The US-based National Cancer Institute (NCI) has commended Novartis' anti-cancer tablet, Gleevec, as an effective therapy for patients suffering from GISTs, metastatic gastro-intestinal tumors.
These tumours do have a rather complicated name. They are found in the digestive system - the gastrointestinal tract. They develop from cells of connective tissues that control the movements of the gut.
The tissues that support body organs are called the 'stroma', so that's where the stromal bit comes from. Cancers of connective tissues are 'sarcomas'. So the full name is gastrointestinal stromal sarcoma.
Some GISTS are benign (not cancerous) but they can become cancerous if not treated. Generally speaking, the larger the GIST, the more likely it is to be cancerous.
It is estimated that approximately 5,000 to 6,000 new patients are diagnosed with GIST each year in the United States.
The NCI said that preliminary results from a large, randomized, placebo-controlled clinical trial for patients with primary GIST, showed that patients who received imatinib mesylate (Gleevec) after complete removal of their tumor were significantly less likely to have a recurrence of their cancer compared to those who did not receive imatinib.
There was no recurrence of cancer in approximately 97 per cent of patients given Gleevec for a year after surgery to remove tumors, compared to approximately 83 per cent of those who underwent surgery but received a placebo.
The Novartis has lately come under a lot of fire over its continuing battle in Indian courts to patent Gleevec. In such a backdrop, the NCI's preliminary findings should be welcome for it.
Novartis supplied Gleevec for use in the study involving 600 patients, and also provided partial funding under a cooperative research and development agreement with NCI to support the clinical development of Gleevec.
"These results have major implications for patients with primary GIST," noted the principal investigator of the study, Ronald DeMatteo, Memorial Sloan-Kettering Cancer Center at New York.
"Conventional chemotherapy agents have been notoriously ineffective in GIST. This study for the first time demonstrated that targeted molecular therapy reduces the rate of recurrence after complete removal of a primary GIST."
Diane Young, Head of Global Medical Affairs at Novartis Oncology, said, "With these new data, we see that Gleevec may help patients with early GIST. We will now work with the investigators on a submission to gain regulatory approval for Gleevec as adjuvant treatment for GIST."
Adjuvant therapy is treatment given in addition to the primary therapy to kill any cancer cells that may have spread, even if the spread cannot be detected by radiologic or laboratory tests.