Adjuvant Imatinib treatment after R0 resection for patients with high-risk gastrointestinal stromal tumors: A median follow-up of 44 months

2011 ◽  
Vol 104 (7) ◽  
pp. 760-764 ◽  
Author(s):  
Wei-Zhong Jiang ◽  
Guo-Xian Guan ◽  
Hui-Shan Lu ◽  
Ying-Hong Yang ◽  
De-Yong Kang ◽  
...  
PLoS ONE ◽  
2018 ◽  
Vol 13 (2) ◽  
pp. e0193048 ◽  
Author(s):  
Michaela Angelika Ihle ◽  
Sebastian Huss ◽  
Wiebke Jeske ◽  
Wolfgang Hartmann ◽  
Sabine Merkelbach-Bruse ◽  
...  

JAMA Oncology ◽  
2020 ◽  
Vol 6 (8) ◽  
pp. 1241 ◽  
Author(s):  
Heikki Joensuu ◽  
Mikael Eriksson ◽  
Kirsten Sundby Hall ◽  
Annette Reichardt ◽  
Barbara Hermes ◽  
...  

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e21515-e21515 ◽  
Author(s):  
B. Kang ◽  
J. Lee ◽  
M. Ryu ◽  
S. Im ◽  
S. Park ◽  
...  

e21515 Background: In our previous study, the presence of c-kit mutation as well as tumor size and mitotic count was an independent poor risk factor for relapse after curative resection of primary localized GIST. The patients with all the 3 poor risk factors had only 30% of 2 year relapse free survival rate (RFSR). (Kim, et al. Clin Cancer Res, 2004) It is also well known that c-kit exon 11 mutant GISTs respond better to imatinib treatment than the other mutant or wild type GISTs. Therefore, the patients who have primary localized GISTs with large size, high mitotic count, and c-kit exon 11 mutation may be the best candidate of adjuvant imatinib treatment. In this phase II study, we have evaluated the efficacy and safety of adjuvant imatinib for this patient group. Methods: Patients who underwent complete resection of a primary GIST with 1) c-kit exon 11 mutation, and 2) ≥10 mitoses/50 HPF, or tumor size ≥10 cm, or ≥5 mitoses/50 HPF and tumor size ≥5 cm were eligible. Patients received imatinib 400mg p.o. daily until recurrence of disease, intolerable toxicities, or for 2 years. The primary end point was relapse-free survival (RFS). Results: A total of 47 patients from 4 centers in Korea were enrolled. The median age was 57.0 years. Stomach was the most common primary site (n=31). Median primary tumor size was 7.5cm and median mitoses index was 12/50 HPF. With a median follow-up of 26.9 months, the median RFS and overall survival (OS) have not yet been reached. RFSR was 97.7% at 1-year and 92.7% at 2-years. Six relapses (12.8%) were documented among the 47 patients. The treatments were generally well tolerated. Grade 3–4 toxicities included neutropenia 27.7%, rash 8.5%, constipation 4.3%, anorexia 2.1%, vomiting 2.1%, and pruritis 2.1%. There were no episode of febrile neutropenia and treatment-related death. Conclusions: Postoperative adjuvant imatinib for 2 years were safe and could prolong the RFS in patients with high-risk of recurrence following complete surgical resection of the primary GIST. However, it remains unknown if this benefit in RFS can be translated into OS benefit. So, further follow-up is needed with comparison of OS with historical controls who could be use imatinib after recurrence. [Table: see text]


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e23524-e23524
Author(s):  
Piotr Rutkowski ◽  
Marcin Zietek ◽  
Bozena Cybulska-Stopa ◽  
Joanna Streb ◽  
Stanislaw Gluszek ◽  
...  

e23524 Background: The real-world data on outcomes of adjuvant therapy in high-risk gastrointestinal stromal tumors (GIST) are very limited. Methods: We have analyzed the data of 107 consecutive patients (52 male, 56 female) with GIST after resection treated with adjuvant imatinib (for planned 3 years with initial dose 400 mg daily, started not later than 4 months after operation) in 6 oncological centers in 2013-2018. All patients were required to have high risk of recurrence (at least 50% according to NCCN/AFIP criteria), known mutational status to exclude PDGFRA D842V mutants and KIT/PDGFRA-wild type cases from therapy. Median follow-up time was 24 months. Results: The most common primary localization of GIST was small bowel (63 patients; 59%), followed by the stomach (40 patients; 37%). The majority of GIST cases harbored exon 11 KIT mutations (88 cases, 82%), 11 cases had exon 9 KIT mutations (10%), 8 had other KIT/PDGFRA mutations potentially sensitive to imatinib. Thirty three patients (31%) finished 3-year adjuvant imatinib therapy as planned, 59 (55%) still continue therapy, 4 (4%) patients had finished adjuvant therapy prematurely due to toxicity, 6 (6%) due to disease progression on treatment and 5 (4%) due to other reasons. The disease relapse was detected in 16 patients, of them in 4 cases in exon 9 KIT mutants (36%), and 10 cases in patients with exon 11 KIT mutations (11%) [p < 0.05]. Estimated 4-year relapse-free survival (RFS) rate is 78%. Conclusions: The early results of adjuvant therapy with imatinib in routine practice outside clinical trials in high-risk mutation-drive GIST patients only confirm high efficacy of this therapy with better tolerability than in clinical trials. Moreover, overrepresentation of exon 9 KIT mutants in a group of patients with disease relapse may indicate that standard 400 mg dose in adjuvant treatment is not sufficient for prevention of disease relapse.


2009 ◽  
Vol 193 (2) ◽  
pp. W100-W105 ◽  
Author(s):  
Dongil Choi ◽  
Eun Young Yoo ◽  
Kyoung-Mee Kim ◽  
Tae Sung Sohn ◽  
Won Jae Lee ◽  
...  

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