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Journal of Cancer Research and Clinical Oncology

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01.01.2010 | Original Paper

A Phase II trial of the combination of vinorelbine and capecitabine as second-line treatment in metastatic breast cancer previously treated with taxanes and/or anthracyclines

verfasst von: George Orphanos, Athanasios Alexopoulos, Savvoula Malliou, George Ioannidis, Alexandros Ardavanis, Constantinos Kandylis, John Stavrakakis, Gerassimos Rigatos

Erschienen in: Journal of Cancer Research and Clinical Oncology | Ausgabe 1/2010

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Abstract

Purpose

Survival time for metastatic breast cancer (MBC) can be substantially improved by combination chemotherapy in the adjuvant setting. Capecitabine and vinorelbine have shown considerable efficacy and favourable toxicity as single agents. The aim of this study is to evaluate the response to the combination of capecitabine and vinorelbine as second-line treatment in patients previously treated with taxanes and/or anthracyclines.

Patients and methods

Thirty-nine patients with MBC, who received a combination of vinorelbine and capecitabine were included in the study.

Results

Overall response rate was 53.9% and disease progression rate was 28.2% for patients who received six cycles of therapy, rates significantly higher than the three-cycle group. The treatment was generally well tolerated and toxicity was mild.

Conclusions

The combination of capecitabine and vinorelbine as salvage therapy in anthracycline- and/or taxane-pre-treated patients with MBC seems to be effective and safe, even more so as the number of treatment cycles increases.

Ahmann DL, Schaid DJ, Bisel HF et al (1987) The effect on survival of initial chemotherapy in advanced breast cancer: polychemotherapy versus single drug. J Clin Oncol 5(12):1928–1932PubMed

Bajetta E, Procopio G, Celio L et al (2005) Safety and efficacy of two different doses of capecitabine in the treatment of advanced breast cancer in older women. J Clin Oncol 23(10):2155–2161. doi:10.1200/JCO.2005.02.167 CrossRefPubMed

Bernard-Marty C, Cardoso F, Piccart MJ (2004) Facts and controversies in systemic treatment of metastatic breast cancer. Oncologist 9(6):617–632. doi:10.1634/theoncologist.9-6-617 CrossRefPubMed

Berruti A, Sperone P, Bottini A et al (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(19):3370–3377PubMed

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(2):485–493PubMed

Blum JL, Dieras V, Lo Russo PM et al (2001) Multicenter, phase II study of capecitabine in taxane-pretreated metastatic breast carcinoma patients. Cancer 92(7):1759–1768. doi:10.1002/1097-0142(20011001)92:7<1759::AID-CNCR1691>3.0.CO;2-A CrossRefPubMed

Bruno S, Puerto VL, Mickiewicz E 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(5):392–396PubMedCrossRef

Cunningham D, Coleman R (2001) New options for outpatient chemotherapy—the role of oral fluoropyrimidines. Cancer Treat Rev 27(4):211–220. doi:10.1053/ctrv.2001.0229 CrossRefPubMed

Davidson NG (1996) Single-agent paclitaxel as first-line treatment of metastatic breast cancer: the British experience. Semin Oncol 23(5) (Suppl 11):6–10

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(12):3097–3104PubMed

Fazeny B, Zifko U, Meryn S et al (1996) Vinorelbine-induced neurotoxicity in patients with advanced breast cancer pretreated with paclitaxel—a phase II study. Cancer Chemother Pharmacol 39(1–2):150–156. doi:10.1007/s002800050551 CrossRefPubMed

Findlay M, von Minckwitz G, Wardley A (2008) Effective oral chemotherapy for breast cancer: pillars of strength. Ann Oncol 19(2):212–222. doi:10.1093/annonc/mdm285 CrossRefPubMed

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(7):1245–1252PubMed

Fumoleau P, Blum JL, Reichardt P (2003) Weekly vinorelbine is an effective palliative regimen after failure with anthracyclines and taxanes in metastatic breast carcinoma. Cancer 98(6):1325–1326. doi:10.1002/cncr.11577 (author reply 1326–1327)CrossRefPubMed

Fumoleau P, Largillier R, Clippe C et al (2004) Multicentre, phase II study evaluating capecitabine monotherapy in patients with anthracycline- and taxane-pretreated metastatic breast cancer. Eur J Cancer 40(4):536–542. doi:10.1016/j.ejca.2003.11.007 CrossRefPubMed

Geyer CE, Forster J, Lindquist D et al (2006) Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med 355(26):2733–2743. doi:10.1056/NEJMoa064320 CrossRefPubMed

Ghosn M, Kattan J, Farhat F et al (2008) Sequential vinorelbine-capecitabine followed by docetaxel in advanced breast cancer: long-term results of a pilot phase II trial. Cancer Chemother Pharmacol 62(1):11–18. doi:10.1007/s00280-007-0565-x CrossRefPubMed

Hess D, Thurlimann B, Pagani O et al (2004) Capecitabine and vinorelbine in elderly patients (> or =65 years) with metastatic breast cancer: a phase I trial (SAKK 25/99). Ann Oncol 15(12):1760–1765. doi:10.1093/annonc/mdh467 CrossRefPubMed

Hortobagyi GN, Yap HY, Kau SW et al (1989) A comparative study of doxorubicin and epirubicin in patients with metastatic breast cancer. Am J Clin Oncol 12(1):57–62. doi:10.1097/00000421-198902000-00014 CrossRefPubMed

Jakob A, Bokemeyer C, Knop S et al (2002) Capecitabine in patients with breast cancer relapsing after high-dose chemotherapy plus autologous peripheral stem cell transplantation—a phase II study. Anticancer Drugs 13(4):405–410. doi:10.1097/00001813-200204000-00009 CrossRefPubMed

Jara-Sanchez C, Martin M, Garcia-Saenz JA et al (2003) Vinorelbine as a 96-hour continuous infusion in heavily pretreated patients with metastatic breast cancer: a cooperative study by the GEICAM group. Clin Breast Cancer 3(6):399–404. doi:10.3816/CBC.2003.n.004 CrossRefPubMed

Jemal A, Siegel R, Ward E et al (2008) Cancer statistics, 2008. CA Cancer J Clin 58(2):71–96. doi:10.3322/CA.2007.0010 CrossRefPubMed

Lee SH, Lee J, Park J et al (2004) Capecitabine monotherapy in patients with anthracycline- and taxane-pretreated metastatic breast cancer. Med Oncol 21(3):223–231. doi:10.1385/MO:21:3:223 CrossRefPubMed

Livingston RB, Ellis GK, Gralow JR et al (1997) Dose-intensive vinorelbine with concurrent granulocyte colony-stimulating factor support in paclitaxel-refractory metastatic breast cancer. J Clin Oncol 15(4):1395–1400PubMed

Loo WT, Sasano H, Chow LW (2007) Effects of capecitabine and vinorelbine on cell proliferation, metabolism and COX2 and p16 expression in breast cancer cell lines and solid tumour tissues. Biomed Pharmacother 61(9):596–600. doi:10.1016/j.biopha.2007.08.022 CrossRefPubMed

Mackey J, Paterson A, Dirix LY (2002) Final results of the phase III randomized trial comparing docetaxel (T), doxorubicin (A) and cyclophosphamide (C) to FAC as first line chemotherapy (CT) for patients (pts) with metastatic breast cancer (MBC). Proc Am Soc Clin Oncol 35:137

Mariani G (2005) New developments in the treatment of metastatic breast cancer: from chemotherapy to biological therapy. Ann Oncol 16(Suppl 2):ii191–ii194. doi:10.1093/annonc/mdi719 CrossRefPubMed

Miller KD, Chap LI, Holmes FA et al (2005) Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer. J Clin Oncol 23(4):792–799. doi:10.1200/JCO.2005.05.098 CrossRefPubMed

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. doi:10.1023/A:1008209429204 CrossRefPubMed

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. doi:10.1200/JCO.2002.09.002 CrossRefPubMed

Oken MM, Creech RH, Tormey DC et al (1982) Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 5(6):649–655. doi:10.1097/00000421-198212000-00014 CrossRefPubMed

Oshaughnessy JA, Blum J, Moiseyenko V et al (2001) Randomized, open-label, phase II trial of oral capecitabine (Xeloda) vs. a reference arm of intravenous CMF (cyclophosphamide, methotrexate and 5-fluorouracil) as first-line therapy for advanced/metastatic breast cancer. Ann Oncol 12(9):1247–1254. doi:10.1023/A:1012281104865 CrossRefPubMed

Pajk B, Cufer T, Canney P et al (2008) Anti-tumor activity of capecitabine and vinorelbine in patients with anthracycline- and taxane-pretreated metastatic breast cancer: findings from the EORTC 10001 randomized phase II trial. Breast 17(2):180–185. doi:10.1016/j.breast.2007.09.002 CrossRefPubMed

Paridaens R, Biganzoli L, Bruning P et al (2000) Paclitaxel versus doxorubicin as first-line single-agent chemotherapy for metastatic breast cancer: a European Organization for Research and Treatment of Cancer Randomized Study with cross-over. J Clin Oncol 18(4):724–733PubMed

Park JO, Lee SI, Song SY et al (2003) Measuring response in solid tumors: comparison of RECIST and WHO response criteria. Jpn J Clin Oncol 33(10):533–537. doi:10.1093/jjco/hyg093 CrossRefPubMed

Reichardt P, Von Minckwitz G, Thuss-Patience PC et al (2003) Multicenter phase II study of oral capecitabine (Xeloda(″)) in patients with metastatic breast cancer relapsing after treatment with a taxane-containing therapy. Ann Oncol 14(8):1227–1233. doi:10.1093/annonc/mdg346 CrossRefPubMed

Romero A, Rabinovich MG, Vallejo CT et al (1994) Vinorelbine as first-line chemotherapy for metastatic breast carcinoma. J Clin Oncol 12(2):336–341PubMed

Schott AF, Rae JM, Griffith KA et al (2006) Combination vinorelbine and capecitabine for metastatic breast cancer using a non-body surface area dosing scheme. Cancer Chemother Pharmacol 58(1):129–135. doi:10.1007/s00280-005-0132-2 CrossRefPubMed

Seidman AD, Reichman BS, Crown JP et al (1995) Paclitaxel as second and subsequent therapy for metastatic breast cancer: activity independent of prior anthracycline response. J Clin Oncol 13(5):1152–1159PubMed

Seidman AD, Hudis CA, Albanell J et al (1998) Dose-dense therapy with weekly 1-hour paclitaxel infusions in the treatment of metastatic breast cancer. J Clin Oncol 16(10):3353–3361PubMed

Sledge GW, Neuberg D, Bernardo P et al (2003) Phase III trial of doxorubicin, paclitaxel, and the combination of doxorubicin and paclitaxel as front-line chemotherapy for metastatic breast cancer: an intergroup trial (E1193). J Clin Oncol 21(4):588–592. doi:10.1200/JCO.2003.08.013 CrossRefPubMed

Sorio R, Robieux I, Galligioni E et al (1997) Pharmacokinetics and tolerance of vinorelbine in elderly patients with metastatic breast cancer. Eur J Cancer 33(2):301–303. doi:10.1016/S0959-8049(96)00426-1 CrossRefPubMed

Talbot DC, Moiseyenko V, Van Belle S et al (2002) Randomised, phase II trial comparing oral capecitabine (Xeloda) with paclitaxel in patients with metastatic/advanced breast cancer pretreated with anthracyclines. Br J Cancer 86(9):1367–1372. doi:10.1038/sj.bjc.6600261 CrossRefPubMed

Udom DI, Vigushin DM, Linardou H et al (2000) Two weekly vinorelbine: administration in patients who have received at least two prior chemotherapy regimes for advanced breast cancer. Eur J Cancer 36(2):177–182. doi:10.1016/S0959-8049(99)00219-1 CrossRefPubMed

Verma S, Wong NS, Trudeau M et al (2007) Survival differences observed in metastatic breast cancer patients treated with capecitabine when compared with vinorelbine after pretreatment with anthracycline and taxane. Am J Clin Oncol 30(3):297–302. doi:10.1097/01.coc.0000258125.97090.3f CrossRefPubMed

Vogel C, O’Rourke M, Winer E et al (1999) Vinorelbine as first-line chemotherapy for advanced breast cancer in women 60 years of age or older. Ann Oncol 10(4):397–402. doi:10.1023/A:1008364222793 CrossRefPubMed

Weber BL, Vogel C, Jones S et al (1995) Intravenous vinorelbine as first-line and second-line therapy in advanced breast cancer. J Clin Oncol 13(11):2722–2730PubMed

Welt A, von Minckwitz G, Oberhoff C et al (2005) Phase I/II study of capecitabine and vinorelbine in pretreated patients with metastatic breast cancer. Ann Oncol 16(1):64–69. doi:10.1093/annonc/mdi024 CrossRefPubMed

Zelek L, Barthier S, Riofrio M et al (2001) Weekly vinorelbine is an effective palliative regimen after failure with anthracyclines and taxanes in metastatic breast carcinoma. Cancer 92(9):2267–2272. doi:10.1002/1097-0142(20011101)92:9<2267::AID-CNCR1572>3.0.CO;2-Q CrossRefPubMed

Titel: A Phase II trial of the combination of vinorelbine and capecitabine as second-line treatment in metastatic breast cancer previously treated with taxanes and/or anthracyclines
verfasst von: George Orphanos
Athanasios Alexopoulos
Savvoula Malliou
George Ioannidis
Alexandros Ardavanis
Constantinos Kandylis
John Stavrakakis
Gerassimos Rigatos
Publikationsdatum: 01.01.2010
Verlag: Springer-Verlag
Erschienen in: Journal of Cancer Research and Clinical Oncology / Ausgabe 1/2010
Print ISSN: 0171-5216
Elektronische ISSN: 1432-1335
DOI: https://doi.org/10.1007/s00432-009-0642-0

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A Phase II trial of the combination of vinorelbine and capecitabine as second-line treatment in metastatic breast cancer previously treated with taxanes and/or anthracyclines