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

被引:5
作者
Lee, Jay M. [1 ,9 ]
Vallieres, Eric [2 ]
Ding, Beiying [3 ]
Johnson, Ann [3 ]
Bhagwakar, Jan [3 ]
Rashidi, Sanam [4 ]
Zhu, Qian [3 ]
Gitlitz, Barbara J. [5 ]
Weksler, Benny [6 ]
Costas, Kimberly [7 ]
Altorki, Nasser [8 ]
机构
[1] Univ Calif Los Angeles, Div Thorac Surg, Los Angeles, CA USA
[2] Swedish Canc Inst, Div Thorac Surg, Seattle, WA USA
[3] US Med Affairs, South San Francisco, CA USA
[4] Genentech Inc, Prod Dev Clin Oncol, South San Francisco, CA USA
[5] Roche Diagnost USA, Med & Sci Affairs, Santa Clara, CA, Cuba
[6] Allegheny Gen Hosp, Dept Thorac & Cardiovasc Surg, Pittsburgh, PA USA
[7] Providence Reg Med Ctr, Div Thorac Surg, Everett, WA USA
[8] NewYork Presbyterian Hosp, Weill Cornell Med, Dept Cardiothorac Surg, New York, NY USA
[9] Ronald Reagan UCLA Med Ctr, Div Thorac Surg, Box 957313,Room 64-128 CHS,10833 Conte Ave, Los Angeles, CA 90095 USA
关键词
IMpower010; adjuvant therapy; atezolizumab; bilobectomy; non-small cell lung cancer; pneumonectomy; SLEEVE LOBECTOMY; MRD PLUS; DURVALUMAB; MANAGEMENT; SURVIVAL; SURGERY; NSCLC;
D O I
10.1016/j.jtcvs.2023.01.012
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objective: 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.Methods: 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.Results: Overall, 871 patients comprised the safety-evaluable randomized stage IIIIIA 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.Conclusions: 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.
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页数:19
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