한빛사논문
- 조회222
Myung-Ju Ahn 1, Kentaro Tanaka 2, Luis Paz-Ares 3, Robin Cornelissen 4, Nicolas Girard 5, Elvire Pons-Tostivint 6, David Vicente Baz 7, Shunichi Sugawara 8, Manuel Cobo 9, Maurice Pérol 10, Céline Mascaux 11, Elena Poddubskaya 12, Satoru Kitazono 13, Hidetoshi Hayashi 14, Min Hee Hong 15, Enriqueta Felip 16, Richard Hall 17, Oscar Juan-Vidal 18, Daniel Brungs 19, Shun Lu 20, Marina Garassino 21, Michael Chargualaf 22, Yong Zhang 22, Paul Howarth 22, Deise Uema 22, Aaron Lisberg 23, Jacob Sands 24; TROPION-Lung01 Trial Investigators
1Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
2Kyushu University Hospital, Fukuoka, Japan.
3Hospital Universitario 12 de Octubre, Madrid, Spain.
4Erasmus MC Cancer Institute, Rotterdam, the Netherlands.
5Institut Curie, Paris, France.
6University Hospital of Nantes, Nantes, France.
7Hospital Universitario Virgen Macarena, Seville, Spain.
8Sendai Kousei Hospital, Sendai, Japan.
9Medical Oncology Intercenter Unit, Regional and Virgen de la Victoria University Hospitals, IBIMA, Málaga, Spain.
10Centre Léon Bérard, Lyon, France.
11Hopitaux Universitaire de Strasbourg, Strasbourg, France.
12VitaMed LLC, Moscow, Russia.
13The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
14Kindai University Hospital, Osaka, Japan.
15Yonsei Cancer Center, Severance Hospital, Seoul, Republic of Korea.
16Vall d'Hebron Hospital Campus, Vall d'Hebron Institute of Oncology, Universitat Autònoma de Barcelona, Spain.
17University of Virginia Health System, Charlottesville, VA.
18Hospital Universitari i Politecnic La Fe, Valencia, Spain.
19Southern Medical Day Care Centre, University of Wollongong, Wollongong, Australia.
20Shanghai Lung Cancer Center, Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
21Department of Medicine, Hematology-Oncology Section, Thoracic Oncology Program, The University of Chicago Medicine & Biological Sciences, Chicago, IL.
22Daiichi Sankyo, Basking Ridge, NJ.
23Department of Medicine, Division of Hematology and Oncology, David Geffen School of Medicine, University of California Los Angeles (UCLA), Los Angeles, CA.
24Dana-Farber Cancer Institute, Boston, MA.
*A.L. and J.S. contributed equally to this work.
Corresponding author : Jacob Sands
Abstract
Purpose: The randomized, open-label, global phase III TROPION-Lung01 study compared the efficacy and safety of datopotamab deruxtecan (Dato-DXd) versus docetaxel in patients with pretreated advanced/metastatic non-small cell lung cancer (NSCLC).
Methods: Patients received Dato-DXd 6 mg/kg or docetaxel 75 mg/m2 once every 3 weeks. Dual primary end points were progression-free survival (PFS) and overall survival (OS). Objective response rate, duration of response, and safety were secondary end points.
Results: In total, 299 and 305 patients were randomly assigned to receive Dato-DXd or docetaxel, respectively. The median PFS was 4.4 months (95% CI, 4.2 to 5.6) with Dato-DXd and 3.7 months (95% CI, 2.9 to 4.2) with docetaxel (hazard ratio [HR], 0.75 [95% CI, 0.62 to 0.91]; P = .004). The median OS was 12.9 months (95% CI, 11.0 to 13.9) and 11.8 months (95% CI, 10.1 to 12.8), respectively (HR, 0.94 [95% CI, 0.78 to 1.14]; P = .530). In the prespecified nonsquamous histology subgroup, the median PFS was 5.5 versus 3.6 months (HR, 0.63 [95% CI, 0.51 to 0.79]) and the median OS was 14.6 versus 12.3 months (HR, 0.84 [95% CI, 0.68 to 1.05]). In the squamous histology subgroup, the median PFS was 2.8 versus 3.9 months (HR, 1.41 [95% CI, 0.95 to 2.08]) and the median OS was 7.6 versus 9.4 months (HR, 1.32 [95% CI, 0.91 to 1.92]). Grade ≥3 treatment-related adverse events occurred in 25.6% and 42.1% of patients, and any-grade adjudicated drug-related interstitial lung disease/pneumonitis occurred in 8.8% and 4.1% of patients, in the Dato-DXd and docetaxel groups, respectively.
Conclusion: Dato-DXd significantly improved PFS versus docetaxel in patients with advanced/metastatic NSCLC, driven by patients with nonsquamous histology. OS showed a numerical benefit but did not reach statistical significance. No unexpected safety signals were observed.
논문정보
- Research article
- 2024년 09월 (BRIC 등록일 2024-09-23)
- 국내+국외 연구진
- 의약학 > 종양의학
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