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A phase 2 trial combining afatinib with cetuximab in patients with EGFR exon 20 insertion-positive non-small cell lung cancer.
van Veggel, Bianca A M H; van der Wekken, Anthonie J; Paats, Marthe S; Hendriks, Lizza E L; Hashemi, Sayed M S; Daletzakis, Antonios; van den Broek, Daan; Bosch, Linda J W; Monkhorst, Kim; Smit, Egbert F; de Langen, Adrianus J.
Afiliación
  • van Veggel BAMH; Department of Thoracic Oncology, Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands.
  • van der Wekken AJ; Department of Pulmonary Diseases, University of Groningen and University Medical Center Groningen, Groningen, the Netherlands.
  • Paats MS; Department of Pulmonary Diseases, Erasmus University Medical Center Cancer Institute, Rotterdam, the Netherlands.
  • Hendriks LEL; Department of Pulmonary Diseases, Maastricht University Medical Center, Maastricht, the Netherlands.
  • Hashemi SMS; Department of Pulmonary Medicine, Amsterdam University Medical Centers, Vrije Universiteit Medical Center, and Cancer Center Amsterdam, Amsterdam, the Netherlands.
  • Daletzakis A; Department of Biometrics, Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands.
  • van den Broek D; Department of Laboratory Medicine, Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands.
  • Bosch LJW; Department of Pathology, Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands.
  • Monkhorst K; Department of Pathology, Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands.
  • Smit EF; Department of Thoracic Oncology, Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands.
  • de Langen AJ; Department of Pulmonary Diseases, Leiden University Medical Center, Leiden, the Netherlands.
Cancer ; 130(5): 683-691, 2024 03 01.
Article en En | MEDLINE | ID: mdl-37905752
BACKGROUND: Epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations are the third most common EGFR mutations in patients with non-small cell lung cancer (NSCLC) and are associated with primary resistance to EGFR tyrosine kinase inhibitors (TKIs). There is evidence of activity of combining EGFR TKIs with monoclonal antibodies. This study reports on the efficacy and safety of afatinib in combination with cetuximab. METHODS: In this single-arm phase 2 trial, patients with advanced NSCLC harboring an EGFR ex20ins mutation were treated with afatinib 40 mg once daily in combination with cetuximab 500 mg/m2 every 2 weeks. The primary end point was disease control rate (DCR) at 18 weeks of treatment. RESULTS: Thirty-seven patients started treatment, with a median age of 65 years (range, 40-80 years), 78% female, and 95% White. The study achieved its primary end point with a DCR of 54% at 18 weeks, an overall response rate (ORR) of 43%, and a 32% confirmed ORR. Best responses were partial (n = 16), stable (n = 16), progressive disease (n = 2), or not evaluable (n = 3). Median progression-free survival was 5.5 months (95% CI, 3.7-8.3 months) and median overall survival was 16.8 months (95% CI, 10.7-25.8 months). The most common treatment-related adverse events (TRAEs) were diarrhea (70%), rash (65%), dry skin (59%), paronychia (54%), and erythema (43%). Grade 3 TRAEs were reported in 54% of all patients. CONCLUSIONS: Combination treatment with afatinib and cetuximab demonstrated antitumor activity with a DCR of 54% at 18 weeks and a 32% confirmed ORR. Toxicity was significant, although manageable, after dose reduction.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Carcinoma de Pulmón de Células no Pequeñas / Neoplasias Pulmonares Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Cancer Año: 2024 Tipo del documento: Article País de afiliación: Países Bajos Pais de publicación: Estados Unidos
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Carcinoma de Pulmón de Células no Pequeñas / Neoplasias Pulmonares Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Cancer Año: 2024 Tipo del documento: Article País de afiliación: Países Bajos Pais de publicación: Estados Unidos