Effect of axitinib (AG-013736) on fatigue, thyroid-stimulating hormone, and biomarkers: A phase I study in Japanese patients

Cancer Science

Volumn 101, Issue 4, 2010, Pages 963-968

  Mukohara, Toru ^a   Nakajima, Hikaru ^a   Mukai, Hirofumi ^a   Nagai, Shunji ^a   Itoh, Kuniaki ^a   Umeyama, Yoshiko ^b   Hashimoto, Junichi ^b   Minami, Hironobu ^a  

^a NATIONAL CANCER CENTER HOSPITAL EAST   (Japan)

^b PFIZER INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AXITINIB; FLUORODEOXYGLUCOSE F 18; STEM CELL FACTOR RECEPTOR; THYROTROPIN; VASCULOTROPIN; VASCULOTROPIN RECEPTOR 2; VASCULOTROPIN RECEPTOR 3; ANGIOGENESIS INHIBITOR; BIOLOGICAL MARKER; IMIDAZOLE DERIVATIVE; INDAZOLE DERIVATIVE;

ADULT; ADVANCED CANCER; AGED; ANEMIA; ANOREXIA; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTICLE; CLINICAL ARTICLE; COLORECTAL CANCER; CONSTIPATION; DIARRHEA; DRUG BLOOD LEVEL; DRUG DOSE REDUCTION; DRUG ERUPTION; DRUG HALF LIFE; DRUG METABOLISM; DRUG SAFETY; DRUG WITHDRAWAL; EPISTAXIS; FATIGUE; FEMALE; GLUCOSE BLOOD LEVEL; HAND FOOT SYNDROME; HEMATURIA; HOARSENESS; HUMAN; HYPERTENSION; HYPOALBUMINEMIA; JAPANESE; KIDNEY CARCINOMA; LEUKOPENIA; LYMPHOCYTOPENIA; MALE; MAXIMUM PLASMA CONCENTRATION; NAUSEA; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PLASMA CONCENTRATION-TIME CURVE; POSITRON EMISSION TOMOGRAPHY; PRIORITY JOURNAL; PROTEINURIA; RECOMMENDED DRUG DOSE; SIDE EFFECT; SOLID TUMOR; STEADY STATE; STOMATITIS; THROMBOCYTOPENIA; TIME TO MAXIMUM PLASMA CONCENTRATION; TUMOR VOLUME; CHEMICALLY INDUCED DISORDER; CLINICAL TRIAL; DRUG ANTAGONISM; MIDDLE AGED; NEOPLASM; PATHOLOGY;

ADULT; AGED; ANGIOGENESIS INHIBITORS; BIOLOGICAL MARKERS; FATIGUE; FEMALE; HUMANS; HYPERTENSION; IMIDAZOLES; INDAZOLES; MALE; MIDDLE AGED; NEOPLASMS; THYROTROPIN; VASCULAR ENDOTHELIAL GROWTH FACTOR RECEPTOR-2;

EID: 77957269382     PISSN: 13479032     EISSN: 13497006     Source Type: Journal    
DOI: 10.1111/j.1349-7006.2009.01465.x     Document Type: Article

References (26)

1. Folkman J. What is the evidence that tumors are angiogenesis dependent? J Natl Cancer Inst 1990; 82: 4-6.
2. Folkman J. The role of angiogenesis in tumor growth. Semin Cancer Biol 1992; 3: 65-71.
3. Hicklin DJ, Ellis LM. Role of the vascular endothelial growth factor pathway in tumor growth and angiogenesis. J Clin Oncol 2005; 23: 1011-27.
4. Ferrara N, Gerber HP, LeCouter J. The biology of VEGF and its receptors. Nat Med 2003; 9: 669-76.
5. Hu-Lowe DD, Zou HY, Grazzini ML et al. Nonclinical anti-angiogenesis and anti-tumor activity of axitinib, an oral, potent, and selective inhibitor of VEGF receptor tyrosine kinases 1, 2, 3. Clin Cancer Res 2008; 14: 7272-83.
6. Wilmes LJ, Pallavicini MG, Fleming LM et al. AG-013736, a novel inhibitor of VEGF receptor tyrosine kinases, inhibits breast cancer growth and decreases vascular permeability as detected by dynamic contrast-enhanced magnetic resonance imaging. Magn Reson Imaging 2007; 25: 319-27.
7. Rugo HS, Herbst RS, Liu G et al. Phase I trial of the oral antiangiogenesis agent AG-013736 in patients with advanced solid tumors: pharmacokinetic and clinical results. J Clin Oncol 2005; 23: 5474-83.
8. Rini BI, Wilding G, Hudes G et al. Phase II study of axitinib in sorafenib-refractory metastatic renal cell carcinoma. J Clin Oncol 2009; 27: 4462-8.
9. Rixe O, Bukowski RM, Michaelson MD et al. Axitinib treatment in patients with cytokine-refractory metastatic renal-cell cancer: a phase II study. Lancet Oncol 2007; 8: 975-84.
10. Cohen EE, Rosen LS, Vokes EE et al. Axitinib is an active treatment for all histologic subtypes of advanced thyroid cancer: results from a phase II study. J Clin Oncol 2008; 26: 4708-13.
11. Schiller JH, Larson T, Ou SH et al. Efficacy and safety of axitinib in patients with advanced non-small-cell lung cancer: results from a phase II study. J Clin Oncol 2009; 27: 3836-41.
12. Fruehauf JP, Lutzky J, McDermott DF et al. Axitinib (AG-013736) in patients with metastatic melanoma: a phase II study (abstract). J Clin Oncol 2008; 26: 484s.
13. Rugo HS, Stopeck A, Joy AA et al. A randomized, double-blind phase II study of the oral tyrosine kinase inhibitor (TKI) axitinib (AG-013736) in combination with docetaxel (DOC) compared to DOC plus placebo (PL) in metastatic breast cancer (MBC) (abstract). J Clin Oncol 2007; 25: 32s.
14. 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 2000; 92: 205-16.
15. Alexandre I, Billemont B, Meric JB, Richard S, Rixe O. Axitinib induces paradoxical erythropoietin synthesis in metastatic renal cell carcinoma. J Clin Oncol 2009; 27: 472-3.
16. van der Veldt AA, Boven E, Vroling L, Broxterman HJ, van den Eertwegh AJ, Haanen JG. Sunitinib-induced hemoglobin changes are related to the dosing schedule. J Clin Oncol 2009; 27: 1339-40.
17. Alexandrescu DT, McClure R, Farzanmehr H, Dasanu CA. Secondary erythrocytosis produced by the tyrosine kinase inhibitors sunitinib and sorafenib. J Clin Oncol 2008; 26: 4047-8.
18. Laurie SA, Gauthier I, Arnold A et al. Phase I and pharmacokinetic study of daily oral AZD2171, an inhibitor of vascular endothelial growth factor tyrosine kinases, in combination with carboplatin and paclitaxel in patients with advanced non-small-cell lung cancer: the National Cancer Institute of Canada clinical trials group. J Clin Oncol 2008; 26: 1871-8.
19. Holden SN, Eckhardt SG, Basser R et al. Clinical evaluation of ZD6474, an orally active inhibitor of VEGF and EGF receptor signaling, in patients with solid, malignant tumors. Ann Oncol 2005; 16: 1391-7.
20. Desai J, Yassa L, Marqusee E et al. Hypothyroidism after sunitinib treatment for patients with gastrointestinal stromal tumors. Ann Intern Med 2006; 145: 660-4.
21. Tamaskar I, Bukowski R, Elson P et al. Thyroid function test abnormalities in patients with metastatic renal cell carcinoma treated with sorafenib. Ann Oncol 2008; 19: 265-8.
22. Rini BI, Tamaskar I, Shaheen P et al. Hypothyroidism in patients with metastatic renal cell carcinoma treated with sunitinib. J Natl Cancer Inst 2007; 99: 81-3.
23. Drevs J, Siegert P, Medinger M et al. Phase I clinical study of AZD2171, an oral vascular endothelial growth factor signaling inhibitor, in patients with advanced solid tumors. J Clin Oncol 2007; 25: 3045-54.
24. Lazarus JH. Silent thyroiditis and subacute thyroiditis. In: Braverman L, Utiger RD, eds. Werner and Ingbar's The Thyroid - A Fundamental and Clinical Text, 7th edn. Philadelphia, PA: Lippincott-Raven Publishing, 1996; 577-91.
25. Faris JE, Moore AF, Daniels GH. Sunitinib (sutent)-induced thyrotoxicosis due to destructive thyroiditis: a case report. Thyroid 2007; 17: 1147-9.
26. Kamba T, Tam BY, Hashizume H et al. VEGF-dependent plasticity of fenestrated capillaries in the normal adult microvasculature. Am J Physiol Heart Circ Physiol 2006; 290: H560-76.