Osimertinib and Bevacizumab Cotreatment for Untreated EGFR-Mutated NSCLC With Malignant Pleural or Pericardial Effusion (SPIRAL II) : A Single-Arm, Open-Label, Phase 2 Clinical Trial

© 2022 The Authors..

Introduction: First-line treatment of EGFR-mutated NSCLC with erlotinib plus antiangiogenic inhibitor exhibits promising results. However, the efficacy of this combination has not been fully investigated. Therefore, we evaluated the efficacy and safety of osimertinib plus bevacizumab in patients with EGFR-mutated NSCLC complicated with malignant pleural or pericardial effusion (MPE) for whom combination therapy may be particularly effective.

Methods: This single-arm, open-label, phase 2 study aimed to investigate the clinical benefits of the bevacizumab (15 mg/kg) and osimertinib (80 mg) combination in the first-line setting for advanced EGFR-mutated NSCLC with MPE. The primary end point of this study was 1-year progression-free survival (PFS). The secondary end points were objective response rate, PFS, overall survival, drainage-free survival without the need for thoracic or pericardial drainage, and safety.

Results: Between January 2019 and August 2020, a total of 31 patients with EGFR-mutated NSCLC were enrolled from Japan in the study. The median PFS was 8.5 months (95% confidence interval [CI]: 5.3-11.3), the 1-year PFS was 32.1% (80% CI: 21.4-43.3), and the objective response rate was 74.2% (95% CI: 56.8-86.3). The median overall survival was not reached. The median drainage-free survival was 18.4 months (95% CI: 10.3-not estimable). Anorexia was the most common grade 3 or higher adverse event (four patients, 12.9%), followed by fatigue and dyspnea (three patients, 9.7%). No treatment-related deaths were recorded.

Conclusions: Osimertinib and bevacizumab combination in patients with advanced EGFR-mutated NSCLC with MPE were safe but did not effectively increase PFS when compared with the inferred value from previous literature.

Medienart:

E-Artikel

Erscheinungsjahr:

2022

Erschienen:

2022

Enthalten in:

Zur Gesamtaufnahme - volume:3

Enthalten in:

JTO clinical and research reports - 3(2022), 12 vom: 15. Dez., Seite 100424

Sprache:

Englisch

Beteiligte Personen:

Hibino, Makoto [VerfasserIn]
Hiranuma, Osamu [VerfasserIn]
Takemura, Yoshizumi [VerfasserIn]
Katayama, Yuki [VerfasserIn]
Chihara, Yusuke [VerfasserIn]
Harada, Taishi [VerfasserIn]
Fujita, Kohei [VerfasserIn]
Kita, Toshiyuki [VerfasserIn]
Tamiya, Nobuyo [VerfasserIn]
Tsuda, Takeshi [VerfasserIn]
Shiotsu, Shinsuke [VerfasserIn]
Tamura, Yukihiro [VerfasserIn]
Aoyama, Takashi [VerfasserIn]
Nakamura, Yoichi [VerfasserIn]
Terashima, Masaaki [VerfasserIn]
Morimoto, Yoshie [VerfasserIn]
Nagata, Kazuhiro [VerfasserIn]
Yoshimura, Kenichi [VerfasserIn]
Uchino, Junji [VerfasserIn]
Takayama, Koichi [VerfasserIn]

Links:

Volltext

Themen:

Angiogenesis inhibitor
Bevacizumab
EGFR tyrosine kinase inhibitors
Journal Article
Osimertinib
Vascular endothelial growth factor

Anmerkungen:

Date Revised 29.11.2022

published: Electronic-eCollection

Citation Status PubMed-not-MEDLINE

doi:

10.1016/j.jtocrr.2022.100424

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM349517525