Gemcitabine and vinorelbine as second-line treatment in patients with metastatic breast cancer: a phase II study
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To evaluate the feasibility and activity of gemcitabine and vinorelbine as a second/third-line approach in patients with advanced breast cancer.
Entered into the study were 51 consecutive patients. All had been previously treated with anthracyclines. Of these 51 patients, 36 had experienced failure or relapse after one chemotherapy line for advanced disease, and 15 after two chemotherapy lines. The dominant sites of involvement were brain in 4 patients (7.8%), liver in 22 (43.2%), lung in 10 (19.6%), bone in 10 (19.6), and soft-tissue in 5 (9.8%). Treatment consisted of vinorelbine 25 mg/m2 and gemcitabine 1000 mg/m2 administered on days 1 and 8 every 21 days.
The scheme was well tolerated. Grade 3/4 neutropenia was observed in 11% of patients. Grade 3 nausea and vomiting occurred in 6%, and grade 2 neurotoxicity in 6%. No patients experienced grade 3/4 alopecia. The median relative dose intensity was 94.6% (49.7–100%) and 90.0% (23.1–100%) for vinorelbine and gemcitabine, respectively. Two patients (3.9%) were not evaluable for disease response, 4 (7.8%) attained a clinical complete response, 13 (25.5%) a partial response (for an overall response rate of 33.3%, 95% coefficient interval 20.0–46.0%), 23 (45.2%) showed stable disease, and 9 (17.6%) progressed. The median time to progression of responding patients was 10.8 months, and the median overall survival of the entire population was 17.8 months.
Vinorelbine and gemcitabine is a manageable scheme with moderate activity in pretreated patients with advanced breast cancer.
KeywordsGemcitabine Vinorelbine Second-line treatment Metastatic breast cancer Phase II
- 1.Verdecchia A (1996) Survival in adult Italian cancer patients (1978–1989). ITACARE Working Group. Tumori 83:39–425Google Scholar
- 2.Hortobagyi GN (1994) Multidisciplinary management of advanced primary and metastatic breast cancer. Cancer 74 [1 Suppl 1]:416–423Google Scholar
- 3.Ellis MJ, Hayes DF, Lippman ME (2000) Treatment of metastatic breast cancer. In: Harris YR, Lippman ME, Morrow M, Osborne CK (eds) Diseases of the breast. Lippincott, Philadelphia, pp 749–787Google Scholar
- 4.Cardoso F, Di Leo A, Lohrisch C, Bernard C, Ferreira F, Piccart MJ (2002) Second and subsequent lines of chemotherapy for metastatic breast cancer: what did we learn in the last two decades? Ann Oncol 13:197–207Google Scholar
- 5.Fellous A, Ohayon R, Vacassin T, Binet S, Lataste H, Krikorian A, Couzinier JP, Meininger V (1989) Biochemical effects of Navelbine on tubulin and associated proteins. Semin Oncol 16 [Suppl 4]:9–14Google Scholar
- 8.Weber BL, Vogel C, Jones S, Harvey H, Hutchins L, Bigley J, Hohneker J (1995) Intravenous vinorelbine as first-line and second-line therapy in advanced breast cancer. J Clin Oncol 13:1245–1252Google Scholar
- 10.Hertel LW, Kroin JS, Misner JW, Tustin JM (1988) Synthesis of 2-deoxy-2′,2′-difluoro-D-ribose and 2-deoxy-2′,2′'-difluoro-D-ribofuranosyl nucleosides. J Org Chem 53:2406–2409Google Scholar
- 15.Krajnik G, Mohn-Staudner A, Thaler J, Greil R, Schmeikal S, Marhold F, Deutsch J, Preiss P, Malayari R, Schafer-Prokop C, Wein W, Huber H, Pirker R (2000) Vinorelbine-gemcitabine in advanced non-small cell lung cancer (NSCLC): an AASLC phase II trial. Ann Oncol 11:993–998CrossRefPubMedGoogle Scholar
- 16.Gianni L, Munzone E, Capri G, Fulfaro F, Tarenzi E, Villani F, Spreafico C, Laffranchi A, Caraceni A, Martini C (1995) Paclitaxel by three-hour infusion in combination with bolus doxorubicin in women with untreated metastatic breast cancer: high antitumor efficacy and cardiac effects in a dose-finding and sequence-finding study. J Clin Oncol 13:2688–2699PubMedGoogle Scholar
- 17.Dogliotti L, Berruti A, Buniva T, Zola P, Bau MG, Farris A, Sarobba MG, Bottini A, Alquati P, Deltetto F, Gosso P, Monzeglio C, Moro G, Sussio M, Perroni D (1996) Lonidamine significantly increases the activity of epirubicin in advanced breast cancer patients: results from a multicenter prospective randomized trial. J Clin Oncol 14:1165–1172PubMedGoogle Scholar
- 18.Haider K, Kornek GV, Kwasny W, Weinlander G, Valencak J, Lang F, Puribauer F, Kovats E, Depisch D, Scheithauer W (1999) Treatment of advanced breast cancer with gemcitabine and vinorelbine plus human granulocyte-colony stimulating factor. Breast Cancer Res Treat 55:203–211CrossRefPubMedGoogle Scholar
- 19.Nicolaides C, Dimopoulos MA, Samantas E, Bafaloukos D, Kalofonos C, Fountzilas G, Razi E, Kosmidis P, Pavlidis N (2000) Gemcitabine and vinorelbine as second-line treatment in patients with metastatic breast cancer progressing after first-line taxane-based chemotherapy: a phase II study conducted by the Hellenic Cooperative Oncology Group. Ann Oncol 11:873–875CrossRefPubMedGoogle Scholar
- 21.Hortobagyi G (2001) Treatment of advanced breast cancer with gemcitabine and vinorelbine. Oncology (Huntingt) 15 [Suppl 3]:15–17Google Scholar
- 27.Buzdar AU, Asmar L, Hortobagyi GN (1997) Impact of patient characteristics on treatment outcome: anthracycline resistance. Eur J Cancer 33 [Suppl 7]:S3–S6Google Scholar
- 28.Berruti A, Sperone P, Bottini A, Gorzegno G, Lorusso V, Brunelli A, Botta M, Tampellini M, Donadio M, Mancarella S, De Lena M, Alquati P, Dogliotti L (2000) Phase II study of vinorelbine with protracted fluorouracil infusion as a second- or third-line approach for advanced breast cancer patients previously treated with anthracyclines. J Clin Oncol 18:3370–3377PubMedGoogle Scholar