A prospective, multicenter, phase 2 study of imatinib mesylate in Korean patients with metastatic or unresectable gastrointestinal stromal tumor

Oncology

Volumn 76, Issue 5, 2009, Pages 326-332

  Ryu, Min Hee ^a   Kang, Won Ki ^b   Bang, Yung Jue ^c   Lee, Kyung Hee ^f   Shin, Dong Bok ^g   Ryoo, Baek Yeol ^h   Roh, Jae Kyung ^d   Kang, Jin Hyoung ^e   Lee, Hyoungnam ^a   Kim, Tae Won ^a   Chang, Heung Moon ^a   Park, Joon Oh ^b   Park, Young Suk ^b   Kim, Tae You ^c   Kim, Min Kyoung ^f   Lee, Woon Kee ^g   Kang, Hye Jin ^h   Kang, Yoon Koo ^a,i  

^a Asan Medical Center   (South Korea)

^b Samsung Medical Center   (South Korea)

^c Seoul National University Hospital   (South Korea)

^d Yonsei University College of Medicine   (South Korea)

^e The Catholic University of Korea   (South Korea)

^f Yeungnam University Hospital   (South Korea)

^g Gachon University   (South Korea)

^h Korea Cancer Center Hospital   (South Korea)

ⁱ University of Ulsan College of Medicine   (South Korea)

Author keywords

Gastrointestinal stromal tumor; Imatinib; KIT

Indexed keywords

ANTIBIOTIC AGENT; IMATINIB; PLATELET DERIVED GROWTH FACTOR RECEPTOR; STEM CELL FACTOR;

ABDOMINAL PAIN; ADULT; AGED; ANEMIA; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED STUDY; CYTOPENIA; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; EDEMA; EXON; FEBRILE NEUTROPENIA; FEMALE; FOLLOW UP; GASTROINTESTINAL STROMAL TUMOR; GENE MUTATION; GENE SEQUENCE; HISTOPATHOLOGY; HUMAN; HUMAN TISSUE; MALE; MULTICENTER STUDY; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROSPECTIVE STUDY; TREATMENT RESPONSE;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; FEMALE; GASTROINTESTINAL STROMAL TUMORS; GENOTYPE; HUMANS; MALE; MIDDLE AGED; NEOPLASM STAGING; PIPERAZINES; POLYMORPHISM, GENETIC; PROGNOSIS; PROSPECTIVE STUDIES; PROTEIN-TYROSINE KINASES; PROTO-ONCOGENE PROTEINS C-KIT; PYRIMIDINES; RECEPTOR, PLATELET-DERIVED GROWTH FACTOR ALPHA; REMISSION INDUCTION; RISK FACTORS; SURVIVAL RATE; TREATMENT OUTCOME;

EID: 62649174800     PISSN: 00302414     EISSN: None     Source Type: Journal    
DOI: 10.1159/000209384     Document Type: Article

References (24)

1. Heinrich MC, Corless CL, Duensing A, Mc-Greevey L, Chen CJ, Joseph N, Singer S, Griffith DJ, Haley A, Town A, Demetri GD, Fletcher CD, et al: PDGFRA activating mutations in gastrointestinal stromal tumors. Science 2003; 299: 708-710.
2. Hirota S, Isozaki K, Moriyama Y, Hashimoto K, Nishida T, Ishiguro S, Kawano K, Hanada M, Kurata A, Takeda M, Muhammad Tunio G, Matsuzawa Y, et al: Gain-of-function mutations of c-kit in human gastrointestinal stromal tumors. Science 1998; 279: 577-580.
3. Savage DG, Antman KH: Imatinib mesylate - a new oral targeted therapy. N Engl J Med 2002; 346: 683-693.
4. Mudan SS, Conlon KC, Woodruff JM, Lewis JJ, Brennan MF: Salvage surgery for patients with recurrent gastrointestinal sarcoma: prognostic factors to guide patient selection. Cancer 2000; 88: 66-74.
5. Verweij J, Casali PG, Zalcberg J, LeCesne A, Reichardt P, Blay JY, Issels R, van Oosterom A, Hogendoorn PC, Van Glabbeke M, Bertulli R, Judson I: Progression-free survival in gastrointestinal stromal tumours with highdose imatinib: randomised trial. Lancet 2004; 364: 1127-1134.
6. Green S, Weiss GR: Southwest Oncology Group standard response criteria, endpoint definitions and toxicity criteria. Invest New Drugs 1992; 10: 239-253.
7. van Oosterom AT, Judson IR, Verweij J, Stroobants S, Dumez H, Donato di Paola E, Sciot R, Van Glabbeke M, Dimitrijevic S, Nielsen OS: Update of phase I study of imatinib (STI571) in advanced soft tissue sarcomas and gastrointestinal stromal tumors: a report of the EORTC Soft Tissue and Bone Sarcoma Group. Eur J Cancer 2002; 38(suppl 5):S83-S87.
8. Verweij J, van Oosterom A, Blay JY, Judson I, Rodenhuis S, van der Graaf W, Radford J, Le Cesne A, Hogendoorn PC, di Paola ED, Brown M, Nielsen OS: Imatinib mesylate (STI-571 Glivec, Gleevec) is an active agent for gastrointestinal stromal tumours, but does not yield responses in other soft-tissue sarcomas that are unselected for a molecular target. Results from an EORTC Soft Tissue and Bone Sarcoma Group phase II study. Eur J Cancer 2003; 39: 2006-2011.
9. Demetri GD, von Mehren M, Blanke CD, Van den Abbeele AD, Eisenberg B, Roberts PJ, Heinrich MC, Tuveson DA, Singer S, Janicek M, Fletcher JA, Silverman SG, et al: Efficacy and safety of imatinib mesylate in advanced gastrointestinal stromal tumors. N Engl J Med 2002; 347: 472-480.
10. Blanke CD, Demetri GD, von Mehren M, Heinrich MC, Eisenberg B, Fletcher JA, Corless CL, Fletcher CD, Roberts PJ, Heinz D, Wehre E, Nikolova Z, et al: Long-term results from a randomized phase II trial of standard- versus higher-dose imatinib mesylate for patients with unresectable or metastatic gastrointestinal stromal tumors expressing KIT. J Clin Oncol 2008; 26: 620-625.
11. Rankin C, Von Mehren M, Blanke C, Benjamin R, Fletcher CDM, Bramwell V, Crowley J, Borden E, Demetri GD, for the Collaborating Investigators of the North American Sarcoma Intergroup: Dose effect of imatinib (IM) in patients (pts) with metastatic GIST - Phase III Sarcoma Group Study S0033 (abstract 9005). Proc Am Soc Clin Oncol 2004, vol 22.
12. Debiec-Rychter M, Dumez H, Judson I, Wasag B, Verweij J, Brown M, Dimitrijevic S, Sciot R, Stul M, Vranck H, Scurr M, Hagemeijer A, 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 2004; 40: 689-695.
13. Debiec-Rychter M, Sciot R, Le Cesne A, Schlemmer M, Hohenberger P, van Oosterom AT, Blay JY, Leyvraz S, Stul M, Casali PG, Zalcberg J, Verweij J, et al: KIT mutations and dose selection for imatinib in patients with advanced gastrointestinal stromal tumours. Eur J Cancer 2006; 42: 1093-1103.
14. Heinrich MC, Corless CL, Demetri GD, Blanke CD, Von Mehren M, Joensuu H, Mc-Greevey LS, Chen CJ, Van Den Abbeele AD, Druker BJ, Kiese B, Eisenberg B, et al: Kinase mutations and imatinib response in patients with metastatic gastrointestinal stromal tumor. J Clin Oncol 2003; 21: 4342-4349.
15. Casali P, Verweij J, Kotasek D, Le Cesne A, Reichardt P, Blay JY, Issels R, Debiec-Rychter M, Van Glabbeke M, Judson I: Imatinib mesylate in advanced gastrointestinal stromal tumors (GIST): survival analysis of the intergroup EORTC/ISG/AGITG randomized trial in 946 patients (ECCO abstract 711). Paris, 2005 ECCO 13 - European Cancer Conference. Eur J Cancer Suppl 2005; 3: 201.
16. Blanke CD, Rankin C, Demetri GD, Ryan CW, von Mehren M, Benjamin RS, Raymond AK, Bramwell VH, Baker LH, Maki RG, Tanaka M, Hecht JR, Heinrich MC, Fletcher CD, Crowley JJ, Borden EC: Phase III randomized, intergroup trial assessing imatinib mesylate at two dose levels in patients with unresectable or metastatic gastrointestinal stromal tumors expressing the kit receptor tyrosine kinase: S0033. J Clin Oncol 2008; 26: 626-632.
17. Van Glabbeke MM, Owzar K, Rankin C, Simes J, Crowley J, for GIST Meta-Analysis Group (MetaGIST): Comparison of two doses of imatinib for the treatment of unresectable or metastatic gastrointestinal stromal tumors (GIST): a meta-analysis based on 1,640 patients (pts) (ASCO abstract 10004). J Clin Oncol 2007; 25: 546s.
18. Heinrich MC, Blanke CD, Druker BJ, Corless CL: Inhibition of KIT tyrosine kinase activity: a novel molecular approach to the treatment of KIT-positive malignancies. J Clin Oncol 2002; 20: 1692-1703.
19. Judson I, Ma P, Peng B, Verweij J, Racine A, di Paola ED, van Glabbeke M, Dimitrijevic S, Scurr M, Dumez H, van Oosterom A: Imatinib pharmacokinetics in patients with gastrointestinal stromal tumour: a retrospective population pharmacokinetic study over time. EORTC Soft Tissue and Bone Sarcoma Group. Cancer Chemother Pharmacol 2005; 55: 379-386.
20. Widmer N, Decosterd LA, Csajka C, Leyvraz S, Duchosal MA, Rosselet A, Rochat B, Eap CB, Henry H, Biollaz J, Buclin T: Population pharmacokinetics of imatinib and the role of alpha-acid glycoprotein. Br J Clin Pharmacol 2006; 62: 97-112.
21. Demetri GD, Wang Y, Wehrle E, Blanke C, Hoensuu H, von Mehren M: Correlation of imatinib plasma levels with clinical benefit in patients (Pts) with unresectable/metastatic gastrointestinal stromal tumors (GIST) (abstract 3). Orlando, January 25-27, 2008, American Society of Clinical Oncology 2008 Gastrointestinal Cancers Symposium.
22. Yeh CN, Chen TW, Lee HL, Liu YY, Chao TC, Hwang TL, Jan YY, Chen MF: Kinase mutations and imatinib mesylate response for 64 Taiwanese with advanced GIST: preliminary experience from Chang Gung Memorial Hospital. Ann Surg Oncol 2007; 14: 1123-1128.
23. Van Glabbeke M, Verweij J, Casali PG, Le Cesne A, Hohenberger P, Ray-Coquard I, Schlemmer M, van Oosterom AT, Goldstein D, Sciot R, Hogendoorn PC, Brown M, et al: Initial and late resistance to imatinib in advanced gastrointestinal stromal tumors are predicted by different prognostic factors: a European Organisation for Research and Treatment of Cancer-Italian Sarcoma Group-Australasian Gastrointestinal Trials Group study. J Clin Oncol 2005; 23: 5795-5804.
24. Zalcberg JR, Verweij J, Casali PG, Le Cesne A, Reichardt P, Blay JY, Schlemmer M, Van Glabbeke M, Brown M, Judson IR: 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 2005; 41: 1751-1757.