Patient-reported outcomes in CodeBreaK 200 : Sotorasib versus docetaxel for previously treated advanced NSCLC with KRAS G12C mutation
Waterhouse, D.M. (Oncology Hematology Care (OHC)/SCRI Research)
Rothschild, S. (University of Basel)
Dooms, C. (UZ Leuven)
Mennecier, B. (University Hospital Strasbourg)
Bozorgmehr, F. (Translational Lung Research Center Heidelberg (TLRC-H))
Majem Tarruella, Margarita (Institut de Recerca Sant Pau)
van den Heuvel, M.H. (Radboud University Medical Center)
Linardou, H. (Metropolitan Hospital)
Chul Cho, B. (Yonsei University College of Medicine)
Roberts-Thomson, R. (Queen Elizabeth Hospital)
Tanaka, K. (Kyushu University Hospital)
Blais, N. (Centre Hospitalier de l'Université de Montréal)
Schvartsman, G. (Hospital Israelita Albert Einstein (Sao Paolo, Brasil))
Holmskov Hansen, K. (Odense University Hospital (Dinamarca))
Chmielewska, I. (Medical University of Lublin)
Forster, M.D. (UCL Cancer Institute/Sarah Cannon Research Institute)
Giannopoulou, C. (Amgen (Europe) GmbH)
Stollenwerk, B. (Amgen (Europe) GmbH)
Obiozor, C.C. (Amgen Inc.)
Wang, Y. (Amgen Inc.)
Novello, Silvia (Università degli Studi Di Torino - San Luigi Hospital Orbassano)
Universitat Autònoma de Barcelona

Data:	2024
Resum:	In the CodeBreaK 200 phase III, open-label trial, sotorasib significantly improved efficacy versus docetaxel in previously treated KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC). Patient-reported outcomes (PROs) for global health status, physical functioning, dyspnea, and cough favored sotorasib over docetaxel. Here, we report sotorasib's additional impact on quality of life (QOL). In CodeBreaK 200, 345 patients who had progressed after prior therapy received sotorasib (960 mg orally daily) or docetaxel (75 mg/m intravenously every 3 weeks). Validated questionnaires captured patients' perception of their QOL and symptom burden for key secondary and exploratory PRO endpoints, including the European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ-C30) and Quality-of-life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13), question GP5 from the Functional Assessment of Cancer Therapy Tool General Form (FACT-G GP5), PRO-Common Terminology Criteria for Adverse Events (PRO-CTCAE), and 5-level EuroQOL-5 dimensions (EQ-5D-5L) including visual analog scale (EQ-5D VAS). Change from baseline to week 12 was assessed with generalized estimating equations for ordinal outcomes. Patients receiving sotorasib were less bothered by treatment side effects than those receiving docetaxel (odds ratio [OR] 5. 7) and experienced symptoms at lower severity (pain: OR 2. 9; aching muscles: OR 4. 4; aching joints: OR 4. 2; mouth or throat sores: OR 4. 3). Further, patients' symptoms interfered less with usual/daily activities (pain: OR 3. 2; aching muscles: OR 3. 9; aching joints: OR 10. 7). QOL remained stable with sotorasib but worsened with docetaxel (change from baseline in EQ-5D VAS score: 1. 5 vs -8. 4 at cycle 1 day 5 and 2. 2 vs -5. 8 at week 12). Patients receiving sotorasib reported less severe symptoms than those receiving docetaxel. In addition to improving clinical efficacy outcomes, sotorasib maintained QOL versus docetaxel, suggesting sotorasib may be a more tolerable treatment option for patients with pretreated, KRAS G12C-mutated advanced NSCLC.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Quality of life ; Side effects ; Symptom burden
Publicat a:	Lung cancer, Vol. 196 (october 2024) , p. 107921, ISSN 1872-8332

DOI: 10.1016/j.lungcan.2024.107921
PMID: 39303400

12 p, 3.5 MB

El registre apareix a les col·leccions:
Documents de recerca > Documents dels grups de recerca de la UAB > Centres i grups de recerca (producció científica) > Ciències de la salut i biociències > Institut de Recerca Sant Pau
Articles > Articles de recerca
Articles > Articles publicats