Characterization and management of adverse events observed with mobocertinib (TAK-788) treatment for EGFR exon 20 insertion–positive non–small cell lung cancer
| Autor: | James Chih-Hsin Yang, Caicun Zhou, Pasi A. Jänne, Suresh S. Ramalingam, Tae Min Kim, Gregory J Riely, Alexander I Spira, Zofia Piotrowska, Tarek Mekhail, Maria Rosario Garcia Campelo, Enriqueta Felip, Lyudmila Bazhenova, Shu Jin, Manmit Kaur, Paul M. Diderichsen, Neeraj Gupta, Veronica Bunn, Jianchang Lin, Eric N. Churchill, Minal Mehta, Danny Nguyen |
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| Přispěvatelé: | Institut Català de la Salut, [Yang JC] Graduate Institute of Oncology, National Taiwan University Hospital and National Taiwan University Cancer Center, Taipei, Taiwan. [Zhou C] Shanghai Pulmonary Hospital, Shanghai, China. [Jänne PA] Dana-Farber Cancer Institute, Boston, MA, USA. [Ramalingam SS] School of Medicine, Emory University, Atlanta, GA, USA. [Kim TM] Seoul National University Hospital, Seoul, South Korea. [Riely GJ] Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA. [Felip E] Vall d’Hebron Hospital Universitari, Barcelona, Spain, Vall d'Hebron Barcelona Hospital Campus |
| Jazyk: | angličtina |
| Rok vydání: | 2023 |
| Předmět: |
Medicaments antineoplàstics - Efectes secundaris
Oncology Other subheadings::Other subheadings::/adverse effects [Other subheadings] Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores] acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antineoplásicos [COMPUESTOS QUÍMICOS Y DROGAS] Pharmacology (medical) Neoplasms::Neoplasms by Site::Thoracic Neoplasms::Respiratory Tract Neoplasms::Lung Neoplasms::Bronchial Neoplasms::Carcinoma Bronchogenic::Carcinoma Non-Small-Cell Lung [DISEASES] Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Antineoplastic Agents [CHEMICALS AND DRUGS] neoplasias::neoplasias por localización::neoplasias torácicas::neoplasias del tracto respiratorio::neoplasias pulmonares::neoplasias de los bronquios::carcinoma broncogénico::carcinoma de pulmón de células no pequeñas [ENFERMEDADES] Other subheadings::Other subheadings::/drug therapy [Other subheadings] Otros calificadores::Otros calificadores::/efectos adversos [Otros calificadores] Pulmons - Càncer - Tractament |
| Zdroj: | Scientia |
| Popis: | Carcinoma; Càncer de pulmó de cèl·lules no petites; Seguretat del pacient Carcinoma; Cáncer de pulmón de células no pequeñas; Seguridad del paciente Carcinoma; Non–small cell lung cancer; Patient safety Background Mobocertinib has demonstrated durable clinical benefit in platinum-pretreated patients (PPP) with epidermal growth factor receptor exon 20 insertion–positive non–small cell lung cancer (NSCLC). Research design and methods Pooled safety analysis of two studies included patients with NSCLC (N = 257) treated with the recommended phase 2 dose (RP2D) of mobocertinib (160 mg once daily). We report overall safety (treatment-emergent adverse events [TEAEs]) in the RP2D population; characterization of GI and skin-related events in 114 PPP from a phase 1/2 study (NCT02716116); and clinical activity in PPP with and without dose reductions due to TEAEs. Results In the RP2D population (N = 257), the most common TEAEs were diarrhea (93%), nausea (47%), rash (38%), and vomiting (37%). In PPP (N = 114), median times to diarrhea onset and resolution were 5 and 2 days, respectively. Median times to onset and resolution of skin-related events were 9 and 78 days, respectively. Among PPP with (n = 29) or without (n = 85) dose reductions due to TEAEs, overall response rates were 21% and 31% and median durations of response were 5.7 and 17.5 months, respectively. Conclusions GI and skin-related events are common with mobocertinib; minimizing dose reductions with proactive management may improve clinical outcomes. The paper received funding from Takeda Development Center Americas Inc., Lexington, MA, USA. |
| Databáze: | OpenAIRE |
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