CI, 0.46-0.90; P = .02). Grade 3 to 4 adverse events with pegargiminase occurred in 36 patients (28.8%) and with placebo in 21 patients (16.9%); drug hypersensitivity and skin reactions occurred in the experimental arm in 3 patients (2.4%) and 2 patients (1.6%), respectively, and none in the placebo arm. Rates of poststudy treatments were comparable in both arms (57 patients [45.6%] with pegargiminase vs 58 patients [46.8%] with placebo). Conclusions and Relevance In this randomized clinical trial of arginine depletion with pegargiminase plus chemotherapy, survival was extended beyond standard chemotherapy with a favorable safety profile in patients with nonepithelioid pleural mesothelioma. Pegargiminase-based chemotherapy as a novel antimetabolite strategy for mesothelioma validates wider clinical testing in oncology. Trial Registration ClinicalTrials.gov Identifier: NCT02709512
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1001/jamaoncol.2023.6789
- https://jamanetwork.com/journals/jamaoncology/articlepdf/2815000/jamaoncology_szlosarek_2024_oi_230088_1707156240.86267.pdf
- OA Status
- bronze
- Cited By
- 32
- References
- 48
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4391839962
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4391839962Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1001/jamaoncol.2023.6789Digital Object Identifier
- Title
-
Pegargiminase Plus First-Line Chemotherapy in Patients With Nonepithelioid Pleural MesotheliomaWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2024Year of publication
- Publication date
-
2024-02-15Full publication date if available
- Authors
-
Peter W. Szlosarek, Ben Creelan, Thomas Sarkodie, Luke Nolan, Paul Taylor, Olga Olevsky, Federica Grosso, Diego Cortinovis, Meenali Chitnis, Amy Roy, D. Gilligan, Hedy L. Kindler, Dionysis Papadatos-Pastos, Giovanni Luca Ceresoli, Aaron S. Mansfield, Anne S. Tsao, Kenneth J. O’Byrne, Anna K. Nowak, Jeremy Steele, Michael Sheaff, Chiung‐Fang Shiu, Chih‐Ling Kuo, Amanda Johnston, John S. Bomalaski, Marjorie G. Zauderer, Dean A. Fennell, Igor I. Rybkin, Christian Rolfo, Melanie Mackean, Nicola Steele, K. Franks, P. Nicholas Shaw, Michael Lind, Sunil Upadhyay, Thomas John, Christos S. Karapetis, Ratnesh Kumar Srivastav, Manlio Mencoboni, Antonio Chella, Nicoletta Zilembo, Filippo de Marinis, Giulia Maria Stella, Inn‐Wen Chong, Chin‐Chou WangList of authors in order
- Landing page
-
https://doi.org/10.1001/jamaoncol.2023.6789Publisher landing page
- PDF URL
-
https://jamanetwork.com/journals/jamaoncology/articlepdf/2815000/jamaoncology_szlosarek_2024_oi_230088_1707156240.86267.pdfDirect link to full text PDF
- Open access
-
YesWhether a free full text is available
- OA status
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bronzeOpen access status per OpenAlex
- OA URL
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https://jamanetwork.com/journals/jamaoncology/articlepdf/2815000/jamaoncology_szlosarek_2024_oi_230088_1707156240.86267.pdfDirect OA link when available
- Concepts
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Medicine, Pemetrexed, Mesothelioma, Carboplatin, Internal medicine, Chemotherapy, Clinical endpoint, Placebo, Surgery, Cisplatin, Randomized controlled trial, Oncology, Pathology, Alternative medicineTop concepts (fields/topics) attached by OpenAlex
- Cited by
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32Total citation count in OpenAlex
- Citations by year (recent)
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2025: 24, 2024: 8Per-year citation counts (last 5 years)
- References (count)
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48Number of works referenced by this work
- Related works (count)
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10Other works algorithmically related by OpenAlex
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| abstract_inverted_index.chemotherapy, | 385 |
| abstract_inverted_index.intramuscular | 129 |
| abstract_inverted_index.mesothelioma, | 57 |
| abstract_inverted_index.mesothelioma. | 43, 402 |
| abstract_inverted_index.pegargiminase | 35, 130, 313, 364, 383 |
| abstract_inverted_index.respectively, | 344 |
| abstract_inverted_index.antimetabolite | 408 |
| abstract_inverted_index.nonepithelioid | 41, 55, 86, 400 |
| abstract_inverted_index.(pegargiminase) | 5 |
| abstract_inverted_index.hypersensitivity | 327 |
| abstract_inverted_index.progression-free | 193, 276 |
| abstract_inverted_index.ClinicalTrials.gov | 420 |
| abstract_inverted_index.chemotherapy-naive | 85 |
| abstract_inverted_index.Pegargiminase-based | 403 |
| abstract_inverted_index.pegargiminase-based | 50 |
| abstract_inverted_index.arginine-auxotrophic | 59 |
| abstract_inverted_index.placebo-chemotherapy | 261, 297 |
| abstract_inverted_index.Cytotoxicity-Mesothelioma) | 25 |
| abstract_inverted_index.pegargiminase-chemotherapy | 250, 286 |
| cited_by_percentile_year.max | 100 |
| cited_by_percentile_year.min | 99 |
| corresponding_author_ids | https://openalex.org/A5022032908 |
| countries_distinct_count | 4 |
| institutions_distinct_count | 44 |
| corresponding_institution_ids | https://openalex.org/I1307195382, https://openalex.org/I166337079, https://openalex.org/I4210113937 |
| citation_normalized_percentile.value | 0.99522512 |
| citation_normalized_percentile.is_in_top_1_percent | True |
| citation_normalized_percentile.is_in_top_10_percent | True |