BACKGROUND: In CodeBreak 300 (NCT05198934), a phase 3 study evaluating two doses of soto (960 mg and 240 mg) + pani against investigator’s choice of T/T or rego in pts with chemorefractory KRAS G12C-mutated mCRC, both doses of soto 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.
METHODS: Patient-reported tolerability was assessed 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 event per CTCAE v5.0 in pts receiving soto + pani based on pooled data from the two arms. Patient-reported outcome (PRO) scores were summarized descriptively in pts who had a baseline and at least one postbaseline PRO score.
RESULTS: Of the 160 randomized pts, 129 (81%) were included in this analysis. Patient’s side effect bother at baseline and week 9 was comparable across all three arms (Table). 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.
CONCLUSIONS: PRO scores suggest that soto + pani do not increase general side effect bother more than T/T or rego despite an increase in skin toxicity. Altogether, PRO scores complement previously reported improvements in clinical outcomes and HRQOL, thus supporting soto 960 mg + pani as a potential standard of care in pts with KRAS G12C-mutated chemorefractory mCRC.
