Capecitabine (X) monotherapy in patients (pts) with pretreated metastatic breast cancer (MBC): Is response correlated to cerbB-2 expression?
Bildiriler > Özet Bildiri
Yazarlar: V. C. Sezgin, U. A. Sanli, B. Karabulut, R. Uslu, G. G. Muezzinoglu, Necmettin ÖZDEMİR, E. Goker
Journal of Clinical Oncology, , , Uluslararası, Özet Bildiri, Wos, cilt 22, ss 760-760
DOI: 10.1200/jco.2004.22.14_suppl.760
Özet
760 Background: Most chemotherapy regimens have marginal activity in pts with heavily pretreated MBC, with the exception of X, which consistently results in overall response rates (ORR) of approximately 20% and overall survival of around 1 year. We studied the efficacy and safety of X in heavily pretreated pts with MBC, with a view to identifying potential predictors of progression-free survival (PFS). Methods: Pts received X 1000 mg/m2 twice daily for 14 days every 3 weeks. We analyzed ER/PR and cerbB-2 expression by immunohistochemistry (IHC). Results: 56/58 pts had prior anthracyclines and taxanes either as adjuvant or MBC therapy, 3% had cardiac contraindication to anthracyclines, 72% had ≥3 prior regimens, 50% had >1 metastatic site, 45% were ER/PR positive, and 60% were cerbB-2 positive (includes +1, +2, +3). Grade 3/4 adverse events were seen in 17 pts (29%): HFS (7%), fatigue (5%), loss of appetite (3%), dyspepsia (3%), nausea (2%), conjunctivitis (2%), infection (2%), elevated bilirubin (3%), elevated ALT (2%). The ORR was 17% with a median duration of 9.4 months. Median PFS was 5 months (95% CI 3.53–6.47 months). Neither the number of metastatic sites nor hormone receptor status was correlated to PFS, although there was a difference between cerbB-2 negative and cerbB-2 positive pts (p<0.05). When only cerbB-2 ≥2+ pts were considered, the difference was non-significant. In the 31 pts who were cerbB-2 ≥2+, the ORR was 10%, and 45% had SD; in the 22 pts with cerbB-2 0 or 1+, the ORR and SD rates were 32% and 55%, respectively. PFS in cerbB-2 ≥2+ vs. 0 or 1+ was 3.7 months vs. 7.4 months (p=0.012). Conclusions: These results compare favorably with the large available database on X, confirming that X has substantial antitumor activity and favorable safety in this setting. Enhanced antitumor activity was observed in patients with cerbB-2 negative MBC compared to positive. As cerbB-2 expression is a known negative prognostic factor in MBC, the combination of X and trastuzumab would likely improve outcomes in cerbB-2 ≥2+ pts. No significant financial relationships to disclose.