دورية أكاديمية
أعرض في EDS

A Phase II Trial of Atezolizumab Plus Carboplatin Plus Pemetrexed Plus Bevacizumab in the Treatment of Patients with Stage IV Non-Squamous Non-Small Cell Lung Cancer: Big Ten Cancer Research Consortium (BTCRC)- LUN 17-139.

التفاصيل البيبلوغرافية
العنوان: A Phase II Trial of Atezolizumab Plus Carboplatin Plus Pemetrexed Plus Bevacizumab in the Treatment of Patients with Stage IV Non-Squamous Non-Small Cell Lung Cancer: Big Ten Cancer Research Consortium (BTCRC)- LUN 17-139.
المؤلفون: Ardeshir-Larijani F; Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, IN., Althouse SK; Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, IN., Leal T; Winship Cancer Institute, Emory University., Feldman LE; University of Illinois Hospital & Health Sciences System, Chicago, IL., Hejleh TA; University of Iowa Hospitals and Clinics, Iowa City, IA., Patel M; Rutgers Cancer Institute of New Jersey, New Brunswick, NJ., Gentzler RD; University of Virginia Cancer Center, Charlottesville, VA., Miller AR; Massachusetts General Hospital, Boston, MA., Hanna NH; Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, IN. Electronic address: nhanna@iu.edu.
المصدر: Clinical lung cancer [Clin Lung Cancer] 2022 Nov; Vol. 23 (7), pp. 578-584. Date of Electronic Publication: 2022 Jul 21.
نوع المنشور: Multicenter Study; Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Elsevier Country of Publication: United States NLM ID: 100893225 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1938-0690 (Electronic) Linking ISSN: 15257304 NLM ISO Abbreviation: Clin Lung Cancer Subsets: MEDLINE
أسماء مطبوعة: Publication: 2011-: [New York] : Elsevier
Original Publication: Dallas, Tex. : Cancer Information Group, c1999-
مواضيع طبية MeSH: Carcinoma, Non-Small-Cell Lung* , Lung Neoplasms* , Neutropenia*/etiology , Sepsis*, Male ; Humans ; Female ; Middle Aged ; Pemetrexed/therapeutic use ; Carboplatin/therapeutic use ; Bevacizumab/therapeutic use ; B7-H1 Antigen ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use
مستخلص: Introduction: LUN17-139 evaluated the safety and efficacy of Atezolizumab (A) plus Carboplatin (C) plus Pemetrexed (Pem) plus Bevacizumab (B) (ACBPem) in treatment naïve patients with stage IV non-squamous non-small cell lung cancer (Ns-NSCLC).
Patients and Methods: In this multicenter, single-arm phase II trial, all patients received A (1200-mg, D1) + C (AUC 5, D1) + Pem (500-mg/m2, D1) + B (15-mg/kg D1) q3 week x4. If no PD (progressive disease), patients received maintenance ABPem until PD or intolerable side effects. The primary endpoint was progression-free survival (PFS). The positive PFS result was considered as PFS>6m (historical control). Secondary endpoints included objective response rate (ORR), disease control rate (DCR) defined by complete response (CR) + partial response (PR) + stable disease (SD) ≥ 2 months, overall survival (OS), and safety.
Results: Thirty patients were enrolled from November 2018 to October 2020. The study was closed early due to 3 patient deaths, possibly related to treatment. Median age 64 (range 38-83); Men/Women 20/10; PD-L1 TPS < 1%/1-49%/ ≥ 50% (8/15/7). The median follow-up was 20.3 months ( 1-28.1). ORR 42.9% (95% CI, 24.5-62.8%), DCR 96.4% (95% CI, 81.7-99.9%). The median PFS and OS were 11.3m (5.5-14.9,P > .05) and 22.4m (22.4-NR), respectively. Four patients had G4 toxicity (anemia, febrile-neutropenia, severe neutropenia, sepsis), and 3 patients had G5 toxicity (thromboembolism, sepsis, colonic perforation).
Conclusion: ABCPem was associated with increased PFS compared to historical controls but this difference did not meet the statistical significance. Three on-treatment deaths and 5 thromboembolic events prompted early closure.
Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2022. Published by Elsevier Inc.)
فهرسة مساهمة: Keywords: Adenocarcinoma; Angiogenesis; Chemotherapy; Immunotherapy; PD-L1; VEGF
المشرفين على المادة: 04Q9AIZ7NO (Pemetrexed)
52CMI0WC3Y (atezolizumab)
BG3F62OND5 (Carboplatin)
2S9ZZM9Q9V (Bevacizumab)
0 (B7-H1 Antigen)
تواريخ الأحداث: Date Created: 20220830 Date Completed: 20221026 Latest Revision: 20230126
رمز التحديث: 20231215
DOI: 10.1016/j.cllc.2022.07.001
PMID: 36041949
قاعدة البيانات: MEDLINE
الوصف
تدمد:1938-0690
DOI:10.1016/j.cllc.2022.07.001