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Phase II study of vinorelbine monotherapy in anthracycline and taxane pre-treated metastatic breast cancer

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Summary

We performed a single-institution phase II study to evaluate the efficacy and toxicities of vinorelbine monotherapy in patients previously treated with anthracyclines and taxanes. Vinorelbine was administered at a dose level of 25 mg/m2 intravenously on days 1, 8, 15 and 22, every four weeks, and responses were assessed after every two cycles of treatment. All of the patients had previously been treated with anthracyclines and taxanes. A total of 26 patients were enrolled in this study between April 2004 and August 2009. The median age of the patients was 47 years (range, 37 to 71 years), and 80.8% had an Eastern Cooperative Oncology Group performance status of 0 or 1. Out of 24 evaluable patients, five partial responses were observed, giving an overall response rate of 20.8%, with a median response duration of 2.8 months. The median time to progression was 3.7 months (range, 0.5 to 22.6 months), and median overall survival duration was 10.4 months (range, 1.3 to 57.6 months). The major toxicities observed were neutropenia, anemia and peripheral neuropathy. Grade 3 or 4 hematologic toxicities included neutropenia in 18 patients (69.2%) and anemia in four patients (15.3%). Grade 1 or 2 peripheral neuropathy was observed in 11 patients (42.3%), however there were no cases of grade 3 or 4 peripheral neuropathy. The results of this study indicate that vinorelbine monotherapy was feasible regimen with manageable toxicities in patients with metastatic breast cancer who were previously exposed to anthracyclines and taxanes.

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References

  1. Shin HR, Jung KW, Won YJ, Kong HJ, Yim SH, Sung J et al (2007) National cancer incidence for the year 2002 in Korea. Cancer Res Treat 39:139–149

    Article  PubMed  Google Scholar 

  2. Cardoso F, Bedard PL, Winer EP, Pagani O, Senkus-Konefka E, Fallowfield LJ et al (2009) International guidelines for management of metastatic breast cancer: combination vs sequential single-agent chemotherapy. J Natl Cancer Inst 101:1174–1181

    Article  CAS  PubMed  Google Scholar 

  3. Fellous A, Ohayon R, Vacassin T, Binet S, Lataste H, Krikorian A et al (1989) Biochemical effects of Navelbine on tubulin and associated proteins. Semin Oncol 16:9–14

    CAS  PubMed  Google Scholar 

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

    CAS  PubMed  Google Scholar 

  5. Romero A, Rabinovich MG, Vallejo CT, Perez JE, Rodriguez R, Cuevas MA et al (1994) Vinorelbine as first-line chemotherapy for metastatic breast carcinoma. J Clin Oncol 12:336–341

    CAS  PubMed  Google Scholar 

  6. Bruno S, Puerto VL, Mickiewicz E, Hegg R, Texeira LC, Gaitan L et al (1995) Phase II trial of weekly i.v. vinorelbine as a single agent in first-line advanced breast cancer chemotherapy. The Latin-American experience. Am J Clin Oncol 18:392–396

    Article  CAS  PubMed  Google Scholar 

  7. Terenziani M, Demicheli R, Brambilla C, Ferrari L, Moliterni A, Zambetti M et al (1996) Vinorelbine: an active, non cross-resistant drug in advanced breast cancer. Results from a phase II study. Breast Cancer Res Treat 39:285–291

    Article  CAS  PubMed  Google Scholar 

  8. Twelves CJ, Dobbs NA, Curnow A, Coleman RE, Stewart AL, Tyrrell CJ et al (1994) A phase II, multicentre, UK study of vinorelbine in advanced breast cancer. Br J Cancer 70:990–993

    Article  CAS  PubMed  Google Scholar 

  9. Vogel C, O'Rourke M, Winer E, Hochster H, Chang A, Adamkiewicz B et al (1999) Vinorelbine as first-line chemotherapy for advanced breast cancer in women 60 years of age or older. Ann Oncol 10:397–402

    Article  CAS  PubMed  Google Scholar 

  10. Weber BL, Vogel C, Jones S, Harvey H, Hutchins L, Bigley J et al (1995) Intravenous vinorelbine as first-line and second-line therapy in advanced breast cancer. J Clin Oncol 13:2722–2730

    CAS  PubMed  Google Scholar 

  11. Degardin M, Bonneterre J, Hecquet B, Pion JM, Adenis A, Horner D et al (1994) Vinorelbine (navelbine) as a salvage treatment for advanced breast cancer. Ann Oncol 5:423–426

    CAS  PubMed  Google Scholar 

  12. Fazeny B, Zifko U, Meryn S, Huber H, Grisold W, Dittrich C (1996) Vinorelbine-induced neurotoxicity in patients with advanced breast cancer pretreated with paclitaxel–a phase II study. Cancer Chemother Pharmacol 39:150–156

    Article  CAS  PubMed  Google Scholar 

  13. Udom DI, Vigushin DM, Linardou H, Graham H, Palmieri C, Coombes RC (2000) Two weekly vinorelbine: administration in patients who have received at least two prior chemotherapy regimes for advanced breast cancer. Eur J Cancer 36:177–182

    Article  CAS  PubMed  Google Scholar 

  14. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L et al (2000) New guidelines to evaluate the response to treatment in solid tumors. European organization for research and treatment of cancer, national cancer institute of the united states, national cancer institute of Canada. J Natl Cancer Inst 92:205–216

    Article  CAS  PubMed  Google Scholar 

  15. Toi M, Saeki T, Aogi K, Sano M, Hatake K, Asaga T et al (2005) Late phase II clinical study of vinorelbine monotherapy in advanced or recurrent breast cancer previously treated with anthracyclines and taxanes. Jpn J Clin Oncol 35:310–315

    Article  PubMed  Google Scholar 

  16. Zelek L, Barthier S, Riofrio M, Fizazi K, Rixe O, Delord JP et al (2001) Weekly vinorelbine is an effective palliative regimen after failure with anthracyclines and taxanes in metastatic breast carcinoma. Cancer 92:2267–2272

    Article  CAS  PubMed  Google Scholar 

  17. Livingston RB, Ellis GK, Gralow JR, Williams MA, White R, McGuirt C et al (1997) Dose-intensive vinorelbine with concurrent granulocyte colony-stimulating factor support in paclitaxel-refractory metastatic breast cancer. J Clin Oncol 15:1395–1400

    CAS  PubMed  Google Scholar 

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Correspondence to Jae Hong Seo.

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Seo, H.Y., Lee, H.J., Woo, O.H. et al. Phase II study of vinorelbine monotherapy in anthracycline and taxane pre-treated metastatic breast cancer. Invest New Drugs 29, 360–365 (2011). https://doi.org/10.1007/s10637-009-9357-y

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  • DOI: https://doi.org/10.1007/s10637-009-9357-y

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