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Datopotamab Deruxtecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III TROPION-Lung01 Study.
Ahn, Myung-Ju; Tanaka, Kentaro; Paz-Ares, Luis; Cornelissen, Robin; Girard, Nicolas; Pons-Tostivint, Elvire; Vicente Baz, David; Sugawara, Shunichi; Cobo, Manuel; Pérol, Maurice; Mascaux, Céline; Poddubskaya, Elena; Kitazono, Satoru; Hayashi, Hidetoshi; Hong, Min Hee; Felip, Enriqueta; Hall, Richard; Juan-Vidal, Oscar; Brungs, Daniel; Lu, Shun; Garassino, Marina; Chargualaf, Michael; Zhang, Yong; Howarth, Paul; Uema, Deise; Lisberg, Aaron; Sands, Jacob.
Afiliación
  • Ahn MJ; Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
  • Tanaka K; Kyushu University Hospital, Fukuoka, Japan.
  • Paz-Ares L; Hospital Universitario 12 de Octubre, Madrid, Spain.
  • Cornelissen R; Erasmus MC Cancer Institute, Rotterdam, the Netherlands.
  • Girard N; Institut Curie, Paris, France.
  • Pons-Tostivint E; University Hospital of Nantes, Nantes, France.
  • Vicente Baz D; Hospital Universitario Virgen Macarena, Seville, Spain.
  • Sugawara S; Sendai Kousei Hospital, Sendai, Japan.
  • Cobo M; Medical Oncology Intercenter Unit, Regional and Virgen de la Victoria University Hospitals, IBIMA, Málaga, Spain.
  • Pérol M; Centre Léon Bérard, Lyon, France.
  • Mascaux C; Hopitaux Universitaire de Strasbourg, Strasbourg, France.
  • Poddubskaya E; VitaMed LLC, Moscow, Russia.
  • Kitazono S; The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
  • Hayashi H; Kindai University Hospital, Osaka, Japan.
  • Hong MH; Yonsei Cancer Center, Severance Hospital, Seoul, Republic of Korea.
  • Felip E; Vall d'Hebron Hospital Campus, Vall d'Hebron Institute of Oncology, Universitat Autònoma de Barcelona, Spain.
  • Hall R; University of Virginia Health System, Charlottesville, VA.
  • Juan-Vidal O; Hospital Universitari i Politecnic La Fe, Valencia, Spain.
  • Brungs D; Southern Medical Day Care Centre, University of Wollongong, Wollongong, Australia.
  • Lu S; Shanghai Lung Cancer Center, Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
  • Garassino M; Department of Medicine, Hematology-Oncology Section, Thoracic Oncology Program, The University of Chicago Medicine & Biological Sciences, Chicago, IL.
  • Chargualaf M; Daiichi Sankyo, Basking Ridge, NJ.
  • Zhang Y; Daiichi Sankyo, Basking Ridge, NJ.
  • Howarth P; Daiichi Sankyo, Basking Ridge, NJ.
  • Uema D; Daiichi Sankyo, Basking Ridge, NJ.
  • Lisberg A; Department of Medicine, Division of Hematology and Oncology, David Geffen School of Medicine, University of California Los Angeles (UCLA), Los Angeles, CA.
  • Sands J; Dana-Farber Cancer Institute, Boston, MA.
J Clin Oncol ; : JCO2401544, 2024 Sep 09.
Article en En | MEDLINE | ID: mdl-39250535
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: J Clin Oncol Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: J Clin Oncol Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos