objective response rate. Tumors were required to be measurable at entry in at least one site of disease, and response characterization was based on Southwestern Oncology Group (SWOG) criteria. There were no differences in response rates between the 2 dose groups. The response rate was 68.5% for the 400 mg group and 67.6% for the 600 mg group. The median time to response was 12 weeks (range was 3-98 weeks) and the estimated median duration of response is 118 weeks (95% CI: 86, not reached).
Adjuvant Treatment of GIST
In the adjuvant setting, Gleevec was investigated in a multicenter, double-blind, placebo-controlled, randomized study involving 713 patients. After complete gross resection of primary GIST, patients were randomized to one of the two arms: Gleevec at 400mg/day or matching placebo for one year. The ages of these patients ranged from 18 to 91years. Patients were included who had a histologic diagnosis of primary GIST expressing KIT protein by immunochemistry and a tumor size ≥3cm in maximum dimension, with complete gross resection of primary GIST within 14 to 70 days prior to registration.
The efficacy endpoint of the study was recurrence free survival (RFS) defined as the time from date of randomization to the date of recurrence or death from any cause. At a median follow up of 14.0 months, there were 30 RFS events in the Gleevec arm compared to 70 RFS events in the placebo arm (hazard ratio=0.398 [95% CI: 0.259, 0.610], p<0.0001). Based on an interim analysis, patients still receiving placebo were allowed to cross over to Gleevec. The current follow-up is too short to eva luate survival.
Figure 3 Recurrence Free Survival
15 REFERENCES
Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings. NIOSH Alert 2004-165.
OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html
American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2006;63:1172-1193.
Polovich, M., White, J. M., & Kelleher, L.O. (eds.) 2005. Chemotherapy and biotherapy guidelines and recommendations for practice (2nd. ed.) Pittsburgh, PA: Oncology Nursing Society
16 HOW SUPPLIED/STORAGE AND HANDLING
Each film-coated tablet contains 100 mg or 400 mg of imatinib free base.
100 mg Tablets
Very dark yellow to brownish orange, film-coated tablets, round, biconvex with bevelled edges, debossed with “NVR” on one side, and “SA” with score on the other side.
Bottles of 90 tablets………………………………….NDC 0078-0401-34
400 mg Tablets
Very dark yellow to brownish orange, film-coated tablets, ovaloid, biconvex with bevelled edges, debossed with “400” on one side with score on the other side, and “SL” on each side of the score.
Bottles of 30 tablets…………………………………NDC 0078-0438-15
Storage and Handling
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture.
Dispense in a tight container, USP.
Procedures for proper handling a
