For Some KIT+ GIST Patients, Extending Adjuvant GLEEVEC Improved Survival
36 months of treatment after surgery increased patient survival compared with 12 months of treatment (view study details)
Results from the Scandinavian Sarcoma Group trial showed that extending adjuvant treatment with GLEEVEC for KIT+ GIST helped prevent the disease from returning and improved patient survival compared with patients who received adjuvant treatment for a shorter time. Trial results were based on a median follow-up at 42 months for recurrence-free survival, and a median follow-up at 48 months for overall survival.
In patients with hypereosinophilic syndrome (a condition with increased eosinophils, which are a type of white blood cell) and heart involvement, cases of heart disease have been associated with the initiation of GLEEVEC therapy. Speak to your doctor regarding appropriate supportive care or discontinuing GLEEVEC
Trial results were based on a median follow-up at 42 months for recurrence-free survival, and a median follow-up at 48 months for overall survival
The SSG trial compared 12 months to 36 months of GLEEVEC treatment at 400 mg/day in adult patients after surgery for KIT+ GIST. Patients in the trial had specific KIT+ GIST disease factors, which included a combination of the following: tumor size, the rate at which the tumor was growing (mitotic rate), and whether or not the tumor had previously ruptured. All patients in the study had KIT+ GIST with one of the following: tumor size >5 cm and mitotic count >5/50 high-power fields (HPFs), or tumor size >10 cm and any mitotic count, or tumor of any size with mitotic count >10/50 HPFs, or tumors ruptured into the peritoneal cavity.
A total of 397 patients who underwent surgery for KIT+ GIST participated in the SSG trial. Of these patients, 199 were treated with GLEEVEC for 12 months (1 year) after surgery. The other 198 were treated with GLEEVEC for 36 months (3 years) after surgery.
In the group treated for 36 months, more patients remained free of KIT+ GIST (median follow-up at 42 months) and more patients survived (median follow-up at 48 months). The optimal length of treatment with GLEEVEC is unknown.
Skin reactions, such as fluid-filled blisters, have been reported with the use of GLEEVEC.
Clinical cases of hypothyroidism (reduction in thyroid hormones) have been reported in patients taking levothyroxine replacement during treatment with GLEEVEC. Your doctor should closely monitor your thyroid hormone levels
More patients were free of KIT+ GIST in the group taking adjuvant GLEEVEC for 36 months. Trial results were based on a median follow-up at 42 months for recurrence-free survival
- In the 36-month group, when data were collected, 25% (50 patients) had recurrence of KIT+ GIST
- In the 12-month group, 42% (84 patients) had recurrence of KIT+ GIST
Trial results were based on a median follow-up at 42 months for recurrence-free survival
Long-term use may result in potential liver, kidney, and/or heart toxicities. Immune system suppression may also result from long-term use
More patients survived in the group taking adjuvant GLEEVEC for 36 months compared with patients treated for 12 months
36 months of treatment after surgery increases patient survival in KIT + GIST
Trial results were based on a median follow-up at 48 months for overall survival
- The survival benefit was doubled in the 36-month group compared to the 12-month group (55%).
GLEEVEC can cause harm to the unborn child when administered to a pregnant woman. Women should be aware of the potential harm to the fetus. Be sure to inform your doctor if you are or think you may be pregnant. You should not breastfeed while taking GLEEVEC
Growth retardation (slowing of growth) has been reported in children taking GLEEVEC. The long-term effects of extended treatment with GLEEVEC on growth in children are unknown. Growth retardation may be monitored in children receiving treatment.
What is the optimal treatment duration with GLEEVEC?
Treatment length varies from patient to patient based on different factors. The optimal length of treatment with GLEEVEC is unknown. Only your oncologist and your treatment team can advise you about the optimal length of treatment for you.