Phase II study of afatinib plus pembrolizumab in patients with squamous cell carcinoma of the lung following progression during or after first-line chemotherapy (LUX-Lung-IO)
| العنوان: | Phase II study of afatinib plus pembrolizumab in patients with squamous cell carcinoma of the lung following progression during or after first-line chemotherapy (LUX-Lung-IO) |
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| المؤلفون: | Benjamin Levy, Fabrice Barlesi, Luis Paz-Ares, Jaafar Bennouna, Mustafa Erman, Enriqueta Felip, Dolores Isla, Hye Ryun Kim, Sang-We Kim, Jeannick Madelaine, Olivier Molinier, Mustafa Özgüroğlu, Delvys Rodríguez Abreu, Abidemi Adeniji, Robert M. Lorence, Isabelle Voccia, Michael J. Chisamore, Jonathan W. Riess |
| المساهمون: | Institut Català de la Salut, [Levy B] Johns Hopkins Sidney Kimmel Cancer Center at Sibley Memorial Hospital, Washington, DC, USA. [Barlesi F] Aix Marseille University, CNRS, INSERM, CRCM, Assistance Publique Hôpitaux de Marseille, Marseille, France. Gustave Roussy Cancer Campus, Villejuif, France. [Paz-Ares L] Department of Medical Oncology, University Hospital 12 De Octubre, Madrid, Spain. [Bennouna J] Department of Pneumology, Thoracic Oncology, University Hospital - Nantes, Nantes, France. [Erman M] Department of Medical Oncology, Hacettepe University Cancer Institute, Ankara, Turkey. [Felip E] Servei d’Oncologia Mèdica, Vall d'Hebron Hospital Universitari, Barcelona, Spain. Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Isla D] Department of Medical Oncology, University Hospital Lozano Blesa, Zaragoza, Spain, Vall d'Hebron Barcelona Hospital Campus, Centre de Recherche en Cancérologie de Marseille (CRCM), Aix Marseille Université (AMU)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Institut Gustave Roussy (IGR), Universidad Complutense de Madrid = Complutense University of Madrid [Madrid] (UCM), Hôpital Foch [Suresnes], Hacettepe University = Hacettepe Üniversitesi, Vall d'Hebron University Hospital [Barcelona], Yonsei University College of Medicine [Séoul, Corée du Sud], Service de pneumologie [CHU Caen], Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN), Centre Hospitalier Le Mans (CH Le Mans) |
| المصدر: | Scientia LUNG CANCER LUNG CANCER, 2022, 166, pp.107-113. ⟨10.1016/j.lungcan.2022.01.023⟩ |
| بيانات النشر: | Elsevier BV, 2022. |
| سنة النشر: | 2022 |
| مصطلحات موضوعية: | Male, Pulmonary and Respiratory Medicine, Neoplasms::Neoplasms by Site::Thoracic Neoplasms::Respiratory Tract Neoplasms::Lung Neoplasms [DISEASES], Cancer Research, Lung Neoplasms, [SDV]Life Sciences [q-bio], Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores], Middle Aged, Afatinib, Antibodies, Monoclonal, Humanized, Other subheadings::Other subheadings::/drug therapy [Other subheadings], Quimioteràpia combinada, ErbB Receptors, neoplasias::neoplasias por localización::neoplasias torácicas::neoplasias del tracto respiratorio::neoplasias pulmonares [ENFERMEDADES], Oncology, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Squamous Cell, Avaluació de resultats (Assistència sanitària), Humans, Female, Pulmons - Càncer - Tractament |
| الوصف: | Afatinib; Carcinoma, Squamous Cell; Pembrolizumab Afatinib; Carcinoma de células escamosas; Pembrolizumab Afatinib; Carcinoma de cèl·lules escamoses; Pembrolizumab Introduction Afatinib and pembrolizumab have separately shown survival benefit in patients with squamous cell carcinoma (SqCC) of the lung, and there is biological rationale for concurrent inhibition of the programmed death ligand-1 and epidermal growth factor receptor (EGFR) pathways in this patient population. Materials and Methods This open-label, single-arm study enrolled patients with SqCC of the lung who had progressed during/after first-line chemotherapy and comprised two parts: a safety run-in to establish the recommended phase II dose (RP2D; afatinib 40 mg or 30 mg once daily with pembrolizumab 200 mg every 3 weeks); and the main part assessing efficacy and safety of the RP2D. The primary endpoint was objective response rate (ORR); secondary endpoints included the RP2D, progression-free survival (PFS) and overall survival (OS). Results Twenty-four patients were treated in the safety run-in (afatinib 40 mg/30 mg cohorts: n = 12/12). Median age was 63.5 years; 79.2% of patients were male. All patients discontinued afatinib and pembrolizumab, most commonly due to disease progression (58.3% and 75.0%, respectively) or adverse events (AEs; 37.5% and 25.0%, respectively). The study was discontinued early after completion of the safety run-in, and no patients entered the main part. ORR was 12.5%; median PFS and OS were 13.1 and 29.3 weeks, respectively. All patients had ≥ 1 drug-related AE (grade ≥ 3: 45.8%). Conclusion While there were no new or unexpected safety findings, exploratory analysis of antitumor activity indicated limited efficacy with afatinib plus pembrolizumab in patients with SqCC of the lung who had progressed during/after first-line chemotherapy. This work was supported by Boehringer Ingelheim International GmbH and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Both study sponsors participated in the design of the study, the collection, analysis, and interpretation of the data, writing this article, and the decision to submit the article for publication. |
| وصف الملف: | application/pdf |
| تدمد: | 0169-5002 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8a6154ee0d6f5200eddf5a3d35311b7fTest https://doi.org/10.1016/j.lungcan.2022.01.023Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....8a6154ee0d6f5200eddf5a3d35311b7f |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 01695002 |
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