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Weekly schedule of vinorelbine in pretreated breast cancer patients

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Abstract

Purpose: In this phase II study, we explored tolerability and activity of vinorelbine administered according to a dose-dense weekly schedule with hematopoietic growth factor support in pretreated, advanced breast cancer patients.

Patients and Methods: From January 1994 to March 1996, 40 patients with metastatic breast cancer, pretreated with at least one prior anthracycline-containing regimen, were entered into the study. Patient characteristics: median age 53 years (range 32–70); ECOG performance status 0-1: 34 patients, 2: 6 patients; dominant visceral metastatic disease: 15 patients, dominant non-visceral: 25; anthracycline-refractory/resistant: 2 patients, sensitive: 38 patients. Six patients were treated as first-line therapy for metastatic disease and 34 in second- or subsequent lines.

All patients received vinorelbine at the dose of 25 mg/m2/week as a short intravenous infusion, together with routine antiemetic medication. Granulocyte-colony stimulating factor (Lenograstim) at the dose of 150 μg/m2 subcutaneously on day 3 was included in the treatment schedule.

Results: The median number of treatment weeks was 23 (range: 4–24), with a delivered dose-intensity (DDI) of 23.8 mg/m2/week (range: 18.7–25, 95.2% of projected dose-intensity).

Toxicity was mild, with non-complicated neutropenia being the main toxicity observed (grade 3–4 in 25% of the patients but only 2% of treatment weeks). Overall response rate was 52.5%, with complete responses in 12.5% of patients. Median duration of the response and median time to progression were 10 and 9 months, respectively. Median overall survival was 19 months.

Conclusion: Dose-dense weekly vinorelbine is safe and effective with minimal toxicity in pretreated advanced breast cancer patients.

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References

  1. Jensen OM, Esteve J, Moller H, Renard H: Cancer in the European Community and its member states. Eur J Cancer 26: 1167–1256, 1990

    Google Scholar 

  2. Holli K, Hakama M: Treatment of the terminal stages of breast cancer. Br Med J 298: 13–14, 1989

    Google Scholar 

  3. Cold S, Jensen NV, Brincker H, Rose C: The influence of chemotherapy on survival after recurrence in breast cancer–a population-based study of patients treated in 1950s, 1960s and 1970s. Eur J Cancer 29A: 1146–1152, 1993

    Google Scholar 

  4. Harris JR, Morrow M, Norton L: Malignant tumors of the breast. In: De Vita VT Jr, Hellman S, Rosenberg SA (eds) Cancer: Principles and Practice of Oncology. JB Lippincott, Philadelphia, 1997, pp 1557–1616

    Google Scholar 

  5. Gregory WM, Smith P, Richards MA, Twelves CJ, Knight RK, Rubens RD: Chemotherapy of advanced breast cancer: outcome and prognostic factors. Br J Cancer 68: 988–995, 1993

    Google Scholar 

  6. Mangeney P, Andriamialisoa RZ, Lallemand JY: 50 Noranhydrovinblastine, prototype of a new class of vinblastine derivatives. Tetrahedron 35: 2175–2179, 1979

    Google Scholar 

  7. Fellous A, Ohayon R, Vacassin T, Binet S, Lataste H, Krikorian A, Couzinier JP, Meininger V: Biochemical effects of navelbine on tubulin and associated proteins. Semin Oncol 16 (suppl 4): 9–14, 1989

    Google Scholar 

  8. Binet S, Fellous A, Lataste H, Krikorian A, Couzinier JP, Meininger V: In situ analysis of the action of navelbine on various types of microtubules using immunofluorescence. Semin Oncol 16 (suppl 4): 5–8, 1989

    Google Scholar 

  9. Romero A, Rabinovich MG, Vallejo CT, Perez JE, Rodriguez R, Cuevas MA, Machiavelli M, Lacava JA, Langhi M, Romero Acuna L, Amato S, Barbieri R, Sabatini C, Leone BA: Vinorelbine as first-line chemotherapy for metastatic breast carcinoma. J Clin Oncol 12: 336–341, 1994

    Google Scholar 

  10. Garcia-Conde J, Lluch A, Martin M, Casado A, Gervasio H, De Oliviera C, De Pablo JL, Gorostiaga J, Giron GC, Cervantes A, Martinez A, Pezous N, Delgado FM, Diaz Rubio E: Phase II trial of weekly i.v. vinorelbine in first-line advanced breast cancer chemotherapy. Ann Oncol 5: 854–857, 1994

    Google Scholar 

  11. Fumoleau P, Delgado FM, Delazier T, Monnier A, Gil Delgado MA, Kerbrat P, Garcia-Giralt E, Keiling R, Namer M, Closon MT, Goudier MJ, Chollet P, Lecourt L, Monteuquet P: Phase II trial of weekly intravenous vinorelbine in firstline advanced breast cancer chemotherapy. J Clin Oncol 11: 1245–1252, 1993

    Google Scholar 

  12. Twelves CJ, Dobbs NA, Curnow A, Coleman RE, Stewart AL, Tyrrell CJ, Canney P, Rubens RD: A phase II, multicentre, UK study of vinorelbine in advanced breast cancer. Br J Cancer 70: 990–993, 1994

    Google Scholar 

  13. Bruno S, Lira Puerto V, Mickiewicz E, Hegg R, Texeira LC, Gaitan L, Martinez L, Fernandez O, Otero J, Kesselring G, Noguera C, Delgado G, Gaubert P, Delgado FM, Solidoro A: Phase II Trial IV vinorelbine as a single agent in first-line advanced breast cancer chemotherapy. Am J Clin Oncol 18(5): 392–396, 1995

    Google Scholar 

  14. Weber BL, Vogel C, Jones S, Harvey H, Hutchins L, Bigley J, Hohneker J: Intravenous vinorelbine as first-line and secondline therapy in advanced breast cancer. J Clin Oncol 13: 2722–2730, 1995

    Google Scholar 

  15. Extra JM, Leandri S, Dieras V, Ferme C, Mignot L, Morvan F, Espie M, Marty M: Phase II study of vinorelbine in first-and second-line treatment of advanced breast cancer. In: Pisolal Celigny P (eds) Navelbine (vinorelbine) Update and New Trends. John Libbey Eurotext, Paris, 1991, pp 213–220.

    Google Scholar 

  16. Canobbio L, Boccardo F, Pastorino G, Brema F, Martini C, Resasco M, Santi L: Phase-II study of Navelbiner in advanced breast cancer. Semin Oncol 16(2): 33–36, 1989

    Google Scholar 

  17. Gasco M, Gardin G, Repetto L, Campora E, Rosso R: Vinorelbine as palliative therapy in advanced breast cancer. Anticancer Research 17: 1431–1434, 1997

    Google Scholar 

  18. Barni S, Ardizzoia A, Bernardo G, Villa S, Strada MR, Cazzaniga M, Archili C, Frontini L: Vinorelbine as single agent in pretreated patients with advanced breast cancer. Tumori 80: 280–282, 1994

    Google Scholar 

  19. Terenziani M, Demicheli R, Brambilla C, Ferrari L, Moliterni A, Zambetti M, Caraceni A, Martini C, Bonadonna G: Vinorelbine: an active, non cross-resistant drug in advanced breast cancer. Results of a Phase II study. Breast Cancer Res Treat 39: 285–291, 1996

    Google Scholar 

  20. Hohneker JA: A summary of vinorelbine (Navelbine) safety data from North American clinical trials. Semin Oncol 21: 42–47, 1994

    Google Scholar 

  21. Miller A, Hoogstraten B, Staquet M, Winkler A: Reporting results of cancer treatment. Cancer 47: 207–214, 1981

    Google Scholar 

  22. Hryniuk WM: The importance of dose intensity in the outcome of chemotherapy: In: De Vita VT, Hellman S, Rosenberg SA (eds) Important Advances in Oncology. Lippincott, Philadelphia (PA), 1988, pp 121–142.

    Google Scholar 

  23. Kaplan EL, Meier P. Nonparametric estimation from incomplete observation: J Am Stat Assoc 53: 475–481, 1958

    Google Scholar 

  24. Toussaint C, Izzo J, Spielmann M, Merle S, May-Levin F, Armand JP, Lacombe D, Tursz T, Sunderland M, Chabot GG, Cvitkovic E: Phase I/II trial of continuous infusion vinorelbine for advanced breast cancer. J Clin Oncol 12: 2102–2112, 1994

    Google Scholar 

  25. Norton LA: Gompertzian model of human breast cancer growth. Cancer Res 48: 7067–7071, 1988

    Google Scholar 

  26. Norton LA: Evolving concepts in the systemic drug therapy of breast cancer. Sem Oncol 24 (4 suppl. 10): 3–10, 1997

    Google Scholar 

  27. Livingston RB, Ellis GK, Williams MA, White R, McGuirt C, Adamkiewicz BB, Long CA: Dose-intensive vinorelbine with concurrent granulocyte colony stimulating factor support in paclitaxel-refractory metastatic breast cancer: J Clin Oncol 15: 1395–1400, 1997

    Google Scholar 

  28. Gasparini G, Caffo O, Barni S, Frontini L, Testolin A, Guglielmi RB, Ambrosini G: Vinorelbine is an active antiprolifrative agent in pretreated advanced breast cancer patients: A Phase II Study. J Clin Oncol 12: 2094–2101, 1994

    Google Scholar 

  29. Jones S, Winer E, Vogel C, Laufman L, Hutchins L, O'Rourke M, Lembersky B, Budman D, Bigley J, Hohnecker J: Randomized comparison of vinorelbine and melphalan in anthracycline-refractory advanced breast cancer. J Clin Oncol 13: 2567–2574, 1995

    Google Scholar 

  30. Pace A, Bove L, Nisticò C, Ranuzzi M, Innocenti P, Pietrangeli A, Terzoli E, Jandolo B: Vinorelbine neurotoxicity: clinical and neurophysiological findings in 23 patients. J Neurol Neurosurg Psychiatry 61: 409–411, 1996

    Google Scholar 

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Authors and Affiliations

  1. Service of Complementary Medical Oncology, Regina Elena Cancer Institute, Roma, Italy

    Cecilia Nisticò, Carlo Garufi, Angela Vaccaro, Anna Maria D'Ottavio, Francesco Tropea, Fiorentino Izzo, Rita Maria D'Attino & Edmondo Terzoli

  2. Division of Medical Oncology I, Regina Elena Cancer Institute, Roma, Italy

    Michele Milella, Alessandra Fabi, Virginia Ferraresi & Salvatore Delella Marco

  3. Service of Neurology, Regina Elena Cancer Institute, Roma, Italy

    Andrea Pace & Loredana Bove

  4. Division of Radiology, Regina Elena Cancer Institute, Roma, Italy

    Annelisa Marsella

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  1. Cecilia Nisticò
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  2. Carlo Garufi
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Nisticò, C., Garufi, C., Milella, M. et al. Weekly schedule of vinorelbine in pretreated breast cancer patients. Breast Cancer Res Treat 59, 223–229 (2000). https://doi.org/10.1023/A:1006390700480

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