Phase II study of 4-weekly capecitabine monotherapy in advanced/metastatic breast cancer
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A multicenter, phase II study was conducted to evaluate the efficacy and safety of the Japanese intermittent 4-week regimen of capecitabine in patients with advanced/metastatic breast cancer.
Fifty patients who had received no more than one prior chemotherapy regimen for advanced/metastatic disease were enrolled from 23 centers and received at least two 4-weekly cycles of capecitabine (828 mg/m2 orally twice daily for 3 weeks followed by a 1-week rest period).
The overall response rate assessed by the Independent Review Committee (standard population, n = 46) was 28.3% (95% confidence interval 16.0–43.5%), including complete responses in 6.5%. Stable disease was observed in 20 patients and maintained for more than 6 months in 10 patients. The median duration of response in 13 evaluable responders was 5.3 months. Among evaluable patients (n = 47), median time to disease progression was 5.1 months. Median overall survival was 20.2 months. The most common treatment-related adverse events (all grades) were hand–foot syndrome (66%), nausea (26%), stomatitis (22%) and diarrhea (20%). Grade 3/4 treatment-related adverse events were seen in 23 patients (46%). The most common grade 3/4 adverse events were lymphocytopenia (22%), hand–foot syndrome (18%) and hyperbilirubinemia (10%).
Although the target overall response rate was not reached, the Japanese intermittent 4-week regimen of capecitabine was shown to be an effective and well-tolerated first- or second-line therapy for advanced/metastatic breast cancer.
KeywordsCapecitabine Breast cancer Advanced Metastatic Efficacy Safety Four-week (Japanese) regimen
- 6.Reichardt P, Von Minckwitz G, Thuss-Patience PC, Jonat W, Kolbl H, Janicke F, et al. Multicenter phase II study of oral capecitabine (Xeloda®) in patients with metastatic breast cancer relapsing after treatment with a taxane-containing therapy. Ann Oncol. 2003;14:1227–33.CrossRefPubMedGoogle Scholar
- 7.O’Shaughnessy J, Miles D, Vukelja S, Moiseyenko V, Ayoub JP, Cervantes G, et al. Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: phase III trial results. J Clin Oncol. 2002;20:2812–23.CrossRefPubMedGoogle Scholar
- 10.Stockler, Blum J, Moiseyenko V, Jones SE, Miles D, Bell D, et al. A randomized trial of capecitabine (C) given intermittently (IC) rather than continuously (CC) compared to classical CMF as first-line therapy for advanced breast cancer (ABC). J Clin Oncol. 2007;25(18S):1031.Google Scholar
- 14.Japanese breast cancer society, general rules for clinical and pathological recording of breast cancer, 12th version, June 1996.Google Scholar
- 16.Cao S, Lu K, Ishitsuka H, Rustum YM. Antitumor efficacy of capecitabine against fluorouracil-sensitive and -resistant tumors. Proc Am Soc Clin Oncol. 1997;16:226a (abstract 795).Google Scholar
- 17.Ishikawa T, Sekiguchi F, Fukase Y, Sawada N, Ishitsuka H. Positive correlation between the efficacy of capecitabine and doxifluridine and the ratio of thymidine phosphorylase to dihydropyrimidine dehydrogenase activities in tumors in human cancer xenografts. Cancer Res. 1998;58:685–90.PubMedGoogle Scholar
- 18.Honda J, Sasa M, Moriya T, Bando Y, Hirose T, Takahashi M, et al. Thymidine phosphorylase and dihydropyrimidine dehydrogenase are predictive factors of therapeutic efficacy of capecitabine monotherapy for breast cancer-preliminary results. J Med Invest. 2008;55(1–2):54–60.CrossRefPubMedGoogle Scholar
- 19.Joensuu H, Kellokumpu-Lehtinen P, Huovinen R, Jukkola-Vuorinen A, Asola R, Kokko R, et al Significant improvement in recurrence-free survival (RFS) when capecitabine (X) is integrated into docetaxel (T) → 5-FU + epirubicin + cyclophosphamide (CEF) adjuvant therapy for high-risk early breast cancer (BC): interim analysis of the FinXX-trial. Proceedings from the 2008 San Antonio Breast Cancer Symposium. Abstract 82.Google Scholar
- 21.Matsumoto K, Iwata H, Sasaki Y, Saeki T, Aogi K, Masuda N, Noguchi S, Fujii H, Fujiwara Y. A phase II study of capecitabine in advanced or recurrent breast cancer relapsing after treatment with a taxane-containing therapy (abstract O-208). The 14th Annual Meeting of the Japanese Breast Cancer Society.Google Scholar