KEY TAKEAWAYS
- The CodeBreaK 200 phase III trial compared patient-reported outcomes from sotorasib versus docetaxel in KRASG12C-mutated NSCLC.
- The study showed that patients with pretreated, KRASG12C-mutated NSCLC showed better outcomes when using sotorasib compared to docetaxel, both in terms of clinical efficacy and patients’ feedback about their overall health and physical condition.
In the phase III CodeBreaK 200 trial, 345 patients (pts) who showed progression post-platinum-based chemotherapy and a checkpoint inhibitor treatment were evenly divided to either be administered with sotorasib (960 mg orally every day) or docetaxel (75 mg/m2 via IV every 3 weeks). Well-established and validated surveys were utilized to gauge the patients’ personal assessment of their QOL and symptom burden. These included the EuroQOL-5 Dimension Visual Analogue Scale (EQ-5D VAS), PRO-Common Terminology Criteria for Adverse Events (CTCAE), Brief Pain Inventory (BPI), and question GP5 from the Functional Assessment of Cancer Therapy Tool General form (FACT-G). Ordinal results were reviewed using generalized estimating equations, particularly changes from the starting point to the 12th week.
Patients on the docetaxel regimen had more pronounced side effects (odds ratio [OR] 5.71) and experienced symptoms of greater intensity (examples include pain: OR 2.94, muscle aches: OR 4.40, joint pain: OR 4.17, and sores in the mouth or throat: OR 4.26). Moreover, these symptoms more profoundly disrupted their typical daily routines. The QOL demonstrated deterioration five days post the initial dose of docetaxel, while it remained consistent for those on sotorasib (with a VAS score change of –8.4 vs 1.5). A prolonged decline in QOL was seen with docetaxel, whereas sotorasib maintained stability in the VAS score (-5.8 vs 2.2 by the end of week 12).
Individuals administered with sotorasib experienced milder symptoms than their counterparts on docetaxel, resulting in a more favorable daily living experience. Beyond just better clinical results, sotorasib also ensured a consistent QOL in comparison to docetaxel. This indicates that sotorasib might be a more tolerable treatment option for patients with pretreated KRASG12C-mutated advanced non-small cell lung cancer (NSCLC).
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT04303780
Waterhouse, D.M., Rothschild, S., Dooms, C., Mennecier, B., Bozorgmehr, F., Tarruella, M.M., Van den Heuvel, M., Linardou, H., Chul-Cho, B., Roberts-Thomson, R., Okamoto, I., Blais, N., Schvartsman, G., Holmskov, K., Chmielewska, I., Forster, M., Stollenwerk, B., Obiozor, C.C., Wang, Y., Novello, S. 4O – Patient-reported outcomes from the CodeBreaK 200 phase III trial comparing sotorasib versus docetaxel in KRAS G12C-mutated NSCLC. Journal of Thoracic Oncology (2023) 18 (4S): S35-S88.
