Health Canada approves first post-surgical treatment for patients with gastrointestinal stromal tumours
February 02, 2016
The study was a double-blind, randomized, multicentre, international study of more than 700 GIST patients throughout the US and Canada who had undergone surgery to remove their tumours. The primary efficacy endpoint of the study was recurrence-free survival (RFS), defined as the time from the date of randomization to the date of recurrence or death from any cause. Participants were randomized to receive either Gleevec* 400 mg/day or a matching placebo for one year.(1)
With a median follow-up of 19.7 months, there were 30 RFS events out of 359 patients in the Gleevec* arm (8%) compared to 70 RFS events out of 354 patients in the placebo arm (20%) (hazard>
The study, known as ACOSOG Z9001, was conducted at multiple cancer centres, including centres in Canada, under a Cooperative Research and Development Agreement between Novartis and the National Cancer Institute. The study was led by the American College of Surgeons Oncology Group (ACOSOG) in association with the Duke Clinical Research Institute.(1)
The investigators reported that Gleevec* therapy was generally well tolerated by most patients, with side effects similar to those observed in previous clinical trials with Gleevec*. The most frequently reported adverse reactions were diarrhea, fatigue, nausea, edema, decreased hemoglobin, rash, vomiting and abdominal pain. No new adverse reactions were reported in the adjuvant GIST treatment setting that had not been previously reported in other patient populations including patients with unresectable and/or malignant metastatic GIST.(1)
Source: NOVARTIS PHARMACEUTICALS CANADA INC.