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The following is a summary of “Patient-reported outcomes in CodeBreak 200: Sotorasib versus docetaxel for previously treated advanced NSCLC with KRAS G12C mutation,” published in the August 2024 issue of Pulmonology by Waterhouse et al.
In the Phase III CodeBreaK 200 trial, sotorasib demonstrated a significant improvement in efficacy compared to docetaxel for patients with previously treated KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC). This study extends the findings by evaluating the impact of sotorasib on patient-reported outcomes (PROs) related to quality of life (QOL), including global health status, physical functioning, dyspnea, and cough.
The CodeBreaK 200 trial involved 345 patients who had progressed after prior therapies, randomly assigned to receive either sotorasib (960 mg orally daily) or docetaxel (75 mg/m2 intravenously every 3 weeks). PROs were assessed using validated questionnaires, including the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30) and Core 13 (EORTC QLQ-LC13), the Functional Assessment of Cancer Therapy Tool General Form (FACT-G GP5), PRO-Common Terminology Criteria for Adverse Events (PRO-CTCAE), and the 5-level EuroQOL-5 Dimensions (EQ-5D-5L) with visual analog scale (EQ-5D VAS). Changes from baseline to week 12 were analyzed using generalized estimating equations for ordinal outcomes.
Patients treated with sotorasib reported fewer treatment-related side effects compared to those on docetaxel, with an odds ratio (OR) of 5.7 for reduced bother from side effects. Symptom severity was lower with sotorasib for various side effects including pain (OR 2.9), aching muscles (OR 4.4), aching joints (OR 4.2), and mouth or throat sores (OR 4.3). Additionally, the impact of symptoms on daily activities was less pronounced in the sotorasib group, with ORs of 3.2 for pain, 3.9 for aching muscles, and 10.7 for aching joints. While sotorasib maintained stable QOL, docetaxel was associated with worsening QOL, as indicated by changes in EQ-5D VAS scores (1.5 vs. -8.4 at cycle 1 day 5 and 2.2 vs. -5.8 at week 12).
Sotorasib was associated with less severe symptoms and a more stable QOL compared to docetaxel, highlighting its potential as a more tolerable treatment option for patients with pretreated, KRAS G12C-mutated advanced NSCLC. These findings suggest that sotorasib not only enhances clinical efficacy but also offers a better quality of life, making it a favorable choice in this patient population.
Source: sciencedirect.com/science/article/pii/S0169500224004550
