The MITO CERV-2 trial: A randomized phase II study of cetuximab plus carboplatin and paclitaxel, in advanced or recurrent cervical cancer.
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Pignata Sandro, Scambia Giovanni, Lorusso Domenica, De Giorgi Ugo, Nicoletto Maria Ornella, Lauria Rossella, Mosconi Anna Maria, Sacco Cosimo, Omarini Claudia, Tagliaferri Pierosandro, Ferrandina Gabriella, Cinieri Saverio, Savarese Antonella, Valabrega Giorgio, Pisano Carmela, Salutari Vanda, Raspagliesi Francesco, Kopf Barbara, Cecere Sabrina Chiara, Amadio Giulia, Maltese Giuseppa, Di Napoli Marilena, Greggi Stefano, Signoriello Simona, Daniele Gennaro, Sacco Alessandra, Losito Simona, Normanno Nicola, Perrone Francesco, Gallo Ciro, Piccirillo Maria Carmela, MITO Investigators
Аннотация
PATIENTS AND METHODS: ARCC patients, ECOG PS ≤ 1, were randomized to CP for 6 cycles with or without CET (400 mg/m2 one week before starting CP, then 250 mg/m2 weekly) until disease progression or unacceptable toxicity. Event-free survival (EFS) was the primary endpoint. With a 4.5 months expected median EFS and a 6.4 months predicted EFS (HR 0.70), 0.20 one-tailed α and 80% power, 89 events were required for the final intent-to-treat analysis.
RESULTS: 108 patients were assigned to CP (n = 53) or CP-CET (n = 55). Median age was 50, 69% were PS0, 76% had recurrent disease, 91% had distant metastasis and 57% had received previous chemotherapy. After a median follow-up of 23 months, 102 patients had an event, 97 progressed and 61 died. Median EFS was 4.7 and 6.0 months (one-tail P = 0.43), median PFS was 5.2 and 7.6 months (one-tail P = 0.20) and median OS was 17.7 and 17 months (one-tail P = 0.27), with CP and CP-CET, respectively. There was no difference in the occurrence of severe adverse events, except for skin toxicity. Biomarker analysis, in a small subgroup of patients, suggests that PIK3CA mutation might be predictive of CET resistance.
CONCLUSION: CP-CET was not more active than CP alone in unselected ARCC patients.