scholarly journals Adjuvant imatinib treatment improves recurrence-free survival in patients with high-risk gastrointestinal stromal tumours (GIST)

2007 ◽  
Vol 96 (11) ◽  
pp. 1656-1658 ◽  
Author(s):  
B Nilsson ◽  
K Sjölund ◽  
L-G Kindblom ◽  
J M Meis-Kindblom ◽  
P Bümming ◽  
...  
2015 ◽  
Vol 97 (3) ◽  
pp. 215-220 ◽  
Author(s):  
Y Li ◽  
X Meng

Introduction Although it has now been accepted that imatinib is a valid treatment for gastrointestinal stromal tumour (GIST) patients in the adjuvant setting, information on its clinical efficacy in improving the prognosis for patients with colorectal GISTs is limited. Methods The clinical and follow-up records of 42 colorectal GIST patients who underwent surgical resection at our institution between January 2004 and December 2013 were reviewed retrospectively. The effect of postoperative imatinib treatment on recurrence free survival and overall survival time was analysed with the Kaplan–Meier method and the multivariate Cox proportional hazards model. Results Sixteen patients were assigned to imatinib treatment (imatinib group) after surgical tumour resection while twenty-six patients did not receive any adjuvant treatment (control group). The one, three and five-year recurrence free survival rates were 100%, 90% and 77% respectively. This was significantly higher than in the control group (92%, 53% and 36%) (logrank test, p=0.012). The one, three and five-year overall survival rates were 100%, 91% and 68% in the imatinib group compared with 96%, 77% and 39% in the control group (logrank test, p=0.021). Analysis with the multivariate Cox regression model yielded similar results on the efficacy of adjuvant imatinib in prolonging both recurrence free survival (hazard ratio [HR]: 0.23, 95% confidence interval [CI]: 0.07–0.80) and overall survival (HR: 0.20, 95% CI: 0.05–0.91). Conclusions Adjuvant imatinib therapy seems to be effective in decreasing the risk of tumour occurrence and prolonging the overall survival time in colorectal GIST patients.


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]


2019 ◽  
Vol 19 (5) ◽  
pp. 363-369
Author(s):  
Ashley Albert ◽  
Sophy Mangana ◽  
Mary R. Nittala ◽  
Toms Vengaloor Thomas ◽  
Lacey Weatherall ◽  
...  

Medicina ◽  
2016 ◽  
Vol 52 (5) ◽  
pp. 276-282 ◽  
Author(s):  
Donatas Samsanavičius ◽  
Vygintas Kaikaris ◽  
Simonas-Jonas Norvydas ◽  
Rokas Liubauskas ◽  
Skaidra Valiukevičienė ◽  
...  

2020 ◽  
Vol 38 (33) ◽  
pp. 3925-3936 ◽  
Author(s):  
Alexander M. M. Eggermont ◽  
Christian U. Blank ◽  
Mario Mandala ◽  
Georgina V. Long ◽  
Victoria G. Atkinson ◽  
...  

PURPOSE We conducted the phase III double-blind European Organisation for Research and Treatment of Cancer (EORTC) 1325/KEYNOTE-054 trial to evaluate pembrolizumab versus placebo in patients with resected high-risk stage III melanoma. On the basis of 351 recurrence-free survival (RFS) events at a 1.25-year median follow-up, pembrolizumab prolonged RFS (hazard ratio [HR], 0.57; P < .0001) compared with placebo. This led to the approval of pembrolizumab adjuvant treatment by the European Medicines Agency and US Food and Drug Administration. Here, we report an updated RFS analysis at the 3.05-year median follow-up. PATIENTS AND METHODS A total of 1,019 patients with complete lymph node dissection of American Joint Committee on Cancer Staging Manual (seventh edition; AJCC-7), stage IIIA (at least one lymph node metastasis > 1 mm), IIIB, or IIIC (without in-transit metastasis) cutaneous melanoma were randomly assigned to receive pembrolizumab at a flat dose of 200 mg (n = 514) or placebo (n = 505) every 3 weeks for 1 year or until disease recurrence or unacceptable toxicity. The two coprimary end points were RFS in the overall population and in those with programmed death-ligand 1 (PD-L1)–positive tumors. RESULTS Pembrolizumab (190 RFS events) compared with placebo (283 RFS events) resulted in prolonged RFS in the overall population (3-year RFS rate, 63.7% v 44.1% for pembrolizumab v placebo, respectively; HR, 0.56; 95% CI, 0.47 to 0.68) and in the PD-L1–positive tumor subgroup (HR, 0.57; 99% CI, 0.43 to 0.74). The impact of pembrolizumab on RFS was similar in subgroups, in particular according to AJCC-7 and AJCC-8 staging, and BRAF mutation status (HR, 0.51 [99% CI, 0.36 to 0.73] v 0.66 [99% CI, 0.46 to 0.95] for V600E/K v wild type). CONCLUSION In resected high-risk stage III melanoma, pembrolizumab adjuvant therapy provided a sustained and clinically meaningful improvement in RFS at 3-year median follow-up. This improvement was consistent across subgroups.


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