Intestinal Stromal Tumors Treatment & Management
- Author: Michael A Choti, MD, MBA, FACS; Chief Editor: Jules E Harris, MD, FACP, FRCPC more...
In general, attempts to treat GISTs with cytotoxic chemotherapy or radiation therapy have been unsuccessful. Effects of radiation therapy on survival are unknown. GISTs are not ideal for this modality because of intra-abdominal motility, and for large tumors, the required field of radiation exposure may cause too much morbidity. Most often, radiation therapy is used in the palliative setting for symptomatic, unresectable disease. Standard cytotoxic chemotherapy has not been helpful in GIST management. One report noted only a 7% response rate (3 of 43 people with GISTs) to doxorubicin and dacarbazine in gastric sarcomas, compared with 22% for leiomyosarcomas. Other chemotherapy combinations have been equally unsuccessful. There is universal agreement that chemotherapy should not be used in patients with GISTs.
Imatinib mesylate (Gleevec), a tyrosine kinase inhibitor, is the first drug that effectively showed response rates against GIST progression.[25, 26, 27] The US Food and Drug Administration (FDA) has approved imatinib for adjuvant therapy of completely resected GISTs in adult patients. The efficacy of imatinib has also altered the paradigm in the treatment of patients with inoperable disease related to the difficulty in achieving negative margins or the risk of severe organ dysfunction. In these patients, imatinib therapy may be given in the neoadjuvant setting to shrink the tumor, with later surgical intervention for a complete resection.[28, 29]
Currently, for most cases of metastatic disease, imatinib therapy is considered the first-line treatment. Due to the success of imatinib therapy, 70% of patients with metastatic disease live more than 2 years after starting therapy; median overall survival is over 4 years. In comparison, only 20% of patients with metastatic disease treated with doxorubicin had a 2-year survival. Present recommendations are for life-long treatment with imatinib for metastatic disease.
The use of imatinib can be guided by genotyping of KIT and PDGFRA mutations :
KIT exon 11 mutants respond well to imatinib.
KIT exon 9 Ala502_Tyr503dup mutants, which occur predominantly in intestinal GISTs, are less sensitive to imatinib. In these patients, a recommended regimen is to initiate imatinib at the standard dose of 400 mg daily and then escalate to 800 mg daily, if tolerated, over approximately 1 month. 
GISTs with an Asp842Val substitution in exon 18, the most common PDGFRA mutation, are resistant to imatinib.
GISTs with secondary mutations in exon 13 and 14 are sensitive to sunitinib.
An international phase III trial in 906 patients with advanced GI stromal tumors found that long-term benefit from imatinib mesylate treatment can be predicted early on through the use of Response Evaluation Criteria in Solid Tumors (RECIST ) classification. Classification of patients at 2 and 4 months as showing response, no change, or progressive disease proved to be highly predictive of further progression or survival. When patients were classified after 6 months of imatinib, however, survival prognosis was the same among responders and those showing no change. These investigators suggest that imatinib be continued as long as patients show no progression according to RECIST.
Sunitinib malate, a multikinase inhibitor, is considered the standard second-line therapy for GISTs. The principal support for sunitinib in this role is a study by Demetri et al that reported significant disease control and superior survival with sunitinib compared with placebo in 312 patients with advanced GIST after failure and discontinuation of imatinab. The FDA has approved sunitinib for use in patients with GISTs that are not responding to imatinib or for patients who cannot tolerate imatinib.
Regorafenib (Stivarga) was approved in February 2013 for locally advanced, unresectable GISTs that no longer respond to imatinib or sunitinib. The pivotal phase III GRID trial showed that regorafenib plus best supportive care (BSC) significantly improved progression-free survival (PFS) compared to placebo plus BSC. Median PFS was 4.8 months for regorafenib and 0.9 months for placebo.
Surgical resection remains the cornerstone of treatment for localized GISTs. A complete resection offers the only chance for cure. Patients with complete tumor resection have a clear survival benefit over those with less radical or no surgery. Complete resection is associated with approximately 50-65% 5-year survival rate, but more than 50% of patients who undergo primary resection develop tumor recurrence (see Table 1 in Mortality/Morbidity).
For small GISTs, local resection may be adequate, if it is technically possible and does not compromise a complete resection. Small intestinal tumors may require segmental resection, and a wedge resection may be used for small gastric GISTs in some cases. Avoid enucleation of small tumors since predicting the preoperative malignant potential of GISTs is difficult, even if the tumor appears benign. Since limited resection is adequate for small malignant GISTs, minimally invasive surgery techniques can be adopted in select cases. Laparoscopic resection of GISTs of the stomach has demonstrated the feasibility and safety of this technique.
Approach all GISTs with an intention of a complete en bloc resection, including resection of any involved organs or structures such as the colon, spleen, kidney, and pancreas. As GISTs rarely metastasize to lymph nodes, routine lymphadenectomy is not indicated and does not show any survival benefit. Direct all efforts at avoiding tumor rupture during the operation. A tumor rupture is associated with a worse prognosis due to peritoneal seeding. Similarly, preoperative percutaneous biopsy of the tumor is not indicated in most cases, because there is a potential for needle track seeding. Preoperative percutaneous biopsy is pursued if the newly available information changes management, as it would in the case of a lymphoma.
The role for surgery in treating GIST metastasis is minimal. Metastasectomy may provide a survival benefit in select patients. These may include patients with well-differentiated GISTs, longstanding disease-free survival, and isolated liver metastases. In patients with good response to imatinib treatment, in whom gross disease can be removed, surgery may be considered on an individual case-by-case basis.
No specific consultations are required.
Decisions regarding postoperative diet are based on the type of surgery and are individualized. No specific diet restrictions are recommended for people with GISTs.
No specific activity restrictions exist.
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|Reference||Period||Patients, No.||Complete Resections, No.||5-y Survival Rate After Complete Resection, %|
|Caterino et al||1999-2009||47||46||65|
|DeMatteo et al||1982-1998||200||80||54|
|Ng et al||1957-1997||191||99||48|
|McGrath et al||1951-1984||51||30||63|
|Shiu et al||1949-1973||38||20||65|
|Akwari et al||1950-1974||108||52||50|
|Tumor Parameters||Risk of Progressive Disease*|
≤5 per 50 HPF
|>2 to ≤5 cm||Very low (1.9%)||Low (8.3%)||Low (4.3%)||Low (8.5%)|
|>5 to ≤10 cm||Low (3.6%)||Insufficient data||Moderate (24%)||Insufficient data|
|>10 cm||Moderate (10%)||High (34%)||High (52%)||High (57%)|
>5 per 50 HPF
|≤2 cm||None*||Insufficient data||High †||High (54%)|
|>2 to ≤5 cm||Moderate (16%)||High (50%)||High (73%)||High (52%)|
|>5 to ≤10 cm||High (55%)||Insufficient data||High (85%)||Insufficient data|
|>10 cm||High (86%)||High (86%)||High (90%)||High (71%)|
|*Defined as metastasis or tumor-related death.
† Denotes small number of cases.
|Data based on long-term follow up of 1055 gastric, 629 small intestinal, 144 duodenal, and 111 rectal GISTs.|
|Stage I||T1 or T2||N0||M0||Low|
|Stage IV||Any T||N1||M0||Any Rate|
|Any T||Any N||M1||Any Rate|