Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: a randomised controlled trial

Lancet

Volumn 368, Issue 9544, 2006, Pages 1329-1338

  Demetri, George D ^a   van Oosterom, Allan T ^b   Garrett, Christopher R ^c   Blackstein, Martin E ^d   Shah, Manisha H ^e   Verweij, Jaap ^f   McArthur, Grant ^g   Judson, Ian R ^h   Heinrich, Michael C ⁱ   Morgan, Jeffrey A ^a   Desai, Jayesh ^a   Fletcher, Christopher D ^j   George, Suzanne ^a   Bello, Carlo L ^k   Huang, Xin ^k   Baum, Charles M ^k   Casali, Paolo G ^l  

^a HARVARD MEDICAL SCHOOL   (United States)

^b Katholieke Universiteit Leuven   (Belgium)

^c H LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE   (United States)

^d MOUNT SINAI HOSPITAL   (Canada)

^e OHIO STATE UNIVERSITY   (United States)

^f ERASMUS MEDICAL CENTER   (Netherlands)

^g ST VINCENT S HOSPITAL   (Australia)

^h ROYAL MARSDEN HOSPITAL   (United Kingdom)

ⁱ OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^j BRIGHAM AND WOMEN S HOSPITAL   (United States)

^k PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United States)

^l NATIONAL CANCER INSTITUTE   (Italy)

more..

Author keywords

[No Author keywords available]

Indexed keywords

DRUG METABOLITE; IMATINIB; PLACEBO; SU 12662; SUNITINIB; UNCLASSIFIED DRUG;

ADULT; AGED; ANEMIA; ANOREXIA; ARTICLE; ASTHENIA; CANCER SURVIVAL; CLINICAL TRIAL; CONGESTIVE HEART FAILURE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; DRUG TOLERABILITY; DYSGEUSIA; DYSPEPSIA; EPISTAXIS; FATIGUE; FEMALE; GASTROINTESTINAL STROMAL TUMOR; GLOSSODYNIA; HAIR COLOR CHANGE; HAND FOOT SYNDROME; HUMAN; HYPERTENSION; HYPOTHYROIDISM; LEUKOPENIA; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; MUCOSA INFLAMMATION; MULTICENTER STUDY; NAUSEA; NEUTROPENIA; PANCREATITIS; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SKIN DISCOLORATION; STOMATITIS; THROMBOCYTOPENIA; TREATMENT FAILURE; TUMOR GROWTH; VOMITING; XEROSTOMIA;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; DOUBLE-BLIND METHOD; FEMALE; GASTROINTESTINAL STROMAL TUMORS; HUMANS; INDOLES; MALE; MIDDLE AGED; PIPERAZINES; PROTEIN KINASE INHIBITORS; PYRIMIDINES; PYRROLES; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

EID: 33749505836     PISSN: 01406736     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0140-6736(06)69446-4     Document Type: Article

References (37)

1. Miettinen M., and Lasota J. Gastrointestinal stromal tumors-definition, clinical, histological, immunohistochemical, and molecular genetic features and differential diagnosis. Virchows Arch 438 (2001) 1-12
2. Pierie J., Choudry U., Muzikansky A., et al. The effect of surgery and grade on outcome of gastrointestinal stromal tumors. Arch Surg 136 (2001) 383-389
3. DeMatteo R., Lewis J., Leung D., et al. Two hundred gastrointestinal stromal tumors: recurrence patterns and prognostic factors for survival. Ann Surg 231 (2000) 51-58
4. Plaat B., Hollema H., Molenaar W., et al. Soft tissue leiomyosarcomas and malignant gastrointestinal stromal tumors: differences in clinical outcome and expression of multidrug resistance proteins. J Clin Oncol 18 (2000) 3211-3220
5. Hirota S., Isozaki K., Moriyama Y., et al. Gain-of-function mutations of c-kit in human gastrointestinal stromal tumors. Science 279 (1998) 577-580
6. Heinrich M., Corless C., Demetri G., et al. Kinase mutations and imatinib response in patients with metastatic gastrointestinal stromal tumor. J Clin Oncol 21 (2003) 4342-4349
7. Heinrich M., Corless C., Duensing A., et al. PDGFRA activating mutations in gastrointestinal stromal tumors. Science 299 (2003) 708-710
8. Dematteo R., Heinrich M., El-Rifai W., and Demetri G. Clinical management of gastrointestinal stromal tumors: before and after STI-571. Hum Pathol 33 (2002) 466-477
9. Edmonson J., Marks R., Buckner J., and Mahoney M. Contrast of response to dacarbazine, mitomycin, doxorubicin, and cisplatin (DMAP) plus GM-CSF between patients with advanced malignant gastrointestinal stromal tumors and patients with other advanced leiomyosarcomas. Cancer Invest 20 (2002) 605-612
10. Joensuu H., Fletcher C., Dimitrijevic S., et al. Management of malignant gastrointestinal stromal tumours. Lancet Oncol 3 (2002) 655-664
11. Demetri G., von Mehren M., Blanke C., et al. Efficacy and safety of imatinib mesylate in advanced gastrointestinal stromal tumors. N Engl J Med 347 (2002) 472-480
12. Verweij J., Casali P., Zalcberg J., et al. Progression-free survival in gastrointestinal stromal tumours with high-dose imatinib: randomised trial. Lancet 364 (2004) 1127-1134
13. Debiec-Rychter M., Cools J., Dumez H., et al. Mechanisms of resistance to imatinib mesylate in gastrointestinal stromal tumors and activity of the PKC412 inhibitor against imatinib-resistant mutants. Gastroenterology 128 (2005) 270-279
14. Chen L., Trent J., Wu E., et al. A missense mutation in KIT kinase domain 1 correlates with imatinib resistance in gastrointestinal stromal tumors. Cancer Res 64 (2004) 5913-5919
15. Antonescu C., Besmer P., Guo T., et al. Acquired resistance to imatinib in gastrointestinal stromal tumor occurs through secondary gene mutation. Clin Cancer Res 11 (2005) 4182-4190
16. Osusky K., Hallahan D., Fu A., et al. The receptor tyrosine kinase inhibitor SU11248 impedes endothelial cell migration, tubule formation, and blood vessel formation in vivo, but has little effect on existing tumor vessels. Angiogenesis 7 (2004) 225-233
17. Abrams T., Lee L., Murray L., Pryer N., and Cherrington J. SU11248 inhibits KIT and platelet-derived growth factor receptor beta in preclinical models of human small cell lung cancer. Mol Cancer Ther 2 (2003) 471-478
18. Mendel D., Laird A., Xin X., et al. In vivo antitumor activity of SU11248, a novel tyrosine kinase inhibitor targeting vascular endothelial growth factor and platelet-derived growth factor receptors: determination of a pharmacokinetic/pharmacodynamic relationship. Clin Cancer Res 9 (2003) 327-337
19. Murray L., Abrams T., Long K., et al. SU11248 inhibits tumor growth and CSF-1R-dependent osteolysis in an experimental breast cancer bone metastasis model. Clin Exp Metastasis 20 (2003) 757-766
20. O'Farrell A., Abrams T., Yuen H., et al. SU11248 is a novel FLT3 tyrosine kinase inhibitor with potent activity in vitro and in vivo. Blood 101 (2003) 3597-3605
21. Schueneman A., Himmelfarb E., Geng L., et al. SU11248 maintenance therapy prevents tumor regrowth after fractionated irradiation of murine tumor models. Cancer Res 63 (2003) 4009-4016
22. Heinrich M., Maki R., Corless C., et al. Sunitinib (SU) response in imatinib-resistant (IM-R) GIST correlates with KIT and PDGFRA mutation status. J Clin Oncol 24 suppl (2006) 9502
23. Therasse P., Arbuck S., Eisenhauer E., et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 92 (2000) 205-216
24. WHO. Handbook for reporting results of cancer treatment (1979), World Health Organization, Geneva
25. Melzack R. The McGill Pain Questionnaire: major properties and scoring methods. Pain 1 (1975) 277-299
26. Smeraglia J. Bioanalytical method validation life cycle for the measurement of SU011248, and metabolites SU012662 and SU012487 in human plasma (oral presentation) (2005), 16th International Reid Bioanalytical Forum, Guildford
27. Lan K., and DeMets D. Discrete sequential boundaries for clinical trials. Biometrika 70 (1983) 659-663
28. von Mehren M., and Watson J. Gastrointestinal stromal tumors. Hematol Oncol Clin North Am 19 (2005) 547-564
29. Zalcberg J., Verweij J., Casali P., et al. Outcome of patients with advanced gastro-intestinal stromal tumours crossing over to a daily imatinib dose of 800 mg after progression on 400 mg. Eur J Cancer 41 (2005) 1751-1757
30. Le Cesne A, Perol D, Ray-Coquard I, et al. Interruption of imatinib (IM) in GIST patients with advanced disease: updated results of the prospective French Sarcoma Group randomized phase III trial on survival and quality of life. Orlando: American Society of Clinical Oncology 41st Annual Meeting, 2005 (abstr 9031). http://www.asco.org/portal/site/ASCOmenuitem. 34d60f5624ba07fd506fe310ee37a01d/?vgnextoid=76f8201eb61a7010VgnVCM100000ed730ad1RCRD&vmview=abst_detail_view&confID=34&abstractID=31090 (accessed Sept 29, 2006).
31. Desai J, Dileo P, Morgan JA, et al. Hypothyroidism may accompany SU11248 therapy in a subset of patients (pts) with metastatic (met) gastrointestinal stromal tumors (GIST) and is manageable with replacement therapy. Orlando: American Society of Clinical Oncology 41st Annual Meeting, 2005 (abstr 3040). http://www.asco.org/portal/site/ASCO/menuitem.34d60f5624ba07fd506fe310ee37a01d/?vgnextoid=76f8201eb61a7010VgnVCM100000ed730ad1RCRD&vmview=abst_detail_view&confID=34&abstractID=30943 (accessed Sept 29, 2006)
32. Zondor S., and Medina P. Bevacizumab: an angiogenesis inhibitor with efficacy in colorectal and other malignancies. Ann Pharmacother 38 (2004) 1258-1264
33. Thomas A., Morgan B., Drevs J., et al. Vascular endothelial growth factor receptor tyrosine kinase inhibitors: PTK787/ZK 222584. Semin Oncol 30 (2003) 32-38
34. Debiec-Rychter M., Dumez H., Judson I., et al. Use of c-KIT/PDGFRA mutational analysis to predict the clinical response to imatinib in patients with advanced gastrointestinal stromal tumours entered on phase I and II studies of the EORTC Soft Tissue and Bone Sarcoma Group. Eur J Cancer 40 (2004) 689-695
35. Tamborini E., Bonadiman L., Greco A., et al. A new mutation in the KIT ATP pocket causes acquired resistance to imatinib in a gastrointestinal stromal tumor patient. Gastroenterology 127 (2004) 294-299
36. Wakai T., Kanda T., Hirota S., et al. Late resistance to imatinib therapy in a metastatic gastrointestinal stromal tumour is associated with a second KIT mutation. Br J Cancer 90 (2004) 2059-2061
37. Wardelmann E., Thomas N., Merkelbach-Bruse S., et al. Acquired resistance to imatinib in gastrointestinal stromal tumours caused by multiple KIT mutations. Lancet Oncol 6 (2005) 249-251