Table 1.

Eligibility criteria for the advanced gastrointestinal stromal tumor (GIST) drug program in Poland (ICD-10: C15–C18, C20, C48).

1.	ADJUVANT TREATMENT WITH IMATINIB: in patients at high risk of recurrence (≥50%) according to AJCC-NCCN-AFIP classification after radical tumor resection of KIT-CD117 GIST of the stomach, duodenum, small intestine and rectum and* palliative treatment with imatinib in patients with disseminated or inoperable gastrointestinal stromal tumor, which aims to stop the progression of the disease.
1.1.	Inclusion criteria for treatment with imatinib in children and* adults
1)	Diagnosis of gastrointestinal stromal tumor (GIST) confirmed histologically.
2)	Expression of CD117 confirmed by immunohistochemistry.
3)	Adjuvant treatment: high risk ≥50% of recurrence after radical resection of tumor with cKIT (CD117-positive GIST of the stomach, duodenum, small intestine and rectum, determined according to the AJCC-NCCN-AFIP classification); the time from primary GIST surgery to the implementation of adjuvant treatment should not exceed 4 months; the presence of KIT or PDGFR-α mutation excluding the PDGFR-αD842V mutation.*
4)	Advanced disease treatment: the inability to perform resection or the presence of metastases documented by clinical examination or imaging.
5)	Lesions measurable by computed tomography (CT).
6)	World Health Organization (WHO) performance status 0–2.
7)	Normal bone marrow examination results (platelet count ≥75,000/mm3, absolute neutrophil count ≥1,000/mm3, hemoglobin level ≥8.0 g/dL).
8)	Normal liver and kidney parameters (≤2.5×ULN and ≤5×ULN for liver function tests in the case of liver metastases).
1.2.	Exclusion from the imatinib treatment program
1)	Hypersensitivity to imatinib.
2)	Relapse of GIST during adjuvant treatment, which may last up to a maximum of 36 months.*
3)	Progression of the disease during treatment with the dose of imatinib up to 800 mg/day; especially primary resistance to imatinib; in children of the area body up to 1m2 progression of the disease when using the drug after increasing the dose of imatinib twice.*
4)	Lack of efficacy after four months of using the drug (increase in the sum of lesions in the spiral CT by 20% or more, except when the density of lesions is less than 15% in relation to the initial density or the appearance of new lesion(s) of at least 10 mm).
5)	Persistence of WHO toxicity of grade ≥ 3 (especially a 3-fold increase in bilirubin above ULN, a 5-fold increase in liver transaminases above the upper limit of normal (ULN), severe anemia, neutropenia or thrombocytopenia).
6)	WHO performance status 3/4.
7)	Significant co-morbidities or organ failure (to be assessed by the attending physician).
8)	Heart disease class III or IV WHO or the New York Heart Association (NYHA).
9)	Use of warfarin in full daily doses.
10)	Pregnancy.
11)	Breastfeeding.
2.	TREATMENT WITH SUNITINIB
2.1.	Inclusion criteria for treatment with sunitinib for children and adults
1)	Diagnosis of GIST confirmed histologically.
2)	Expression of CD117 confirmed by immunohistochemistry.
3)	The inability to perform resection or the presence of metastases documented by clinical examination or imaging.
4)	Lesions measurable on CT.
5)	Documented progression during imatinib treatment (resistance) or imatinib intolerance (toxicity of grade 3/4).
6)	WHO performance status 0–3.
7)	Results of a blood count analysis with a smear: platelet count ≥75 000/mm3, absolute neutrophil count ≥1 000/mm3, hemoglobin level ≥8.0 g/dL.
8)	Normal liver and kidney parameters (≤2.5×ULN and ≤5×ULN for liver function tests in the case of liver metastases).
2.2.	Exclusion from the sunitinib treatment program
1	Hypersensitivity to sunitinib.
2)	Documented progression of the disease during the use of the drug.
3)	Lack of efficacy (in the form of disease progression) after 3 months of using the drug, unacceptable, recurrent (despite dose modifications) toxicity of WHO grade ≥3 (especially 3-fold increase in bilirubin, 5-fold increase in liver transaminases, neutropenia or thrombocytopenia; symptoms of congestive heart failure, acute coronary insufficiency, uncontrolled hypertension and unstable arrhythmias requiring treatment).
4)	WHO performance status 4.
3.	TREATMENT WITH SORAFENIB
3.1.	Inclusion criteria for sorafenib treatment
1)	≥18 years of age.
2)	Diagnosis of GIST confirmed histologically.
3)	The inability to resect the primary lesions or the presence of metastases documented by clinical examination or imaging.
4)	Lesions measurable on CT.
5)	Documented failure of previous treatment with imatinib (progression during treatment with imatinib) and documented progression during treatment with sunitinib (resistance) or sunitinib intolerance.
6)	Lack of metastases in the central nervous system;
7)	Zubrod – WHO performance status 0/1.
8)	Results of a blood count analysis with a smear: the number of plates blood ≥100 000/mm3, absolute neutrophil count ≥1,500/mm3, hemoglobin concentration ≥10.0 g/dL.
9)	Normal liver and kidney parameters (≤2.5×ULN and ≤5×ULN for liver function tests in the case of liver metastases).
10)	No contraindications to the use of sorafenib.
3.2.	Exclusion from the sorafenib treatment program
1)	Hypersensitivity to sorafenib.
2)	Documented progression of the disease during the use of sorafenib;
3)	Long-lasting (>28 days) adverse reactions of grade ≥3 (WHO) not susceptible to symptomatic treatment and dose reduction.
4)	Persistent deterioration of Zubrod–WHO performance status 2–4.
5)	Consent withdrawal.
4.	DURATION OF TREATMENT
	Treatment lasts until the decision of the attending physician is taken to exclude the patient from the program in accordance with the exclusion criteria.

AJCC – American Joint Committee on Cancer; NCCN – National Comprehensive Cancer Network; AFIP – Armed Forces Institute of Pathology.

^*Patients excluded from analysis.