Your browser doesn't support javascript.
loading
Canakinumab as Adjuvant Therapy in Patients With Completely Resected Non-Small-Cell Lung Cancer: Results From the CANOPY-A Double-Blind, Randomized Clinical Trial.
Garon, Edward B; Lu, Shun; Goto, Yasushi; De Marchi, Pedro; Paz-Ares, Luis; Spigel, David R; Thomas, Michael; Yang, James Chih-Hsin; Ardizzoni, Andrea; Barlesi, Fabrice; Orlov, Sergey; Yoshioka, Hiroshige; Mountzios, Giannis; Khanna, Sadhvi; Bossen, Claudia; Carbini, Mariana; Turri, Sabine; Myers, Andrea; Cho, Byoung Chul.
Afiliação
  • Garon EB; David Geffen School of Medicine at UCLA/TRIO-US/TRIO-Global Network, Los Angeles, CA.
  • Lu S; Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
  • Goto Y; National Cancer Center, Tokyo, Japan.
  • De Marchi P; Oncoclinicas, Rio de Janeiro, Brazil.
  • Paz-Ares L; University Hospital 12 de Octubre, CNIO-H120 Lung Cancer Unit, Completense University and Ciberonc, Madrid, Spain.
  • Spigel DR; Sarah Cannon Research Institute, Nashville, TN.
  • Thomas M; Thoraxklinik and National Center for Tumor Diseases at Heidelberg University Hospital, Translational Lung Research Center Heidelberg (TLRH-C), German Center for Lung Research (DZL), Heidelberg, Germany.
  • Yang JC; National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei, Taiwan.
  • Ardizzoni A; IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
  • Barlesi F; Medical Oncology Department, Gustave Roussy, Villejuif, France.
  • Orlov S; Faculté de Médecine, Université Paris-Saclay, Bicêtre, France.
  • Yoshioka H; Saint Petersburg Electrotechnical University, Saint Petersburg, Russia.
  • Mountzios G; Department of Thoracic Oncology, Kansai Medical University, Hirakata, Japan.
  • Khanna S; Fourth Oncology Department and Clinical Trials Unit, Henry Dunant Hospital Center, Athens, Greece.
  • Bossen C; Novartis Pharma S.A.S, Rueil-Malmaison, France.
  • Carbini M; Novartis Pharma AG, Basel, Switzerland.
  • Turri S; Novartis Pharma AG, Basel, Switzerland.
  • Myers A; Novartis Pharma S.A.S, Rueil-Malmaison, France.
  • Cho BC; Novartis Pharmaceuticals Corporation, East Hanover, NJ.
J Clin Oncol ; 42(2): 180-191, 2024 Jan 10.
Article em En | MEDLINE | ID: mdl-37788412
ABSTRACT

PURPOSE:

Effective treatments for resectable non-small-cell lung cancer (NSCLC) are limited and relapse rates are high. The interleukin (IL)-1ß pathway has been linked with tumor development and progression, including in the Canakinumab Anti-Inflammatory Thrombosis Outcomes cardiovascular study in which IL-1ß pathway inhibition with canakinumab reduced lung cancer incidence and mortality in an exploratory analysis.

METHODS:

CANOPY-A (ClinicalTrials.gov identifier NCT03447769) is a phase III, randomized, double-blind, multicenter study of canakinumab versus placebo for adult patients with stage II-IIIA or IIIB (T >5 cm, N2-positives II-IIIB; American Joint Committee on Cancer/Union for International Cancer Control version 8), completely resected NSCLC who had received adjuvant cisplatin-based chemotherapy. The primary end point was disease-free survival (DFS) and the key secondary end point was overall survival (OS).

RESULTS:

In total, 1,382 patients were randomized to 200 mg canakinumab (n = 693) or placebo (n = 689) once every 3 weeks for 18 cycles. Grade ≥3 adverse events (AEs) were reported in 20.8% and 19.6% of patients receiving canakinumab and placebo, respectively; AEs led to discontinuation in 4.3% and 4.1% of patients in these groups, respectively. This study did not meet its primary end point. Median DFS was 35.0 months (canakinumab arm) and 29.7 months (placebo arm; hazard ratio, 0.94; 95% CI, 0.78 to 1.14; one-sided P = .258). DFS subgroup analyses did not show any meaningful differences between arms. As expected, because of canakinumab-driven IL-1ß pathway inhibition, C-reactive protein and IL-6 levels decreased in the canakinumab arm versus placebo arm, but had no correlation with differential clinical outcomes. OS was not formally tested as DFS was not statistically significant.

CONCLUSION:

CANOPY-A did not show a DFS benefit of adding canakinumab after surgery and adjuvant cisplatin-based chemotherapy in patients with resected, stage II-III NSCLC. No new safety signals were identified with canakinumab.
Assuntos

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Carcinoma Pulmonar de Células não Pequenas / Neoplasias Pulmonares Tipo de estudo: Clinical_trials Limite: Adult / Humans Idioma: En Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Carcinoma Pulmonar de Células não Pequenas / Neoplasias Pulmonares Tipo de estudo: Clinical_trials Limite: Adult / Humans Idioma: En Ano de publicação: 2024 Tipo de documento: Article