Adjuvant imatinib after resection of gastrointestinal stromal tumour – systematic review and meta-analysis Original article
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Published:
Dec 31, 2013
Keywords:
adjuvant therapy, gastrointensial stromal tumor, GIST, imatynib, systematic review
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Abstract
Background: Adjuvant therapy is recommended for the population of patients with high risk of recurrence of gastrointestinal stromal tumour after resection.
The aim of the study: Evaluation of the clinical efficacy and safety profile of imatinib used in adjuvant therapy in patients after complete resection of a gastrointestinal stromal tumour.
Material and methods: A systematic review of the literature published up to 30.03.2012 was performed, and a meta-analysis of identified studies was carried out. Databases were searched: PubMed, EMBASE, The Cochrane Library and others.
Results: Two randomised clinical trials regarding comparisons of: imatinib vs. placebo and 12 months of adjuvant imatinib vs. 36 months of adjuvant imatinib as well as 20 non-randomised trials fulfilled the established criteria. Adjuvant imatinib statistically significantly improves recurrence-free survival compared with placebo. Patients with high risk of recurrence benefit most from assigned treatment. Three years of adjuvant imatinib therapy improves recurrence-free state and overall survival compared with 1 year of imatinib in patients after resection of a gastrointestinal stromal tumour. The safety profile of imatinib in the analyzed population is acceptable.
Conclusions: For patients with a significant risk of recurrence adjuvant therapy with imatinib should be considered for every patient, due to the clinical benefits it brings.
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Kawalec P, Kryst J, Laczewski T, Martyna L. Adjuvant imatinib after resection of gastrointestinal stromal tumour – systematic review and meta-analysis. OncoReview [Internet]. 2013Dec.31 [cited 2024Jul.4];3(4(12):232-4. Available from: https://journalsmededu.pl/index.php/OncoReview/article/view/347
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Copyright: © Medical Education sp. z o.o. This is an Open Access article distributed under the terms of the Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). License (https://creativecommons.org/licenses/by-nc/4.0/), allowing third parties to copy and redistribute the material in any medium or format and to remix, transform, and build upon the material, provided the original work is properly cited and states its license.
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2. Rutkowski P., Nowecki Z., Ruka W.: Nowotwory podścieliskowe przewodu pokarmowego (GIST). W: Zalecenia postępowania diagnostycznoterapeutycznego w nowotworach złośliwych. Krzakowski M. (red.). Via Medica, Gdańsk 2009.
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6. Rutkowski P., Nowecki Z.: Aspekty molekularno-kliniczne nowotworów podścieliskowych przewodu pokarmowego. Onkol. Prakt. Klin. 2009; 5(6): 219-228.
7. Fletcher C., Berman J., Corless C. et al.: Diagnosis of gastrointestinal stromal tumors: a consensus approach. Hum. Pathol. 2002; 33(5): 459-465.
8. Dirnhofer S., Leyvraz S.: Current standards and progress in understanding and treatment of GIST. Swiss Med. Wkly 2009; 139(7-8): 90-102.
9. Joensuu H.: Risk stratification of patients diagnosed with gastrointestinal stromal tumor. Hum. Pathol. 2008; 39(10): 1411-1419.
10. Miettinen M., Lasota J.: Gastrointestinal stromal tumors: review on morphology, molecular pathology, prognosis, and differential diagnosis. Arch. Pathol. Lab. Med. 2006; 130(10): 1466-78.
11. Rutkowski P., Kulig J., Krzakowski M. et al.: Zasady postępowania diagnostyczno-terapeutycznego u chorych na nowotwory podścieliskowe przewodu pokarmowego (GIST) w 2010 roku. Onkol. Prakt. Klin. 2010; 6(4): 181-194.
12. Ruka W., Rutkowski P., Zdzienicki M., Nowecki Z.: Leczenie chirurgiczne nowotworów podścieliskowych przewodu pokarmowego (GIST). Gastroenterol. Pol. 2009; 16(2): 129-134.
13. Rutkowski P., Nowecki Z., Michej W. et al.: Risk criteria and prognostic factors for predicting recurrences after resection of primary gastrointestinal stromal tumor. Ann. Surg. Oncol. 2007; 14(7): 2018-27.
14. Essat M., Cooper K.: Imatinib as adjuvant therapy for gastrointestinal stromal tumors: a systematic review. Int. J. Cancer 2011; 128(9): 2202-2214.
15. Rutkowski P.: Nowotwory podścieliskowe przewodu pokarmowego. Gastroenterol. Klin. 2011; 3(3): 127-135.
16. National Institute for Clinical Excellence. Imatinib for the treatment of unresectable and/or metasatic gastrointestinal stromal tumours. Technology Appraisal 86, NICE, London, 2004.
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18. DeMatteo R., Ballman K., Antonescu C. et al.: Adjuvant imatinib mesylate after resection of localised, primary gastrointestinal stromal tumour: a randomised, double-blind, placebo-controlled trial. Lancet 2009; 373(9669): 1097-1104.
19. DeMatteo R., Owzar K., Maki R. et al.: Adjuvant imatinib mesylate increases recurrence free survival (RFS) in patients with completely resected localized primary gastrointestinal stromal tumor (GIST): North American Intergroup Phase III trial ACOSOG Z9001. 2007 ASCO Annual Meeting, abstrakt nr 10079.
20. Online: http://www.clinicaltrials.gov/ct2/show/NCT00041197... (Access: march 2012).
21. Cohen M., Cortazar P., Justice R., Pazdur R.: Approval summary: imatinib mesylate in the adjuvant treatment of malignant gastrointestinal stromal tumors. Oncologist 2010; 15(3): 300-307.
22. Wytyczne Cochrane Collaboration. Online: www.cochrane.org (Access: march 2012).
23. Joensuu H., Eriksson M., Sundby Hall K. et al.: One vs three years of adjuwant imatinib for operable gastrointestinal stromal tumor. A randomized trial. JAMA 2012; 307(12): 1265-1272.
24. Joensuu H., Eriksson M., Hatrmann J. et al.: Twelve versus 36 months of adjuvant imatinib (IM) as treatment of operable GIST with a high risk of recurrence: Final results of a randomized trial (SSGXVIII/AIO). J. Clin. Oncol. 2011; 29(suppl.): abstrakt nr LBA1.
25. Blanke C.: Optimal duration of adjuvant therapy for patients with resected gastrointestinal stromal tumors. JAMA 2012; 307(12): 1312-1314.
26. Online: http://www.clinicaltrials.gov/ct2/show/NCT00116935... (Access: march 2012).
27. Li J., Gong J., Wu A., Shen L.: Post-operative imatinib in patients with intermediate or high risk gastrointestinal stromal tumor. Eur. J. Surg. Oncol. 2011; 37(4): 319-324.
28. Li J., Gong J., Li J., Wu A., Shen L.: Adjuvant therapy with imatinib in gastrointestinal stromal tumor (GIST) patients with intermediate or high risk: Analysis from a single-center contrast study. 2009 ASCO Annual Meeting, abstrakt nr 10556.
29. Shen L., Li J., Li J., Gong J., Wu A.: Adjuvant post-surgery therapy with imatinib in intermediate or high-risk gastrointestinal stromal tumour (GIST) patients: interim analysis from a single centre comparison study. Ann. Oncol. 2008; 19(suppl.8): 267.
30. Jiang W., Guan G., Lu., Yang Y., Kang D., Huang H.: Adjuvant imatinib treatment after R0 resection for patients with high-risk gastrointestinal stromal tumors: a median follow-up of 44 months. J. Surg. Oncol. 2011; 104(7): 760-764.
31. Nilsson B., Sjölund K., Kindblom L. et al.: Adjuvant imatinib treatment improves recurrence-free survival in patients with high-risk gastrointestinal stromal tumours (GIST). Br. J. Cancer 2007; 96(11): 1656-1658.
32. DeMatteo R., Antonescu C., Chadaram V. et al.: Adjuvant imatinib mesylate in patients with primary high risk gastrointestinal stromal tumor (GIST) following complete resection: safety results from the US Intergroup Phase II trial ACOSOG Z9000. J. Clin. Oncol. 2005; 23(suppl.): abstrakt 16S.
33. DeMatteo R., Owzar K., Antonescu C. et al.: Efficacy of adjuvant imatinib mesylate following complete resection of localized, primary gastrointestinal stromal tumor (GIST) at high risk of recurrence: the U.S. Intergroup phase II trial ACOSOG Z9000 Abstract. ASCO 2008 GI Cancer Symposium, abstrakt nr FL. A-8.
34. Online: http://www.clinicaltrials.gov/ct2/show/NCT00025246... (Access: march 2012).
35. Kang Y., Kang B., Ryu M. et al.: A phase II study of imatinib mesylate as adjuvant treatment for curatively resected high-risk localized gastrointestinal stromal tumors with C-Kit exon 11 mutation. ASCO 2009 GI Cancer Symposium, abstrakt nr 95.
36. Kang B., Lee J., Ryu M. et al.: A phase II study of imatinib mesylate as adjuvant treatment for curatively resected high-risk localized gastrointestinal stromal tumors. J. Clin. Oncol. 2009; 27(suppl.): e21515.
37. Online: http://www.clinicaltrials.gov/ct2/show/NCT00278876... (Access: march 2012).
38. Zhan W., Wang P., Shao Y. et al.: Efficacy and safety of adjuvant post-surgical therapy with imatinib in gastrointestinal stromal tumor patients with high risk of recurrence: interim analysis from a multicenter prospective clinical trial. Zhonghua Wei Chang Wai Ke Za Zhi 2006; 9(5): 383-387.
39. Zhan W.: Efficacy and safety of adjuvant post-surgical therapy with imatinib in patients with high risk of relapsing gastrointestinal stromal tumor. J. Clin. Oncol. 2007; 25(suppl.): abstrakt nr 10045.
40. Nishida T., Kanda T., Wada N. et al.: Phase II trial of adjuvant imatinib mesylate after resection of localized, primary high risk gastrointestinal stromal tumour (GIST) in Japan. Eur. J. Cancer 2009; suppl. 7(2): 593.
41. Online: http://www.clinicaltrials.gov/ct2/show/NCT00171977?term=NCT00171977... (Access: march 2012).
42. Online: http://www.novctrd.com/ctrdWebApp/clinicaltrialrepository/displayFile.do? trialResult=3560 (Access: march 2012).
43. Bümming P., Andersson J., Meis-Kindblom J. et al.: Neoadjuvant, adjuvant and palliative treatment of gastrointestinal stromal tumours (GIST) with imatinib: a centre-based study of 17 patients. Br. J. Cancer 2003; 89(3): 460-464.
44. Shi Y., Du C., Zhou Y.: Efficacy and safety of the imatinib in the treatment of 73 gastrointestinal stromal tumors. J. Clin. Oncol. 2008; 26(suppl.): abstrakt nr 21512.
45. Hatoum T., Trent J., Guo A., Lin S., Sirulnik A., Sasane M.: Outcome of adjuvant imatinib in patients with gastrointestinal stromal tumor: Results of a population-based, matched cohort study. J. Clin. Oncol. 2011; 29(suppl.): abstrakt 10052.
46. Trent J., von Mehren M., Pisters P., Stealey E., Sirulnik L., Blanke C.: Adjuvant imatinib therapy of 208 gastrointestinal stromal tumor (GIST) patients: Dose, duration, and risk assessment. J. Clin. Oncol. 2010; 28(suppl.): abstrakt nr 10061.
47. Manouras A., Pappas A., Katergiannakis V. et al.: Gastrointestinal Stromal Tumors or the rectum: report of five cases. Acta Gastroenterol. Belg. 2009; 72(2): 257-261.
48. Cruz Jr R., Vincenzi R., Ketzer B., Cecilio A., Cepeda L.: Spontaneous intratumoral bleeding and rupture of giant gastric stromal tumor (> 30 cm) in a young patient. World J. Surg. Oncol. 2008; 6: 76.
49. Armbrust T., Sobotta M., Ramadori G.: Follow up of three cases after adjuvant treatment of high risk gastrointestinal stromal tumors with imatinib. Ann. Oncol. 2007; 18(6): 1123-1125.
50. Bogoevski D., Mann O., Schurr P., Izbicki J., Strate T.: Laparoscopic gastric tailoring for huge subcardial gastrointestinal stromal tumor. JSLS 2007; 11(3): 394-397.
51. Osada T., Nagahara A., Kodani T. et al.: Gastrointestinal stromal tumor of the stomach with a giant abscess penetrating the gastric lumen. World J. Gastroenterol. 2007; 13(16): 2385-2387.
52. Efremidou E., Liratzopoulos N., Papageorgiou M., Romanidis K., Manolas K., Minopoulos G.: Perforated GIST of the small intestine as a rare cause of acute abdomen: surgical treatment and adjuvant therapy. Case report. J. Gastrointestin. Liver Dis. 2006; 15(3): 297-299.
53. Ferraresi V., Catricala C., Ciccarese M., Ferrari A., Zeuli M., Cognetti F.: Severe skin reaction in a patient with gastrointestinal stromal tumor treated with imatinib mesylate. Anticancer Res. 2006; 26(6C): 4771-4774.
54. Lai I., Hu R., Chang K.: Is imatinib justified as an adjuvant chemotherapy for patients with recurrent gastrointestinal stromal tumors. Hepatogastroenterology 2005; 52(63): 826-828.
55. Cunningham S., Shibata D., Volpe C.: Isolated abdominal wound metastasis from a gastrointestinal stromal tumor. Int. J. Gastrointest. Cancer 2003; 33(2-3): 129-132.
56. Online: http://www.clinicaltrials.gov/ct2/show/NCT00867113... (Access: march 2012).
57. Online: http://www.clinicaltrials.gov/ct2/show/NCT01172548... (Access: march 2012).
58. Online: http://www.clinicaltrials.gov/ct2/show/NCT00103168... (Access: march 2012).
59. Online: http://cancer.gov/clinicaltrials/search/view?cdrid=410825&version= healthprofessional (Access: march 2012)
60. Nilsson B., Bümming P., Meis-Kindblom J. et al.: Gastrointestinal stromal tumors: the incidence, prevalence, clinical course, and prognostication in the preimatinib mesylate era – a population-based study in western Sweden. Cancer 2005; 103(4): 821-829.
61. DeMatteo R., Lewis J., Leung D., Mudan S., Woodruff J., Brennan M.: Two hundred gastrointestinal stromal tumours: recurrence patterns and prognostic factors for survival. Ann. Surg. 2000; 231(1): 51-57.
62. Imatinib for the adjuvant treatment of gastrointestinal stromal tumours. National Institute for Health and Clinical Excellence (NICE) technology appraisal guidance 196. Sierpień 2010.
63. Online: http://www.novartis.com/newsroom/media-releases/en/2012/1579137.shtml (Access: march 2012).
64. von Mehren M., Benjamin R., Bui M. et al.: NCCN Clinical Practice Guidelines in Oncology. Soft Tissue Sarcoma. Version 2.2011.
65. Hou Y., Grabellus F., Weber F. et al.: Impact of KIT and PDGFRA gene mutations on prognosis of patients with gastrointestinal stromal tumors after complete primary tumor resection. J. Gastrointest. Surg. 2009; 13(9): 1583-1592.
66. Heinrich M., Corless C., Demetri G. et al.: Kinase mutations and imatinib response in patients with metastatic gastrointestinal stromal tumor. J. Clin. Oncol. 2003; 21(23): 4342-4349.