Treatment of advanced thyroid cancer with axitinib: Phase 2 study with pharmacokinetic/pharmacodynamic and quality-of-life assessments

Cancer

Volumn 120, Issue 17, 2014, Pages 2694-2703

  Locati, Laura D ^a   Licitra, Lisa ^a   Agate, Laura ^b   Ou, Sai Hong I ^c   Boucher, Andree ^d   Jarzab, Barbara ^e   Qin, Shukui ^f   Kane, Madeleine A ^g   Wirth, Lori J ^h   Chen, Connie ⁱ   Kim, Sinil ^j   Ingrosso, Antonella ^j   Pithavala, Yazdi K ^j   Bycott, Paul ^j   Cohen, Ezra E W ^k  

^a NATIONAL CANCER INSTITUTE   (Italy)

^b UNIVERSITY OF PISA   (Italy)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d CENTRE HOSPITALIER DE L UNIVERSITÉ DE MONTRÉAL   (Canada)

^e INSTITUTE OF ONCOLOGY   (Poland)

^f Nanjing Bayi Hospital   (China)

^g UNIVERSITY OF COLORADO CANCER CENTER   (United States)

^h DANA FARBER CANCER INSTITUTE   (United States)

ⁱ Pfizer Ltd   (United States)

^j PFIZER INC   (United States)

^k UNIVERSITY OF CHICAGO MEDICAL CENTER   (United States)

more..

Author keywords

axitinib; MD Anderson Symptom Inventory; metastatic disease; pharmacodynamic; pharmacokinetic; quality of life; radioactive iodine refractory; thyroid cancer; tyrosine kinase inhibitor

Indexed keywords

AXITINIB;

ADULT; ADVANCED CANCER; ANEMIA; AREA UNDER THE CURVE; ARTICLE; CANCER SURVIVAL; CLINICAL EFFECTIVENESS; CONTROLLED STUDY; COUGHING; DAILY LIFE ACTIVITY; DECREASED APPETITE; DIARRHEA; DISEASE SEVERITY; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DYSPNEA; FATIGUE; FEMALE; HAND FOOT SYNDROME; HUMAN; HYPERGLYCEMIA; HYPERTENSION; HYPOCALCEMIA; HYPOKALEMIA; HYPONATREMIA; LEUKOPENIA; LIMB PAIN; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; MD ANDERSON SYMPTOM INVENTORY; MULTICENTER STUDY; MYALGIA; NEUTROPENIA; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; QUALITY OF LIFE; QUESTIONNAIRE; SURVIVAL TIME; THROMBOCYTOPENIA; THYROID CANCER;

AXITINIB; MD ANDERSON SYMPTOM INVENTORY; METASTATIC DISEASE; PHARMACODYNAMIC; PHARMACOKINETIC; QUALITY OF LIFE; RADIOACTIVE IODINE-REFRACTORY; THYROID CANCER; TYROSINE KINASE INHIBITOR;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; CARCINOMA, PAPILLARY; DIARRHEA; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; IMIDAZOLES; INDAZOLES; KAPLAN-MEIER ESTIMATE; LUNG NEOPLASMS; MALE; MIDDLE AGED; QUALITY OF LIFE; THYROID NEOPLASMS; TREATMENT OUTCOME;

EID: 84906789850     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.28766     Document Type: Article

References (36)

1. Kilfoy BA, Zheng T, Holford TR, et al. International patterns and trends in thyroid cancer incidence, 1973-2002. Cancer Causes Control. 2009; 20: 525-531.
2. Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM,. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010; 127: 2893-2917.
3. Yu GP, Li JC, Branovan D, McCormick S, Schantz SP,. Thyroid cancer incidence and survival in the National Cancer Institute Surveillance, Epidemiology, and End Results race/ethnicity groups. Thyroid. 2010; 20: 465-473.
4. Simard EP, Ward EM, Siegel R, Jemal A,. Cancers with increasing incidence trends in the United States: 1999 through 2008. CA Cancer J Clin. 2012; 62: 118-128.
5. Durante C, Haddy N, Baudin E, et al. Long-term outcome of 444 patients with distant metastases from papillary and follicular thyroid carcinoma: benefits and limits of radioiodine therapy. J Clin Endocrinol Metab. 2006; 91: 2892-2899.
6. Klein M, Picard E, Vignaud JM, et al. Vascular endothelial growth factor gene and protein: strong expression in thyroiditis and thyroid carcinoma. J Endocrinol. 1999; 161: 41-49.
7. Ahmed M, Barbachano Y, Riddell A, et al. Analysis of the efficacy and toxicity of sorafenib in thyroid cancer: a phase II study in a UK based population. Eur J Endocrinol. 2011; 165: 315-322.
8. Bible KC, Suman VJ, Molina JR, et al. Efficacy of pazopanib in progressive, radioiodine-refractory, metastatic differentiated thyroid cancers: results of a phase 2 consortium study. Lancet Oncol. 2010; 11: 962-972.
9. Cabanillas ME, Brose MS, Ramies DA, Lee Y, Miles D, SI S,. Antitumor activity of cabozantinib (XL184) in a cohort of patients (pts) with differentiated thyroid cancer (DTC) [abstract]. J Clin Oncol. 2012; 30 (suppl). Abstract 5547.
10. Carr LL, Mankoff DA, Goulart BH, et al. Phase II study of daily sunitinib in FDG-PET-positive, iodine-refractory differentiated thyroid cancer and metastatic medullary carcinoma of the thyroid with functional imaging correlation. Clin Cancer Res. 2010; 16: 5260-5268.
11. 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: 4708-4713.
12. Elisei R, Schlumberger MJ, Muller SP, et al. Cabozantinib in progressive medullary thyroid cancer. J Clin Oncol. 2013; 31: 3639-3646.
13. Gupta-Abramson V, Troxel AB, Nellore A, et al. Phase II trial of sorafenib in advanced thyroid cancer. J Clin Oncol. 2008; 26: 4714-4719.
14. Kloos RT, Ringel MD, Knopp MV, et al. Phase II trial of sorafenib in metastatic thyroid cancer. J Clin Oncol. 2009; 27: 1675-1684.
15. 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. 2011; 29: 2660-2666.
16. Leboulleux S, Bastholt L, Krause T, et al. Vandetanib in locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 2 trial. Lancet Oncol. 2012; 13: 897-905.
17. Schlumberger MJ, Elisei R, Bastholt L, et al. Phase II study of safety and efficacy of motesanib in patients with progressive or symptomatic, advanced or metastatic medullary thyroid cancer. J Clin Oncol. 2009; 27: 3794-3801.
18. Schoffski P, Elisei R, Muller S, et al. An international, double-blind, randomized, placebo-controlled phase III trial (EXAM) of cabozantinib (XL184) in medullary thyroid carcinoma (MTC) patients (pts) with documented RECIST progression at baseline [abstract]. J Clin Oncol. 2012; 30 (suppl). Abstract 5508.
19. Sherman SI, Wirth LJ, Droz JP, et al. Motesanib diphosphate in progressive differentiated thyroid cancer. N Engl J Med. 2008; 359: 31-42.
20. Wells SA Jr, Robinson BG, Gagel RF, et al. Vandetanib in patients with locally advanced or metastatic medullary thyroid cancer: a randomized, double-blind phase III trial. J Clin Oncol. 2012; 30: 134-141.
21. Brose MS, Smit J, Capdevila J, et al. Regional approaches to the management of patients with advanced, radioactive iodine-refractory differentiated thyroid carcinoma. Expert Rev Anticancer Ther. 2012; 12: 1137-1147.
22. Anderson RT, Linnehan JE, Tongbram V, Keating K, Wirth LJ,. Clinical, safety, and economic evidence in radioactive iodine-refractory differentiated thyroid cancer: a systematic literature review. Thyroid. 2013; 23: 392-407.
23. Hu-Lowe DD, Zou HY, Grazzini ML, et al. Nonclinical antiangiogenesis and antitumor activities of axitinib (AG-013736), an oral, potent, and selective inhibitor of vascular endothelial growth factor receptor tyrosine kinases 1, 2, 3. Clin Cancer Res. 2008; 14: 7272-7283.
24. Pfizer Inc. Inlyta (axitinib) [prescribing information]. New York: Pfizer Inc.; 2012.
25. 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: 205-216.
26. Cancer Therapy Evaluation Program (CTEP). Common Terminology Criteria for Adverse Events, Version 3.0. Bethesda, MD: National Cancer Institute; 2006. Available at: http://ctep.cancer.gov/protocolDevelopment/electronic- applications/docs/ctcaev3.pdf. Accessed September 27, 2013.
27. Cleeland CS,. The MD Anderson Symptom Inventory User Guide: June 25, 2013 [draft]. Houston, TX: The University of Texas MD Anderson Cancer Center; 2013. Available at: http://www.mdanderson.org/education-and-research/departments- programs-and-labs/departments-and-divisions/symptom-research/ symptom-assessment-tools/MDASI-userguide.pdf. Accessed November 6, 2013.
28. Rini BI, Garrett M, Poland B, et al. Axitinib in metastatic renal cell carcinoma: results of a pharmacokinetic and pharmacodynamic analysis. J Clin Pharmacol. 2013; 53: 491-504.
29. Motzer RJ, Escudier B, Tomczak P, et al. Axitinib versus sorafenib as second-line treatment for advanced renal cell carcinoma: overall survival analysis and updated results from a randomised phase 3 trial. Lancet Oncol. 2013; 14: 552-562.
30. Rini BI, Schiller JH, Fruehauf JP, et al. Diastolic blood pressure as a biomarker of axitinib efficacy in solid tumors. Clin Cancer Res. 2011; 17: 3841-3849.
31. Rini BI, Escudier B, Tomczak P, et al. Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial. Lancet. 2011; 378: 1931-1939.
32. Brose MS, Nutting C, Jarzab B, et al. Sorafenib in locally advanced or metastatic patients with radioactive iodine-refractory differentiated thyroid cancer: the phase III DECISION trial [abstract]. J Clin Oncol. 2013; 31 (suppl). Abstract 4.
33. Edgerly M, Fojo T,. Is there room for improvement in adverse event reporting in the era of targeted therapies? J Natl Cancer Inst. 2008; 100: 240-242.
34. Singer S, Lincke T, Gamper E, et al. Quality of life in patients with thyroid cancer compared with the general population. Thyroid. 2012; 22: 117-124.
35. Husson O, Haak HR, Buffart LM, et al. Health-related quality of life and disease specific symptoms in long-term thyroid cancer survivors: a study from the population-based PROFILES registry. Acta Oncol. 2013; 52: 249-258.
36. Roberts KJ, Lepore SJ, Urken ML,. Quality of life after thyroid cancer: an assessment of patient needs and preferences for information and support. J Cancer Educ. 2008; 23: 186-191.