Neoadjuvant atezolizumab plus chemotherapy in gastric and gastroesophageal junction adenocarcinoma: the phase 2 PANDA trial

Gastric and gastroesophageal junction (G/GEJ) cancers carry a poor prognosis, and despite recent advancements, most patients die of their disease. Although immune checkpoint blockade became part of the standard-of-care for patients with metastatic G/GEJ cancers, its efficacy and impact on the tumor...

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Published in:Nature medicine Vol. 30; no. 2; pp. 519 - 530
Main Authors: Verschoor, Yara L., van de Haar, Joris, van den Berg, José G., van Sandick, Johanna W., Kodach, Liudmila L., van Dieren, Jolanda M., Balduzzi, Sara, Grootscholten, Cecile, IJsselsteijn, Marieke E., Veenhof, Alexander A. F. A., Hartemink, Koen J., Vollebergh, Marieke A., Jurdi, Adham, Sharma, Shruti, Spickard, Erik, Owers, Emilia C., Bartels-Rutten, Annemarieke, den Hartog, Peggy, de Miranda, Noel F. C. C., van Leerdam, Monique E., Haanen, John B. A. G., Schumacher, Ton N., Voest, Emile E., Chalabi, Myriam
Format: Journal Article
Language:English
Published: New York Nature Publishing Group US 01.02.2024
Nature Publishing Group
Subjects:
631/67/580
692/308/2779/109/1941
692/308/53
692/699/67/1504/1829
Adenocarcinoma
Adenocarcinoma - drug therapy
Adenocarcinoma - pathology
Adverse events
Antibodies, Monoclonal, Humanized
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Apoptosis
Biomedical and Life Sciences
Biomedicine
Cancer
Cancer Research
CD8 antigen
Cell death
Chemotherapy
Effectiveness
Esophageal Neoplasms
Esophagogastric Junction - pathology
Fatalities
Humans
Immune checkpoint inhibitors
Immunotherapy
Infectious Diseases
Lymphocytes
Lymphocytes T
Medical prognosis
Metabolic Diseases
Metastases
Molecular Medicine
Monoclonal antibodies
Neoadjuvant Therapy
Neurosciences
Oxaliplatin
Patients
PD-1 protein
PD-L1 protein
Programmed Cell Death 1 Receptor
Stomach Neoplasms - drug therapy
Stomach Neoplasms - pathology
Targeted cancer therapy
Tumor Microenvironment
Tumors
ISSN:1078-8956, 1546-170X, 1546-170X
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Abstract Gastric and gastroesophageal junction (G/GEJ) cancers carry a poor prognosis, and despite recent advancements, most patients die of their disease. Although immune checkpoint blockade became part of the standard-of-care for patients with metastatic G/GEJ cancers, its efficacy and impact on the tumor microenvironment (TME) in early disease remain largely unknown. We hypothesized higher efficacy of neoadjuvant immunotherapy plus chemotherapy in patients with nonmetastatic G/GEJ cancer. In the phase 2 PANDA trial, patients with previously untreated resectable G/GEJ tumors ( n  = 21) received neoadjuvant treatment with one cycle of atezolizumab monotherapy followed by four cycles of atezolizumab plus docetaxel, oxaliplatin and capecitabine. Treatment was well tolerated. There were grade 3 immune-related adverse events in two of 20 patients (10%) but no grade 4 or 5 immune-related adverse events, and all patients underwent resection without treatment-related delays, meeting the primary endpoint of safety and feasibility. Tissue was obtained at multiple time points, allowing analysis of the effects of single-agent anti-programmed cell death ligand 1 (PD-L1) and the subsequent combination with chemotherapy on the TME. Twenty of 21 patients underwent surgery and were evaluable for secondary pathologic response and survival endpoints, and 19 were evaluable for exploratory translational analyses. A major pathologic response (≤10% residual viable tumor) was observed in 14 of 20 (70%, 95% confidence interval 46–88%) patients, including 9 (45%, 95% confidence interval 23–68%) pathologic complete responses. At a median follow-up of 47 months, 13 of 14 responders were alive and disease-free, and five of six nonresponders had died as a result of recurrence. Notably, baseline anti-programmed cell death protein 1 (PD-1) + CD8 + T cell infiltration was significantly higher in responders versus nonresponders, and comparison of TME alterations following anti-PD-L1 monotherapy versus the subsequent combination with chemotherapy showed an increased immune activation on single-agent PD-1/L1 axis blockade. On the basis of these data, monotherapy anti-PD-L1 before its combination with chemotherapy warrants further exploration and validation in a larger cohort of patients with nonmetastatic G/GEJ cancer. ClinicalTrials.gov registration: NCT03448835 . A neoadjuvant treatment regimen of anti-PD-L1 monotherapy followed by anti-PD-L1 plus chemotherapy was well tolerated and led to a major pathologic response rate of 70% in patients with resectable gastric or gastroesophageal junction adenocarcinoma.
AbstractList Gastric and gastroesophageal junction (G/GEJ) cancers carry a poor prognosis, and despite recent advancements, most patients die of their disease. Although immune checkpoint blockade became part of the standard-of-care for patients with metastatic G/GEJ cancers, its efficacy and impact on the tumor microenvironment (TME) in early disease remain largely unknown. We hypothesized higher efficacy of neoadjuvant immunotherapy plus chemotherapy in patients with nonmetastatic G/GEJ cancer. In the phase 2 PANDA trial, patients with previously untreated resectable G/GEJ tumors ( n  = 21) received neoadjuvant treatment with one cycle of atezolizumab monotherapy followed by four cycles of atezolizumab plus docetaxel, oxaliplatin and capecitabine. Treatment was well tolerated. There were grade 3 immune-related adverse events in two of 20 patients (10%) but no grade 4 or 5 immune-related adverse events, and all patients underwent resection without treatment-related delays, meeting the primary endpoint of safety and feasibility. Tissue was obtained at multiple time points, allowing analysis of the effects of single-agent anti-programmed cell death ligand 1 (PD-L1) and the subsequent combination with chemotherapy on the TME. Twenty of 21 patients underwent surgery and were evaluable for secondary pathologic response and survival endpoints, and 19 were evaluable for exploratory translational analyses. A major pathologic response (≤10% residual viable tumor) was observed in 14 of 20 (70%, 95% confidence interval 46–88%) patients, including 9 (45%, 95% confidence interval 23–68%) pathologic complete responses. At a median follow-up of 47 months, 13 of 14 responders were alive and disease-free, and five of six nonresponders had died as a result of recurrence. Notably, baseline anti-programmed cell death protein 1 (PD-1) + CD8 + T cell infiltration was significantly higher in responders versus nonresponders, and comparison of TME alterations following anti-PD-L1 monotherapy versus the subsequent combination with chemotherapy showed an increased immune activation on single-agent PD-1/L1 axis blockade. On the basis of these data, monotherapy anti-PD-L1 before its combination with chemotherapy warrants further exploration and validation in a larger cohort of patients with nonmetastatic G/GEJ cancer. ClinicalTrials.gov registration: NCT03448835 .
Gastric and gastroesophageal junction (G/GEJ) cancers carry a poor prognosis, and despite recent advancements, most patients die of their disease. Although immune checkpoint blockade became part of the standard-of-care for patients with metastatic G/GEJ cancers, its efficacy and impact on the tumor microenvironment (TME) in early disease remain largely unknown. We hypothesized higher efficacy of neoadjuvant immunotherapy plus chemotherapy in patients with nonmetastatic G/GEJ cancer. In the phase 2 PANDA trial, patients with previously untreated resectable G/GEJ tumors (n = 21) received neoadjuvant treatment with one cycle of atezolizumab monotherapy followed by four cycles of atezolizumab plus docetaxel, oxaliplatin and capecitabine. Treatment was well tolerated. There were grade 3 immune-related adverse events in two of 20 patients (10%) but no grade 4 or 5 immune-related adverse events, and all patients underwent resection without treatment-related delays, meeting the primary endpoint of safety and feasibility. Tissue was obtained at multiple time points, allowing analysis of the effects of single-agent anti-programmed cell death ligand 1 (PD-L1) and the subsequent combination with chemotherapy on the TME. Twenty of 21 patients underwent surgery and were evaluable for secondary pathologic response and survival endpoints, and 19 were evaluable for exploratory translational analyses. A major pathologic response (≤10% residual viable tumor) was observed in 14 of 20 (70%, 95% confidence interval 46-88%) patients, including 9 (45%, 95% confidence interval 23-68%) pathologic complete responses. At a median follow-up of 47 months, 13 of 14 responders were alive and disease-free, and five of six nonresponders had died as a result of recurrence. Notably, baseline anti-programmed cell death protein 1 (PD-1) CD8 T cell infiltration was significantly higher in responders versus nonresponders, and comparison of TME alterations following anti-PD-L1 monotherapy versus the subsequent combination with chemotherapy showed an increased immune activation on single-agent PD-1/L1 axis blockade. On the basis of these data, monotherapy anti-PD-L1 before its combination with chemotherapy warrants further exploration and validation in a larger cohort of patients with nonmetastatic G/GEJ cancer. ClinicalTrials.gov registration: NCT03448835 .
Gastric and gastroesophageal junction (G/GEJ) cancers carry a poor prognosis, and despite recent advancements, most patients die of their disease. Although immune checkpoint blockade became part of the standard-of-care for patients with metastatic G/GEJ cancers, its efficacy and impact on the tumor microenvironment (TME) in early disease remain largely unknown. We hypothesized higher efficacy of neoadjuvant immunotherapy plus chemotherapy in patients with nonmetastatic G/GEJ cancer. In the phase 2 PANDA trial, patients with previously untreated resectable G/GEJ tumors ( n  = 21) received neoadjuvant treatment with one cycle of atezolizumab monotherapy followed by four cycles of atezolizumab plus docetaxel, oxaliplatin and capecitabine. Treatment was well tolerated. There were grade 3 immune-related adverse events in two of 20 patients (10%) but no grade 4 or 5 immune-related adverse events, and all patients underwent resection without treatment-related delays, meeting the primary endpoint of safety and feasibility. Tissue was obtained at multiple time points, allowing analysis of the effects of single-agent anti-programmed cell death ligand 1 (PD-L1) and the subsequent combination with chemotherapy on the TME. Twenty of 21 patients underwent surgery and were evaluable for secondary pathologic response and survival endpoints, and 19 were evaluable for exploratory translational analyses. A major pathologic response (≤10% residual viable tumor) was observed in 14 of 20 (70%, 95% confidence interval 46–88%) patients, including 9 (45%, 95% confidence interval 23–68%) pathologic complete responses. At a median follow-up of 47 months, 13 of 14 responders were alive and disease-free, and five of six nonresponders had died as a result of recurrence. Notably, baseline anti-programmed cell death protein 1 (PD-1) + CD8 + T cell infiltration was significantly higher in responders versus nonresponders, and comparison of TME alterations following anti-PD-L1 monotherapy versus the subsequent combination with chemotherapy showed an increased immune activation on single-agent PD-1/L1 axis blockade. On the basis of these data, monotherapy anti-PD-L1 before its combination with chemotherapy warrants further exploration and validation in a larger cohort of patients with nonmetastatic G/GEJ cancer. ClinicalTrials.gov registration: NCT03448835 . A neoadjuvant treatment regimen of anti-PD-L1 monotherapy followed by anti-PD-L1 plus chemotherapy was well tolerated and led to a major pathologic response rate of 70% in patients with resectable gastric or gastroesophageal junction adenocarcinoma.
Gastric and gastroesophageal junction (G/GEJ) cancers carry a poor prognosis, and despite recent advancements, most patients die of their disease. Although immune checkpoint blockade became part of the standard-of-care for patients with metastatic G/GEJ cancers, its efficacy and impact on the tumor microenvironment (TME) in early disease remain largely unknown. We hypothesized higher efficacy of neoadjuvant immunotherapy plus chemotherapy in patients with nonmetastatic G/GEJ cancer. In the phase 2 PANDA trial, patients with previously untreated resectable G/GEJ tumors (n = 21) received neoadjuvant treatment with one cycle of atezolizumab monotherapy followed by four cycles of atezolizumab plus docetaxel, oxaliplatin and capecitabine. Treatment was well tolerated. There were grade 3 immune-related adverse events in two of 20 patients (10%) but no grade 4 or 5 immune-related adverse events, and all patients underwent resection without treatment-related delays, meeting the primary endpoint of safety and feasibility. Tissue was obtained at multiple time points, allowing analysis of the effects of single-agent anti-programmed cell death ligand 1 (PD-L1) and the subsequent combination with chemotherapy on the TME. Twenty of 21 patients underwent surgery and were evaluable for secondary pathologic response and survival endpoints, and 19 were evaluable for exploratory translational analyses. A major pathologic response (≤10% residual viable tumor) was observed in 14 of 20 (70%, 95% confidence interval 46–88%) patients, including 9 (45%, 95% confidence interval 23–68%) pathologic complete responses. At a median follow-up of 47 months, 13 of 14 responders were alive and disease-free, and five of six nonresponders had died as a result of recurrence. Notably, baseline anti-programmed cell death protein 1 (PD-1)+CD8+ T cell infiltration was significantly higher in responders versus nonresponders, and comparison of TME alterations following anti-PD-L1 monotherapy versus the subsequent combination with chemotherapy showed an increased immune activation on single-agent PD-1/L1 axis blockade. On the basis of these data, monotherapy anti-PD-L1 before its combination with chemotherapy warrants further exploration and validation in a larger cohort of patients with nonmetastatic G/GEJ cancer. ClinicalTrials.gov registration: NCT03448835. A neoadjuvant treatment regimen of anti-PD-L1 monotherapy followed by anti-PD-L1 plus chemotherapy was well tolerated and led to a major pathologic response rate of 70% in patients with resectable gastric or gastroesophageal junction adenocarcinoma.
Gastric and gastroesophageal junction (G/GEJ) cancers carry a poor prognosis, and despite recent advancements, most patients die of their disease. Although immune checkpoint blockade became part of the standard-of-care for patients with metastatic G/GEJ cancers, its efficacy and impact on the tumor microenvironment (TME) in early disease remain largely unknown. We hypothesized higher efficacy of neoadjuvant immunotherapy plus chemotherapy in patients with nonmetastatic G/GEJ cancer. In the phase 2 PANDA trial, patients with previously untreated resectable G/GEJ tumors (n = 21) received neoadjuvant treatment with one cycle of atezolizumab monotherapy followed by four cycles of atezolizumab plus docetaxel, oxaliplatin and capecitabine. Treatment was well tolerated. There were grade 3 immune-related adverse events in two of 20 patients (10%) but no grade 4 or 5 immune-related adverse events, and all patients underwent resection without treatment-related delays, meeting the primary endpoint of safety and feasibility. Tissue was obtained at multiple time points, allowing analysis of the effects of single-agent anti-programmed cell death ligand 1 (PD-L1) and the subsequent combination with chemotherapy on the TME. Twenty of 21 patients underwent surgery and were evaluable for secondary pathologic response and survival endpoints, and 19 were evaluable for exploratory translational analyses. A major pathologic response (≤10% residual viable tumor) was observed in 14 of 20 (70%, 95% confidence interval 46-88%) patients, including 9 (45%, 95% confidence interval 23-68%) pathologic complete responses. At a median follow-up of 47 months, 13 of 14 responders were alive and disease-free, and five of six nonresponders had died as a result of recurrence. Notably, baseline anti-programmed cell death protein 1 (PD-1)+CD8+ T cell infiltration was significantly higher in responders versus nonresponders, and comparison of TME alterations following anti-PD-L1 monotherapy versus the subsequent combination with chemotherapy showed an increased immune activation on single-agent PD-1/L1 axis blockade. On the basis of these data, monotherapy anti-PD-L1 before its combination with chemotherapy warrants further exploration and validation in a larger cohort of patients with nonmetastatic G/GEJ cancer. ClinicalTrials.gov registration: NCT03448835 .Gastric and gastroesophageal junction (G/GEJ) cancers carry a poor prognosis, and despite recent advancements, most patients die of their disease. Although immune checkpoint blockade became part of the standard-of-care for patients with metastatic G/GEJ cancers, its efficacy and impact on the tumor microenvironment (TME) in early disease remain largely unknown. We hypothesized higher efficacy of neoadjuvant immunotherapy plus chemotherapy in patients with nonmetastatic G/GEJ cancer. In the phase 2 PANDA trial, patients with previously untreated resectable G/GEJ tumors (n = 21) received neoadjuvant treatment with one cycle of atezolizumab monotherapy followed by four cycles of atezolizumab plus docetaxel, oxaliplatin and capecitabine. Treatment was well tolerated. There were grade 3 immune-related adverse events in two of 20 patients (10%) but no grade 4 or 5 immune-related adverse events, and all patients underwent resection without treatment-related delays, meeting the primary endpoint of safety and feasibility. Tissue was obtained at multiple time points, allowing analysis of the effects of single-agent anti-programmed cell death ligand 1 (PD-L1) and the subsequent combination with chemotherapy on the TME. Twenty of 21 patients underwent surgery and were evaluable for secondary pathologic response and survival endpoints, and 19 were evaluable for exploratory translational analyses. A major pathologic response (≤10% residual viable tumor) was observed in 14 of 20 (70%, 95% confidence interval 46-88%) patients, including 9 (45%, 95% confidence interval 23-68%) pathologic complete responses. At a median follow-up of 47 months, 13 of 14 responders were alive and disease-free, and five of six nonresponders had died as a result of recurrence. Notably, baseline anti-programmed cell death protein 1 (PD-1)+CD8+ T cell infiltration was significantly higher in responders versus nonresponders, and comparison of TME alterations following anti-PD-L1 monotherapy versus the subsequent combination with chemotherapy showed an increased immune activation on single-agent PD-1/L1 axis blockade. On the basis of these data, monotherapy anti-PD-L1 before its combination with chemotherapy warrants further exploration and validation in a larger cohort of patients with nonmetastatic G/GEJ cancer. ClinicalTrials.gov registration: NCT03448835 .
Author de Miranda, Noel F. C. C.
van Leerdam, Monique E.
Voest, Emile E.
IJsselsteijn, Marieke E.
Grootscholten, Cecile
Verschoor, Yara L.
Kodach, Liudmila L.
Bartels-Rutten, Annemarieke
Chalabi, Myriam
Vollebergh, Marieke A.
Veenhof, Alexander A. F. A.
Hartemink, Koen J.
Jurdi, Adham
Haanen, John B. A. G.
Schumacher, Ton N.
van Dieren, Jolanda M.
Sharma, Shruti
Owers, Emilia C.
den Hartog, Peggy
van Sandick, Johanna W.
Spickard, Erik
Balduzzi, Sara
van de Haar, Joris
van den Berg, José G.
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  orcidid: 0009-0005-7217-1460
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  organization: Department of Gastrointestinal Oncology, Netherlands Cancer Institute – Antoni van Leeuwenhoek Hospital
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  surname: van den Berg
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  givenname: Johanna W.
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  givenname: Jolanda M.
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  surname: van Dieren
  fullname: van Dieren, Jolanda M.
  organization: Department of Gastrointestinal Oncology, Netherlands Cancer Institute – Antoni van Leeuwenhoek Hospital
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  givenname: Sara
  orcidid: 0000-0003-1205-1895
  surname: Balduzzi
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– sequence: 9
  givenname: Marieke E.
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  fullname: IJsselsteijn, Marieke E.
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  givenname: Alexander A. F. A.
  surname: Veenhof
  fullname: Veenhof, Alexander A. F. A.
  organization: Department of Surgery, Netherlands Cancer Institute – Antoni van Leeuwenhoek Hospital
– sequence: 11
  givenname: Koen J.
  surname: Hartemink
  fullname: Hartemink, Koen J.
  organization: Department of Surgery, Netherlands Cancer Institute – Antoni van Leeuwenhoek Hospital
– sequence: 12
  givenname: Marieke A.
  surname: Vollebergh
  fullname: Vollebergh, Marieke A.
  organization: Department of Gastrointestinal Oncology, Netherlands Cancer Institute – Antoni van Leeuwenhoek Hospital, Department of Medical Oncology, Netherlands Cancer Institute – Antoni van Leeuwenhoek Hospital
– sequence: 13
  givenname: Adham
  orcidid: 0000-0002-2985-3053
  surname: Jurdi
  fullname: Jurdi, Adham
  organization: Natera, Inc
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  givenname: Shruti
  surname: Sharma
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  organization: Natera, Inc
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  givenname: Erik
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  surname: Spickard
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  organization: Natera, Inc
– sequence: 16
  givenname: Emilia C.
  surname: Owers
  fullname: Owers, Emilia C.
  organization: Department of Nuclear Medicine, Netherlands Cancer Institute – Antoni van Leeuwenhoek Hospital
– sequence: 17
  givenname: Annemarieke
  surname: Bartels-Rutten
  fullname: Bartels-Rutten, Annemarieke
  organization: Department of Radiology, Netherlands Cancer Institute – Antoni van Leeuwenhoek Hospital
– sequence: 18
  givenname: Peggy
  surname: den Hartog
  fullname: den Hartog, Peggy
  organization: Department of Gastrointestinal Oncology, Netherlands Cancer Institute – Antoni van Leeuwenhoek Hospital
– sequence: 19
  givenname: Noel F. C. C.
  orcidid: 0000-0001-6122-1024
  surname: de Miranda
  fullname: de Miranda, Noel F. C. C.
  organization: Department of Pathology, Leiden University Medical Center
– sequence: 20
  givenname: Monique E.
  orcidid: 0000-0002-5719-3208
  surname: van Leerdam
  fullname: van Leerdam, Monique E.
  organization: Department of Gastrointestinal Oncology, Netherlands Cancer Institute – Antoni van Leeuwenhoek Hospital, Department of Gastroenterology and Hepatology, Leiden University Medical Center
– sequence: 21
  givenname: John B. A. G.
  orcidid: 0000-0001-5884-7704
  surname: Haanen
  fullname: Haanen, John B. A. G.
  organization: Department of Medical Oncology, Netherlands Cancer Institute – Antoni van Leeuwenhoek Hospital, Department of Medical Oncology, Leiden University Medical Center, Oncology Service, Centre Hospitalier Universitaire Vaudois
– sequence: 22
  givenname: Ton N.
  orcidid: 0000-0003-0517-8804
  surname: Schumacher
  fullname: Schumacher, Ton N.
  organization: Department of Molecular Oncology and Immunology, Netherlands Cancer Institute – Antoni van Leeuwenhoek Hospital, Oncode Institute, Department of Hematology, Leiden University Medical Center
– sequence: 23
  givenname: Emile E.
  orcidid: 0000-0001-8249-9586
  surname: Voest
  fullname: Voest, Emile E.
  organization: Department of Gastrointestinal Oncology, Netherlands Cancer Institute – Antoni van Leeuwenhoek Hospital, Department of Molecular Oncology and Immunology, Netherlands Cancer Institute – Antoni van Leeuwenhoek Hospital, Oncode Institute
– sequence: 24
  givenname: Myriam
  orcidid: 0000-0002-8607-6174
  surname: Chalabi
  fullname: Chalabi, Myriam
  email: m.chalabi@nki.nl
  organization: Department of Gastrointestinal Oncology, Netherlands Cancer Institute – Antoni van Leeuwenhoek Hospital, Department of Medical Oncology, Netherlands Cancer Institute – Antoni van Leeuwenhoek Hospital
BackLink https://www.ncbi.nlm.nih.gov/pubmed/38191613$$D View this record in MEDLINE/PubMed
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Snippet Gastric and gastroesophageal junction (G/GEJ) cancers carry a poor prognosis, and despite recent advancements, most patients die of their disease. Although...
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SubjectTerms 631/67/580
692/308/2779/109/1941
692/308/53
692/699/67/1504/1829
Adenocarcinoma
Adenocarcinoma - drug therapy
Adenocarcinoma - pathology
Adverse events
Antibodies, Monoclonal, Humanized
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Apoptosis
Biomedical and Life Sciences
Biomedicine
Cancer
Cancer Research
CD8 antigen
Cell death
Chemotherapy
Effectiveness
Esophageal Neoplasms
Esophagogastric Junction - pathology
Fatalities
Humans
Immune checkpoint inhibitors
Immunotherapy
Infectious Diseases
Lymphocytes
Lymphocytes T
Medical prognosis
Metabolic Diseases
Metastases
Molecular Medicine
Monoclonal antibodies
Neoadjuvant Therapy
Neurosciences
Oxaliplatin
Patients
PD-1 protein
PD-L1 protein
Programmed Cell Death 1 Receptor
Stomach Neoplasms - drug therapy
Stomach Neoplasms - pathology
Targeted cancer therapy
Tumor Microenvironment
Tumors
Title Neoadjuvant atezolizumab plus chemotherapy in gastric and gastroesophageal junction adenocarcinoma: the phase 2 PANDA trial
URI https://link.springer.com/article/10.1038/s41591-023-02758-x
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Volume 30
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