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

被引：2

作者：

Hibino, Makoto ^{[1
]}

Hiranuma, Osamu ^{[2
]}

Takemura, Yoshizumi ^{[2
]}

Katayama, Yuki ^{[3
]}

Chihara, Yusuke ^{[4
]}

Harada, Taishi ^{[5
]}

Fujita, Kohei ^{[6
]}

Kita, Toshiyuki ^{[7
]}

Tamiya, Nobuyo ^{[8
]}

Tsuda, Takeshi ^{[9
]}

Shiotsu, Shinsuke ^{[10
]}

Tamura, Yukihiro ^{[11
]}

Aoyama, Takashi ^{[12
]}

Nakamura, Yoichi ^{[13
]}

Terashima, Masaaki ^{[14
]}

Morimoto, Yoshie ^{[15
]}

Nagata, Kazuhiro ^{[16
]}

Yoshimura, Kenichi ^{[17
]}

Uchino, Junji ^{[3
,18
]}

Takayama, Koichi ^{[3
]}

机构：

[1] Shonan Fujisawa Tokushukai Hosp, Dept Resp Med, Fujisawa, Japan

[2] Otsu City Hosp, Dept Pulm Med, Otsu, Japan

[3] Kyoto Prefectural Univ Med, Grad Sch Med Sci, Dept Pulm Med, Kyoto, Japan

[4] Uji Tokushukai Med Ctr, Dept Resp Med, Uji, Japan

[5] Fukuchiyama City Hosp, Med Oncol, Fukuchiyama, Japan

[6] Natl Hosp Org Kyoto Med Ctr, Ctr Resp Dis, Div Resp Med, Fushimi, Japan

[7] Natl Hosp Org Kanazawa Med Ctr, Dept Resp Med, Kanazawa, Japan

[8] Rakuwakai Otowa Hosp, Dept Resp Med, Kyoto, Japan

[9] Toyama Prefectural Cent Hosp, Dept Resp Med, Toyama, Japan

[10] Japanese Red Cross Kyoto Daiichi Hosp, Dept Resp Med, Kyoto, Japan

[11] Oosumi Kanoya Hosp, Internal Med, Kanoya, Japan

[12] Fukuoka Univ Hosp, Dept Resp Med, Fukuoka, Japan

[13] Tochigi Canc Ctr, Div Thorac Oncol, Utsunomiya, Japan

[14] Izumi City Gen Hosp, Dept Med Oncol, Izumi, Osaka, Japan

[15] Kyoto Kuramaguchi Med Ctr, Dept Pulm Med, Kyoto, Japan

[16] Koseikai Takeda Hosp, Resp Ctr, Kyoto, Japan

[17] Hiroshima Univ, Med Ctr Translat & Clin Res, Hiroshima, Japan

[18] Kyoto Prefectural Univ Med, Grad Sch Med Sci, Dept Pulm Med, 465 Kajiicho, Kyoto 6028566, Japan

来源：

JTO CLINICAL AND RESEARCH REPORTS | 2022年 / 3卷 / 12期

关键词：

Angiogenesis inhibitor; Bevacizumab; EGFR tyrosine kinase inhibitors; Osimertinib; Vascular endothelial growth factor; CELL LUNG-CANCER; GROWTH-FACTOR RECEPTOR; MUTATIONS; EXPRESSION; ERLOTINIB; CRITERIA; L858R;

D O I：

10.1016/j.jtocrr.2022.100424

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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.(c) 2022 The Authors. Published by Elsevier Inc. on behalf of the International Association for the Study of Lung Cancer. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

引用

页数：13

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