Phase II study of gemcitabine in combination with vinorelbine versus gemcitabine followed by vinorelbine for metastatic breast cancer

In Hae Park1, Jungsil Ro1, Keun Seok Lee1, Shi Nae Kim2, Young Ho Yun3, Byung Ho Nam2
1Center for Breast Cancer, National Cancer Center, 111 Jungbalsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, 410-769, Korea
2Center for Clinical Trials, National Cancer Center, 111 Jungbalsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, Korea
3Quality of Cancer Care Branch, Research Institute for National Cancer Control and Evaluation, National Cancer Center, 111 Jungbalsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, Korea

Tóm tắt

Từ khóa


Tài liệu tham khảo

Figgitt DP, Wiseman LR (2000) Docetaxel: an update of its use in advanced breast cancer. Drugs 59:621–651

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 18:724–733

Michelotti A, Venturini M, Tibaldi C et al (2000) Single agent epirubicin as first line chemotherapy for metastatic breast cancer patients. Breast Cancer Res Treat 59:133–139

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 11:1245–1252

Carmichael J, Possinger K, Phillip P et al (1995) Advanced breast cancer: a phase II trial with gemcitabine. J Clin Oncol 13:2731–2736

Blum JL (2001) The role of capecitabine, an oral, enzymatically activated fluoropyrimidine, in the treatment of metastatic breast cancer. Oncologist 6:56–64

Blum JL, Jones SE, Buzdar AU et al (1999) Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer. J Clin Oncol 17:485–493

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 15:1395–1400

Modi S, Currie VE, Seidman AD et al (2005) A phase II trial of gemcitabine in patients with metastatic breast cancer previously treated with an anthracycline and taxane. Clin Breast Cancer 6:55–60

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 20:2812–2823. doi:10.1200/JCO.2002.09.002

Albain KS, Nag SM, Calderillo-Ruiz G et al (2008) Gemcitabine plus Paclitaxel versus Paclitaxel monotherapy in patients with metastatic breast cancer and prior anthracycline treatment. J Clin Oncol 26:3950–3957. doi:10.1200/JCO.2007.11.9362

Martin M, Ruiz A, Munoz M et al (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 8:219–225. doi:10.1016/S1470-2045(07)70041-4

Miles D, von Minckwitz G, Seidman AD (2002) Combination versus sequential single-agent therapy in metastatic breast cancer. Oncologist 7(Suppl 6):13–19

Therasse P, Arbuck SG, Eisenhauer EA 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

Aaronson NK, Ahmedzai S, Bergman B et al (1993) The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 85:365–376

Yun YH, Park YS, Lee ES et al (2004) Validation of the Korean version of the EORTC QLQ-C30. Qual Life Res 13:863–868

Fayers PM, Aaronson NK, Bjordal K, Groenvold M, Curran D, Bottomley A, EORTC Quality of Life Group (2001) The EORTC QLQ-C30 scoring manual, 3rd edn. European Organization for Research and Treatment of Cancer, Brussels

Mauri D, Polyzos NP, Salanti G et al (2008) Multiple-treatments meta-analysis of chemotherapy and targeted therapies in advanced breast cancer. J Natl Cancer Inst 100:1780–1791. doi:10.1093/jnci/djn414

Fossati R, Confalonieri C, Torri V et al (1998) Cytotoxic and hormonal treatment for metastatic breast cancer: a systematic review of published randomized trials involving 31, 510 women. J Clin Oncol 16:3439–3460

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 92:2267–2272

Silvestris N, Cinieri S, La Torre I et al (2008) Role of gemcitabine in metastatic breast cancer patients: a short review. Breast 17:220–226. doi:10.1016/j.breast.2007.10.009

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 21:588–592. doi:10.1200/JCO.2003.08.013

Morabito A, Filippelli G, Palmeri S et al (2003) The combination of gemcitabine and vinorelbine is an active regimen as second-line therapy in patients with metastatic breast cancer pretreated with taxanes and/or anthracyclines: a phase I–II study. Breast Cancer Res Treat 78:29–36. doi:10.1023/A:1022197109592

Valenza R, Leonardi V, Gebbia V, Agostara B (2000) Gemcitabine and vinorelbine in pretreated advanced breast cancer: a pilot study. Ann Oncol 11:495–496

Stathopoulos GP, Rigatos SK, Pergantas N et al (2002) Phase II trial of biweekly administration of vinorelbine and gemcitabine in pretreated advanced breast cancer. J Clin Oncol 20:37–41

Modi S, Panageas KS, Duck ET et al (2002) Prospective exploratory analysis of the association between tumor response, quality of life, and expenditures among patients receiving paclitaxel monotherapy for refractory metastatic breast cancer. J Clin Oncol 20:3665–3673. doi:10.1200/JCO.2002.08.057

Shin DB, Bang SM, Park SH et al (2008) Correlation of quality of life with tumor response in patients receiving palliative chemotherapy for advanced gastrointestinal tumors. Med Oncol 25:81–87. doi:10.1007/s12032-007-0045-5