Cabozantinib in patients with advanced prostate cancer: Results of a phase II randomized discontinuation trial

Journal of Clinical Oncology

Volumn 31, Issue 4, 2013, Pages 412-419

  Smith, David C ^a   Smith, Matthew R ^c   Sweeney, Christopher ^d   Elfiky, Aymen A ^d   Logothetis, Christopher ^e   Corn, Paul G ^e   Vogelzang, Nicholas J ^g   Small, Eric J ^h   Harzstark, Andrea L ^h   Gordon, Michael S ^l   Vaishampayan, Ulka N ^b   Haas, Naomi B ^m   Spira, Alexander I ^f,n   Lara, Primo N ^j   Lin, Chia Chi ^o   Srinivas, Sandy ^k   Sella, Avishay ^p   Schöffski, Patrick ^q   Scheffold, Christian ⁱ   Weitzman, Aaron L ⁱ   Hussain, Maha ^a   more..

^a UNIVERSITY OF MICHIGAN   (United States)

^b WAYNE STATE UNIVERSITY   (United States)

^c MASSACHUSETTS GENERAL HOSPITAL   (United States)

^d DANA FARBER CANCER INSTITUTE   (United States)

^e UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^f Developmental Therapeutics Committee and Co Chair of the Genitourinary Committee   (United States)

^g US Oncology Comprehensive Cancer Centers of Nevada ^*  (United States)

^h UNIVERSITY OF CALIFORNIA   (United States)

ⁱ EXELIXIS INC   (United States)

^j UNIVERSITY OF CALIFORNIA   (United States)

^k STANFORD UNIVERSITY MEDICAL CENTER   (United States)

^l Pinnacle Oncology Hematology   (United States)

^m UNIVERSITY OF PENNSYLVANIA   (United States)

ⁿ Virginia Cancer Specialists   (United States)

^o NATIONAL TAIWAN UNIVERSITY HOSPITAL   (Taiwan)

^p ASSAF HAROFEH MEDICAL CENTER   (Israel)

^q UNIVERSITY HOSPITALS LEUVEN   (Belgium)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALKALINE PHOSPHATASE; CABOZANTINIB; CARBOXY TERMINAL TELOPEPTIDE; NARCOTIC AGENT; PLACEBO; ANILIDE; ANTINEOPLASTIC AGENT; COLLAGEN TYPE 1; COLLAGEN TYPE I TRIMERIC CROSS LINKED PEPTIDE; COLLAGEN TYPE I TRIMERIC CROSS-LINKED PEPTIDE; PEPTIDE; PROTEIN TYROSINE KINASE; PYRIDINE DERIVATIVE; TUMOR MARKER;

ABDOMINAL PAIN; ADULT; AGED; ALKALINE PHOSPHATASE BLOOD LEVEL; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; ASTHENIA; BODY WEIGHT; BONE PAIN; BONE SCINTISCANNING; CANCER REGRESSION; CANCER SURVIVAL; CASTRATION RESISTANT PROSTATE CANCER; COHORT ANALYSIS; CONSTIPATION; CONTROLLED STUDY; COUGHING; DECREASED APPETITE; DEHYDRATION; DIARRHEA; DIZZINESS; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSGEUSIA; DYSPEPSIA; DYSPHONIA; DYSPNEA; FATIGUE; GASTROESOPHAGEAL REFLUX; HAND FOOT SYNDROME; HUMAN; HYPERTENSION; HYPOTHYROIDISM; INSOMNIA; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; MOUTH PAIN; MUCOSA INFLAMMATION; NAUSEA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROTEIN BLOOD LEVEL; RANDOMIZED CONTROLLED TRIAL; RETROSPECTIVE STUDY; SIDE EFFECT; STOMATITIS; TASTE DISORDER; TREATMENT RESPONSE; VOMITING; XEROSTOMIA; BLOOD; BONE REMODELING; BONE TUMOR; CONTROLLED CLINICAL TRIAL; DISEASE FREE SURVIVAL; DRUG ANTAGONISM; FOLLOW UP; KAPLAN MEIER METHOD; LYMPH NODE METASTASIS; METASTASIS; MIDDLE AGED; MULTICENTER STUDY; ORCHIECTOMY; PATHOLOGY; PROSTATE TUMOR; TREATMENT OUTCOME;

AGED; AGED, 80 AND OVER; ALKALINE PHOSPHATASE; ANILIDES; ANTINEOPLASTIC AGENTS; BONE NEOPLASMS; BONE REMODELING; COLLAGEN TYPE I; DISEASE-FREE SURVIVAL; FOLLOW-UP STUDIES; HUMANS; KAPLAN-MEIER ESTIMATE; LYMPHATIC METASTASIS; MALE; MIDDLE AGED; ORCHIECTOMY; PEPTIDES; PROSTATIC NEOPLASMS; PYRIDINES; RECEPTOR PROTEIN-TYROSINE KINASES; TREATMENT OUTCOME; TUMOR MARKERS, BIOLOGICAL;

MLCS; MLOWN;

EID: 84874787799     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2012.45.0494     Document Type: Article

References (28)

1. Humphrey PA, Zhu X, Zarnegar R, et al: Hepatocyte growth factor and its receptor (c-MET) in prostatic carcinoma. Am J Pathol 147: 386-396, 1995
2. Pisters LL, Troncoso P, Zhau HE, et al: c-met proto-oncogene expression in benign and malignant human prostate tissues. J Urol 154:293- 298, 1995
3. Zhang S, Zhau HE, Osunkoya AO, et al: Vascular endothelial growth factor regulates myeloid cell leukemia-1 expression through neuropilin-1- dependent activation of c-MET signaling in human prostate cancer cells. Mol Cancer 9:9, 2010
4. Knudsen BS, Gmyrek GA, Inra J, et al: High expression of the Met receptor in prostate cancer metastasis to bone. Urology 60: 1113-1117, 2002 (Pubitemid 35447590)
5. Humphrey PA, Halabi S, Picus J, 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 4: 269-274, 2006 (Pubitemid 43779884)
6. Bok RA, Halabi S, Fei DT, et al: Vascular endothelial growth factor and basic fibroblast growth factor urine levels as predictors of outcome in hormone-refractory prostate cancer patients: A Cancer and Leukemia Group B study. Cancer Res 61: 2533-2536, 2001 (Pubitemid 32685834)
7. George DJ, Halabi S, Shepard TF, et al: Prognostic significance of plasma vascular endothelial growth factor levels in patients with hormonerefractory prostate cancer treated on Cancer and Leukemia Group B 9480. Clin Cancer Res 7:1932- 1936, 2001 (Pubitemid 32994827)
8. Pfeiffer MJ, Smit FP, Sedelaar JP, et al: Steroidogenic enzymes and stem cell markers are upregulated during androgen deprivation in prostate cancer. Mol Med 17: 657-664, 2011
9. Sirotnak FM, She Y, Khokhar NZ, et al: Microarray analysis of prostate cancer progression to reduced androgen dependence: Studies in unique models contrasts early and late molecular events. Mol Carcinog 41: 150-163, 2004 (Pubitemid 39435112)
10. Verras M, Lee J, Xue H, et al: The androgen receptor negatively regulates the expression of c-Met: Implications for a novel mechanism of prostate cancer progression. Cancer Res 67:967- 975, 2007
11. Inaba M, Koyama H, Hino M, et al: Regulation of release of hepatocyte growth factor from human promyelocytic leukemia cells, HL-60, by 1,25- dihydroxyvitamin D3, 12-O-tetradecanoylphorbol 13-acetate, and dibutyryl cyclic adenosine monophosphate. Blood 82: 53-59, 1993 (Pubitemid 23188746)
12. Grano M, Galimi F, Zambonin G, et al: Hepatocyte growth factor is a coupling factor for osteoclasts and osteoblasts in vitro. Proc Natl Acad Sci U S A 93: 7644-7648, 1996 (Pubitemid 26277090)
13. Ono K, Kamiya S, Akatsu T, et al: Involvement of hepatocyte growth factor in the development of bone metastasis of a mouse mammary cancer cell line, BALB/c-MC. Bone 39: 27-34, 2006 (Pubitemid 43831769)
14. Street J, Lenehan B: Vascular endothelial growth factor regulates osteoblast survival: Evidence for an autocrine feedback mechanism. J Orthop Surg Res 4:19, 2009
15. Zelzer E, Olsen BR: Multiple roles of vascular endothelial growth factor (VEGF) in skeletal development, growth, and repair. Curr Top Dev Biol 65: 169-187, 2005
16. Yakes FM, Chen J, Tan J, et al: Cabozantinib (XL184), a novel MET and VEGFR2 inhibitor, simultaneously suppresses metastasis, angiogenesis, and tumor growth. Mol Cancer Ther 10: 2298-2308, 2011
17. You WK, Sennino B, Williamson CW, et al: VEGF and c-Met blockade amplify angiogenesis inhibition in pancreatic islet cancer. Cancer Res 71: 4758-4768, 2011
18. Schimmoller F, Zayzafoon M, Chung LWK, et al: Cabozantinib (XL184), a dual MET-VEGFR2 inhibitor, blocks osteoblastic and osteolytic progression of human prostate cancer xenografts in mouse bone. Mol Cancer Ther 10:233, 2011 (suppl; abstr)
19. Kurzrock R, Sherman SI, Ball DW, et al: Activity of XL184 (cabozantinib), an oral tyrosine kinase inhibitor, in patients with medullary thyroid cancer. J Clin Oncol 29: 2660-2666, 2011
20. Gordon MS, Vogelzang NJ, Schoffski P, et al: Activity of cabozantinib (XL184) in soft tissue and bone: Results of a phase II randomized discontinuation trial (RDT) in patients (pts) with advanced solid tumors. J Clin Oncol 29:196s, 2011 (suppl; abstr 3010)
21. Therasse P, Arbuck SG, Eisenhauer EA, 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. J Natl Cancer Inst 92: 205-216, 2000
22. Ratain MJ, Eisen T, Stadler WM, et al: Phase II placebo-controlled randomized discontinuation trial of sorafenib in patients with metastatic renal cell carcinoma. J Clin Oncol 24: 2505-2512, 2006 (Pubitemid 46630627)
23. Kelly WK, Halabi S, Carducci M, et al: Randomized, double-blind, placebo-controlled phase III trial comparing docetaxel and prednisone with or without bevacizumab in men with metastatic castration-resistant prostate cancer: CALGB 90401. J Clin Oncol 30: 1534-1540, 2012
24. Dahut WL, Scripture C, Posadas E, et al: A phase II clinical trial of sorafenib in androgenindependent prostate cancer. Clin Cancer Res 14: 209-214, 2008 (Pubitemid 351377997)
25. Reid AH, Attard G, Danila DC, et al: Significant and sustained antitumor activity in post-docetaxel, castration-resistant prostate cancer with the CYP17 inhibitor abiraterone acetate. J Clin Oncol 28:1489- 1495, 2010
26. Yu EY, Wilding G, Posadas E, et al: Phase II study of dasatinib in patients with metastatic castration-resistant prostate cancer. Clin Cancer Res 15: 7421-7428, 2009
27. Yap TA, Olmos D, Brunetto AT, et al: Phase I trial of a selective c-MET inhibitor ARQ 197 incorporating proof of mechanism pharmacodynamic studies. J Clin Oncol 29: 1271-1279, 2011
28. Aftab DT, McDonald DM: MET and VEGF: Synergistic targets in castration-resistant prostate cancer. Clin Transl Oncol 13: 703-709, 2011