Phase II study of gemcitabine and bevacizumab as first-line treatment in taxane-pretreated, HER2-negative, locally recurrent or metastatic breast cancer

Clinical Breast Cancer

Volumn 12, Issue 5, 2012, Pages 322-330

  Borson, Rachel ^a   Harker, Graydon ^b   Reeves, James ^c   Beck, Thaddeus ^d   Hager, Steven ^e   Horvath, William ^f   Jones, Michael ^g   Tillinghast, Guy ^h   Arrowsmith, Edward ⁱ   Harrer, Grant ^j   Kudrik, Fred J ^k   Malamud, Stephen C ^l   Bromund, Jane ^m   Zeigler, Haoyue ⁿ   Tai, Datchen Fritz ^m   Kornberg, Lori J ⁿ   Obasaju, Coleman ^m   Orlando, Mauro ^m   Yardley, Denise A ^o,p  

^a Mercy Clinic   (United States)

^b Utah Cancer Specialists   (United States)

^c Mercy Hospital   (United States)

^d Highlands Oncology Group   (United States)

^e Cancer Care Associates of Fresno   (United States)

^f HOA Cancer Center   (United States)

^g Jones Clinic   (United States)

^h Riverside Cancer Care Center   (United States)

ⁱ Chattanooga Oncology Associates   (United States)

^j Sletten Cancer Institute   (United States)

^k South Carolina Oncology Associates   (United States)

^l BETH ISRAEL MEDICAL CENTER   (United States)

^m ELI LILLY AND COMPANY   (United States)

ⁿ SYNEOS HEALTH   (United States)

^o SARAH CANNON RESEARCH INSTITUTE   (United States)

^p PLLC   (United States)

more..

Author keywords

Biological therapy; Combination therapy; Cytotoxic chemotherapy; Locoregionally recurrent; Monoclonal antibody

Indexed keywords

BEVACIZUMAB; EPIDERMAL GROWTH FACTOR RECEPTOR 2; GEMCITABINE; TAXANE DERIVATIVE;

ACUTE KIDNEY FAILURE; ADULT; AGED; ALOPECIA; ANEMIA; ARTICLE; BREAST CANCER; CANCER ADJUVANT THERAPY; CANCER CHEMOTHERAPY; CANCER SURVIVAL; CONSTIPATION; DECREASED APPETITE; DIARRHEA; DISEASE FREE INTERVAL; DISTANT METASTASIS; DIZZINESS; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; DRUG WITHDRAWAL; DYSPEPSIA; EPISTAXIS; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FLU LIKE SYNDROME; FLUID RETENTION; HEADACHE; HEMOLYTIC UREMIC SYNDROME; HUMAN; HYPERTENSION; LEUKOENCEPHALOPATHY; LEUKOPENIA; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PROGRESSION FREE SURVIVAL; PROTEINURIA; RECURRENT CANCER; SIDE EFFECT; SKIN INFECTION; STOMATITIS; SURVIVAL RATE; THROMBOCYTOPENIA; TREATMENT RESPONSE; VOMITING;

EID: 84867076133     PISSN: 15268209     EISSN: 19380666     Source Type: Journal    
DOI: 10.1016/j.clbc.2012.07.004     Document Type: Article

References (35)

1. D. Robson, S. Verma Anthracyclines in early-stage breast cancer: is it the end of an era? Oncologist 14 2009 950 958
2. I.C. Henderson, D.A. Berry, G.D. Demetri Improved outcomes from adding sequential paclitaxel but not from escalating doxorubicin dose in an adjuvant chemotherapy regimen for patients with node-positive primary breast cancer J Clin Oncol 21 2003 976 983
3. S.E. Jones, M.A. Savin, F.A. Holmes Phase III trial comparing doxorubicin plus cyclophosphamide with docetaxel plus cyclophosphamide as adjuvant therapy for operable breast cancer J Clin Oncol 24 2006 5381 5387
4. E.P. Mamounas, J. Bryant, B. Lembersky Paclitaxel after doxorubicin plus cyclophosphamide as adjuvant chemotherapy for node-positive breast cancer: results from NSABP B-28 J Clin Oncol 23 2005 3686 3696
5. M. Martin, T. Pienkowski, J. Mackey Adjuvant docetaxel for node-positive breast cancer N Engl J Med 352 2005 2302 2313
6. J. O'Shaughnessy Extending survival with chemotherapy in metastatic breast cancer Oncologist 10 Suppl 3 2005 20 29
7. National Cancer Comprehensive Network NCCN Clinical Practice Guidelines in Oncology: Breast Cancer http://www.nccn.org/professionals/physician-gls/pdf/ breast.pdf Accessed: April 30, 2012
8. K.S. Albain, S.M. Nag, G. Calderillo-Ruiz Gemcitabine plus paclitaxel versus paclitaxel monotherapy in patients with metastatic breast cancer and prior anthracycline treatment J Clin Oncol 26 2008 3950 3957
9. J. O'Shaughnessy, D. Miles, S. Vukelja Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: phase III trial results J Clin Oncol 20 2002 2812 2823
10. N. Ferrara, K.J. Hillan, H.P. Gerber Discovery and development of bevacizumab, an anti-VEGF antibody for treating cancer Nat Rev Drug Discov 3 2004 391 400
11. K. Miller, M. Wang, J. Gralow Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer N Engl J Med 357 2007 2666 2676
12. D.W. Miles, A. Chan, L.Y. Dirix Phase III study of bevacizumab plus docetaxel compared with placebo plus docetaxel for the first-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer J Clin Oncol 28 2010 3239 3247
13. N.J. Robert, V. Diéras, J. Glaspy Ribbon-1: randomized, double-blind, placebo-controlled, phase III trial of chemotherapy with or without bevacizumab for first-line treatment of human epidermal growth factor receptor 2-negative, locally recurrent or metastatic breast cancer J Clin Oncol 29 2011 1252 1260
14. P. Therasse, S.G. Arbuck, E.A. Eisenhauer 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 2000 205 216
15. J.R. Kroep, G.J. Peters, R.A. Nagourney Clinical activity of gemcitabine as a single agent and in combination G.J. Peters, Deoxynucleoside Analogs in Cancer Therapy 2006 Humana Press Totowa, NJ 253 288
16. P. Sanchez-Rovira, E. Gonzalez, M.B. Medina Results from a phase II study of gemcitabine in combination with paclitaxel in metastatic breast cancer (MBC) Breast Cancer Res Treat 57 1999 87 abstract 344
17. S. Tomao, A. Romiti, F. Tomao A phase II trial of a biweekly combination of paclitaxel and gemcitabine in metastatic breast cancer BMC Cancer 6 2006 137
18. D.M. Loesch, L. Asmar, K.J. McIntyre Phase II trial of gemcitabine (plus trastuzumab) in metastatic breast cancer patients Breast Cancer Res Treat 94 2005 S1 S287 abstract 6092
19. R. Colomer, A. Llombart-Cussac, A. Lluch Biweekly paclitaxel plus gemcitabine in advanced breast cancer: phase II trial and predictive value of HER2 extracellular domain Ann Oncol 15 2004 201 206
20. M. Blackstein, C.L. Vogel, R. Ambinder Gemcitabine as first-line therapy in patients with metastatic breast cancer: a phase II trial Oncology 62 2002 2 8
21. O. Feher, P. Vodvarka, J. Jassem First-line gemcitabine versus epirubicin in postmenopausal women aged 60 or older with metastatic breast cancer: a multicenter, randomized, phase III study Ann Oncol 16 2005 899 908
22. K. Possinger, M. Kaufmann, R. Coleman Phase II study of gemcitabine as first-line chemotherapy in patients with advanced or metastatic breast cancer Anti Cancer Drugs 10 1999 155 162
23. J. O'Shaughnessy, D. Miles, R.J. Gray A meta-analysis of overall survival data from three randomized trials of bevacizumab (BV) and first-line chemotherapy as treatment for patients with metastatic breast cancer (MBC) J Clin Oncol 28 2010 15s (Abstract 1005)
24. A.M. Brufsky, S. Hurvitz, E. Perez RIBBON-2: a randomized, double-blind, placebo-controlled, phase III trial evaluating the efficacy and safety of bevacizumab in combination with chemotherapy for second-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer J Clin Oncol 29 2011 4286 4293
25. A. Brufsky, K. Hoelzer, T. Beck A randomized phase II study of paclitaxel and bevacizumab with and without gemcitabine as first-line treatment for metastatic breast cancer Clin Breast Cancer 11 2011 211 220
26. P. Vici, P. Foggi, E. Capomolla Biweekly paclitaxel/gemcitabine (P/G) as salvage treatment in breast cancer patients (pts): preliminary results Proc Am Soc Clin Oncol 21 2002 abstract:2054
27. D.A. Yardley Gemcitabine plus paclitaxel in breast cancer Semin Oncol 32 suppl 6 2005 S14 S21
28. M.L. Rothenberg, A. Sharma, G.R. Weiss Phase I trial of paclitaxel and gemcitabine administered every two weeks in patients with refractory solid tumors Ann Oncol 9 1998 733 738
29. R.B. Walter, M. Joerger, B.C. Pestalozzi Gemcitabine-associated hemolytic-uremic syndrome Am J Kidney Dis 40 2002 E16
30. H.L. Kindler, D. Niedzwiecki, D. Hollis Gemcitabine plus bevacizumab compared with gemcitabine plus placebo in patients with advanced pancreatic cancer: phase III trial of the Cancer and Leukemia Group B (CALGB 80303) J Clin Oncol 28 2010 3617 3622
31. A.J. Montero, K. Avancha, S. Glück A cost-benefit analysis of bevacizumab in combination with paclitaxel in the first-line treatment of patients with metastatic breast cancer Breast Cancer Res Treat 132 2012 747 751
32. K.J. Dedes, K. Matter-Walstra, M. Schwenkglenks Bevacizumab in combination with paclitaxel for HER-2 negative metastatic breast cancer: an economic evaluation Eur J Cancer 45 2009 1397 1406
33. K. Hastak, E. Alli, J.M. Ford Synergistic chemosensitivity of triple-negative breast cancer cell lines to poly(ADP-ribose) polymerase inhibition, gemcitabine, and cisplatin Cancer Res 70 2010 7970 7980
34. N. Koshy, D. Quispe, R. Shi Cisplatin-gemcitabine therapy in metastatic breast cancer: improved outcome in triple negative breast cancer patients compared to non-triple negative patients Breast 19 2010 246 248
35. A. Brufsky, V. Valero, B. Tiangco Second-line bevacizumab-containing therapy in patients with triple-negative breast cancer: subgroup analysis of the ribbon-2 trial Breast Cancer Res Treat 133 2012 1067 1075