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The MITO CERV-2 trial: A randomized phase II study of cetuximab plus carboplatin and paclitaxel, in advanced or recurrent cervical cancer.
- Source :
-
Gynecologic Oncology . Jun2019, Vol. 153 Issue 3, p535-540. 6p. - Publication Year :
- 2019
-
Abstract
- 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. 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. 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. CP-CET was not more active than CP alone in unselected ARCC patients. • Cervical cancer cells often express the epidermal growth factor receptor (EGFR). • However, the addition of cetuximab to chemotherapy did not produce benefit for advanced/recurrent cervical cancer patients. • The presence of PIK3CA mutations may be associated with resistance to cetuximab treatment. [ABSTRACT FROM AUTHOR]
- Subjects :
- *CERVICAL cancer
*EPIDERMAL growth factor receptors
*THERAPEUTICS
Subjects
Details
- Language :
- English
- ISSN :
- 00908258
- Volume :
- 153
- Issue :
- 3
- Database :
- Academic Search Index
- Journal :
- Gynecologic Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 136712436
- Full Text :
- https://doi.org/10.1016/j.ygyno.2019.03.260