Main Article Content
Purpose: To compare the efficacy and side effects of brand-name capecitabine (Xeloda®) vs. generic (Osloda®) in metastatic breast cancer.
Methods: In this non-randomized clinical trial, 39 patients with metastatic breast cancer were included and divide into Xeloda® (19 patients, mean age of 49.5 years) or Osloda® (20 patients, mean age of 51.7 years) groups. A total of six 3-week cycles (1250 mg/m2 daily) were administered. Efficacy and side effects were documented in a three-year follow-up period.
Results: The four most common treatment-related adverse events did not differ significantly in Xeloda group vs. Osloda group including hand-foot syndrome (68.4% vs. 65%, P= 0.82), Anorexia (47.4% vs. 50%, P= 0.86), pain (57.9% vs. 40%; P= 0.26), and nausea (52.6% vs. 35%; P= 0.26). Most patients in both groups (25 subjects) showed partial response. Nine patients in each group died (47.4% in Xeloda group and 45% in Osloda group, P= 0.88). Mean overall survival was 20.13 months in Xeloda group and 25.82 months in Osloda group (P= 0.47).
Conclusion: Xeloda and Osloda had comparable efficacy and side effects in metastatic breast cancer. Considering the lower cost of Osloda, this agent can be used instead of Xeloda.
Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015; 65(2):87-108. DOI:https://doi.org/10.3322/caac.21262
Zeichner SB, Terawaki H, Gogineni K. A review of systemic treatment in metastatic triple-negative breast cancer. Breast Cancer (Auckl). 2016;10:25-36.
Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005; 365(9472):1687-717. DOI:https://doi.org/10.1016/S0140-6736(05)66544-0
Babacan T, Efe O, Hasirci AS, Demirci F, Buyukhatipoglu H, Balakan O, et al. Efficacy of capecitabine monotherapy as the first-line treatment of metastatic HER2-negative breast cancer. Tumori. 2015; 101(4):418-23. DOI:https://doi.org/10.5301/tj.5000332
Amari M, Ishida T, Takeda M, Ohuchi N. Capecitabine monotherapy is efficient and safe in all line settings in patients with metastatic and advanced breast cancer. Jpn J Clin Oncol. 2010;40(3):188-93.
Wang Y, Yang H, Wei JF, Meng L. Efficacy and toxicity of capecitabine-based chemotherapy in patients with metastatic or advanced breast cancer: results from ten randomized trials. Curr Med Res Opin. 2012;28(12):1911-9.
Ershler WB. Capecitabine monotherapy: Safe and effective treatment for metastatic breast cancer. Oncologist. 2006;11(4):325-35. DOI:https://doi.org/10.1634/theoncologist.11-4-325
Fumoleau P, Largillier R, Clippe C, Dieras V, Orfeuvre H, Lesimple T, et al. Multicentre, phase II study evaluating capecitabine monotherapy in patients with anthracycline- and taxane-pretreated metastatic breast cancer. Eur J Cancer. 2004;40(4):536-42.
Stathopoulos GP, Koutantos J, Lazaki H, Rigatos SK, Stathopoulos J, Deliconstantinos G. Capecitabine (Xeloda) as monotherapy in advanced breast and colorectal cancer: Effectiveness and side-effects. Anticancer Res. 2007(3B); 27:1653-6.
Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2): 228-47. DOI:https://doi.org/10.1016/j.ejca.2008.10.026
Dupont AG, Heller F. Generics and cost-effective prescribing in Belgium: does bioequivalence always translate in therapeutic equivalence? Acta Clin Belg. 2009;64(5):406-14. DOI:https://doi.org/10.1179/acb.2009.067
Zargarzadeh AH, Emami MH, Hosseini F. Drug-related hospital admissions in a generic pharmaceutical system. Clin Exp Pharmacol Physiol. 2007;34(5-6):494-8.
Borgheini G. The bioequivalence and therapeutic efficacy of generic versus brand-name psychoactive drugs. Clin Ther. 2003;25(6):1578-92.
Heller FR, Dupont AG. Generics: need for clinical concern? Acta Clin Belg. 2009; 64(5):415-22. DOI:https://doi.org/10.1179/acb.2009.068
Oshaughnessy JA, Blum J, Moiseyenko V, Jones SE, Miles D, Bell D, et al. Randomized, open-label, phase II trial of oral capecitabine (Xeloda) vs. a reference arm of intravenous CMF (cyclophosphamide, methotrexate and 5-fluorouracil) as first-line therapy for advanced/metastatic breast cancer. Ann Oncol. 2001;12(9):1247-54.