Analysis of the efficacy and toxicity of sorafenib in thyroid cancer: A phase II study in a UK based population

European Journal of Endocrinology

Volumn 165, Issue 2, 2011, Pages 315-322

  Ahmed, Merina ^a   Barbachano, Yolanda ^a   Riddell, Angela ^a   Hickey, Jen ^a   Newbold, Katie L ^a   Viros, Amaya ^b   Harrington, Kevin J ^a,b   Marais, Richard ^b   Nutting, Christopher M ^a  

^a INSTITUTE OF CANCER RESEARCH   (United Kingdom)

^b INSTITUTE OF CANCER RESEARCH   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CALCITONIN; CARCINOEMBRYONIC ANTIGEN; LIOTHYRONINE; SORAFENIB; THYROTROPIN; THYROXINE; B RAF KINASE; BIOLOGICAL MARKER; TRIACYLGLYCEROL LIPASE; ANTINEOPLASTIC AGENT; BENZENESULFONIC ACID DERIVATIVE; PYRIDINE DERIVATIVE;

ABDOMINAL PAIN; ACUTE PANCREATITIS; ADULT; AGED; ALOPECIA; ANEMIA; ANOREXIA; ARTHRALGIA; ARTICLE; BLEEDING; BONE MARROW SUPPRESSION; BONE PAIN; BRAF GENE; CANCER SURVIVAL; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; COMMON COLD; CONSTIPATION; COUGHING; DEPRESSION; DERMATITIS; DIARRHEA; DIFFERENTIATED THYROID CANCER; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FEVER; DRUG HYPERSENSITIVITY; DRUG INDUCED HEADACHE; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPEPSIA; DYSPHAGIA; DYSPNEA; ERYTHEMA; FACE ERYTHEMA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FLATULENCE; FLU LIKE SYNDROME; FOLLICULAR OCCLUSION; GENE; GLOSSITIS; GLOSSODYNIA; HAIR COLOR; HAIR DISEASE; HAND FOOT SYNDROME; HOARSENESS; HOT FLUSH; HUMAN; HYPERAMYLASEMIA; HYPERTENSION; HYPERTRANSAMINASEMIA; HYPOPIGMENTATION; HYPOTHYROIDISM; INFECTION; INSOMNIA; MALE; MUCOSA INFLAMMATION; MUCOSAL DRYNESS; MUSCLE CRAMP; MYALGIA; NAUSEA; NEUROPATHY; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RET GENE; SIDE EFFECT; SKIN DISEASE; SKIN TOXICITY; SORE THROAT; TACHYCARDIA; THYROID MEDULLARY CARCINOMA; THYROTROPIN BLOOD LEVEL; TRIACYLGLYCEROL LIPASE BLOOD LEVEL; UNITED KINGDOM; WEIGHT REDUCTION; XEROSIS; DISEASE COURSE; DRUG ERUPTION; DRUG SAFETY; LIVER DYSFUNCTION; OUTCOME ASSESSMENT; PHOTOSENSITIVITY; POPULATION RESEARCH; PROTEIN ANALYSIS; THYROIDECTOMY; TREATMENT DURATION; TREATMENT RESPONSE; VOMITING; CARCINOMA; CLINICAL TRIAL; MIDDLE AGED; MORTALITY; POPULATION; SURVIVAL; THYROID TUMOR; TREATMENT OUTCOME;

ADULT; AGED; ANTINEOPLASTIC AGENTS; BENZENESULFONATES; CARCINOMA; FEMALE; GREAT BRITAIN; HUMANS; MALE; MIDDLE AGED; POPULATION; PYRIDINES; SURVIVAL ANALYSIS; THYROID NEOPLASMS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 79960179069     PISSN: 08044643     EISSN: 1479683X     Source Type: Journal    
DOI: 10.1530/EJE-11-0129     Document Type: Article

References (28)

1. Jemal A, Murray T, Ward E, Samuels A, Tiwari RC, Ghafoor A, Feuer EJ & Thun MJ. Cancer statistics. CA: A Cancer Journal for Clinicians 2005 55 10-30. (doi:10.3322/canjclin.55.1.10)
2. IARC, Cancer Incidence, Prevalence and Mortality Worldwide (2002 estimates). 2006. (http://globocan.iarc.fr/)
3. Wang W, Macapinlac H, Larson SM, Yeh SD, Akhurst T, Finn RD, Rosai J & Robbins RJ. [18F]-2-fluoro-2-deoxy-D-glucose positron emission tomography localizes residual thyroid cancer in patients with negative diagnostic (131)I whole body scans and elevated serum thyroglobulin levels. Journal of Clinical Endocrinology and Metabolism 1999 84 2291-2302. (doi:10.1210/jc.84.7.2291)
4. Mazzaferri EL. An overview of the management of papillary and follicular thyroid carcinoma. Thyroid 1999 9 421-427. (doi:10.1089/thy.1999.9.421)
5. Orlandi F, Caraci P, Mussa A, Saggiorato E, Pancani G & Angeli A. Treatment of medullary thyroid carcinoma: an update. Endocrine- Related Cancer 2001 8 135-147. (doi:10.1677/erc.0.0080135)
6. Wright PA, Lemoine NR, Mayall ES, Wyllie FS, Hughes D, Williams ED & Wynford-Thomas D. Papillary and follicular thyroid carcinomas show a different pattern of ras oncogene mutation. British Journal of Cancer 1989 60 576-577. (doi:10.1038/bjc.1989.316)
7. Xing M. BRAF mutation in thyroid cancer. Endocrine-Related Cancer 2005 12 245-262. (doi:10.1677/erc.1.0978)
8. Knauf JA, Ma X, Smith EP, Zhang L, Mitsutake N, Liao XH, Refetoff S, Nikiforov YE & Fagin JA. Targeted expression of BRAFV600E in thyroid cells of transgenic mice results in papillary thyroid cancers that undergo dedifferentiation. Cancer Research 2005 65 4238-4245. (doi:10.1158/0008-5472. CAN-05-0047)
9. Vasko V, Ferrand M, Di Cristofaro J, Carayon P, Henry JF & de Micco C. Specific pattern of RAS oncogene mutations in follicular thyroid tumors. Journal of Clinical Endocrinology and Metabolism 2003 88 2745-2752. (doi:10.1210/jc.2002-021186)
10. Mulligan LM, Kwok JB, Healey CS, Elsdon MJ, Eng C, Gardner E, Love DR, Mole SE, Moore JK & Papi L. Germ-line mutations of the RET proto-oncogene in multiple endocrine neoplasia type 2A. Nature 1993 363 458-460. (doi:10.1038/363458a0)
11. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC & Gwyther SG. 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. Journal of National Cancer Institute 2000 92 205-216. (doi:10.1093/jnci/92.3.205)
12. 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'Dwyer PJ & Ratain MJ. Sorafenib in advanced melanoma: a phase II randomised discontinuation trial analysis. British Journal of Cancer 2006 95 581-586. (doi:10.1038/sj.bjc.6603291)
13. A'Hern RP. Sample size tables for exact single-stage phase II designs. Statistics in Medicine 2001 20 859-866. (doi:10.1002/sim.721)
14. Kloos RT, Ringel MD, Knopp MV, Hall NC, King M, Stevens R, Liang J, Wakely PE Jr, Vasko VV, Saji M, Rittenberry J, Wei L, Arbogast D, Collamore M, Wright JJ, Grever M & Shah MH. Phase II trial of sorafenib in metastatic thyroid cancer. Journal of Clinical Oncology 2009 27 1675-1684. (doi:10.1200/JCO.2008.18.2717)
15. Gupta-Abramson V, Troxel AB, Nellore A, Puttaswamy K, Redlinger M, Ransone K, Mandel SJ, Flaherty KT, Loevner LA, O'Dwyer PJ & Brose MS. Phase II trial of sorafenib in advanced thyroid cancer. Journal of Clinical Oncology 2008 26 4714-4719. (doi:10.1200/JCO.2008.16.3279)
16. Cohen EE, Rosen LS, Vokes EE, Kies MS, Forastiere AA, Worden FP, Kane MA, Sherman E, Kim S, Bycott P, Tortorici M, Shalinsky DR, Liau KF & Cohen RB. Axitinib is an active treatment for all histologic subtypes of advanced thyroid cancer: results from a phase II study. Journal of Clinical Oncology 2008 26 4708-4713. (doi:10.1200/JCO.2007.15.9566)
17. Sherman SI, Wirth LJ, Droz JP, Hofmann M, Bastholt L, Martins RG, Licitra L, Eschenberg MJ, Sun YN, Juan T, Stepan DE, Schlumberger MJ & Motesanib Thyroid Cancer Study Group . Motesanib diphosphate in progressive differentiated thyroid cancer. New England Journal of Medicine 2008 359 31-42. (doi:10.1056/NEJMoa075853)
18. Lam ET, Ringel MD, Kloos RT, Prior TW, Knopp MV, Liang J, Sammet S, Hall NC, Wakely PE Jr, Vasko VV, Saji M, Snyder PJ, Wei L, Arbogast D, Collamore M, Wright JJ, Moley JF, Villalona- Calero MA & Shah MH. Phase II clinical trial of sorafenib in metastatic medullary thyroid cancer. Journal of Clinical Oncology 2010 28 2323-2330. (doi:10.1200/JCO.2009.25.0068)
19. Hauschild A, Agarwala SS, Trefzer U, Hogg D, Robert C, Hersey P, Eggermont A, Grabbe S, Gonzalez R, Gille J, Peschel C, Schadendorf D, Garbe C, O'Day S, Daud A, White JM, Xia C, Patel K, Kirkwood JM & Keilholz U. Results of a phase III, randomized, placebo-controlled study of sorafenib in combination with carboplatin and paclitaxel as second-line treatment in patients with unresectable stage III or stage IV melanoma. Journal of Clinical Oncology 2009 27 2823-2830. (doi:10.1200/JCO.2007.15.7636)
20. Davies H, Bignell GR, Cox C, Stephens P, Edkins S, Clegg S, Teague J, Woffendin H, Garnett MJ, Bottomley W, Davis N, Dicks E, Ewing R, Floyd Y, Gray K, Hall S, Hawes R, Hughes J, Kosmidou V, Menzies A, Mould C, Parker A, Stevens C, Watt S, Hooper S, Wilson R, Jayatilake H, Gusterson BA, Cooper C, Shipley J, Hargrave D, Pritchard-Jones K, Maitland N, Chenevix-Trench G, Riggins GJ, Bigner DD, Palmieri G, Cossu A, Flanagan A, Nicholson A, Ho JW, Leung SY, Yuen ST, Weber BL, Seigler HF, Darrow TL, Paterson H, Marais R, Marshall CJ, Wooster R, Stratton MR & Futreal PA. Mutations of the BRAF gene in human cancer. Nature 2002 417 949-954. (doi:10.1038/nature00766)
21. Chapman P, Puzanov I, Sosman J, Kim K, Ribas A, McArthur G, Lee R, Grippo J, Nolop K & Flaherty K. Early efficacy signal demonstrated in advanced melanoma in a phase I trial of the oncogenic BRAF-selective inhibitor PLX4032. European Journal of Cancer. Supplements 2009 7 5. In Joint ECCO 15-34th ESMO. Berlin. (doi:10.1016/S1359-6349(09)72036-1)
22. Ratain MJ & Eckhardt SG. Phase II studies of modern drugs directed against new targets: if you are fazed, too, then resist RECIST. Journal of Clinical Oncology 2004 22 4442-4445. (doi:10.1200/JCO.2004.07.960)
23. Flaherty KT, Rosen MA, Heitjan DF, Gallagher ML, Schwartz B, Schnall MD & O'Dwyer PJ. Pilot study of DCE-MRI to predict progression-free survival with sorafenib therapy in renal cell carcinoma. Cancer Biology & Therapy 2008 7 496-501. (doi:10.4161/cbt.7.4.5624)
24. Dottorini ME, Assi A, Sironi M, Sangalli G, Spreafico G & Colombo L. Multivariate analysis of patients with medullary thyroid carcinoma. Prognostic significance and impact on treatment of clinical and pathologic variables. Cancer 1996 77 1556-1565. (doi:10.1002/(SICI)1097-0142(19960415)77:8〈1556:: AID-CNCR20〉3.0.CO;2-Y)
25. Barbet J, Campion L, Kraeber-Bodéré F, Chatal JF & GTE Study Group . Prognostic impact of serum calcitonin and carcinoembryonic antigen doubling-times in patients with medullary thyroid carcinoma. Journal of Clinical Endocrinology and Metabolism 2005 90 6077-6084. (doi:10.1210/jc.2005- 0044)
26. Escudier B, Szczylik C, Hutson TE, Demkow T, Staehler M, Rolland F, Negrier S, Laferriere N, Scheuring UJ, Cella D, Shah S & Bukowski RM. Randomized phase II trial of first-line treatment with sorafenib versus interferon Alfa-2a in patients with metastatic renal cell carcinoma. Journal of Clinical Oncology 2009 27 1280-1289. (doi:10.1200/JCO.2008.19.3342)
27. Akeno-Stuart N, Croyle M, Knauf JA, Malaguarnera R, Vitagliano D, Santoro M, Stephan C, Grosios K, Wartmann M, Cozens R, Caravatti G, Fabbro D, Lane HA & Fagin JA. The RET kinase inhibitor NVP-AST487 blocks growth and calcitonin gene expression through distinct mechanisms in medullary thyroid cancer cells. Cancer Research 2007 67 6956-6964. (doi:10.1158/0008-5472.CAN-06-4605)
28. 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, Häussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J & SHARP Investigators Study Group . Sorafenib in advanced hepatocellular carcinoma. New England Journal of Medicine 2008 359 378-390. (doi:10.1056/NEJMoa0708857)