Gemcitabine in combination with vinorelbine in elderly patients with anthracycline- and taxane-pretreated metastatic breast cancer
- 181 Downloads
To evaluate the efficacy and safety of gemcitabine in combination with vinorelbine in elderly patients with anthracycline- and taxane-pretreated metastatic breast cancer (MBC).
Patients and methods
Elderly patients with MBC received gemcitabine 1,000 mg m−2 and vinorelbine 25 mg m−2 on days 1 and 8 every 3 weeks for a maximum of 6 cycles. The primary end points were objective response and toxicity. The secondary end points included progression-free survival (PFS), overall survival (OS), and prognostic factors associated with disease control, PFS, and OS.
Fifty-one patients with a median age of 73 years (range, 65–84 years) were included. The response rate according to Response Evaluation Criteria in Solid Tumors was 33.3% (95% confidence interval [CI], 20.4 to 46.2%). At a median follow-up of 16.2 months, median PFS and OS were 6.2 (95% CI, 4.6 to 7.8) and 17.0 months (95% CI, 14.5 to 19.5), respectively. Grade 3 to 4 adverse events included neutropenia (25.5%), anemia (13.7%), thrombocytopenia (9.8%), fatigue (5.9%), constipation (3.9%), neuropathy (3.9%), and hepatotoxicity (3.9%). Neutropenic fever occurred in 2 patients. There was one toxic death due to massive gastrointestinal hemorrhage. The study of prognostic factors did not reveal any predictive factor of disease control, while response to treatment and Eastern Cooperative Oncology Group performance status was the main factor conditioning PFS and OS, respectively.
Gemcitabine in combination with vinorelbine is active and safe in elderly patients with anthracycline- and taxane-pretreated metastatic breast cancer.
KeywordsGemcitabine Vinorelbine Chemotherapy Elder Metastatic breast cancer
We thank Dr. Jun Ren for his assistance during the writing of the article.
Conflict of interest
All authors indicated no potential conflicts of interest.
- 3.Carlson RW, Moench S, Hurria A, Balducci L, Burstein HJ, Goldstein LJ, Gradishar WJ, Hughes KS, Jahanzeb M, Lichtman SM, Marks LB, McClure JS, McCormick B, Nabell LM, Pierce LJ, Smith ML, Topham NS, Traina TA, Ward JH, Winer EP (2008) NCCN task force report: breast cancer in the older woman. J Natl Compr Cancer Netw 6(Suppl 4):S1–S25Google Scholar
- 7.Modi S, Currie VE, Seidman AD, Bach AM, Panageas KS, Theodoulou M, Moasser MM, D’Andrea GM, Lake DE, Choi J, Norton L, Hudis CA (2005) A phase II trial of gemcitabine in patients with metastatic breast cancer previously treated with an anthracycline and taxane. Clin Breast Cancer 6:55–60PubMedCrossRefGoogle Scholar
- 11.Toi M, Saeki T, Aogi K, Sano M, Hatake K, Asaga T, Tokuda Y, Mitsuyama S, Kimura M, Kobayashi T, Tamura M, Tabei T, Shin E, Nishimura R, Ohno S, Takashima S (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 35:310–315PubMedCrossRefGoogle Scholar
- 12.Jara-Sánchez C, Martín M, García-Sáenz JA, Barnada A, Fernández-Aramburo A, López-Vega JM, Pelegrí A, Alba E, Casado A, Spanish Group for Research in Breast Cancer (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 3:399–404PubMedCrossRefGoogle Scholar
- 19.Donadio M, Ardine M, Berruti A, Ritorto G, Fea F, Mistrangelo M, Coccorullo Z, Bergnolo P, Comandone A, Bertetto O (2003) Gemcitabine and vinorelbine as second-line treatment in patients with metastatic breast cancer: a phase II study. Cancer Chemother Pharmacol 52:147–152PubMedCrossRefGoogle Scholar
- 20.Martín M, Ruiz A, Muñoz M, Balil A, García-Mata J, Calvo L, Carrasco E, Mahillo E, Casado A, García-Saenz JA, Escudero MJ, Guillem V, Jara C, Ribelles N, Salas F, Soto C, Morales-Vasquez F, Rodríguez CA, Adrover E, Mel JR (2007) Gemcitabine plus vinorelbine versus vinorelbine monotherapy in patients with metastatic breast cancer previously treated with anthracyclines and taxanes: final results of the phase III Spanish Breast Cancer Research Group (GEICAM) trial. Lancet Oncol 8:219–225PubMedCrossRefGoogle Scholar
- 21.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 11:873–875PubMedCrossRefGoogle Scholar
- 24.Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG (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 92:205–216PubMedCrossRefGoogle Scholar
- 27.Pallis AG, Boukovinas I, Ardavanis A, Varthalitis I, Malamos N, Georgoulias V, Mavroudis D (2011) A multicenter randomized phase III trial of vinorelbine/gemcitabine doublet versus capecitabine monotherapy in anthracycline- and taxane-pretreated women with metastatic breast cancer. Ann Oncol (Epub ahead of print)Google Scholar
- 30.Pierga JY, Fumoleau P, Brewer Y, Zelek L, Martin D, Turpin FL, Goudier MJ, Gil-Delgado M, Baticle JL, Namer M, Chollet P, Sutherland W, Barats JC, Cooperative Group of the French capecitabine compassionate use program (2004) Efficacy and safety of single agent capecitabine in pretreated metastatic breast cancer patients from the French compassionate use program. Breast Cancer Res Treat 88:117–129PubMedCrossRefGoogle Scholar