메뉴 건너뛰기




Volumn 14, Issue 9, 2008, Pages 2726-2731

A phase i study of the safety and pharmacokinetics of the combination of pertuzumab (rhuMab 2C4) and capecitabine in patients with advanced solid tumors

Author keywords

[No Author keywords available]

Indexed keywords

CAPECITABINE; EPIDERMAL GROWTH FACTOR RECEPTOR 2; PERTUZUMAB; TRASTUZUMAB; ANTINEOPLASTIC AGENT; DEOXYCYTIDINE; DRUG DERIVATIVE; FLUOROURACIL; MONOCLONAL ANTIBODY;

EID: 52049104951     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-07-1980     Document Type: Article
Times cited : (39)

References (43)
  • 1
    • 0033187884 scopus 로고    scopus 로고
    • The biology of human epidermal growth factor receptor 2
    • Sundaresan S, Penuel E, Sliwkowski MX. The biology of human epidermal growth factor receptor 2. Curr Oncol Rep 1999;1:16-22.
    • (1999) Curr Oncol Rep , vol.1 , pp. 16-22
    • Sundaresan, S.1    Penuel, E.2    Sliwkowski, M.X.3
  • 4
    • 58349109085 scopus 로고    scopus 로고
    • tiple stromal ligands. Biochim Biophys Acta 1998; 1377: M 25-37.
    • tiple stromal ligands. Biochim Biophys Acta 1998; 1377: M 25-37.
  • 5
    • 0030944455 scopus 로고    scopus 로고
    • ErbB-2, the preferred heterodimerization partner of all ErbB receptors, is a mediator of lateral signaling
    • Graus-Porta D, Beerli RR, Daly JM, et al. ErbB-2, the preferred heterodimerization partner of all ErbB receptors, is a mediator of lateral signaling. EMBO J 1997;16:1647-55.
    • (1997) EMBO J , vol.16 , pp. 1647-1655
    • Graus-Porta, D.1    Beerli, R.R.2    Daly, J.M.3
  • 6
    • 0033009389 scopus 로고    scopus 로고
    • Binding specificities and affinities of egf domains for ErbB receptors
    • Jones JT, Akita RW, Sliwkowski MX. Binding specificities and affinities of egf domains for ErbB receptors. FEBS Lett 1999;447:227-31.
    • (1999) FEBS Lett , vol.447 , pp. 227-231
    • Jones, J.T.1    Akita, R.W.2    Sliwkowski, M.X.3
  • 7
    • 1842605531 scopus 로고    scopus 로고
    • Insights into ErbB signaling from the structure of the ErbB2-pertuzumab complex
    • Franklin MC, Carey KD, Vajdos FF, et al. Insights into ErbB signaling from the structure of the ErbB2-pertuzumab complex. Cancer Cell 2004;5:317-28.
    • (2004) Cancer Cell , vol.5 , pp. 317-328
    • Franklin, M.C.1    Carey, K.D.2    Vajdos, F.F.3
  • 8
    • 19044380618 scopus 로고    scopus 로고
    • Targeting ligand-activated ErbB2 signaling inhibits breast and prostate tumor growth
    • Agus DB, Akita RW, Fox WD, et al. Targeting ligand-activated ErbB2 signaling inhibits breast and prostate tumor growth. Cancer Cell 2002;2:127-37.
    • (2002) Cancer Cell , vol.2 , pp. 127-137
    • Agus, D.B.1    Akita, R.W.2    Fox, W.D.3
  • 9
    • 0028358856 scopus 로고
    • Coex-pression of erbB2 and erbB3 proteins reconstitutes a high affinity receptor for heregulin
    • Sliwkowski MX, Schaefer G, Akita RW, et al. Coex-pression of erbB2 and erbB3 proteins reconstitutes a high affinity receptor for heregulin. J Biol Chem 1994; 269:14661-5.
    • (1994) J Biol Chem , vol.269 , pp. 14661-14665
    • Sliwkowski, M.X.1    Schaefer, G.2    Akita, R.W.3
  • 10
    • 0030830039 scopus 로고    scopus 로고
    • Gamma-heregulin: A novel heregulin isoform that is an autocrine growth factor for the human breast cancer cell line, MDA-MB-175
    • Schaefer G, FitzpatrickVD, Sliwkowski MX. Gamma-heregulin: a novel heregulin isoform that is an autocrine growth factor for the human breast cancer cell line, MDA-MB-175. Oncogene 1997;15:1385-94.
    • (1997) Oncogene , vol.15 , pp. 1385-1394
    • Schaefer, G.1    Fitzpatrick, V.D.2    Sliwkowski, M.X.3
  • 11
    • 0032504049 scopus 로고    scopus 로고
    • Formation of a high affinity heregulin binding site using the soluble extracellular domains of ErbB2 with ErbB3 or ErbB4
    • Fitzpatrick VD, Pisacane Pl,Vandlen RL, et al. Formation of a high affinity heregulin binding site using the soluble extracellular domains of ErbB2 with ErbB3 or ErbB4. FEBS Lett1998;431:102-6.
    • FEBS Lett1998;431 , pp. 102-106
    • Fitzpatrick, V.D.1    Pisacane, P.2    Vandlen, R.L.3
  • 12
    • 0036727115 scopus 로고    scopus 로고
    • Neuregulin-1 activates the JAK-STAT pathway and regulates lung epithelial cell proliferation
    • Liu J, Kern JA. Neuregulin-1 activates the JAK-STAT pathway and regulates lung epithelial cell proliferation. Am J Respir Cell Mol Biol 2002;27:306-13.
    • (2002) Am J Respir Cell Mol Biol , vol.27 , pp. 306-313
    • Liu, J.1    Kern, J.A.2
  • 13
    • 0036792117 scopus 로고    scopus 로고
    • Inhibition of ligand-mediated HER2 activation in androgen-inde-pendent prostate cancer
    • Mendoza N, Phillips GL, Silva J, et al. Inhibition of ligand-mediated HER2 activation in androgen-inde-pendent prostate cancer. Cancer Res 2002;62: 5485-8.
    • (2002) Cancer Res , vol.62 , pp. 5485-5488
    • Mendoza, N.1    Phillips, G.L.2    Silva, J.3
  • 14
    • 0037434791 scopus 로고    scopus 로고
    • Cho HS, Mason K, Ramyar KX, et al. Structure of the extracellular region of HER2 alone and in complex with the Herceptin Fab. Nature 2003;421:756-60.
    • Cho HS, Mason K, Ramyar KX, et al. Structure of the extracellular region of HER2 alone and in complex with the Herceptin Fab. Nature 2003;421:756-60.
  • 15
    • 0025318271 scopus 로고
    • Characterization of murine monoclonal antibodies reactive to either the human epidermal growth factor receptor or HER2/neu gene product
    • Fendly BM,Winget M, Hudziak RM, et al. Characterization of murine monoclonal antibodies reactive to either the human epidermal growth factor receptor or HER2/neu gene product. Cancer Res 1990;50: 1550-8.
    • (1990) Cancer Res , vol.50 , pp. 1550-1558
    • Fendly, B.M.1    Winget, M.2    Hudziak, R.M.3
  • 16
    • 0029879442 scopus 로고    scopus 로고
    • Growth regulation of human breast and ovarian tumor cells by heregulin: Evidence for the requirement of ErbB2 as a critical component in mediating heregulin responsiveness
    • Lewis GD, Lofgren JA, McMurtrey AE, et al. Growth regulation of human breast and ovarian tumor cells by heregulin: evidence for the requirement of ErbB2 as a critical component in mediating heregulin responsiveness. Cancer Res 1996;56:1457-65.
    • (1996) Cancer Res , vol.56 , pp. 1457-1465
    • Lewis, G.D.1    Lofgren, J.A.2    McMurtrey, A.E.3
  • 17
    • 1942474587 scopus 로고    scopus 로고
    • The HER-2-targeting antibodies trastuzumab and pertuzumab synergisti-cally inhibit the survival of breast cancer cells
    • Nahta R, Hung MC, Esteva FJ. The HER-2-targeting antibodies trastuzumab and pertuzumab synergisti-cally inhibit the survival of breast cancer cells. Cancer Res 2004;64:2343-6.
    • (2004) Cancer Res , vol.64 , pp. 2343-2346
    • Nahta, R.1    Hung, M.C.2    Esteva, F.J.3
  • 18
    • 33644591261 scopus 로고    scopus 로고
    • Dose-response studies of recombinant humanised monoclonal antibody 2C4 in tumour xenograft models [abstract]
    • Malik MA, Totpal K, Baiter I, et al. Dose-response studies of recombinant humanised monoclonal antibody 2C4 in tumour xenograft models [abstract]. Proc Am Assoc Cancer Res 2003:44:773.
    • (2003) Proc Am Assoc Cancer Res , vol.44 , pp. 773
    • Malik, M.A.1    Totpal, K.2    Baiter, I.3
  • 19
    • 58349091266 scopus 로고    scopus 로고
    • FriessT, Bauer S, Burger AM, et al. In vivo activity of recombinant humanised monoclonal antibody 2C4 in xenografts is independent of tumour type and degree of HER-2 overexpression [abstract]. EORTC-NCI-AACR Conference, Frankfurt, Germany 2002:953.
    • FriessT, Bauer S, Burger AM, et al. In vivo activity of recombinant humanised monoclonal antibody 2C4 in xenografts is independent of tumour type and degree of HER-2 overexpression [abstract]. EORTC-NCI-AACR Conference, Frankfurt, Germany 2002:953.
  • 20
    • 0035004747 scopus 로고    scopus 로고
    • Targeting cycloox-ygenase 2 and HER-2/neu pathways inhibits colorectal carcinoma growth
    • Mann M, Sheng H, Shao J, et al. Targeting cycloox-ygenase 2 and HER-2/neu pathways inhibits colorectal carcinoma growth. Gastroenterology 2001:120: 1713-9.
    • (2001) Gastroenterology , vol.120 , pp. 1713-1719
    • Mann, M.1    Sheng, H.2    Shao, J.3
  • 21
    • 20244378677 scopus 로고    scopus 로고
    • Phase I clinical study of pertuzumab, a novel HER dimerization inhibitor, in patients with advanced cancer
    • Agus DB, Gordon MS,Taylor C, et al. Phase I clinical study of pertuzumab, a novel HER dimerization inhibitor, in patients with advanced cancer. J Clin Oncol 2005;23:2534-43.
    • (2005) J Clin Oncol , vol.23 , pp. 2534-2543
    • Agus, D.B.1    Gordon, M.S.2    Taylor, C.3
  • 22
    • 0032127244 scopus 로고    scopus 로고
    • Miwa M, Ura M, Nishida M, et al. Design of a novel oral fluoropyrimidine carbamate, capecitabine, which generates 5-fluorouracil selectively in tumours by enzymes concentrated in human liver and cancer tissue. EurJ Cancer1998;34:1274 - 81.
    • Miwa M, Ura M, Nishida M, et al. Design of a novel oral fluoropyrimidine carbamate, capecitabine, which generates 5-fluorouracil selectively in tumours by enzymes concentrated in human liver and cancer tissue. EurJ Cancer1998;34:1274 - 81.
  • 23
    • 0031859855 scopus 로고    scopus 로고
    • Preliminary studies of a novel oral fluoropyrimidine carbamate: Capecitabine
    • Budman DR, Meropol NJ, Reigner B, et al. Preliminary studies of a novel oral fluoropyrimidine carbamate: capecitabine. J Clin Oncol 1998:16:1795-802.
    • (1998) J Clin Oncol , vol.16 , pp. 1795-1802
    • Budman, D.R.1    Meropol, N.J.2    Reigner, B.3
  • 24
    • 0034016415 scopus 로고    scopus 로고
    • Preferential activation of capecitabine in tumor following oral administration to colorectal cancer patients
    • Schuller J, Cassidy J, Dumont E, et al. Preferential activation of capecitabine in tumor following oral administration to colorectal cancer patients. Cancer Chemother Pharmacol 2000;45:291 -7.
    • (2000) Cancer Chemother Pharmacol , vol.45 , pp. 291-297
    • Schuller, J.1    Cassidy, J.2    Dumont, E.3
  • 25
    • 11144354462 scopus 로고    scopus 로고
    • Oral capecitabine vs intravenous 5-fluorouracil and leucovorin: Integrated efficacy data and novel analyses from two large, randomised, phase III trials
    • Van Cutsem E, Hoff PM, Harper P, et al. Oral capecitabine vs intravenous 5-fluorouracil and leucovorin: integrated efficacy data and novel analyses from two large, randomised, phase III trials. Br J Cancer 2004; 90:1190-7.
    • (2004) Br J Cancer , vol.90 , pp. 1190-1197
    • Van Cutsem, E.1    Hoff, P.M.2    Harper, P.3
  • 26
    • 21244497388 scopus 로고    scopus 로고
    • Capecitabine as adjuvant treatment for stage III colon cancer
    • Twelves C, Wong A, Nowacki MP, et al. Capecitabine as adjuvant treatment for stage III colon cancer. N Engl J Med 2005;352:2696-704.
    • (2005) N Engl J Med , vol.352 , pp. 2696-2704
    • Twelves, C.1    Wong, A.2    Nowacki, M.P.3
  • 27
    • 2942638081 scopus 로고    scopus 로고
    • XELOX (capecitabine plus oxaliplatin): Active first-line therapy for patients with metastatic colorectal cancer
    • Cassidy J, Tabernero J, Twelves C, et al. XELOX (capecitabine plus oxaliplatin): active first-line therapy for patients with metastatic colorectal cancer. J Clin Oncol 2004;22:2084-91.
    • (2004) J Clin Oncol , vol.22 , pp. 2084-2091
    • Cassidy, J.1    Tabernero, J.2    Twelves, C.3
  • 28
    • 20144386870 scopus 로고    scopus 로고
    • A phase I clinical and pharmacokinetic study of capecitabine (Xeloda) and irinotecan combination therapy (XELIRI) in patients with metastatic gastrointestinal tumours
    • Delord JP, Pierga JY, DierasV, et al. A phase I clinical and pharmacokinetic study of capecitabine (Xeloda) and irinotecan combination therapy (XELIRI) in patients with metastatic gastrointestinal tumours. Br J Cancer 2005;92:820-6.
    • (2005) Br J Cancer , vol.92 , pp. 820-826
    • Delord, J.P.1    Pierga, J.Y.2    DierasV3
  • 29
    • 0037096755 scopus 로고    scopus 로고
    • Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: Phase III trial results
    • O'Shaughnessy J, Miles D,Vukelja S, et al. Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: phase III trial results. J Clin Oncol 2002;20:2812-23.
    • (2002) J Clin Oncol , vol.20 , pp. 2812-2823
    • O'Shaughnessy, J.1    Miles, D.2    Vukelja, S.3
  • 30
    • 0033050165 scopus 로고    scopus 로고
    • Multicenter phase II study of capecitabine in paclitaxel-refracto-ry metastatic breast cancer
    • Blum JL, Jones SE, Buzdar AU, et al. Multicenter phase II study of capecitabine in paclitaxel-refracto-ry metastatic breast cancer. J Clin Oncol 1999;17: 485-93.
    • (1999) J Clin Oncol , vol.17 , pp. 485-493
    • Blum, J.L.1    Jones, S.E.2    Buzdar, A.U.3
  • 31
    • 0034016343 scopus 로고    scopus 로고
    • Capecitabine, an oral fluoropyrimidine carbamate with substantial activity in advanced colorectal cancer: Results of a randomized phase II study
    • Van Cutsem E, Findlay M, Osterwalder B, et al. Capecitabine, an oral fluoropyrimidine carbamate with substantial activity in advanced colorectal cancer: results of a randomized phase II study. J Clin Oncol 2000;18:1337-45.
    • (2000) J Clin Oncol , vol.18 , pp. 1337-1345
    • Van Cutsem, E.1    Findlay, M.2    Osterwalder, B.3
  • 32
    • 23244455101 scopus 로고    scopus 로고
    • Population pharmacokinetics of trastuzumab in patients with HER2+ metastatic breast cancer
    • Bruno R, Washington CB, Lu JF, et al. Population pharmacokinetics of trastuzumab in patients with HER2+ metastatic breast cancer. Cancer Chemother Pharmacol 2005:56:361 -9.
    • (2005) Cancer Chemother Pharmacol , vol.56 , pp. 361-369
    • Bruno, R.1    Washington, C.B.2    Lu, J.F.3
  • 33
    • 33745343753 scopus 로고    scopus 로고
    • Rationale for fixed dosing of pertuzumab in cancer patients based on population pharmacokinetic analysis
    • Ng CM, Lum BL, Gimenez V, et al. Rationale for fixed dosing of pertuzumab in cancer patients based on population pharmacokinetic analysis. Pharm Res 2006;23:1275-84.
    • (2006) Pharm Res , vol.23 , pp. 1275-1284
    • Ng, C.M.1    Lum, B.L.2    Gimenez, V.3
  • 34
    • 0037429725 scopus 로고    scopus 로고
    • The ErbB receptors and their role in cancer progression
    • HolbroT, Civenni G, Hynes NE.The ErbB receptors and their role in cancer progression. Exp Cell Res 2003;284:99-110.
    • (2003) Exp Cell Res , vol.284 , pp. 99-110
    • Holbro, T.1    Civenni, G.2    Hynes, N.E.3
  • 35
    • 0034597662 scopus 로고    scopus 로고
    • Enhanced drug resistance in cells coexpressing ErbB2 with EGF receptor or ErbB3
    • Chen X, YeungTK, Wang Z. Enhanced drug resistance in cells coexpressing ErbB2 with EGF receptor or ErbB3. Biochem Biophys Res Commun 2000;277: 757-63.
    • (2000) Biochem Biophys Res Commun , vol.277 , pp. 757-763
    • Chen, X.1    Yeung, T.K.2    Wang, Z.3
  • 37
    • 33645742923 scopus 로고    scopus 로고
    • A phase II study of fixed-dose capecitabine and assessment of predictors of toxicity in patients with advanced/metastatic colorectal cancer
    • Sharma R, Rivory L, Beale P, Ong S, Horvath L, Clarke SJ. A phase II study of fixed-dose capecitabine and assessment of predictors of toxicity in patients with advanced/metastatic colorectal cancer. Br J Cancer 2006;94:964-8.
    • (2006) Br J Cancer , vol.94 , pp. 964-968
    • Sharma, R.1    Rivory, L.2    Beale, P.3    Ong, S.4    Horvath, L.5    Clarke, S.J.6
  • 38
    • 33745206649 scopus 로고    scopus 로고
    • Open label, randomized, phase II study of pertuzumab (P) in patients (pts) with metastatic breast cancer (MBC) with low expression of HER2 [abstract]
    • Cortes J, Baselga P, Kellokumpu-Lehtinen G, et al. Open label, randomized, phase II study of pertuzumab (P) in patients (pts) with metastatic breast cancer (MBC) with low expression of HER2 [abstract]. J Clin Oncol 2005;23:208.
    • (2005) J Clin Oncol , vol.23 , pp. 208
    • Cortes, J.1    Baselga, P.2    Kellokumpu-Lehtinen, G.3
  • 39
    • 33749003463 scopus 로고    scopus 로고
    • Clinical activity of pertuzumab (rhu MAb 2C4 C), a HER dimerization inhibitor, in advanced ovarian cancer: Potential predictive relationship with tumor HER2 activation status
    • Gordon MS, Matei D, Aghajanian C, et al. Clinical activity of pertuzumab (rhu MAb 2C4 C), a HER dimerization inhibitor, in advanced ovarian cancer: potential predictive relationship with tumor HER2 activation status. J Clin Oncol 2006;24:4324-32.
    • (2006) J Clin Oncol , vol.24 , pp. 4324-4332
    • Gordon, M.S.1    Matei, D.2    Aghajanian, C.3
  • 40
    • 33748528800 scopus 로고    scopus 로고
    • Presence of HER2/HER3 heterodimers predicts antitumor effects of pertuzumab (OMNITARG) in different human xenograft models [abstract 5342]
    • Bossenmaier B, Hasmann M, Koll H. Presence of HER2/HER3 heterodimers predicts antitumor effects of pertuzumab (OMNITARG) in different human xenograft models [abstract 5342]. Proc Am Assoc Cancer Res 2004:45:1232.
    • (2004) Proc Am Assoc Cancer Res , vol.45 , pp. 1232
    • Bossenmaier, B.1    Hasmann, M.2    Koll, H.3
  • 41
    • 33746905493 scopus 로고    scopus 로고
    • Rationale for a phase II trial of pertuzumab, a HER-2 dimerization inhibitor, in patients with non-small cell lung cancer
    • s
    • Johnson BE, Janne PA. Rationale for a phase II trial of pertuzumab, a HER-2 dimerization inhibitor, in patients with non-small cell lung cancer. Clin Cancer Res 2006;12:4436-40s.
    • (2006) Clin Cancer Res , vol.12 , pp. 4436-4440
    • Johnson, B.E.1    Janne, P.A.2
  • 42
    • 33645651433 scopus 로고    scopus 로고
    • A phase II trial with trastuzumab and pertuzumab in patients with HER2-overexpressed locally advanced and metastatic breast cancer
    • Walshe JM, Denduluri N, Berman AW, et al. A phase II trial with trastuzumab and pertuzumab in patients with HER2-overexpressed locally advanced and metastatic breast cancer. Clin Breast Cancer 2006;6: 535-9.
    • (2006) Clin Breast Cancer , vol.6 , pp. 535-539
    • Walshe, J.M.1    Denduluri, N.2    Berman, A.W.3
  • 43
    • 36248938567 scopus 로고    scopus 로고
    • Objective response rate in a phase II multicenter trial of pertuzumab (P), a HER2 dimerization inhibiting monoclonal antibody, in combination with trastuzumab (T) in patients (pts) with HER2-positive metastatic breast cancer (MBC) which has progressed during treatment with T [abstract 1004]
    • Baselga J, Cameron D, Miles D, et al. Objective response rate in a phase II multicenter trial of pertuzumab (P), a HER2 dimerization inhibiting monoclonal antibody, in combination with trastuzumab (T) in patients (pts) with HER2-positive metastatic breast cancer (MBC) which has progressed during treatment with T [abstract 1004], J Clin Oncol 2007;25.
    • (2007) J Clin Oncol , pp. 25
    • Baselga, J.1    Cameron, D.2    Miles, D.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.