Targeted MET inhibition in castration-resistant prostate cancer: A randomized phase II study and biomarker analysis with rilotumumab plus mitoxantrone and prednisone

Clinical Cancer Research

Volumn 19, Issue 1, 2013, Pages 215-224

  Ryan, Charles J ^a   Rosenthal, Mark ^b   Ng, Siobhan ^c   Alumkal, Joshi ^d   Picus, Joel ^e   Gravis, Gwenaëlle ^f   Fizazi, Karim ^g   Forget, Fréd́eric ^h   Machiels, Jean Pascal ⁱ   Srinivas, Sandy ^j   Zhu, Min ^k   Tang, Rui ^k   Oliner, Kelly S ^k   Jiang, Yizhou ^k   Loh, Elwyn ^k   Dubey, Sarita ^k   Gerritsen, Winald R ^l  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b ROYAL MELBOURNE HOSPITAL   (Australia)

^c ST JOHN OF GOD HOSPITAL   (Australia)

^d OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^e WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^f INSTITUT PAOLI CALMETTES   (France)

^g INSTITUT GUSTAVE ROUSSY   (France)

^h Centre Hospitalier de l'Ardenne   (Belgium)

ⁱ CLINIQUES UNIVERSITAIRES SAINT LUC   (Belgium)

^j STANFORD UNIVERSITY   (United States)

^k AMGEN INC   (United States)

^l VU UNIVERSITY MEDICAL CENTER   (Netherlands)

more..

Author keywords

[No Author keywords available]

Indexed keywords

MITOXANTRONE; PLACEBO; PREDNISONE; RILOTUMUMAB; SCATTER FACTOR; SCATTER FACTOR RECEPTOR; TAXANE DERIVATIVE;

ADULT; AGED; ANEMIA; ARTHRALGIA; ARTICLE; ASTHENIA; BACKACHE; BONE PAIN; CASTRATION RESISTANT PROSTATE CANCER; CHEMOTHERAPY INDUCED EMESIS; CONSTIPATION; CONTROLLED STUDY; DECREASED APPETITE; DIARRHEA; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DYSPNEA; FATIGUE; FEVER; HUMAN; LIMB PAIN; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PERIPHERAL EDEMA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROTEIN EXPRESSION; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; WEIGHT REDUCTION;

AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; HUMANS; MALE; MIDDLE AGED; MITOXANTRONE; MOLECULAR TARGETED THERAPY; ORCHIECTOMY; PREDNISONE; PROSTATIC NEOPLASMS; PROTO-ONCOGENE PROTEINS C-MET; TREATMENT OUTCOME; TUMOR MARKERS, BIOLOGICAL;

EID: 84871962904     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-12-2605     Document Type: Article

References (27)

1. Holzbeierlein J, Lal P, LaTulippe E, Smith A, Satagopan J, Zhang L, et al. Gene expression analysis of human prostate carcinoma during hormonal therapy identifies androgen-responsive genes and mechanisms of therapy resistance. Am J Pathol 2004;164:217-27.
2. Montgomery RB, Mostaghel EA, Vessella R, Hess DL, Kalhorn TF, Higano CS, et al. Maintenance of intratumoral androgens in metastatic prostate cancer: a mechanism for castration-resistant tumor growth. Cancer Res 2008;68:4447-54.
3. Carver BS, Chapinski C, Wongvipat J, Hieronymus H, Chen Y, Chandarlapaty S, et al. Reciprocal feedback regulation of PI3K and androgen receptor signaling in PTEN-deficient prostate cancer. Cancer Cell 2011;19:575-86.
4. de Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chu L, et al. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med 2011;364:1995-2005.
5. de Bono JS, Oudard S, Ozguroglu M, Hansen S, Machiels JP, Kocak I, et al. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet 2010;376:1147-54.
6. Rosenberg JE, Weinberg VK, Kelly WK, Michaelson D, Hussain MH, Wilding G, et al. Activity of second-line chemotherapy in docetaxel-refractory hormone-refractory prostate cancer patients: randomized phase 2 study of ixabepilone or mitoxantrone and prednisone. Cancer 2007;110:556-63.
7. Naughton M, Picus J, Zhu X, Catalona WJ, Vollmer RT, Humphrey PA. Scatter factor-hepatocyte growh factor elevation in the serum of patients with prostate cancer. J Urol 2001;165:1325-8.
8. Humphrey PA, Halabi S, Picus J, Sanford B, Vogelzang NJ, Small EJ, et al. Prognostic significance of plasma scatter factor/hepatocyte growth factor levels in patients with metastatic hormone-refractory prostate cancer: results from cancer and leukemia group B 150005/9480. Clin Genitourin Cancer 2006;4:269-74.
9. Knudsen BS, Edlund M. Prostate cancer and the met hepatocyte growth factor receptor. Adv Cancer Res 2004;91:31-67.
10. Verras M, Lee J, Xue H, Li TH, Wang Y, Sun Z. The androgen receptor negatively regulates the expression of c-Met: implications for a novel mechanism of prostate cancer progression. Cancer Res 2007;67:967-75.
11. Singh AP, Bafna S, Chaudhary K, Venkatraman G, Smith L, Eudy JD, et al. Genome-wide expression profiling reveals transcriptomic variation and perturbed gene networks in androgen-dependent and androgen-independent prostate cancer cells. Cancer Lett 2008;259:28-38.
12. van Leenders GJ, Sookhlall R, Teubel WJ, de Ridder CM, Reneman S, Sacchetti A, et al. Activation of c-MET induces a stem-like phenotype in human prostate cancer. PLoS ONE 2011;6:e26753.
13. van Leenders GJ, van Balken B, Aalders T, Hulsbergen-van de Kaa C, Ruiter D, Schalken J. Intermediate cells in normal and malignant prostate epithelium express c-MET: implications for prostate cancer invasion. Prostate 2002;51:98-107.
14. Maeda A, Nakashiro K, Hara S, Sasaki T, Miwa Y, Tanji N, et al. Inactivation of AR activates HGF/c-Met system in human prostatic carcinoma cells. Biochem Biophys Res Commun 2006;347:1158-65.
15. Jun HT, Sun J, Rex K, Radinsky R, Kendall R, Coxon A, et al.AMG 102, a fully human anti-hepatocyte growth factor/scatter factor neutralizing antibody, enhances the efficacy of temozolomide or docetaxel in U-87 MG cells and xenografts. Clin Cancer Res 2007;13:6735-42.
16. Zhang YW, Su Y, Lanning N, Gustafson M, Shinomiya N, Zhao P, et al. Enhanced growth of human met-expressing xenografts in a new strain of immunocompromised mice transgenic for human hepatocyte growth factor/scatter factor. Oncogene 2005;24:101-6.
17. Cao B, Su Y, Oskarsson M, Zhao P, Kort EJ, Fisher RJ, et al. Neutralizing monoclonal antibodies to hepatocyte growth factor/scatter factor (HGF/SF) display antitumor activity in animal models. Proc Natl Acad Sci U S A 2001;98:7443-8.
18. Gao CF, Xie Q, Zhang YW, Su Y, Zhao P, Cao B, et al. Therapeutic potential of hepatocyte growth factor/scatter factor neutralizing antibodies: inhibition of tumor growth in both autocrine and paracrine hepatocyte growth factor/scatter factor:c-Met-driven models of leiomyosarcoma. Mol Cancer Ther 2009;8:2803-10.
19. Wen PY, Schiff D, Cloughesy TF, Raizer JJ, Laterra J, Smitt M, et al. A phase II study evaluating the effi cacy and safety of AMG 102 (rilotumumab) in patients with recurrent glioblastoma. Neuro Oncol 2011;13:437-46.
20. Gordon MS, Sweeney CS, Mendelson DS, Eckhardt SG, Anderson A, Beaupre DM, et al. Safety, pharmacokinetics, and pharmacodynamics of AMG 102, a fully human hepatocyte growth factor-neutralizing monoclonal antibody, in a first-in-human study of patients with advanced solid tumors. Clin Cancer Res 2010;16:699-710.
21. Rosen PJ, Sweeney CJ, Park DJ, Beaupre DM, Deng H, Leitch IM, et al. A phase Ib study of AMG 102 in combination with bevacizumab or motesanib in patients with advanced solid tumors. Clin Cancer Res 2010;16:2677-87.
22. Doshi S, Kathman S, Tang R, Gisleskog PO, Loh E, Dubey S, et al. Modeling the combined effi cacy of rilotumumab (R; AMG 102) plus epirubicin/cisplatin/ capecitabine (ECX) for the treatment of locally advanced or metastatic gastric or esophagogastric junction (G/EGJ) cancer. J Clin Oncol 30, 2012 (suppl; abstr 2594).
23. Schoffski P, Garcia JA, Stadler WM, Gil T, Jonasch E, Tagawa ST, et al. A phase II study of the efficacy and safety of AMG 102 in patients with metastatic renal cell carcinoma. BJU Int 2011;108:679-86.
24. Gisleskog PO, Lu JF, Perez-Ruixo JJ, Magnusson MO, Zhu M. A mechanistic model to characterize binding dynamics of AMG 102 to HGF ligands in cancer patients. Clin Pharm Ther 2010;87(Suppl 1):S83.
25. Ryan CJ, Li J, Kheoh T, Scher HI, Molina A. Baseline serum adrenal androgens are prognostic and predictive of overall survival (OS) in patients (pts) with metastatic castrate-resistant prostate cancer (mCRPC): results of the COU-AA-301 phase 3 randomized trial [abstract]. In: Proceedings of the 103rd Annual Meeting of the American Association for Cancer Research; 2012 Mar 31-Apr 4; Chicago, IL. Philadelphia (PA): AACR; 2012. Abstract nr LB-434.
26. Hussain M, Smith MR, Sweeney C,Corn PG, Elfiky A, Gordon MS, et al. Cabozantinib (XL184) in metastatic castration-resistant prostate cancer (mCRPC): Results from a phase II randomized discontinuation trial. J Clin Oncol 29, 2011 (suppl; abstr 4516).
27. Sennino B, Ishiguro-Oonuma T, Wei Y, Naylor RM, Williamson CW, Bhagwandin V, et al. Suppression of tumor invasion and metastasis by concurrent inhibition of c-Met and VEGF signaling in pancreatic neuroendocrine tumors. Cancer Discov 2012;2:270-87.