Systematic review of escalated imatinib doses compared with sunitinib or best supportive care, for the treatment of people with unresectable/metastatic gastrointestinal stromal tumours whose disease has progressed on the standard imatinib dose

Journal of Gastrointestinal Cancer

Volumn 43, Issue 2, 2012, Pages 168-176

  Hislop, Jennifer ^a   Mowatt, Graham ^a   Sharma, Pawana ^a   Fraser, Cynthia ^a   Elders, Andrew ^a   Jenkinson, David ^a   Vale, Luke ^a,b   Petty, Russell ^c  

^a UNIVERSITY OF ABERDEEN   (United Kingdom)

^b UNIVERSITY OF ABERDEEN   (United Kingdom)

^c ABERDEEN ROYAL INFIRMARY   (United Kingdom)

Author keywords

Cancer; Gastrointestinal stromal tumours; GIST; Imatinib; Metastatic; Sunitinib; Unresectable

Indexed keywords

IMATINIB; SUNITINIB;

ANEMIA; DISEASE COURSE; DOSE RESPONSE; DRUG DOSE ESCALATION; DRUG EFFICACY; FATIGUE; GASTROINTESTINAL STROMAL TUMOR; HUMAN; INFORMATION PROCESSING; METASTATIC GASTROINTESTINAL STROMAL TUMOR; NEUTROPENIA; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SURVIVAL; SYSTEMATIC REVIEW; UNRESECTABLE GASTROINTESTINAL STROMAL TUMOR;

ANTINEOPLASTIC AGENTS; CLINICAL TRIALS AS TOPIC; DISEASE PROGRESSION; DISEASE-FREE SURVIVAL; DOSE-RESPONSE RELATIONSHIP, DRUG; GASTROINTESTINAL STROMAL TUMORS; HUMANS; INDOLES; PIPERAZINES; PYRIMIDINES; PYRROLES; TREATMENT OUTCOME;

EID: 84863877145     PISSN: 19416628     EISSN: 19416636     Source Type: Journal    
DOI: 10.1007/s12029-011-9325-6     Document Type: Review

References (45)

1. Graadt van Roggen JF, van Velthuysen ML, Hogendoorn PC. The histopathological differential diagnosis of gastrointestinal stromal tumours. J Clin Pathol. 2001;54:96-102.
2. Guidelines for the management of gastrointestinal stromal tumours (GISTs) in Scotland. Glasgow: Scottish Sarcoma Network; 2009 [accessed December 2010]. URL: http://www.ssn.scot.nhs.uk/protocolsandguidelines/ Scottish%20GIST%20guidelines-NOV545-no%.
3. Kindblom LG, Remotti HE, Aldenborg F, Meis-Kindblom JM. Gastrointestinal pacemaker cell tumor (GIPACT): gastrointestinal stromal tumors show phenotypic characteristics of the interstitial cells of Cajal. Am J Pathol. 1998;152:1259-69. (Pubitemid 28221878)
4. Medeiros F, Corless CL, Duensing A, Hornick JL, Oliveira AM, Heinrich MC, et al. KIT-negative gastrointestinal stromal tumors: proof of concept and therapeutic implications. Am J Surg Pathol. 2004;28:889-94. (Pubitemid 38856844)
5. Miettinen M, Majidi M, Lasota J. Pathology and diagnostic criteria of gastrointestinal stromal tumors (GISTs): a review. Eur J Cancer. 2002;38:S39-51.
6. Conlon KC, Casper ES, Brennan MF. Primary gastrointestinal sarcomas: analysis of prognostic variables. Ann Surg Oncol. 1995;2:26-31.
7. Dematteo RP, Lewis JJ, Leung D, Mudan SS, Woodruff JM, Brennan MF. Two hundred gastrointestinal stromal tumors: recurrence patterns and prognostic factors for survival. Ann Surg. 2000;231:51-8. (Pubitemid 30043939)
8. Casali P, Blay JY. Gastrointestinal stromal tumours. ESMO clinical practice guidelines for diagnosis, treatment and followup. Ann Oncol. 2010;21:v98-v102.
9. Guidelines for the management of gastrointestinal stromal tumours (GISTs). London: Association of Upper Gastrointestinal Surgeons of Great Britian and Ireland; 2005 [accessed February 2011]. URL: http://www.augis.org/news- guidelines/management-guidelines.htm.
10. Demetri GD, von MM, Antonescu CR, Dematteo RP, Ganjoo KN, Maki RG, et al. NCCN Task Force report: update on the management of patients with gastrointestinal stromal tumors. J Natl Comp Cancer Network 2010;8:Suppl-41.
11. Alymani NA, Smith MD, Williams DJ, Petty RD. Predictive biomarkers for personalised anti-cancer drug use: discovery to clinical implementation. Eur J Cancer. 2010;46:869-79.
12. Gastrointestinal Stromal Tumor Meta-Analysis Group. Comparison of two doses of imatinib for the treatment of unresectable or metastatic gastrointestinal stromal tumors: a meta-analysis of 1,640 patients. J Clin Oncol. 2010;28:1247-53.
13. Blanke CD, Rankin C, Demetri GD, Ryan CW, von Mehren M, Benjamin RS, et al. 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;26:626-32. (Pubitemid 351264358)
14. Blay JY, Le Cesne A, Ray-Coquard I, Bui B, Duffaud F, Delbaldo C, et al. Prospective multicentric randomized phase III study of imatinib in patients with advanced gastrointestinal stromal tumors comparing interruption versus continuation of treatment beyond 1 year: the French Sarcoma Group. J Clin Oncol. 2007;25:1107-13. (Pubitemid 46596763)
15. Gramza AW, Corless CL, Heinrich MC. Resistance to tyrosine kinase inhibitors in gastrointestinal stromal tumors. Clin Cancer Res. 2009;15:7510-8.
16. Verweij J, Casali PG, Zalcberg J, LeCesne A, Reichardt P, Blay JY, et al. Progression-free survival in gastrointestinal stromal tumours with high-dose imatinib: randomised trial. Lancet. 2004;364:1127-34. (Pubitemid 39296599)
17. Zalcberg JR, Verweij J, Casali PG, Le Cesne A, Reichardt P, Blay JY, 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. 2005;41:1751-7. (Pubitemid 41132637)
18. Ahmed N, Ahmedzai S, Vora V, Hillam S, Paz A. Supportive care for patients with gastrointestinal cancer. Cochrane Database Syst Rev. 2004. doi:10.1002/14651858.CD003445.pub2. Art. No.: CD003445.
19. Haywood KL, Hargreaves J, White R, Lamb SE. Reviewing measures of outcome: reliability of data extraction. J Eval Clin Pract. 2004;10:329-37. (Pubitemid 38823236)
20. Systematic reviews: CRD's guidance for undertaking systematic reviews in health care [document on the Internet]. University of York: Centre for Reviews and Dissemination; 2009 [accessed January 2011]. URL: http://www.york.ac.uk/ inst/crd/SysRev/!SSL!/WebHelp/SysRev3.htm.
21. Downs SH, Black N. The feasibility of creating a checklist for the assessment of the methodological quality both of randomised and non-randomised studies of health care interventions. J Epidemiol Community Health. 1998;52:377-84. (Pubitemid 28438523)
22. Verhagen AP, de Vet HC, de Bie RA, Kessels AG, Boers M, Bouter LM, et al. The Delphi list: a criteria list for quality assessment of randomized clinical trials for conducting systematic reviews developed by Delphi consensus. J Clin Epidemiol. 1998;51:1235-41. (Pubitemid 29009523)
23. Blanke CD, Demetri GD, von Mehren M, Heinrich MC, Eisenberg B, Fletcher JA, 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;26:620-5. (Pubitemid 351264357)
24. Debiec-Rychter M, Sciot R, Le Cesne A, Schlemmer M, Hohenberger P, Van Oosterom AT, et al. KIT mutations and dose selection for imatinib in patients with advanced gastrointestinal stromal tumours. Eur J Cancer. 2006;42:1093-103. (Pubitemid 44275331)
25. Demetri GD, von Mehren M, Blanke CD, Van den Abbeele AD, Eisenberg B, Roberts PJ, et al. Efficacy and safety of imatinib mesylate in advanced gastrointestinal stromal tumors. N Engl J Med. 2002;347:472-80. (Pubitemid 34879334)
26. Park I, Ryu MH, Sym SJ, Lee SS, Jang G, Kim TW, et al. Dose escalation of imatinib after failure of standard dose in Korean patients with metastatic or unresectable gastrointestinal stromal tumor. Jpn J Clin Oncol. 2009;39:105-10.
27. Dileo P, Rankin CJ, Benjamin RS, von Mehren M, Blanke C, Bramwell V, et al. Incidence and reasons for dose modification of standard-dose vs. high-dose imatinib mesylate (IM) in the Phase III Intergroup Study S0033 of patients (pts) with unresectable or metastatic gastrointestinal stromal tumor (GIST). J Clin Oncol. 2005;23(16 Suppl):824S.
28. Kang Y, Reichardt P, Ruka W, Seddon B, Baum C, Demetri G. Efficacy and safety of sunitinib ina worldwide treatment-use trial of gist patients following imatinib failure. Ann Oncol. 2007;18 Suppl 7:vii16. Abstract O-0017.
29. Rankin C, von Mehren M, Blanke C, Benjamin R, Fletcher CDM, Bramwell V, et al. Dose effect of imatinib (IM) in patients (pts) with metastatic GIST-phase III Sarcoma Group Study S0033. J Clin Oncol. 2004;22(14S). Abstract 9005.
30. Reichardt P, Kang Y, Ruka W, Seddon B, Nieto A, Breazna A, et al. Sunitinib (Su) in a worldwide treatment-use trial of patients with GIST: updated efficacy and safety analysis. Ann Oncol. 2008;19 Suppl 8:viii267. Abstract 869PD.
31. Reichardt P, Kang Y, Ruka W, Seddon B, Guerriero A, Breazna A, et al. Detailed analysis of survival and sfety with sunitinib (SU) in a worldwide treatment-use trial of patients with advanced GIST. J Clin Oncol. 2008;26(15 Suppl). Abstract 10548.
32. Rutkowski P, Reichardt P, Kang Y, Ruka W, Seddon B, Guerriero A, et al. Sunitinib in a worldwide treatment-use trial of patients with imatinib, resistant/intolerant gastrointestinal stromal tumor: detailed analysis of survival and safety. Ann Oncol. 2008;19 Suppl 6:vii12. Abstract O-013.
33. Schutte J, Reichardt P, Schlemmer M, Wendtner CM, Demetri GD. Efficacy and safety of sunitinib in patients with gastrointestinal stromal tumour resistant or intolerant of prior imatinib therapy: Results from a worldwide treatment-use study. Onkologie. 2008;31 suppl 1:77. Abstract OP130.
34. Seddon B, Reichardt P, Ruka W, Kang YK, Baum CM, Demetri GD. Safety and efficacy results of sunitinib from a worldwide treatment. use trial of gastrointestinal stromal tumour (GIST) patients (pts) with resistance or intolerance to prior imatinib therapy. Eur J Cancer Suppl. 2007;5(4):405. Abstract 7511.
35. Seddon B, Reichardt P, Kang YK, Ruka W, Nieto A, Breazna A, et al. Detailed anlaysis of survival and safety with Sunitinib in a worldwide treatment-use trial of patients with advanced imatinibresistant/ intolerant GIST. Connective Tissue Oncology Society, 14th Annual Meeting, London, November 2008. Abstract 34980.
36. Zalcberg JR, Verweij J, Casali PG, Le Cesne A, Reichardt P, Blay JY, et al. Outcome of patients with advanced gastro-intestinal stromal tumors (GIST) crossing over to a daily imatinib dose of 800 mg (HD) after progression on 400 mg (LO)-an international, intergroup study of the EORTC, ISG and AGITG. J Clin Oncol. 2004;22(14S):9004.
37. An JY, Choi MG, Noh JH, Sohn TS, Kang WK, Park CK, et al. Gastric GIST: a single institutional retrospective experience with surgical treatment for primary disease. Eur J Surg Oncol. 2007;33:1030-5. (Pubitemid 47408742)
38. Chu TF, Rupnick MA, Kerkela R, Dallabrida SM, Zurakowski D, Nguyen L, et al. Cardiotoxicity associated with tyrosine kinase inhibitor sunitinib. Lancet. 2007;370:2011-9. (Pubitemid 350236338)
39. Goerres GW, Stupp R, Barghouth G, Hany TF, Pestalozzi B, Dizendorf E, et al. The value of PET, CT and in-line PET/CT in patients with gastrointestinal stromal tumours: long-term outcome of treatment with imatinib mesylate. Eur J Nucl Med Molecul Imag. 2005;32:153-62. (Pubitemid 40248485)
40. Nishida T, Shirao K, Sawaki A, Koseki M, Okamura T, Ohtsu A, et al. Efficacy and safety profile of imatinib mesylate (ST1571) in Japanese patients with advanced gastrointestinal stromal tumors: a phase II study (STI571B1202). Int J Clin Oncol. 2008;13:244-51. (Pubitemid 351871892)
41. Phongkitkarun S, Phaisanphrukkun C, Jatchavala J, Sirachainan E. Assessment of gastrointestinal stromal tumors with computed tomography following treatment with imatinib mesylate. World J Gastroenterol. 2008;14:892-8. (Pubitemid 351325028)
42. Pfizer Inc. Safety And Effectiveness Of Daily Dosing With Sunitinib Or Imatinib In Patients With Gastrointestinal Stromal Tumors. ClinicalTrials.gov Identifier NCT00372567. ClinicalTrials.gov; 2006 [accessed February 2011]. URL: http://clinicaltrials.gov/.
43. Demetri GD, Van Oosterom AT, Garrett CR, Blackstein ME, Shah MH, Verweij J, et al. Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: a randomised controlled trial. Lancet. 2006;368:1329-38. (Pubitemid 44528723)
44. Parmar MK, Torri V, Stewary L. Extracting summary statistics to perform meta-analyses of the published literature for survival endpoints. Stat Med. 1998;17:2815-34. (Pubitemid 28562978)
45. Arends LR, Hunink MG, Stijnen T. Meta-analysis of summary survival curve data. Stat Med. 2008;27:4381-96.