The MITO CERV-2 trial: A randomized phase II study of cetuximab plus carboplatin and paclitaxel, in advanced or recurrent cervical cancer
Gynecologic Oncology Apr 13, 2019
Pignata S, et al. - Researchers tested cetuximab (CET, an anti-EGFR [epidermal growth factor receptor] antibody) plus carboplatin (C) and paclitaxel (P), in advanced/recurrent cervical cancer (ARCC) patients, ECOG PS ≤ 1. Overall 108 patients were included, who were randomized to CP for 6 cycles with (n = 55, CP-CET) or without CET (n = 53)(400 mg/m2 one week before starting CP, then 250 mg/m2 weekly) until disease progression or unacceptable toxicity. Median follow-up was 23 months. CP and CP-CET offered median event-free survival (EFS) of 4.7 and 6.0 months, median PFS of 5.2 and 7.6 months and median OS of 17.7 and 17 months, respectively. Except for skin toxicity, severe adverse events did not differ between the two treatment regimens. PIK3CA mutation might be predictive of CET resistance, as indicated in biomarker analysis including a small subgroup of patients. Overall, compared with CP alone, CP-CET was not more active in unselected ARCC patients.
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