The MITO CERV-2 trial: A randomized phase II study of cetuximab plus carboplatin and paclitaxel, in advanced or recurrent cervical cancer

Autor: Giovanni Scambia, Cosimo Sacco, Giorgio Valabrega, Maria Carmela Piccirillo, Antonella Savarese, Pierosandro Tagliaferri, Rossella Lauria, Francesco Perrone, Ugo De Giorgi, Sabrina Chiara Cecere, Marilena Di Napoli, Saverio Cinieri, Gabriella Ferrandina, Ciro Gallo, Giulia Amadio, Maria Ornella Nicoletto, Vanda Salutari, Nicola Normanno, Sandro Pignata, Domenica Lorusso, Simona Losito, Giuseppa Maltese, Gennaro Daniele, Anna Maria Mosconi, Claudia Omarini, Alessandra Sacco, Carmela Pisano, Stefano Greggi, Simona Signoriello, Barbara Kopf, Francesco Raspagliesi
Přispěvatelé: Pignata, S., Scambia, G., Lorusso, D., De Giorgi, U., Nicoletto, M. O., Lauria, R., Mosconi, A. M., Sacco, C., Omarini, C., Tagliaferri, P., Ferrandina, G., Cinieri, S., Savarese, A., Valabrega, G., Pisano, C., Salutari, V., Raspagliesi, F., Kopf, B., Cecere, S. C., Amadio, G., Maltese, G., Di Napoli, M., Greggi, S., Signoriello, S., Daniele, G., Sacco, A., Losito, S., Normanno, N., Perrone, F., Gallo, C., Piccirillo, M. C.
Rok vydání: 2019
Předmět:
0301 basic medicine
Oncology
Adult
medicine.medical_specialty
Paclitaxel
Class I Phosphatidylinositol 3-Kinases
medicine.medical_treatment
Phases of clinical research
Cetuximab
Uterine Cervical Neoplasms
PIK3CA mutation
Carboplatin
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
Clinical endpoint
medicine
Humans
Progression-free survival
Prospective Studies
Response Evaluation Criteria in Solid Tumors
Chemotherapy
business.industry
Standard treatment
Cervical cancer
Randomized phase 2
Disease Progression
Female
Middle Aged
Neoplasm Recurrence
Local
Progression-Free Survival
Obstetrics and Gynecology
030104 developmental biology
Neoplasm Recurrence
chemistry
Local
030220 oncology & carcinogenesis
business
medicine.drug
Zdroj: Gynecologic oncology. 153(3)
ISSN: 1095-6859
Popis: Background Cervical cancer cells often express Epidermal Growth Factor Receptor (EGFR). Cetuximab (CET), an anti-EGFR antibody, can be safely combined with carboplatin (C) and paclitaxel (P), a standard treatment for advanced/recurrent cervical cancer (ARCC) patients. 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.
Databáze: OpenAIRE
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