Dual antiangiogenic inhibition: a phase I dose escalation and expansion trial targeting VEGF-A and VEGFR in patients with advanced solid tumors
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  • 作者:Gerald S. Falchook (1)
    Jennifer J. Wheler (2)
    Aung Naing (2)
    Sarina A. Piha-Paul (2)
    Siqing Fu (2)
    Apostolia M. Tsimberidou (2)
    David S. Hong (2)
    Filip Janku (2)
    Ralph Zinner (2)
    Yunfang Jiang (2)
    Mei Huang (2)
    Quan Lin (2)
    Kristin Parkhurst (2)
    Razelle Kurzrock (3)
  • 关键词:Bevacizumab ; Sorafenib ; VEGF ; VEGFR ; Angiogenesis
  • 刊名:Investigational New Drugs
  • 出版年:2015
  • 出版时间:February 2015
  • 年:2015
  • 卷:33
  • 期:1
  • 页码:215-224
  • 全文大小:652 KB
  • 参考文献:1. Beaudry P, Force J, Naumov GN, Wang A, Baker CH, Ryan A, Soker S, Johnson BE, Folkman J, Heymach JV (2005) Differential effects of vascular endothelial growth factor receptor-2 inhibitor ZD6474 on circulating endothelial progenitors and mature circulating endothelial cells: implications for use as a surrogate marker of antiangiogenic activity. Clin Cancer Res 11(9):3514鈥?522. doi:10.1158/1078-0432.CCR-04-2271 CrossRef
    2. Folkman J (1971) Tumor angiogenesis: therapeutic implications. N Engl J Med 285(21):1182鈥?186. doi:10.1056/NEJM197111182852108 CrossRef
    3. Hicklin DJ, Ellis LM (2005) Role of the vascular endothelial growth factor pathway in tumor growth and angiogenesis. J Clin Oncol 23(5):1011鈥?027. doi:10.1200/JCO.2005.06.081 CrossRef
    4. Fidler IJ, Ellis LM (1994) The implications of angiogenesis for the biology and therapy of cancer metastasis. Cell 79(2):185鈥?88 CrossRef
    5. Weihua Z, Tsan R, Huang WC, Wu Q, Chiu CH, Fidler IJ, Hung MC (2008) Survival of cancer cells is maintained by EGFR independent of its kinase activity. Cancer Cell 13(5):385鈥?93. doi:10.1016/j.ccr.2008.03.015 CrossRef
    6. Ferrara N, Hillan KJ, Gerber HP, Novotny W (2004) Discovery and development of bevacizumab, an anti-VEGF antibody for treating cancer. Nat Rev Drug Discov 3(5):391鈥?00. doi:10.1038/nrd1381 CrossRef
    7. Burger RA, Sill MW, Monk BJ, Greer BE, Sorosky JI (2007) Phase II trial of Bevacizumab in persistent or recurrent epithelial ovarian cancer or primary peritoneal cancer: a gynecologic oncology group study. J Clin Oncol 25(33):5165鈥?171. doi:10.1200/JCO.2007.11.5345 CrossRef
    8. Ferrara N (2005) VEGF as a therapeutic target in cancer. Oncology 69(Suppl 3):11鈥?6. doi:10.1159/000088479 CrossRef
    9. Hurwitz H, Fehrenbacher L, Novotny W, Cartwright T, Hainsworth J, Heim W, Berlin J, Baron A, Griffing S, Holmgren E, Ferrara N, Fyfe G, Rogers B, Ross R, Kabbinavar F (2004) Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 350(23):2335鈥?342. doi:10.1056/NEJMoa032691 CrossRef
    10. Johnson DH, Fehrenbacher L, Novotny WF, Herbst RS, Nemunaitis JJ, Jablons DM, Langer CJ, DeVore RF 3rd, Gaudreault J, Damico LA, Holmgren E, Kabbinavar F (2004) Randomized phase II trial comparing bevacizumab plus carboplatin and paclitaxel with carboplatin and paclitaxel alone in previously untreated locally advanced or metastatic non-small-cell lung cancer. J Clin Oncol 22(11):2184鈥?191. doi:10.1200/JCO.2004.11.022 CrossRef
    11. Miller KD, Chap LI, Holmes FA, Cobleigh MA, Marcom PK, Fehrenbacher L, Dickler M, Overmoyer BA, Reimann JD, Sing AP, Langmuir V, Rugo HS (2005) Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer. J Clin Oncol 23(4):792鈥?99. doi:10.1200/JCO.2005.05.098 CrossRef
    12. Yang JC, Haworth L, Sherry RM, Hwu P, Schwartzentruber DJ, Topalian SL, Steinberg SM, Chen HX, Rosenberg SA (2003) A randomized trial of bevacizumab, an anti-vascular endothelial growth factor antibody, for metastatic renal cancer. N Engl J Med 349(5):427鈥?34. doi:10.1056/NEJMoa021491 CrossRef
    13. Friedman HS, Prados MD, Wen PY, Mikkelsen T, Schiff D, Abrey LE, Yung WK, Paleologos N, Nicholas MK, Jensen R, Vredenburgh J, Huang J, Zheng M, Cloughesy T (2009) Bevacizumab alone and in combination with irinotecan in recurrent glioblastoma. J Clin Oncol 27(28):4733鈥?740. doi:10.1200/JCO.2008.19.8721 CrossRef
    14. Kreisl TN, Kim L, Moore K, Duic P, Royce C, Stroud I, Garren N, Mackey M, Butman JA, Camphausen K, Park J, Albert PS, Fine HA (2009) Phase II trial of single-agent bevacizumab followed by bevacizumab plus irinotecan at tumor progression in recurrent glioblastoma. J Clin Oncol 27(5):740鈥?45. doi:10.1200/JCO.2008.16.3055 CrossRef
    15. Wilhelm S, Carter C, Lynch M, Lowinger T, Dumas J, Smith RA, Schwartz B, Simantov R, Kelley S (2006) Discovery and development of sorafenib: a multikinase inhibitor for treating cancer. Nat Rev Drug Discov 5(10):835鈥?44. doi:10.1038/nrd2130 CrossRef
    16. Ratain MJ, Eisen T, Stadler WM, Flaherty KT, Kaye SB, Rosner GL, Gore M, Desai AA, Patnaik A, Xiong HQ, Rowinsky E, Abbruzzese JL, Xia C, Simantov R, Schwartz B, O鈥睤wyer PJ (2006) Phase II placebo-controlled randomized discontinuation trial of sorafenib in patients with metastatic renal cell carcinoma. J Clin Oncol 24(16):2505鈥?512. doi:10.1200/JCO.2005.03.6723 CrossRef
    17. Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M, Negrier S, Chevreau C, Solska E, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Freeman S, Schwartz B, Shan M, Simantov R, Bukowski RM (2007) Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med 356(2):125鈥?34. doi:10.1056/NEJMoa060655 CrossRef
    18. Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Haussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J (2008) Sorafenib in advanced hepatocellular carcinoma. N Engl J Med 359(4):378鈥?90. doi:10.1056/NEJMoa0708857 CrossRef
    19. Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP (1982) Toxicity and response criteria of the eastern cooperative oncology group. Am J Clin Oncol 5(6):649鈥?55 CrossRef
    20. Trotti A, Colevas AD, Setser A, Rusch V, Jaques D, Budach V, Langer C, Murphy B, Cumberlin R, Coleman CN, Rubin P (2003) CTCAE v3.0: development of a comprehensive grading system for the adverse effects of cancer treatment. Semin Radiat Oncol 13(3):176鈥?81. doi:10.1016/S1053-4296(03)00031-6 CrossRef
    21. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG (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 Nat Cancer Instit 92(3):205鈥?16 CrossRef
    22. Falchook GS, Wheler JJ, Naing A, Hong DS, Moulder SL, Piha-Paul SA, Ng CS, Jackson E, Kurzrock R (2010) A phase I study of bevacizumab in combination with sunitinib, sorafenib, and erlotinib plus cetuximab, and trastuzumab plus lapatinib. Paper presented at the American Society of Clinical Oncology Annual Meeting. IL, Chicago
    23. Arkenau HT, Olmos D, Ang JE, de Bono J, Judson I, Kaye S (2008) Clinical outcome and prognostic factors for patients treated within the context of a phase I study: the royal Marsden hospital experience. Br J Cancer 98(6):1029鈥?033. doi:10.1038/sj.bjc.6604218 CrossRef
    24. Wheler J, Tsimberidou AM, Hong D, Naing A, Falchook G, Piha-Paul S, Fu S, Moulder S, Stephen B, Wen S, Kurzrock R (2012) Survival of 1,181 patients in a phase I clinic: the MD Anderson clinical center for targeted therapy experience. Clin Cancer Res 18(10):2922鈥?929. doi:10.1158/1078-0432.CCR-11-2217 CrossRef
    25. Schneider BP, Wang M, Radovich M, Sledge GW, Badve S, Thor A, Flockhart DA, Hancock B, Davidson N, Gralow J, Dickler M, Perez EA, Cobleigh M, Shenkier T, Edgerton S, Miller KD (2008) Association of vascular endothelial growth factor and vascular endothelial growth factor receptor-2 genetic polymorphisms with outcome in a trial of paclitaxel compared with paclitaxel plus bevacizumab in advanced breast cancer: ECOG 2100. J Clin Oncol 26(28):4672鈥?678. doi:10.1200/JCO.2008.16.1612 CrossRef
    26. Azad NS, Posadas EM, Kwitkowski VE, Steinberg SM, Jain L, Annunziata CM, Minasian L, Sarosy G, Kotz HL, Premkumar A, Cao L, McNally D, Chow C, Chen HX, Wright JJ, Figg WD, Kohn EC (2008) Combination targeted therapy with sorafenib and bevacizumab results in enhanced toxicity and antitumor activity. J Clin Oncol 26(22):3709鈥?714. doi:10.1200/JCO.2007.10.8332 CrossRef
    27. Hong DS, Garrido-Laguna I, Ekmekcioglu S, Falchook GS, Naing A, Wheler JJ, Fu S, Moulder SL, Piha-Paul S, Tsimberidou AM, Wen Y, Culotta KS, Anderes K, Davis DW, Liu W, George GC, Camacho LH, Percy Ivy S, Kurzrock R (2014) Dual inhibition of the vascular endothelial growth factor pathway: a phase 1 trial evaluating Bevacizumab and AZD2171 (cediranib) in patients with advanced solid tumors. Cancer. doi:10.1002/cncr.28701
    28. Feldman DR, Baum MS, Ginsberg MS, Hassoun H, Flombaum CD, Velasco S, Fischer P, Ronnen E, Ishill N, Patil S, Motzer RJ (2009) Phase I trial of bevacizumab plus escalated doses of sunitinib in patients with metastatic renal cell carcinoma. J Clin Oncol 27(9):1432鈥?439. doi:10.1200/JCO.2008.19.0108 CrossRef
    29. Hong DS, Gordon MS, Samlowski WE, Kurzrock R, Tannir N, Friedland D, Mendelson DS, Vogelzang NJ, Rasmussen E, Wu BM, Bass MB, Zhong ZD, Friberg G, Appleman LJ (2014) A phase I, open-label study of trebananib combined with sorafenib or sunitinib in patients with advanced renal cell carcinoma. Clin Genitourin Cance 12(3):167鈥?77. doi:10.1016/j.clgc.2013.11.007 , e162 CrossRef
    30. Eisen T, Ahmad T, Flaherty KT, Gore M, Kaye S, Marais R, Gibbens I, Hackett S, James M, Schuchter LM, Nathanson KL, Xia C, Simantov R, Schwartz B, Poulin-Costello M, O鈥睤wyer PJ, Ratain MJ (2006) Sorafenib in advanced melanoma: a Phase II randomised discontinuation trial analysis. Br J Cancer 95(5):581鈥?86. doi:10.1038/sj.bjc.6603291 CrossRef
    31. Handolias D, Hamilton AL, Salemi R, Tan A, Moodie K, Kerr L, Dobrovic A, McArthur GA (2010) Clinical responses observed with imatinib or sorafenib in melanoma patients expressing mutations in KIT. Br J Cancer 102(8):1219鈥?223. doi:10.1038/sj.bjc.6605635 CrossRef
    32. Minor DR, Kashani-Sabet M, Garrido M, O鈥睤ay SJ, Hamid O, Bastian BC (2012) Sunitinib therapy for melanoma patients with KIT mutations. Clin Cancer Res 18(5):1457鈥?463. doi:10.1158/1078-0432.CCR-11-1987 CrossRef
    33. Dingemans AM, Mellema WW, Groen HJ, van Wijk A, Burgers SA, Kunst PW, Thunnissen E, Heideman DA, Smit EF (2013) A phase II study of sorafenib in patients with platinum-pretreated, advanced (Stage IIIb or IV) non-small cell lung cancer with a KRAS mutation. Clin Cancer Res 19(3):743鈥?51. doi:10.1158/1078-0432.CCR-12-1779 CrossRef
    34. Bottsford-Miller JN, Coleman RL, Sood AK (2012) Resistance and escape from antiangiogenesis therapy: clinical implications and future strategies. J Clin Oncol 30(32):4026鈥?034. doi:10.1200/JCO.2012.41.9242 CrossRef
    35. Janku F, Huang HJ, Angelo LS, Kurzrock R (2013) A kinase-independent biological activity for insulin growth factor-1 receptor (IGF-1R): implications for inhibition of the IGF-1R signal. Oncotarget 4(3):463鈥?73
    36. Blackwell KL, Burstein HJ, Storniolo AM, Rugo H, Sledge G, Koehler M, Ellis C, Casey M, Vukelja S, Bischoff J, Baselga J, O鈥睸haughnessy J (2010) Randomized study of Lapatinib alone or in combination with trastuzumab in women with ErbB2-positive, trastuzumab-refractory metastatic breast cancer. J Clin Oncol 28(7):1124鈥?130. doi:10.1200/JCO.2008.21.4437 CrossRef
    37. Baselga J, Bradbury I, Eidtmann H, Di Cosimo S, de Azambuja E, Aura C, Gomez H, Dinh P, Fauria K, Van Dooren V, Aktan G, Goldhirsch A, Chang TW, Horvath Z, Coccia-Portugal M, Domont J, Tseng LM, Kunz G, Sohn JH, Semiglazov V, Lerzo G, Palacova M, Probachai V, Pusztai L, Untch M, Gelber RD, Piccart-Gebhart M (2012) Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): a randomised, open-label, multicentre, phase 3 trial. Lancet 379(9816):633鈥?40. doi:10.1016/S0140-6736(11)61847-3 CrossRef
    38. de Azambuja E, Holmes AP, Piccart-Gebhart M, Holmes E, Di Cosimo S, Swaby RF, Untch M, Jackisch C, Lang I, Smith I, Boyle F, Xu B, Barrios CH, Perez EA, Azim HA Jr, Kim SB, Kuemmel S, Huang CS, Vuylsteke P, Hsieh RK, Gorbunova V, Eniu A, Dreosti L, Tavartkiladze N, Gelber RD, Eidtmann H, Baselga J (2014) Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): survival outcomes of a randomised, open-label, multicentre, phase 3 trial and their association with pathological complete response. Lancet Oncol 15(10):1137鈥?146. doi:10.1016/S1470-2045(14)70320-1 CrossRef
    39. Said R, Hong DS, Warneke CL, Lee JJ, Wheler JJ, Janku F, Naing A, Falchook GS, Fu S, Piha-Paul S, Tsimberidou AM, Kurzrock R (2013) P53 mutations in advanced cancers: clinical characteristics, outcomes, and correlation between progression-free survival and bevacizumab-containing therapy. Oncotarget 4(5):705鈥?14
  • 作者单位:Gerald S. Falchook (1)
    Jennifer J. Wheler (2)
    Aung Naing (2)
    Sarina A. Piha-Paul (2)
    Siqing Fu (2)
    Apostolia M. Tsimberidou (2)
    David S. Hong (2)
    Filip Janku (2)
    Ralph Zinner (2)
    Yunfang Jiang (2)
    Mei Huang (2)
    Quan Lin (2)
    Kristin Parkhurst (2)
    Razelle Kurzrock (3)

    1. Sarah Cannon Research Institute at HealthONE, Presbyterian/St. Luke鈥檚 Medical Center, 1800 Williams Street, Suite 300, Denver, CO, 80218, USA
    2. Department of Investigational Cancer Therapeutics (Phase I Program), The University of Texas MD Anderson Cancer Center, Houston, TX, 77030, USA
    3. Center for Personalized Cancer Therapy, Moores Cancer Center, University of California - San Diego, San Diego, CA, 92093, USA
  • 刊物类别:Medicine
  • 刊物主题:Medicine & Public Health
    Oncology
    Pharmacology and Toxicology
  • 出版者:Springer Netherlands
  • ISSN:1573-0646
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