메뉴 건너뛰기




Volumn 24, Issue 3, 2015, Pages 182-190

Trebananib (AMG 386) plus weekly paclitaxel with or without bevacizumab as first-line therapy for HER2-negative locally recurrent or metastatic breast cancer: A phase 2 randomized study

(20)  Diéras, Véronique a   Wildiers, Hans b   Jassem, Jacek c   Dirix, Luc Y d   Guastalla, Jean Paul e   Bono, Petri f   Hurvitz, Sara A g   Gonçalves, Anthony h   Romieu, Gilles i   Limentani, Steven A j   Jerusalem, Guy k   Lakshmaiah, K C l   Roché, Henri m   Sánchez Rovira, Pedro n   Pienkowski, Tadeusz o   Seguí Palmer, Miguel Ángel p   Li, Ai q   Sun, Yu Nien q   Pickett, Cheryl A q   Slamon, Dennis J q  


Author keywords

AMG 386; Bevacizumab; HER2 negative; Paclitaxel; Trebananib

Indexed keywords

BEVACIZUMAB; PACLITAXEL; PLACEBO; TREBANANIB; ANGIOGENESIS INHIBITOR; ANTINEOPLASTIC AGENT; HYBRID PROTEIN;

EID: 84937641865     PISSN: 09609776     EISSN: 15323080     Source Type: Journal    
DOI: 10.1016/j.breast.2014.11.003     Document Type: Article
Times cited : (43)

References (27)
  • 1
    • 7944220649 scopus 로고    scopus 로고
    • Suppression of angiogenesis and tumor growth by selective inhibition of angiopoietin-2
    • Oliner J., Min H., Leal J., Yu D., Rao S., You E., et al. Suppression of angiogenesis and tumor growth by selective inhibition of angiopoietin-2. Cancer Cell 2004, 6:507-516.
    • (2004) Cancer Cell , vol.6 , pp. 507-516
    • Oliner, J.1    Min, H.2    Leal, J.3    Yu, D.4    Rao, S.5    You, E.6
  • 2
    • 79960227968 scopus 로고    scopus 로고
    • VEGF and angiopoietin signaling in tumor angiogenesis and metastasis
    • Saharinen P., Eklund L., Pulkki K., Bono P., Alitalo K. VEGF and angiopoietin signaling in tumor angiogenesis and metastasis. Trends Mol Med 2011, 17:347-362.
    • (2011) Trends Mol Med , vol.17 , pp. 347-362
    • Saharinen, P.1    Eklund, L.2    Pulkki, K.3    Bono, P.4    Alitalo, K.5
  • 3
    • 77950254591 scopus 로고    scopus 로고
    • Complementary actions of inhibitors of angiopoietin-2 and VEGF on tumor angiogenesis and growth
    • Hashizume H., Falcon B.L., Kuroda T., Baluk P., Coxon A., Yu D., et al. Complementary actions of inhibitors of angiopoietin-2 and VEGF on tumor angiogenesis and growth. Cancer Res 2010, 70:2213-2223.
    • (2010) Cancer Res , vol.70 , pp. 2213-2223
    • Hashizume, H.1    Falcon, B.L.2    Kuroda, T.3    Baluk, P.4    Coxon, A.5    Yu, D.6
  • 4
    • 79952271693 scopus 로고    scopus 로고
    • Specifically targeting angiopoietin-2 inhibit angiogenesis, Tie2 expressing monocyte infiltration and tumor growth
    • Huang H., Lai J.Y., Do J., Liu D., Li L., Del Rosario J., et al. Specifically targeting angiopoietin-2 inhibit angiogenesis, Tie2 expressing monocyte infiltration and tumor growth. Clin Cancer Res 2011, 17:1001-1011.
    • (2011) Clin Cancer Res , vol.17 , pp. 1001-1011
    • Huang, H.1    Lai, J.Y.2    Do, J.3    Liu, D.4    Li, L.5    Del Rosario, J.6
  • 5
    • 60749124285 scopus 로고    scopus 로고
    • Angiopoietin-1/Tie-2 activation contributes to vascular survival and tumor growth during VEGF blockade
    • Huang J., Bae J.O., Tsai J.P., Kadenhe-Chiweshe A., Papa J., Lee A., et al. Angiopoietin-1/Tie-2 activation contributes to vascular survival and tumor growth during VEGF blockade. Int J Oncol 2009, 34:79-87.
    • (2009) Int J Oncol , vol.34 , pp. 79-87
    • Huang, J.1    Bae, J.O.2    Tsai, J.P.3    Kadenhe-Chiweshe, A.4    Papa, J.5    Lee, A.6
  • 6
    • 81155123190 scopus 로고    scopus 로고
    • 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
    • Brufsky A.M., Hurvitz S., Perez E., Swamy R., Valero V., O'Neill V., et al. 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. JClin Oncol 2011, 29:4286-4293.
    • (2011) JClin Oncol , vol.29 , pp. 4286-4293
    • Brufsky, A.M.1    Hurvitz, S.2    Perez, E.3    Swamy, R.4    Valero, V.5    O'Neill, V.6
  • 7
    • 77954700380 scopus 로고    scopus 로고
    • 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
    • Miles D.W., Chan A., Dirix L.Y., Cortes J., Pivot X., Tomczak P., et al. 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. JClin Oncol 2010, 28:3239-3247.
    • (2010) JClin Oncol , vol.28 , pp. 3239-3247
    • Miles, D.W.1    Chan, A.2    Dirix, L.Y.3    Cortes, J.4    Pivot, X.5    Tomczak, P.6
  • 8
    • 37549040613 scopus 로고    scopus 로고
    • Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer
    • Miller K., Wang M., Gralow J., Dickler M., Cobleigh M., Perez E.A., et al. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. NEngl J Med 2007, 357:2666-2676.
    • (2007) NEngl J Med , vol.357 , pp. 2666-2676
    • Miller, K.1    Wang, M.2    Gralow, J.3    Dickler, M.4    Cobleigh, M.5    Perez, E.A.6
  • 9
    • 79953874259 scopus 로고    scopus 로고
    • 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
    • Robert N.J., Dieras V., Glaspy J., Brufsky A.M., Bondarenko I., Lipatov O.N., et al. 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. JClin Oncol 2011, 29:1252-1260.
    • (2011) JClin Oncol , vol.29 , pp. 1252-1260
    • Robert, N.J.1    Dieras, V.2    Glaspy, J.3    Brufsky, A.M.4    Bondarenko, I.5    Lipatov, O.N.6
  • 10
    • 84904740329 scopus 로고    scopus 로고
    • Asystematic review of bevacizumab efficacy in breast cancer
    • Kumler I., Christiansen O.G., Nielsen D.L. Asystematic review of bevacizumab efficacy in breast cancer. Cancer Treat Rev 2014, 40:960-973.
    • (2014) Cancer Treat Rev , vol.40 , pp. 960-973
    • Kumler, I.1    Christiansen, O.G.2    Nielsen, D.L.3
  • 11
    • 79960240479 scopus 로고    scopus 로고
    • Reputation and precedent in the bevacizumab decision
    • Carpenter D., Kesselheim A.S., Joffe S. Reputation and precedent in the bevacizumab decision. NEngl J Med 2011, 365:e3.
    • (2011) NEngl J Med , vol.365 , pp. e3
    • Carpenter, D.1    Kesselheim, A.S.2    Joffe, S.3
  • 12
    • 79960241809 scopus 로고    scopus 로고
    • Sr Changing end points in breast-cancer drug approval-the Avastin story
    • D'Agostino R.B., Sr Changing end points in breast-cancer drug approval-the Avastin story. NEngl J Med 2011, 365:e2.
    • (2011) NEngl J Med , vol.365 , pp. e2
    • D'Agostino, R.B.1
  • 13
    • 77958042477 scopus 로고    scopus 로고
    • Context-dependent role of angiopoietin-1 inhibition in the suppression of angiogenesis and tumor growth: implications for AMG 386, an angiopoietin-1/2-neutralizing peptibody
    • Coxon A., Bready J., Min H., Kaufman S., Leal J., Yu D., et al. Context-dependent role of angiopoietin-1 inhibition in the suppression of angiogenesis and tumor growth: implications for AMG 386, an angiopoietin-1/2-neutralizing peptibody. Mol Cancer Ther 2010, 9:2641-2651.
    • (2010) Mol Cancer Ther , vol.9 , pp. 2641-2651
    • Coxon, A.1    Bready, J.2    Min, H.3    Kaufman, S.4    Leal, J.5    Yu, D.6
  • 14
    • 70249114453 scopus 로고    scopus 로고
    • Safety, pharmacokinetics, and antitumor activity of AMG 386, a selective angiopoietin inhibitor, in adult patients with advanced solid tumors
    • Herbst R.S., Hong D., Chap L., Kurzrock R., Jackson E., Silverman J.M., et al. Safety, pharmacokinetics, and antitumor activity of AMG 386, a selective angiopoietin inhibitor, in adult patients with advanced solid tumors. JClin Oncol 2009, 27:3557-3565.
    • (2009) JClin Oncol , vol.27 , pp. 3557-3565
    • Herbst, R.S.1    Hong, D.2    Chap, L.3    Kurzrock, R.4    Jackson, E.5    Silverman, J.M.6
  • 15
    • 77953097101 scopus 로고    scopus 로고
    • Phase 1 study of AMG 386, a selective angiopoietin 1/2-neutralizing peptibody, in combination with chemotherapy in adults with advanced solid tumors
    • Mita A.C., Takimoto C.H., Mita M., Tolcher A., Sankhala K., Sarantopoulos J., et al. Phase 1 study of AMG 386, a selective angiopoietin 1/2-neutralizing peptibody, in combination with chemotherapy in adults with advanced solid tumors. Clin Cancer Res 2010, 16:3044-3056.
    • (2010) Clin Cancer Res , vol.16 , pp. 3044-3056
    • Mita, A.C.1    Takimoto, C.H.2    Mita, M.3    Tolcher, A.4    Sankhala, K.5    Sarantopoulos, J.6
  • 16
    • 84862275233 scopus 로고    scopus 로고
    • Exposure-response relationship of AMG 386 in combination with weekly paclitaxel in recurrent ovarian cancer and its implication for dose selection
    • Lu J.-F., Rasmussen E., Karlan B.Y., Vergote I.B., Navale L., Kuchimanchi M., et al. Exposure-response relationship of AMG 386 in combination with weekly paclitaxel in recurrent ovarian cancer and its implication for dose selection. Cancer Chemother Pharmacol 2012, 69:1135-1144.
    • (2012) Cancer Chemother Pharmacol , vol.69 , pp. 1135-1144
    • Lu, J.-F.1    Rasmussen, E.2    Karlan, B.Y.3    Vergote, I.B.4    Navale, L.5    Kuchimanchi, M.6
  • 17
    • 84863012011 scopus 로고    scopus 로고
    • Randomized, double-blind, placebo-controlled phase II study of AMG 386 combined with weekly paclitaxel in patients with recurrent ovarian cancer
    • Karlan B.Y., Oza A.M., Richardson G.E., Provencher D.M., Hansen V.L., Buck M., et al. Randomized, double-blind, placebo-controlled phase II study of AMG 386 combined with weekly paclitaxel in patients with recurrent ovarian cancer. JClin Oncol 2012, 30:362-371.
    • (2012) JClin Oncol , vol.30 , pp. 362-371
    • Karlan, B.Y.1    Oza, A.M.2    Richardson, G.E.3    Provencher, D.M.4    Hansen, V.L.5    Buck, M.6
  • 18
    • 0034594628 scopus 로고    scopus 로고
    • 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
    • Therasse P., Arbuck S.G., Eisenhauer E.A., Wanders J., Kaplan R.S., Rubinstein L., et al. 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. JNatl Cancer Inst 2000, 92:205-216.
    • (2000) JNatl Cancer Inst , vol.92 , pp. 205-216
    • Therasse, P.1    Arbuck, S.G.2    Eisenhauer, E.A.3    Wanders, J.4    Kaplan, R.S.5    Rubinstein, L.6
  • 20
    • 0002429117 scopus 로고
    • Aconfidence interval for the median survival time
    • Brookmeyer R., Crowley J. Aconfidence interval for the median survival time. Biometrics 1982, 38:29-41.
    • (1982) Biometrics , vol.38 , pp. 29-41
    • Brookmeyer, R.1    Crowley, J.2
  • 21
    • 79953196070 scopus 로고    scopus 로고
    • Motesanib, or open-label bevacizumab, in combination with paclitaxel, as first-line treatment for HER2-negative locally recurrent or metastatic breast cancer: a phase 2, randomised, double-blind, placebo-controlled study
    • Martin M., Roche H., Pinter T., Crown J., Kennedy M.J., Provencher L., et al. Motesanib, or open-label bevacizumab, in combination with paclitaxel, as first-line treatment for HER2-negative locally recurrent or metastatic breast cancer: a phase 2, randomised, double-blind, placebo-controlled study. Lancet Oncol 2011, 12:369-376.
    • (2011) Lancet Oncol , vol.12 , pp. 369-376
    • Martin, M.1    Roche, H.2    Pinter, T.3    Crown, J.4    Kennedy, M.J.5    Provencher, L.6
  • 22
    • 80051713290 scopus 로고    scopus 로고
    • Sunitinib plus paclitaxel versus bevacizumab plus paclitaxel for first-line treatment of patients with advanced breast cancer: a phase III, randomized, open-label trial
    • Robert N.J., Saleh M.N., Paul D., Generali D., Gressot L., Copur M.S., et al. Sunitinib plus paclitaxel versus bevacizumab plus paclitaxel for first-line treatment of patients with advanced breast cancer: a phase III, randomized, open-label trial. Clin Breast Cancer 2011, 11:82-92.
    • (2011) Clin Breast Cancer , vol.11 , pp. 82-92
    • Robert, N.J.1    Saleh, M.N.2    Paul, D.3    Generali, D.4    Gressot, L.5    Copur, M.S.6
  • 23
    • 80052729506 scopus 로고    scopus 로고
    • Arandomized phase II study of paclitaxel and bevacizumab with and without gemcitabine as first-line treatment for metastatic breast cancer
    • Brufsky A., Hoelzer K., Beck T., Whorf R., Keaton M., Nadella P., et al. Arandomized phase II study of paclitaxel and bevacizumab with and without gemcitabine as first-line treatment for metastatic breast cancer. Clin Breast Cancer 2011, 11:211-220.
    • (2011) Clin Breast Cancer , vol.11 , pp. 211-220
    • Brufsky, A.1    Hoelzer, K.2    Beck, T.3    Whorf, R.4    Keaton, M.5    Nadella, P.6
  • 24
    • 84903517779 scopus 로고    scopus 로고
    • Anti-angiopoietin therapy with trebananib for recurrent ovarian cancer (TRINOVA-1): a randomised, multicentre, double-blind, placebo-controlled phase 3 trial
    • Monk B.J., Poveda A., Vergote I., Raspagliesi F., Fujiwara K., Bae D., et al. Anti-angiopoietin therapy with trebananib for recurrent ovarian cancer (TRINOVA-1): a randomised, multicentre, double-blind, placebo-controlled phase 3 trial. Lancet Oncol 2014, 15:799-808.
    • (2014) Lancet Oncol , vol.15 , pp. 799-808
    • Monk, B.J.1    Poveda, A.2    Vergote, I.3    Raspagliesi, F.4    Fujiwara, K.5    Bae, D.6
  • 25
    • 33845313345 scopus 로고    scopus 로고
    • The clinical toxicity profile of vascular endothelial growth factor (VEGF) and vascular endothelial growth factor receptor (VEGFR) targeting angiogenesis inhibitors; a review
    • Eskens F.A., Verweij J. The clinical toxicity profile of vascular endothelial growth factor (VEGF) and vascular endothelial growth factor receptor (VEGFR) targeting angiogenesis inhibitors; a review. Eur J Cancer 2006, 42:3127-3139.
    • (2006) Eur J Cancer , vol.42 , pp. 3127-3139
    • Eskens, F.A.1    Verweij, J.2
  • 26
    • 84874566567 scopus 로고    scopus 로고
    • Phase II randomized, double-blind, placebo-controlled study of AMG 386 (trebananib) in combination with cisplatin and capecitabine in patients with metastatic gastro-oesophageal cancer
    • Eatock M., Tebbutt N., Bampton C.L., Strickland A., Valladares-Ayerbes M., Swieboda-Sadlej A., et al. Phase II randomized, double-blind, placebo-controlled study of AMG 386 (trebananib) in combination with cisplatin and capecitabine in patients with metastatic gastro-oesophageal cancer. Ann Oncol 2013, 24:710-718.
    • (2013) Ann Oncol , vol.24 , pp. 710-718
    • Eatock, M.1    Tebbutt, N.2    Bampton, C.L.3    Strickland, A.4    Valladares-Ayerbes, M.5    Swieboda-Sadlej, A.6
  • 27
    • 79960746726 scopus 로고    scopus 로고
    • Randomized phase II trials: a long-term investment with promising returns
    • Sharma M.R., Stadler W.M., Ratain M.J. Randomized phase II trials: a long-term investment with promising returns. JNatl Cancer Inst 2011, 103:1093-1100.
    • (2011) JNatl Cancer Inst , vol.103 , pp. 1093-1100
    • Sharma, M.R.1    Stadler, W.M.2    Ratain, M.J.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.