Pathology & Oncology Research

, Volume 23, Issue 3, pp 505–511 | Cite as

Capecitabine in Combination with Docetaxel in First Line in HER2-Negative Metastatic Breast Cancer: an Observational Study

  • Renáta Kószó
  • Dóra Sántha
  • László Büdi
  • József Erfán
  • Károly Győrfy
  • Zsolt Horváth
  • Judit Kocsis
  • László Landherr
  • Erika Hitre
  • Károly Máhr
  • Gábor Pajkos
  • Zsuzsanna Pápai
  • Zsuzsanna KahánEmail author
Original Article


Due to the limited experience with capecitabine plus docetaxel (XT) combination in the first-line treatment of metastatic breast cancer in Hungary, the main objective of the study was to analyze the effectiveness and tolerability of XT therapy. A prospective, open-label, non-randomized, single-arm, multicenter, observational study was designed. All female patients were eligible whose metastatic breast cancer could be treated with the XT protocol according to the summary of product characteristics of the drugs. The median progression free survival was 9.9 ± 3.0 months. Time to treatment failure was 4.6 ± 5.1 months on average. The overall response rate was 28.9 %, the clinical benefit rate was 73.3 %. The treatment was discontinued in 35.6 % of patients due to disease progression and in 20.0 % due to adverse events (AE). 33 patients with a total of 73 AEs have been reported, and 13 of them had serious adverse events (SAE). The efficacy and the safety profile of XT chemotherapy proven in the study are consistent with the results demonstrated in randomized trials. First-line XT chemotherapy effectively improves the PFS in metastatic breast cancer.


Capecitabine Docetaxel HER2-negative metastatic breast cancer Toxicity 


  1. 1.
    Rich TA, Shepard RC, Mosley ST (2004) Four decades of continuing innovation with fluorouracil: current and future approaches to fluorouracil chemoradiation therapy. J Clin Oncol 22:2214–2232CrossRefPubMedGoogle Scholar
  2. 2.
    Lockshin A, Danenberg PV (1981) Biochemical factors affecting the tightness of 5-fluorodeoxyuridylate binding to human thymidylate synthetase. Biochem Pharmacol 30:247–257CrossRefPubMedGoogle Scholar
  3. 3.
    Milano G, Etienne MC, Renée N, Thyss A, Schneider M, Ramaioli A, Demard F (1994) Relationship between fluorouracil systemic exposure and tumor response and patient survival. J Clin Oncol 12:1291–1295CrossRefPubMedGoogle Scholar
  4. 4.
    Miwa M, Ura M, Nishida M, Sawada N, Ishikawa T, Mori K, Shimma N, Umeda I, Ishitsuka H (1998) Design of a novel oral fluoropyrimidine carbamate, capecitabine, which generates 5-fluorouracil selectively in tumours by enzymes concentrated in human liver and cancer tissue. Eur J Cancer 34:1274–1281CrossRefPubMedGoogle Scholar
  5. 5.
    Budman DR, Meropol NJ, Reigner B, Creaven PJ, Lichtman SM, Berghorn E, Behr J, Gordon RJ, Osterwalder B, Griffin T (1998) Preliminary studies of a novel oral fluoropyrimidine carbamate: capecitabine. J Clin Oncol 16:1795–1802CrossRefPubMedGoogle Scholar
  6. 6.
    Sawada N, Ishikawa T, Fukase Y, Nishida M, Yoshikubo T, Ishitsuka H (1998) Induction of thymidine phosphorylase activity and enhancement of capecitabine efficacy by taxol/taxotere in human cancer xenografts. Clin Cancer Res 4:1013–1019PubMedGoogle Scholar
  7. 7.
    Liang X, Yan Y, Wang L, Song G, DI L, Jiang H, Wang C, Li H (2015) First-line chemotherapy with docetaxel plus capecitabine followed by capecitabine or hormone maintenance therapy for the treatment of metastatic breast cancer patients Oncol Lett 9: 987–993Google Scholar
  8. 8.
    Pronk LC, Vasey P, Sparreboom A, Reigner B, Planting AS, Gordon RJ, Osterwalder B, Verweij J, Twelves C (2000) A phase I and pharmacokinetic study of the combination of capecitabine and docetaxel in patients with advanced solid tumours. Br J Cancer 83:22–29CrossRefPubMedPubMedCentralGoogle Scholar
  9. 9.
    O’Shaughnessy J, Miles D, Vukelja S, Moiseyenko V, Ayoub JP, Cervantes G, Fumoleau P, Jones S, Lui WY, Mauriac L, Twelves C, Van Hazel G, Verma S, Leonard R (2002) Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: phase III trial results. J Clin Oncol 20:2812–2823CrossRefPubMedGoogle Scholar
  10. 10.
    Beslija S, Obralic N, Basic H, Tatarevic A, Naila M, Banjin M, Cardzic A, Sosevic A, Pasic A, Ceric T, Salkic B (2006) Randomized trial of sequence vs. combination of capecitabine (X) and docetaxel (T): XT vs. T followed by X after progression as first-line therapy for patients (pts) with metastatic breast cancer (MBC). J Clin Oncol 24(Suppl 18):571Google Scholar
  11. 11.
    Chan S, Romieu G, Huober J, Tubiana-Hulin M, Schneeweiss A, Lluch A, Llombart A, du Bois A, Kreienberg R, Mayordomo JI, Antón A, Harrison M, Jones A, Carrasco E, Thareau Vaury A, Frimodt-Moller B, Fumoleau B (2009) Phase III study of gemcitabine plus docetaxel compared with capecitabine plus docetaxel for anthracycline-pretreated patients with metastatic breast cancer. J Clin Oncol 27:1753–1760CrossRefPubMedGoogle Scholar
  12. 12.
    Buzdar AU, Xu B, Digumarti R, Goedhals L, Hu X, Semiglazov V, Cheporov S, Gotovkin E, Hoersch S, Rittweger K, Miles DW, O’Shaughnessy J, Tjulandin S, NO16853 trial group (2012) Randomized phase II non-inferiority study (NO16853) of two different doses of capecitabine in combination with docetaxel for locally advanced/metastatic breast cancer. Ann Oncol 23:589–597CrossRefPubMedGoogle Scholar
  13. 13.
    Vici P, Giotta F, Di Lauro L, Sergi D, Vizza E, Mariani L, Latorre A, Pizzuti L, D’Amico C, Giannarelli D, Colucci G (2011) A multicenter phase II randomized trial of docetaxel/gemcitabine versus docetaxel/capecitabine as first-line treatment for advanced breast cancer: a Gruppo Oncologico Italia Meridionale study. Oncology 81:230–236CrossRefPubMedGoogle Scholar
  14. 14.
    Harvey V, Mouridsen H, Semiglazov V, Jakobsen E, Voznyi E, Robinson BA, Groult V, Murawsky M, Cold S (2006) Phase III trial comparing three doses of docetaxel for second-line treatment of advanced breast cancer. J Clin Oncol 24:4963–4970CrossRefPubMedGoogle Scholar
  15. 15.
    Soto C, Torrecillas L, Reyes S, Ramirez M, Perez L, Cervantes G, Gonzalez F, Tellez E, Cortes P, Benitez H (2006) Capecitabine (X) and taxanes in patients (pts) with anthracycline-pretreated metastatic breast cancer (MBC): sequential vs. combined therapy results from a MOSG randomized phase III trial. J Clin Oncol 24 (Suppl 18): 570Google Scholar
  16. 16.
    Mavroudis D, Papakotoulas P, Ardavanis A, Syrigos K, Kakolyris S, Ziras N, Kouroussis C, Malamos N, Polyzos A, Christophyllakis C, Kentepozidis N, Georgoulias V, Breast Cancer Investigators of the Hellenic Oncology Research Group (2010) Randomized phase III trial comparing docetaxel plus epirubicin versus docetaxel plus capecitabine as firstline treatment in women with advanced breast cancer. Ann Oncol 21:48–54CrossRefPubMedGoogle Scholar
  17. 17.
    Michalaki V, Gennatas S, Gennatas K (2009) Low-dose capecitabine plus docetaxel as first-line therapy for metastatic breast cancer: phase II results. Anti-Cancer Drugs 20:204–207CrossRefPubMedGoogle Scholar
  18. 18.
    Seidman AD, Brufsky A, Ansari RH, Hart LL, Stein RS, Schwartzberg LS, Stewart JF, Russell CA, Chen SC, Fein LE, De La Cruz Vargas JA, Kim SB, Cavalheiro J, Zhao L, Gill JF, Obasaju CK, Orlando M, Tai DF (2011) Phase III trial of gemcitabine plus docetaxel versus capecitabine plus docetaxel with planned crossover to the alternate single agent in metastatic breast cancer. Ann Oncol 22:1094–1101CrossRefPubMedGoogle Scholar
  19. 19.
    Bachelot T, Bajard A, Ray-Coquard I, Provencal J, Coeffic D, Agostini C, Boisseau M, Kaphan R, Dramais D, Oprea C, Ferri-Dessens RM, Guastalla JP, Perol D (2011) Final results of ERASME-4: a randomized trial of first-line docetaxel plus either capecitabine or epirubicin for metastatic breast cancer. Oncology 80:262–268CrossRefPubMedGoogle Scholar
  20. 20.
    Yu J, Lj DI, Song G, Che L, Hf J, Zhu YI, Liang X, Jia J, Zhang J, Yang H, Wang XI, Xn Z, Ren J (2011) Randomized clinical case-control trial for the comparison of docetaxel plus thiotepa versus docetaxel plus capecitabine in patients with metastatic breast cancer. Beijing Da Xue Xue Bao 43:151–156PubMedGoogle Scholar
  21. 21.
    Gradishar WJ, Meza LA, Amin B, Samid D, Hill T, Chen YM, Lower EE, Marcom PK (2004) Capecitabine plus paclitaxel as front-line combination therapy for metastatic breast cancer: a multicenter phase II study. J Clin Oncol 22:2321–2327CrossRefPubMedGoogle Scholar
  22. 22.
    Blum JL, Dees EC, Chacko A, Doane L, Ethirajan S, Hopkins J, McMahon R, Merten S, Negron A, Neubauer M, Ilegbodu D, Boehm KA, Asmar L, O’Shaughnessy JA (2006) Phase II trial of capecitabine and weekly paclitaxel as first-line therapy for metastatic breast cancer. J Clin Oncol 24:4384–4390CrossRefPubMedGoogle Scholar

Copyright information

© Arányi Lajos Foundation 2016

Authors and Affiliations

  • Renáta Kószó
    • 1
  • Dóra Sántha
    • 1
  • László Büdi
    • 2
  • József Erfán
    • 3
  • Károly Győrfy
    • 4
  • Zsolt Horváth
    • 5
  • Judit Kocsis
    • 6
  • László Landherr
    • 7
  • Erika Hitre
    • 8
  • Károly Máhr
    • 9
  • Gábor Pajkos
    • 10
  • Zsuzsanna Pápai
    • 11
  • Zsuzsanna Kahán
    • 1
    Email author
  1. 1.Department of OncotherapyUniversity of SzegedSzegedHungary
  2. 2.Borsod-Abauj-Zemplén County HospitalMiskolcHungary
  3. 3.Szabolcs-Szatmár-Bereg County Jósa András HospitalNyíregyházaHungary
  4. 4.Kaposi Mór Teaching HospitalKaposvárHungary
  5. 5.Medical CenterUniversity of DebrecenDebrecenHungary
  6. 6.3rd Department of Internal MedicineSemmelweis UniversityBudapestHungary
  7. 7.Uzsoki HospitalBudapestHungary
  8. 8.National Institute of OncologyBudapestHungary
  9. 9.Zala County HospitalZalaegerszegHungary
  10. 10.Bács-Kiskun County HospitalKecskemétHungary
  11. 11.Hungarian Army Medical CenterBudapestHungary

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