GUELPH, ON, April 1 /CNW/ - Clinical study results just published in the
journal The Lancet confirm Gleevec (imatinib mesylate) as a safe and effective
post-surgical treatment for patients with gastrointestinal stromal tumors
(GIST), and signal the urgent need for patient access to this life-saving
treatment. In fact, this Phase III clinical trial was halted early, after
investigators found that 98 per cent of patients with primary GIST, who had
received Gleevec for one year following surgery, did not have a return of
"Seeing these significant results published in a world-renowned medical
journal gives renewed hope for patients with primary GIST. Until now, these
patients could only 'wait and watch' after surgery, fearing their cancer's
return," says David Josephy, president of GIST Sarcoma Life Raft Group Canada.
"While some provinces are already providing access to Gleevec as a
post-surgical treatment for GIST, others, such as Ontario and Alberta, must
also find a way to offer patients this life-saving treatment option where no
GIST, a rare cancer of the gastrointestinal tract, is difficult to
diagnose, causing few symptoms in the early stages of the disease. GIST tumors
can grow to be very large before becoming symptomatic, and many people only
find out about the cancer after it has already spread. While surgery is the
mainstay of treatment for GIST, even after surgery, GISTs will often recur,
months to years after the operation.(2)
"Up to fifty per cent of patients with GIST may have a recurrent tumor
within five years, with surgery alone. Although we have seen a great tumour
response and increased survival with Gleevec in the metastatic setting,
advanced stage patients eventually suffer from progressive disease and may
die. We want to be able to reduce the risk of recurrence right from the
beginning - and now we know that we can" says Dr. Jawaid Younus, medical
oncologist at the London Regional Cancer Program, London Health Sciences
Centre, in Ontario. "This study, published in The Lancet, demonstrates
significant effectiveness of post-operative treatment with Gleevec for one
year to reduce the risk of GIST coming back. This is a pioneering step in the
adjuvant treatment of GIST."
At present, Gleevec is approved in Canada for the treatment of
unresectable, recurrent or metastatic GIST. The primary GIST indication for
Gleevec has already been approved by the FDA in the U.S.A., and has been
submitted for review by Health Canada.
"Despite evidence clearly showing that Gleevec is an essential therapy to
prevent the spread of this disease, patient access is sporadic, depending on
where in Canada they live," says Josephy. "Our hope is that Health Canada and
provincial drug programs will expedite their review processes so that patients
can have unimpeded access to this life-saving drug treatment."
About GIST Sarcoma Life Raft Group Canada
GIST Sarcoma Life Raft Group Canada is a not-for-profit Canadian
corporation, allied with the Life Raft Group USA. The mission of the
organization is to ensure the survival of Canadian GIST patients, while
maintaining the quality of their lives. The organization also provides support
to patients and caregivers, works to increase awareness of the disease amongst
the public and health care professionals, helps to establish support groups
and supports GIST research in Canada.
(1) Z9001: A Phase III Randomized Double-blind Study of Adjuvant STI571
(Gleevec) Versus Placebo in Patients Following the Resection of Primary
Gastrointestinal Stromal Tumor (GIST).
(2) Eisenberg BL, Judson I. Surgery and imatinib in the management of
GIST: emerging approaches to adjuvant and neoadjuvant therapy. Annals of
Surgical Oncology. 2004 May; 11(5): 465-75.
For further information:
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