Safety of adjuvant atezolizumab after pneumonectomy/bilobectomy in stage II-IIIA non-small cell lung cancer in the randomized phase III IMpower010 trial.


Journal

The Journal of thoracic and cardiovascular surgery
ISSN: 1097-685X
Titre abrégé: J Thorac Cardiovasc Surg
Pays: United States
ID NLM: 0376343

Informations de publication

Date de publication:
09 2023
Historique:
received: 30 09 2022
revised: 12 12 2022
accepted: 01 01 2023
medline: 14 8 2023
pubmed: 26 2 2023
entrez: 25 2 2023
Statut: ppublish

Résumé

Adjuvant atezolizumab is a standard of care after chemotherapy in completely resected stage II-IIIA programmed death ligand-1 tumor cell 1% or greater non-small cell lung cancer based on results from the phase III IMpower010 study. We explored the safety and tolerability of adjuvant atezolizumab by surgery type in IMpower010. Patients had completely resected stage IB-IIIA non-small cell lung cancer (Union Internationale Contre le Cancer/American Joint Committee on Cancer, 7th Ed), received up to four 21-day cycles of cisplatin-based chemotherapy, and were randomized 1:1 to receive atezolizumab 1200 mg every 3 weeks (≤16 cycles or 1 year) or best supportive care. Adverse events and clinical characteristics were investigated by surgery type (pneumonectomy/bilobectomy or lobectomy/sleeve lobectomy) in the randomized stage II-IIIA population who received 1 or more atezolizumab dose or with 1 or more postbaseline assessment (safety evaluable) for best supportive care. Overall, 871 patients comprised the safety-evaluable randomized stage II-IIIA population. In the atezolizumab arm, 23% (100/433) received pneumonectomy/bilobectomy and 77% (332/433) received lobectomy/sleeve lobectomy. Atezolizumab discontinuation occurred in 32% (n = 32) and 35% (n = 115) of the pneumonectomy/bilobectomy and lobectomy/sleeve lobectomy groups, respectively. Grade 3/4 adverse events were reported in 21% (n = 21) and 23% (n = 76) of patients in the atezolizumab arms in the pneumonectomy/bilobectomy and lobectomy/sleeve lobectomy groups, respectively. In the atezolizumab arms of the surgery groups, 13% (n = 13) and 17% (n = 55) had an adverse event leading to hospitalization. Atezolizumab-related adverse events leading to hospitalization occurred in 5% (n = 5) and 7% (n = 23) of the surgery groups. These exploratory findings support use of adjuvant atezolizumab after platinum-based chemotherapy in patients with completely resected stage II-IIIA programmed death ligand-1 tumor cell 1% or more non-small cell lung cancer, regardless of surgery type.

Identifiants

pubmed: 36841745
pii: S0022-5223(23)00080-6
doi: 10.1016/j.jtcvs.2023.01.012
pii:
doi:

Substances chimiques

atezolizumab 52CMI0WC3Y

Types de publication

Randomized Controlled Trial Clinical Trial, Phase III Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

655-666.e7

Commentaires et corrections

Type : CommentIn

Informations de copyright

Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.

Auteurs

Jay M Lee (JM)

Division of Thoracic Surgery, University of California, Los Angeles, Los Angeles, Calif. Electronic address: jaymoonlee@mednet.ucla.edu.

Eric Vallières (E)

Division of Thoracic Surgery, Swedish Cancer Institute, Seattle, Wash.

Beiying Ding (B)

US Medical Affairs and Product Development Clinical Oncology, Genentech Inc, South San Francisco, Calif.

Ann Johnson (A)

US Medical Affairs and Product Development Clinical Oncology, Genentech Inc, South San Francisco, Calif.

Jan Bhagwakar (J)

US Medical Affairs and Product Development Clinical Oncology, Genentech Inc, South San Francisco, Calif.

Sanam Rashidi (S)

Medical and Scientific Affairs, Roche Diagnostics USA, Santa Clara, Calif.

Qian Cindy Zhu (QC)

US Medical Affairs and Product Development Clinical Oncology, Genentech Inc, South San Francisco, Calif.

Barbara J Gitlitz (BJ)

Product Development Clinical Oncology, Genentech Inc, South San Francisco, Calif.

Benny Weksler (B)

Department of Thoracic and Cardiovascular Surgery, Allegheny General Hospital, Pittsburgh, Pa.

Kimberly Costas (K)

Division of Thoracic Surgery, Providence Regional Medical Center, Everett, Wash.

Nasser Altorki (N)

Department of Cardiothoracic Surgery, NewYork-Presbyterian Hospital, Weill Cornell Medicine, New York, NY.

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Classifications MeSH