Takeaway
- Adding cetuximab to carboplatin+paclitaxel fails to improve oncologic outcomes in patients with advanced/recurrent cervical cancer.
- PIK3CA mutation status predicted resistance to cetuximab treatment.
Why this matters
- These findings do not support phase 3 evaluation of cetuximab in this setting.
Study design
- Randomized phase 2 MITO CERV-2 trial: 108 unselected patients with advanced/recurrent cervical cancer received standard treatment (carboplatin and paclitaxel)±cetuximab.
- Primary endpoint: event-free survival (EFS; time from randomization to progression, death, treatment discontinuation, or loss to follow-up).
- Funding: Merck KGaA, Darmstadt, Germany.
Key results
- Median follow-up, 23 months.
- Patients in the standard treatment group showed no significant difference vs those in the add-on cetuximab group in:
- median EFS (4.7 vs 6.0 months; HR, 0.97; one-tail P=.43),
- median PFS (5.2 vs 7.6 months; HR, 0.84; one-tail P=.20),
- median OS (17.7 vs 17 months; HR, 0.85; one-tail P=.27), and
- objective response rate (43% vs 38%; P=.79).
- 58% of patients in the standard group and 80% in the cetuximab group experienced grade ≥3 adverse events; skin toxicity was reported in the cetuximab group only.
- Cetuximab improved EFS in the PIK3CA wild-type subgroup (HR, 0.09; 95% CI, 0.01-0.87), but not in the PIK3CA mutant subgroup (HR, 1.69; 95% CI, 0.46-6.47; Pinteraction=.001).
Limitations
- Open-label design.
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