KEY TAKEAWAYS
- The CodeBreak300 phase 3 trial aimed to investigate patient-reported tolerability of sotorasib plus panitumumab versus trifluridine/tipiracil or regorafenib in KRAS G12C-mutated mCRC.
- Researchers noticed sotorasib plus panitumumab does not increase general side effect bother.
In CodeBreak 300 (NCT05198934), a phase 3 study evaluating two doses of sotorasib (960 mg and 240 mg) plus panitumumab against investigator’s choice of trifluridine/tipiracil or regorafenib in patients with chemorefractory KRAS G12C-mutated metastatic colorectal cancer (CRC), both doses of sotorasib resulted in better health-related quality of life (HRQOL) and a trend to decreased risk of deterioration. Here, we present patient-reported tolerability from CodeBreaK 300.
Julien Taieb and the team aimed to assess the patient-reported tolerability of sotorasib plus panitumumab compared to trifluridine/tipiracil or regorafenib in patients with chemorefractory KRAS G12C-mutated metastatic CRC.
They performed an inclusive analysis of patient-reported tolerability using the Functional Assessment of Cancer Therapy – General (FACT-G) item GP5 (“I am bothered by side effects of treatment”) at study baseline and every 4 weeks thereafter. Responses to the FACT-G GP5 item were rated on a 5-point Likert scale from “Not at all” to “Very much.” Patient-reported tolerability was also assessed by skin toxicity adverse events per CTCAE v5.0 in patients receiving sotorasib plus panitumumab based on pooled data from the 2 arms. Patient-reported outcome (PRO) scores were summarized descriptively in patients who had a baseline and at least one postbaseline PRO score.
About 160 randomized pts, 129 (81%) were included in this analysis. Patients’ side effect bother at baseline and week 9 was comparable across all 3 arms. Among pts treated with soto + pani, pts experiencing grade ≥ 2 skin toxicity reported more “Quite a bit” or “Very much” side effect bother at week 9 than pts experiencing grade ≤ 1 (23% vs 10%); however, this difference was transient.
The study concluded that PRO scores suggest sotorasib plus panitumumab do not increase general side effect bother more than trifluridine/tipiracil or regorafenib despite an increase in skin toxicity. Altogether, PRO scores complement previously reported improvements in clinical outcomes and HRQOL, supporting sotorasib 960 mg plus panitumumab as a potential standard of care in patients with KRAS G12C-mutated chemorefractory mCRC.
The trial was sponsored by the Amgen.
Source: https://cslide.ctimeetingtech.com/esmogi24hybrid/attendee/confcal/show/session/3
Clinical Trial: https://clinicaltrials.gov/study/NCT05198934
Julien Taieb, Marwan Fakih, Lisa Salvatore, et al. (2024). “32P – Patient-reported tolerability of sotorasib (soto) and panitumumab (pani) versus trifluridine/tipiracil (T/T) or regorafenib (rego) in patients (pts) with metastatic colorectal cancer (mCRC) in the CodeBreaK 300 study.” Presented at ESMO-GI 2024 (Abstract 32P).
