Data published online and in an upcoming print issue of The Lancet show that Glivec (imatinib), when taken after surgery, substantially reduces the rate of recurrence of Kit-positive gastrointestinal stromal tumours (GIST) compared with placebo.
The phase III study published was led by the American College of Surgeons Oncology Group (ACOSOG) and examined post-surgery, or adjuvant, treatment of more than 700 GIST patients. Researchers found that 98 per cent of patients receiving 400 mg of Glivec daily remained tumour-free one year after surgery. The study also found Glivec to be safe and well-tolerated, with a low rate of serious adverse events.
GIST is a life-threatening cancer of the gastrointestinal tract. After initial surgery to remove the tumour, GIST can return in one of two patients within a median of two years.
"The standard of care after surgical removal of primary GIST has been clinical and radiologic observation, since standard chemotherapeutic agents have been ineffective in this disease. This frequently resulted in tumour recurrence," said Ronald DeMatteo, MD, Memorial Sloan Kettering Cancer Center, New York, NY. "Now, as The Lancet reports, by treating patients with Glivec after removal of their initial tumour, we can proactively impact the course of this disease by delaying, and in some patients possibly preventing, the return of the cancer."
Glivec was recently approved in the US, Switzerland and several other countries for the treatment of GIST in the adjuvant setting, based on the ACOSOG data. This approval represented the tenth indication for Glivec in the US.
Glivec is approved in more than 90 countries including the US, EU and Japan, for the treatment of all phases of Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML). Glivec is also approved in the US, EU and other countries for the treatment of patients with Kit (CD117)-positive gastrointestinal tumours (GIST), which cannot be surgically removed and/or have already spread to other parts of the body (metastasized). In the US, Glivec was recently approved for the post-surgery treatment of adult patients following complete surgical removal of Kit (CD117)-positive gastrointestinal stromal tumours. In the EU, Glivec is also approved for the treatment of adult patients with newly diagnosed Ph+ acute lymphoblastic leukaemia (Ph+ ALL) in combination with chemotherapy and as a single agent for patients with relapsed or refractory Ph+ ALL. Glivec is also approved for the treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP) who are not eligible for surgery. Glivec is also approved for the treatment of patients with myelodysplastic/myeloproliferative diseases (MDS/MPD). Glivec is also approved for hypereosinophilic syndrome and/or chronic eosinophilic leukaemia (HES/CEL).