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Efficacy and Safety of Rociletinib Versus Chemotherapy in Patients With EGFR -Mutated NSCLC: The Results of TIGER-3, a Phase 3 Randomized Study.

التفاصيل البيبلوغرافية
العنوان: Efficacy and Safety of Rociletinib Versus Chemotherapy in Patients With EGFR -Mutated NSCLC: The Results of TIGER-3, a Phase 3 Randomized Study.
المؤلفون: Yang JC; Department of Oncology, National Taiwan University Hospital, Taipei City, Republic of China., Reckamp KL; Department of Medical Oncology, Cedars-Sinai Medical Center, Los Angeles, California., Kim YC; Department of Internal Medicine, Chonnam National University Hwasun Hospital, Hwasun-gun, Jeollanam-do, Republic of Korea., Novello S; Department of Oncology, University of Turin, Azienda Ospedaliero-Universitaria San Luigi Gonzaga, Orbassano, Italy., Smit EF; Department of Thoracic Oncology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands., Lee JS; Division of Hematology and Medical Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea., Su WC; Department of Internal Medicine, National Cheng Kung University Hospital, Tainan City, Republic of China., Akerley WL; Medical Oncology, Huntsman Cancer Institute, Salt Lake City, Utah., Blakely CM; Division of Hematology/Oncology, Department of Medicine, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, California., Groen HJM; Department of Pulmonary Diseases, University of Groningen and University Medical Center Groningen, Groningen, The Netherlands., Bazhenova L; Division of Hematology and Medical Oncology, University of California San Diego Moores Cancer Center, La Jolla, California., Carcereny Costa E; Medical Oncology Department, Catalan Institute of Oncology Badalona, Badalona Applied Research Group in Oncology, Badalona, Spain., Chiari R; Medical Oncology, AULSS6 Euganea-Ospedali Riuniti Padova Sud, Padua, Italy., Hsia TC; Department of Respiratory Therapy, China Medical University, China Medical University Hospital, Taichung City, Republic of China., Golsorkhi T; Clinical Development, Clovis Oncology, Inc., Boulder, Colorado., Despain D; Biostatistics, Clovis Oncology, Inc., Boulder, Colorado., Shih D; Clinical Operations, Clovis Oncology, Inc., Boulder, Colorado., Popat S; Lung Unit, The Royal Marsden Hospital, Royal Marsden NHS Foundation Trust, London, United Kingdom., Wakelee H; Division of Oncology, Department of Medicine, Stanford University, Stanford, California.
المصدر: JTO clinical and research reports [JTO Clin Res Rep] 2020 Oct 26; Vol. 2 (2), pp. 100114. Date of Electronic Publication: 2020 Oct 26 (Print Publication: 2021).
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: Elsevier Inc Country of Publication: United States NLM ID: 101769967 Publication Model: eCollection Cited Medium: Internet ISSN: 2666-3643 (Electronic) Linking ISSN: 26663643 NLM ISO Abbreviation: JTO Clin Res Rep Subsets: PubMed not MEDLINE
أسماء مطبوعة: Publication: [New York] : Elsevier Inc., [2020]-
مستخلص: Introduction: The TIGER-3 (NCT02322281) study was initiated to compare the efficacy and safety of rociletinib, a third-generation EGFR tyrosine kinase inhibitor (TKI) that targets EGFR T790M and common EGFR -activating mutations, versus chemotherapy in patients with NSCLC who progressed on first- or second-generation EGFR TKIs.
Methods: Patients with advanced or metastatic EGFR -mutated NSCLC with disease progression on standard therapy (previous EGFR TKI and platinum-based chemotherapy) were randomized to oral rociletinib (500 or 625 mg twice daily) or single-agent chemotherapy (pemetrexed, gemcitabine, docetaxel, or paclitaxel).
Results: Enrollment was halted when rociletinib development was discontinued in 2016. Of 149 enrolled patients, 75 were randomized to rociletinib (n = 53: 500 mg twice daily; n = 22: 625 mg twice daily) and 74 to chemotherapy. The median investigator-assessed progression-free survival (PFS) was 4.1 months (95% confidence interval [CI]: 2.6-5.4) in the rociletinib 500-mg group and 5.5 months (95% CI: 1.8-8.1) in the 625-mg group versus 2.5 months (95% CI: 1.4-2.9) in the chemotherapy group. An improved PFS was observed in patients with T790M-positive NSCLC treated with rociletinib (n = 25; 500 mg and 625 mg twice daily) versus chemotherapy (n = 20; 6.8 versus 2.7 mo; hazard ratio = 0.55, 95% CI: 0.28-1.07, p  = 0.074). Grade 3 or higher hyperglycemia (24.0%), corrected QT prolongation (6.7%), diarrhea (2.7%), and vomiting (1.3%) were more frequent with rociletinib than chemotherapy (0%, 0%, 1.4%, and 0%, respectively).
Conclusions: Rociletinib had a more favorable median PFS versus chemotherapy but had higher rates of hyperglycemia and corrected QT prolongation in patients with advanced EGFR -mutated NSCLC who progressed on previous EGFR TKI. Incomplete enrollment prevented evaluation of the primary efficacy end point.
(© 2020 The Authors.)
References: N Engl J Med. 2009 Sep 3;361(10):947-57. (PMID: 19692680)
Clin Cancer Res. 2017 Feb 1;23(3):618-622. (PMID: 27821604)
N Engl J Med. 2018 Jan 11;378(2):113-125. (PMID: 29151359)
J Clin Oncol. 2013 Sep 20;31(27):3327-34. (PMID: 23816960)
N Engl J Med. 2009 Sep 3;361(10):958-67. (PMID: 19692684)
Oncologist. 2016 Nov;21(11):1326-1336. (PMID: 27473045)
N Engl J Med. 2017 Feb 16;376(7):629-640. (PMID: 27959700)
N Engl J Med. 2008 Sep 25;359(13):1367-80. (PMID: 18815398)
Cancer Discov. 2013 Dec;3(12):1404-15. (PMID: 24065731)
J Clin Oncol. 2017 Apr 20;35(12):1288-1296. (PMID: 28221867)
JCO Precis Oncol. 2018 Nov;2:1-13. (PMID: 35135111)
Clin Cancer Res. 2013 Apr 15;19(8):2240-7. (PMID: 23470965)
J Hematol Oncol. 2016 Apr 12;9:34. (PMID: 27071706)
Jpn J Clin Oncol. 2019 Jan 01;49(1):29-36. (PMID: 30508196)
Nat Rev Cancer. 2007 Mar;7(3):169-81. (PMID: 17318210)
PLoS Med. 2005 Mar;2(3):e73. (PMID: 15737014)
N Engl J Med. 2016 Jun 9;374(23):2296-7. (PMID: 27195670)
فهرسة مساهمة: Keywords: EGFR tyrosine kinase inhibitor*; Epidermal growth factor receptor mutations*; Non–small cell lung cancer*; Phase III randomized clinical trial*; Rociletinib*
تواريخ الأحداث: Date Created: 20210930 Latest Revision: 20230921
رمز التحديث: 20240829
مُعرف محوري في PubMed: PMC8474221
DOI: 10.1016/j.jtocrr.2020.100114
PMID: 34589984
قاعدة البيانات: MEDLINE
الوصف
تدمد:2666-3643
DOI:10.1016/j.jtocrr.2020.100114