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Sequential vinorelbine–capecitabine followed by docetaxel in advanced breast cancer: long-term results of a pilot phase II trial

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Abstract

Purpose

To evaluate the response rate of the combination of capecitabine (C) and vinorelbine (V) followed by Docetaxel (D) in the 1st line treatment of advanced and metastatic breast cancer patients.

Patients and methods

Patients with measurable disease and no prior chemotherapy in advanced disease were eligible. Pts received V 25 mg/m2 on day 1 and 8 in combination with C 825 mg/m2 twice a day from day 1 to 14 every 3 weeks for four cycles followed by 12 consecutive weeks of D 25 mg/m2/w.

Results

Between March 2002 and November 2003, 40 patients were enrolled. Median age was 57 years. Of patients, 77.5% of pts had visceral involvement and 32.5% had more than two metastatic sites. In the adjuvant setting, 62.5% received anthracycline and 10% Taxanes. In the intent-to-treat population, an overall objective response was observed in 25 patients (62.5, 95% CI, 45.8–77.27) and stable disease in 5 (12.5%). Median time till progression (TTP) was 12.3 months (range 1.5–48; 95% CI, 10.05–14.54). The median survival was 35.7 months (range 2–47). Reported grade 3–4 toxicities under Navcap were neutropenia (4 pts), anemia (1 pt), thrombopenia (1 pt) and febrile neutropenia (3 pts). Reported grade 3–4 toxicities under weekly Docetaxel were neutropenia (1 pt), thrombopenia (2 pts), leucopenia (1 pt) and anemia (1 pt).

Conclusion

The sequential use of Navcap followed by weekly Docetaxel demonstrated an interesting efficacy with a prolonged TTP and OS and warrants further evaluation.

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References

  1. Mariani G (2005) New developments in the treatment of metastatic breast cancer: from chemotherapy to biological therapy. Ann Oncol 16(suppl 2):ii191–ii194

    Article  PubMed  Google Scholar 

  2. Bernard-Marty C, Cardoso F, Piccart MJ (2004) Facts and controversies in systemic treatment of metastatic breast cancer. Oncologist 9:617–632

    Article  PubMed  Google Scholar 

  3. Fumoleau P, Delgado FM, Delozier T et al (1993) Phase II trial of weekly intravenous vinorelbine in first-line advanced breast cancer chemotherapy. J Clin Oncol 11:1245–1252

    PubMed  CAS  Google Scholar 

  4. Berruti A, Sperone P, Bottini A et al (2000) Phase II study of protracted fluorouracil infusion as second or third-line approach for advanced breast cancer patients previously treated with anthracycline. J Clin Oncol 18:3370–3377

    PubMed  CAS  Google Scholar 

  5. Aboul Enein M, Moussa M, Sabri A et al (2004) Vinorelbine-5 fluorouracil combination as first line chemotherapy in anthracycline pretreated patients with metastatic breast cancer. Ann Oncol 15(S3):47 (Abstr 177P)

    Google Scholar 

  6. Nole F, De Braud F, Aapro M et al (1997) Phase I-II study of vinorelbine in combination with 5-fluorouracil and folinic acid as first-line chemotherapy in metastatic breast cancer: a regimen with a low subjective toxic burden. Ann Oncol 8:865–870

    Article  PubMed  CAS  Google Scholar 

  7. Dieras V, Extra JM, Bellissant E et al (1996) Efficacy and tolerance of vinorelbine and fluorouracil combination as first-line chemotherapy of advanced breast cancer: results of a phase II study using a sequential group method. J Clin Oncol 14:3097–3104

    PubMed  CAS  Google Scholar 

  8. Blum JL, Jones SE, Buzdar AU et al (1999) Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer. J Clin Oncol 17:485–494

    PubMed  CAS  Google Scholar 

  9. Blum JL, Dieras V, Lorusso PM et al (2001) Multicenter phase II study of oral capecitabine in taxane-pretreated metastatic breast cancer. Cancer 92:1759–1768

    Article  PubMed  CAS  Google Scholar 

  10. O’Shaughnessy J, Blum J, Moiseyenko V et al (2001) Randomised open-label, phase II trial of oral capecitabine (xeloda) versus a reference arm of intravenous CMF (cyclophosphamide, methotrexate and 5-fluorouracil) as first-line therapy for advanced/metastatic breast cancer. Ann Oncol 12:1247–1254

    Article  CAS  Google Scholar 

  11. O’Shaughnessy J, Miles D, Vukelja S et al (2002) Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: phase III trial results. J Clin Oncol 20:2812–2823

    Article  PubMed  CAS  Google Scholar 

  12. Welt G. von Minckwitz, Oberhof C et al (2005) Phase I/II study of capecitabine and vinorelbine in pretreated patients with metastatic breast cancer. Ann Oncol 16:64–69

    Article  Google Scholar 

  13. Jin-Hee Ahn, Sung-Bae Kim, Tae-Won Kim et al (2004) Capecitabine and Vinorelbine in patients with metastatic breast cancer previously treated with anthracycline and taxane. J Korean Med Sci 19:547–553

    Google Scholar 

  14. Ghosn M, Kattan J, Farhat F, Younes F, Gasmi J (2006) Phase II trial of capecitabine and Vinorelbine as first-line chemotherapy for metastatic breast cancer patients. Anticancer Res 26(3):2451–2456

    PubMed  CAS  Google Scholar 

  15. Burstein HJ, Manola J, Younger J et al (2000) Docetaxel administered on a weekly basis for metastatic breast cancer. J Clin Oncol 18:1212–1219

    PubMed  CAS  Google Scholar 

  16. Gennari A, Guarneri V, Landucci E, et al., Eniu A, Palmieri FM, Perez EA et al (2005) Weekly administration of docetaxel and paclitaxel in metastatic or advanced breast cancer. Oncologist 10(9):665–685

    Article  Google Scholar 

  17. Saintigny P, Assouad S, Gligorov J et al (2004) Dose density and dose intensity in the treatment of breast cancer. Bull du cancer 91(suppl 4):S244–S253

    Google Scholar 

  18. Rodenhuis S (2000) The status of high-dose chemotherapy in breast cancer. Oncologist 5(5):369–375

    Article  PubMed  CAS  Google Scholar 

  19. Soto C, Torrecillas L, Reyes S et al (2006) Capecitabine (X) and taxanes in patients (pts) with anthracycline-pretreated metastatic breast cancer (MBC): Sequential versus combined therapy results from a MOSG randomized phase III trial. Supplement to Journal of Clinical Oncology, 24 (18S), part I of II, p 20s, (abstract 570)

  20. Conte PF, Guarneri V, Bruzzi P et al (2004) Concomitant versus sequential administration of epirubicin and paclitaxel as first-line therapy in metastatic breast carcinoma: results for the Gruppo Oncologico Nord Ovest randomized trial. Cancer 101(4):704–712

    Google Scholar 

  21. Alba E, Martin M, Ramos M (2004) Multicenter randomized trial comparing sequential with concomitant administration of doxorubicin and docetaxel as first-line treatment of metastatic breast cancer: a Spanish breast cancer research group (GEICAM-9903) phase III study. J Clin Oncol 22(13):2587–2593

    Article  PubMed  CAS  Google Scholar 

  22. Cresta S, Grasselli G, Mansutti M et al (2004) A randomized phase II study of combination, alternating and sequential regimens of doxorubicin and docetaxel as first-line chemotherapy for women with metastatic breast cancer. Ann Oncol 15(3):433–439

    Article  PubMed  CAS  Google Scholar 

  23. Beslija S, Obralic N, Basic H et al (2006) Randomized trial of sequence versus combination of capecitabine (X) and docetaxel (T): XT versus T followed by X after progression as first-line therapy for patients (pts) with metastatic breast cancer (MBC). Proc Am Soc Clin Oncol 24(18S), part I of II, p 20s, abstract 571

  24. Fleming TR (1982) One-sample multiple testing procedures for phase II clinical trials. Biometrics 43:143–151

    Article  Google Scholar 

  25. Docetaxel (1999) Standard recommended dose of 100 mg/m2 is effective but not feasible for some metastatic breast cancer patients heavily pretreated with chemotherapy—a phase II single-center study. J Clin Oncol 17(4):1127–1131

  26. Tabernero J, Climent MA, Lluch A et al (2004) A multicentre, randomised phase II study of weekly or 3-weekly docetaxel in patients with metastatic breast cancer. Ann Oncol 15:1358–1365

    Article  PubMed  CAS  Google Scholar 

  27. Riviera E, Mejia JA, Arun B et al (2006) Phase III study of docetaxel weekly (DW) versus every 3 weeks (D) in patients with metastatic breast cancer: final results. Proc Am Soc Clin Oncol 24(18S), part I of II, p 21s, abstract 574

  28. Jones SE, Erban J, Overmoyer B et al (2005) Randomized phase III study of docetaxel compared with paclitaxel in metastatic breast cancer. J Clin Oncol 23(24):5434–5436

    Article  CAS  Google Scholar 

  29. O’Shaughnessy J, Miles D, Vukelja S et al (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(12):2812–2823

    Article  PubMed  CAS  Google Scholar 

  30. Moinpour C, Wu J, Donaldson G, Liepa A et al (2004) Gemcitabine plus paclitaxel (GT) versus paclitaxel (T) as first-line treatment for anthracycline pre-treated metastatic breast cancer (MBC): Quality of life (QoL) and pain palliation results from the global phase III study. Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition). 22(14S) (July 15 Supplement):621

  31. Beslija S, Obralic N, Basic H et al (2006) Randomized trial of sequence versus combination of capecitabine (X) and docetaxel (T): XT versus T followed by X after progression as first-line therapy for patients (pts) with metastatic breast cancer (MBC). Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings Part I. 24(18S) (June 20 Supplement):571

  32. Soto C, Torrecillas L, Reyes S et al (2006) Capecitabine (X) and taxanes in patients (pts) with anthracycline-pretreated metastatic breast cancer (MBC): Sequential versus combined therapy results from a MOSG randomized phase III trial. Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings Part I. 24(18S) (June 20 Supplement):570

  33. Nole F, de Braud F, Aapro M et al (1997) Phase I–II study of vinorelbine in combination with 5-fluorouracil and folinic acid as first-line chemotherapy in metastatic breast cancer: a regimen with a low subjective toxic burden. Ann Oncol 8(9):865–870

    Article  PubMed  CAS  Google Scholar 

  34. Fuentes H, Calderillo G, Alexander F et al (2006) Phase II study of gemcitabine plus cisplatin in metastatic breast cancer. Anticancer Drugs 17(5):565–570

    Article  PubMed  CAS  Google Scholar 

  35. Ocana A, Hortobagyi GN, Esteva FJ (2006) Concomitant versus sequential chemotherapy in the treatment of early-stage and metastatic breast cancer. Clin Breast Cancer 6(6):495–504

    Article  PubMed  CAS  Google Scholar 

  36. Hochster HS, Vogel CL, Burman SL et al (2001) Activity and safety of vinorelbine combined with doxorubicin or fluorouracil as first-line therapy in advanced breast cancer: a stratified phase II study. Oncologist 6(3):269–277

    Article  PubMed  CAS  Google Scholar 

  37. Burstein HJ, Manola J, Younger J et al (2000) Docetaxel administered on a weekly basis for metastatic breast cancer. J Clin Oncol 18(6):1212–1219

    PubMed  CAS  Google Scholar 

  38. Ramaswamy B, Elias AD, Kelbick NT et al (2006) Phase II trial of bevacizumab in combination with weekly docetaxel in metastatic breast cancer patients. Clin Cancer Res 12(10):3124–3129

    Article  PubMed  CAS  Google Scholar 

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Correspondence to Marwan Ghosn.

Additional information

This study was supported in part by Institut de Recherche Pierre-Fabre and by sanofi-aventis.

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Ghosn, M., Kattan, J., Farhat, F. et al. Sequential vinorelbine–capecitabine followed by docetaxel in advanced breast cancer: long-term results of a pilot phase II trial. Cancer Chemother Pharmacol 62, 11–18 (2008). https://doi.org/10.1007/s00280-007-0565-x

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  • DOI: https://doi.org/10.1007/s00280-007-0565-x

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