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NICE Recommends Sunitinib Malate as Second-Line Therapy for Advanced GIST
NEW YORK -- May 28, 2009 --The National Institute for Health and Clinical Excellence (NICE) has issued its final appraisal document (FAD) recommending sunitinib malate (Sutent) as a second-line treatment for patients with advanced gastrointestinal stromal tumour (GIST).
The guidance states that sunitinib malate is recommended for reimbursement as a treatment option for patients with advanced GIST after disease progression on or intolerance to imatinib mesylate, and who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
According to NICE, "the benefits seen in time to tumour progression and progression free survival were such that a substantial improvement in overall survival with sunitinib treatment was probable."
NICE's decision was based on data from a pivotal phase 3 trial of sunitinib malate compared with placebo in patients with advanced GIST. Sunitinib malate increased time to tumour progression in the study by almost 5 months (6.4 weeks vs 27.3 weeks; P < .0001). Following these early findings, 84% of patients receiving placebo switched to sunitinib malate treatment.
Updated analyses of this trial demonstrated a median overall survival of 73.9 weeks for sunitinib malate-treated patients vs. 64.9 weeks for those initially receiving placebo (P = .161). However, according to an exploratory analysis calculating what the difference may have been if the patients had remained on placebo, estimated overall survival for sunitinib malate patients was 73.9 weeks, compared with 35 weeks for those receiving placebo.
The most common adverse reactions in clinical trials were fatigue, asthenia, diarrhoea, nausea, mucositis/stomatitis, vomiting, dyspensia, abdominal pain, constipation, hypertension, rash, hand-foot syndrome, skin discoloration, altered taste, anorexia, and bleeding.
SOURCE: Pfizer Oncology
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