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

Investigational New Drugs

Volumn 28, Issue 5, 2010, Pages 659-669

  Park, In Hae ^a   Ro, Jungsil ^a   Lee, Keun Seok ^a   Kim, Shi Nae ^a   Yun, Young Ho ^a   Nam, Byung Ho ^a  

^a National Cancer Center   (South Korea)

Author keywords

Breast cancer; Gemcitabine; Quality of life; Vinorelbine

Indexed keywords

CAPECITABINE; CYCLOPHOSPHAMIDE; DOCETAXEL; DOXORUBICIN; FLUOROURACIL; GEMCITABINE; MITOMYCIN; NAVELBINE; ANTINEOPLASTIC AGENT; DEOXYCYTIDINE; VINBLASTINE;

ADULT; AGED; ANEMIA; ANOREXIA; ARTICLE; ASTHENIA; BREAST CANCER; BREAST METASTASIS; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE COURSE; DOSAGE SCHEDULE COMPARISON; DRUG DOSE REDUCTION; DRUG RESPONSE; DRUG WITHDRAWAL; DYSPNEA; EDEMA; FATIGUE; FEMALE; HEALTH STATUS; HUMAN; HYPERGLYCEMIA; INFECTION; LEUKOPENIA; MAJOR CLINICAL STUDY; MONOTHERAPY; MOTOR NEUROPATHY; MULTIPLE CYCLE TREATMENT; MYALGIA; NAUSEA; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PHLEBITIS; PRIORITY JOURNAL; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; SENSORY NEUROPATHY; SIDE EFFECT; SOCIAL STATUS; THROMBOCYTOPENIA; TREATMENT FAILURE; VOMITING; ANALOGS AND DERIVATIVES; BREAST NEOPLASMS; COMPARATIVE STUDY; METASTASIS; MIDDLE AGED; PATHOLOGY; SURVIVAL; TIME;

ADULT; AGED; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; DEOXYCYTIDINE; FEMALE; HUMANS; MIDDLE AGED; NEOPLASM METASTASIS; QUALITY OF LIFE; SURVIVAL ANALYSIS; TIME FACTORS; TREATMENT FAILURE; VINBLASTINE;

EID: 77956057802     PISSN: 01676997     EISSN: None     Source Type: Journal    
DOI: 10.1007/s10637-009-9285-x     Document Type: Article

References (27)

1. DP Figgitt LR Wiseman 2000 Docetaxel: an update of its use in advanced breast cancer Drugs 59 621 651 10.2165/00003495-200059030-00015 1:CAS:528:DC%2BD3cXjtV2htrY%3D 10776837
2. R Paridaens L Biganzoli P Bruning, 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 1:CAS:528:DC%2BD3cXhs1akuro%3D 10673513
3. A Michelotti M Venturini C Tibaldi, et al. 2000 Single agent epirubicin as first line chemotherapy for metastatic breast cancer patients Breast Cancer Res Treat 59 133 139 10.1023/A:1006394801389 1:CAS:528:DC%2BD3cXjslWitr4%3D 10817348
4. P Fumoleau FM Delgado T Delozier, et al. 1993 Phase II trial of weekly intravenous vinorelbine in first-line advanced breast cancer chemotherapy J Clin Oncol 11 1245 1252 1:STN:280:DyaK3szgtFKmtQ%3D%3D 8315421
5. J Carmichael K Possinger P Phillip, et al. 1995 Advanced breast cancer: a phase II trial with gemcitabine J Clin Oncol 13 2731 2736 1:CAS:528: DyaK28XitlGmtQ%3D%3D 7595731
6. JL Blum 2001 The role of capecitabine, an oral, enzymatically activated fluoropyrimidine, in the treatment of metastatic breast cancer Oncologist 6 56 64 10.1634/theoncologist.6-1-56 1:CAS:528:DC%2BD3MXhtlKjtr4%3D 11161228
7. JL Blum SE Jones AU Buzdar, et al. 1999 Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer J Clin Oncol 17 485 493 1:CAS:528:DyaK1MXht1Wmurw%3D 10080589
8. RB Livingston GK Ellis JR Gralow, 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 1:CAS:528:DyaK2sXivVehsrg%3D 9193331
9. S Modi VE Currie AD Seidman, 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 10.3816/CBC.2005.n.009 1:CAS:528:DC%2BD2MXlslWns7c%3D 15899073
10. J O'Shaughnessy D Miles S Vukelja, 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 10.1200/JCO.2002.09.002 10.1200/JCO.2002.09.002 12065558
11. KS Albain SM Nag G Calderillo-Ruiz, 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 10.1200/JCO.2007.11.9362 10.1200/JCO.2007.11.9362 18711184
12. M Martin A Ruiz M Munoz, 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 10.1016/S1470-2045(07)70041-4 10.1016/S1470-2045(07)70041-4 1:CAS:528: DC%2BD2sXisVCqs74%3D 17329192
13. D Miles G von Minckwitz AD Seidman 2002 Combination versus sequential single-agent therapy in metastatic breast cancer Oncologist 7 Suppl 6 13 19 1:CAS:528:DC%2BD3sXksV2itA%3D%3D 12454315
14. P Therasse SG Arbuck EA Eisenhauer, 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 10.1093/jnci/92.3.205 1:STN:280:DC%2BD3c7it1Gitg%3D%3D 10655437
15. NK Aaronson S Ahmedzai B Bergman, 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 10.1093/jnci/85.5.365 1:STN:280:DyaK3s7msVarsQ%3D%3D 8433390
16. YH Yun YS Park ES Lee, et al. 2004 Validation of the Korean version of the EORTC QLQ-C30 Qual Life Res 13 863 868 10.1023/B:QURE.0000021692.81214.70 1:STN:280:DC%2BD2c3jtVOltQ%3D%3D 15129896
17. 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
18. D Mauri NP Polyzos G Salanti, et al. 2008 Multiple-treatments meta-analysis of chemotherapy and targeted therapies in advanced breast cancer J Natl Cancer Inst 100 1780 1791 10.1093/jnci/djn414 10.1093/jnci/djn414 1:CAS:528:DC%2BD1MXhtVGksA%3D%3D 19066278
19. R Fossati C Confalonieri V Torri, 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 1:CAS:528:DyaK1cXmvFGrurs%3D 9779724
20. L Zelek S Barthier M Riofrio, et al. 2001 Weekly vinorelbine is an effective palliative regimen after failure with anthracyclines and taxanes in metastatic breast carcinoma Cancer 92 2267 2272 10.1002/1097-0142(20011101)92: 9<2267::AID-CNCR1572>3.0.CO;2-Q 1:CAS:528:DC%2BD3MXotl2itLw%3D 11745280
21. N Silvestris S Cinieri I La Torre, et al. 2008 Role of gemcitabine in metastatic breast cancer patients: a short review Breast 17 220 226 10.1016/j.breast.2007.10.009 10.1016/j.breast.2007.10.009 18037292
22. GW Sledge D Neuberg P Bernardo, 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 10.1200/JCO.2003.08.013 10.1200/JCO.2003.08.013 12586793
23. A Morabito G Filippelli S Palmeri, 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 10.1023/A:1022197109592 10.1023/A:1022197109592 1:CAS:528:DC%2BD3sXntV2rsQ%3D%3D 12611454
24. R Valenza V Leonardi V Gebbia B Agostara 2000 Gemcitabine and vinorelbine in pretreated advanced breast cancer: a pilot study Ann Oncol 11 495 496 10.1023/A:1008348704373 1:STN:280:DC%2BD3cvotVGmuw%3D%3D 10847474
25. GP Stathopoulos SK Rigatos N Pergantas, et al. 2002 Phase II trial of biweekly administration of vinorelbine and gemcitabine in pretreated advanced breast cancer J Clin Oncol 20 37 41 10.1200/JCO.20.1.37 1:CAS:528: DC%2BD38XnsFektQ%3D%3D 11773151
26. S Modi KS Panageas ET Duck, 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 10.1200/JCO.2002.08.057 10.1200/JCO.2002.08. 057 1:CAS:528:DC%2BD38XntVynsrY%3D 12202668
27. DB Shin SM Bang SH Park, 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 10.1007/s12032-007-0045-5 10.1007/s12032-007-0045-5 18188719