The Role of Capecitabine in Early Stage Breast Cancer

Early Breast Cancer Trialists’ Collaborative Group. Lancet 1998; 352:930–942. American Cancer Society. Cancer Facts & Figures 2011. Atlanta, American Cancer Society, 2011. Romond EH, Perez EA, Bryant J, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005;353(16):1673–84. Piccart-Gebhart MJ, Procter M, Leyland-Jones B, et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005;353(16):1659–72. Joensuu H, Kellokumpu-Lehtinen PL, Bono P, et al. Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer. N Engl J Med. 2006;354:809–20. Valero V, Slamon DJ, Eiermann W, et al. Efficacy results of node-negative HER2-amplified breast cancer subset from BCIRG 006 study: A phase III randomized trial comparing doxorubicin and cyclophosphamide followed by docetaxel (AC-T) with doxorubicin and cyclophosphamide followed by docetaxel and trastuzumab (AC-TH) with docetaxel, carboplatin, and trastuzumab (TCH). J Clin Oncol 29: 2011 (suppl; abstract 553) Stockler MR, Sourjina T, Grimison P, et al. A randomized trial of capecitabine (C) given intermittently (IC) rather than continuously (CC) compared to classical CMF as first-line chemotherapy for advanced breast cancer (ABC). J Clin Oncol 2007; 25:39s (Abstract 1031). Zielinski C, Gralow J, Martin M. Optimising the dose of capecitabine in metastatic breast cancer: confused, clarified or confirmed? Ann Oncol. 2010;11:2145–52. O’Shaughnessy J, Miles D, Vukelja S, 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. Miles D, Vukelja S, Moiseyenko V, et al. Survival benefit with capecitabine/docetaxel versus docetaxel alone: analysis of therapy in a randomized phase III trial. Clin Breast Cancer. 2004;5:273–8. Batista N, Perez-Manga G, Constela M, et al. Phase II study of capecitabine in combination with paclitaxel in patients with anthracycline-pretreated advanced/metastatic breast cancer. Br J Cancer. 2004;90:1740–6. Gradishar W, Meza LA, Amin B, et al. Capecitabine plus paclitaxel as front-line combination therapy for metastatic breast cancer: a multicenter phase II study. J Clin Oncol. 2004;22:2321–7. Ahn JH, Kim SB, Ahn SH, et al. Phase II study of capecitabine and vinorelbine in anthracycline and taxane pretreated breast cancer patients: Final results. Proc Am Soc Clin Oncol 2003; 22:54 (Abstract 216). Venturini M, Durando A, Garrone O, et al. Capecitabine in combination with docetaxel and epirubicin in patients with previously untreated, advanced breast carcinoma. Cancer. 2003;97:1174–80. Sawada N, Ishikawa T, Fukase Y, et al. Induction of thymidine phosphorylase activity and enhancement of capecitabine efficacy by taxol/taxotere in human cancer xenografts. Clin Cancer Res. 1998;4:1013–9. Steger GG, Greil R, Jakesz R, et al. Pathologic complete response (pCR) in patient subgroups: An analysis of ABCSG-24, a phase III, randomized study of anthracycline- and taxane-based neo-adjuvant therapy with or without capecitabine in early breast cancer. J Clin Oncol 2010; 28:15s (suppl; abstract 530). Steger GG, Greil R, Jakesz, et al. ABCSG-24: Efficacy of anthracycline and taxane-based neo-adjuvant therapy +/− capecitabine in triple-negative early breast cancer. Ann Oncol 2010; 21 (suppl 8)(Abstract 216). Steger GG, Greil R, Jakesz R, et al. Final Results of ABCSG-24, a Randomized Phase III Study Comparing Epirubicin, Docetaxel, and Capecitabine (EDC) to Epirubicin and Docetaxel (ED) as Neo-adjuvant Treatment for Early Breast Cancer and Comparing ED/EDC+ Trastuzumab (T) to ED/EDC as Neo-adjuvant Treatment for Early HER-2 Positive Breast Cancer. Cancer Res 2009; 69 (Suppl 24): abstract 1081. Lee KS, Ro J, Nam BH, et al. A randomized phase-III trial of docetaxel/capecitabine versus doxorubicin/cyclophosphamide as primary chemotherapy for patients with stage II/III breast cancer. Breast Cancer Res Treat. 2008;109:481–9. Untch M, Rezai M, Loibl S, et al. Neo-adjuvant Treatment With Trastuzumab in HER2-Positive Breast Cancer: Results From the GeparQuattro Study. J Clin Oncol. 2010;2024:31. Gunter von Minckwitz G, Rezai M, Sibylle Loibl S, et al. Capecitabine in Addition to Anthracycline- and Taxane-Based Neo-adjuvant Treatment in Patients With Primary Breast Cancer: Phase III GeparQuattro Study. J Clin Oncol 2010:2015–2023. Berton-Rigaud D, H. Roché, F. Penault-Llorca, et al. Benefit of neo-adjuvant capecitabine + epirubicin + cyclophosphamide (CEX) versus 5-FU + epirubicin + cyclophosphamide (FEC) for operable breast cancer (BC) followed by adjuvant docetaxel (T). J Clin Oncol 2008; 26: (abstract 598). Jinno H, Sakata M, Hayashida T, et al. A phase II trial of capecitabine and docetaxel followed by 5-fluorouracil/epirubicin/cyclophosphamide (FEC) as preoperative treatment in women with stage II/III breast cancer. Ann Oncol. 2010;21(6):1262–6. Wildiers H, Neven P, Christiaens MR, et al. Neo-adjuvant capecitabine and docetaxel (plus trastuzumab): an effective non-anthracycline-based chemotherapy regimen for patients with locally advanced breast cancer. Ann Oncol. 2011;22(3):588–94. Perez EA, Hillman DW, Dentchev T, et al. North Central Cancer Treatment Group (NCCTG) N0432: phase II trial of docetaxel with capecitabine and bevacizumab as first-line chemotherapy for patients with metastatic breast cancer. Ann Oncol. 2010;2:269–74. Greil R, Moik M, Reitsamer R, et al. Neo-adjuvant bevacizumab, docetaxel and capecitabine combination therapy for HER2/neu-negative invasive breast cancer: Efficacy and safety in a phase II pilot study. Eur J Surg Oncol. 2009;35:1048–54. Ro J, Myung SK, Berton-Rigaud D, et al. The addition of capecitabine to neo-adjuvant chemotherapy for early breast cancer (EBC): a review of clinical study data. Eur J Cancer Suppls 2010; 8:72 (Abstract 48). von Minckwitz G, M. Untch, E. Nueesch, et al. Impact of treatment characteristics on response of different breast cancer subtypes: Pooled multilayer analysis of the German neo-adjuvant chemotherapy trials. J Clin Oncol 2010; 28:15s (suppl; abstract 501). • Muss HB, Berry DA, Cirrincione CT, et al. N Engl J Med 2009, 360:2055–65. This article describes a well-conducted clinical trial in a subgroup of elderly patients historically poorly represented in most adjuvant trials. • Joensuu H, Kellokumpu-Lehtinen PL, Huovinen R, et al. Adjuvant capecitabine in combination with docetaxel and cyclophosphamide plus epirubicin for breast cancer: an open-label, randomised controlled trial. Lancet Oncol 2009; 12:1145–51. This is the first trial to demonstrate a benefit for the incorporation of capecitabine to a standard anthracycline-taxane adjuvant regimen. Kurosumi M, Tabei T, Suemasu K, et al. Enhancement of immunohistochemical reactivity for thymidine phosphorylase in breast carcinoma cells after administration of docetaxel as a neo-adjuvant chemotherapy in advanced breast cancer patients. Oncol Rep. 2000;7(5):945–8. Fujimoto-Ouchi K, Tanaka Y, Tominaga T. Clin Cancer Res. 2001;7:1079–8. Joensuu H, P. Kellokumpu-Lehtinen, R. Huovinen, et al. Integration of capecitabine (X) into adjuvant therapy comprising docetaxel (T) followed by 5-FU, epirubicin, and cyclophosphamide (CEF): Efficacy in patients with triple-negative breast cancer (BC). J Clin Oncol 2010; 28:15s, (suppl; abstract 531). O’Shaughnessy J, Paul D, Stokoe C, et al. First Efficacy Results of a Randomized, Open-Label, Phase III Study of Adjuvant Doxorubicin Plus Cyclophosphamide, Followed by Docetaxel with or without Capecitabine, in High-Risk Early Breast Cancer. Cancer Res 2010; 70 (Suppl 24): abstract S4-2. Shao Z, Huang B, Zhang J, et al. First interim analysis of a randomized trial comparing capecitabine/epirubicin/cyclophosphamide (XEC) vs 5-FU/epirubicin/cyclophosphamide (FEC) as adjuvant therapy for medium- or high-risk early breast cancer (EBC). Eur J Cancer Suppls 2010; 8:64 (Abstract 22). Martin M, et al. First Safety Data from a Randomised Phase III Trial Comparing Adjuvant Epirubicin-Cyclophosphamide followed by Docetaxel (EC followed by T) vs. ET followed by Capecitabine (X) in Node-Positive Operable Breast Cancer (BC). Presented at St. Gallen Oncology Conference 'Primary Therapy of Early Breast Cancer’ March 13, 2009. Poster 0145. Mulders M, Vingerhoets A, Breed W. The impact of cancer and chemotherapy: perceptual similarities and differences between cancer patients, nurses and physicians. Eur J Oncol Nurs. 2008;12(2):97–102. Lemieux J, Maunsell E, Provencher L, et al. Chemotherapy-induced alopecia and effects on quality of life among women with breast cancer: a literature review. Psychooncology. 2008;17(4):317–28. Shin HW, Noh DY, Lee ES, et al. Correlates of existential well-being and their association with health-related quality of life in breast cancer survivors compared with the general population. Breast Cancer Res Treat. 2009;118(1):139–50. Macquart-Moulin G, Viens P, Bouscary ML, et al. Discordance between physicians’ estimations and breast cancer patients’ self-assessment of side-effects of chemotherapy: an issue for quality of care. Br J Cancer. 1997;76(12):1640–5. Möbus V, Conrad, A. Schneeweis, et al. Gain study: A phase III trial to compare ETC versus EC-TX and ibandronate versus observation in patients with node-positive primary breast cancer. J Clin Oncol 2009; 27:15s, (suppl; abstract 568). Reimer T, Nitz U, Potenberg J, et al. ICE Study: A prospective, multi-centre, controlled, open-label, randomized phase III trial of ibandronate (I) with or without capecitabine (X) in elderly patients (pts) with early breast cancer (GBG 32). Eur J Cancer Suppls 2009; 7:215 (Abstract O-4003). Sledge G, Miller K, Sohl J, et al. Safety and efficacy of capecitabine plus bevacizumab as first line in metastatic breast cancer. J Clin Oncol 2007; 25(18), Abstract 1013. Rugo H, Roche H, Thomas E, et al. Ixabepilone plus capecitabine vs. capecitabine in patients with triple negative tumors: a pooled analysis of patients from two large phase III clinical studies. Cancer Res 2008; 68 (Suppl 22): abstract 3057. Steger GG, Barrios CH, O’Shaughnessy J, et al. Review of Capecitabine for the Treatment of Triple-Negative Early Breast Cancer. Cancer Res 2010; 70 (Suppl 24): abstract PD01-03. Lluch A, Torrecillas L, Barrios CH, et al. CIBOMA/2004–01: a randomised phase III trial assessing adjuvant capecitabine maintenance therapy after standard chemotherapy for triple-negative early breast cancer. Eur J Cancer Suppls 2009; 7:304 (Abstract P-5150). Lluch A, Gómez H, Ruiz-Borrego M, et al. First safety data from a randomized phase III (CIBOMA 2004–01 / GEICAM 2003–11) trial assessing adjuvant capecitabine maintenance therapy after standard chemotherapy for triple-negative early breast cancer. Cancer Res 2010; 70 (Suppl 24): abstract P5-1015. Poole C, Barrios C, O’Shaughnessy J, et al. Ongoing Evaluation of Capecitabine-Based Therapy in Early Breast Cancer (EBC). Cancer Res 2010; 70 (Suppl 24): abstract P5-1011. http://clinicaltrials.gov; identifier: NCT00301925. http://clinicaltrials.gov; identifier: NCT00433589.