f patients had surgery other than a biopsy at the time of initial diagnosis. Of those patients undergoing resection, 73% underwent a subtotal resection and 27% underwent a gross total resection. Eighteen percent of patients had surgery at the time of first relapse. The median time from initial diagnosis to first relapse was 13.8 months (4.2–75.4).
TEMODAR Capsules were given for the first 5 consecutive days of a 28-day cycle at a starting dose of 150 mg/m2/day. If the nadir and day of dosing (Day 29, Day 1 of next cycle) absolute neutrophil count was ≥1.5 × 109/L (1500/µL) and the nadir and Day 29, Day 1 of next cycle platelet count was ≥100 × 109/L (100,000/µL), the TEMODAR dose was increased to 200 mg/m2/day for the first 5 consecutive days of a 28-day cycle.
In the refractory anaplastic astrocytoma population, the overall tumor response rate (CR + PR) was 22% (12/54 patients) and the complete response rate was 9% (5/54 patients). The median duration of all responses was 50 weeks (range: 16–114 weeks) and the median duration of complete responses was 64 weeks (range:52–114 weeks). In this population, progression-free survival at 6 months was 45% (95% CI: 31%–58%) and progression-free survival at 12 months was 29% (95% CI: 16%–42%). Median progression-free survival was 4.4 months. Overall survival at 6 months was 74% (95% CI: 62%–86%) and 12-month overall survival was 65% (95% CI: 52%–78%). Median overall survival was 15.9 months.
15 REFERENCES
OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999.
American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2006; 63:1172–1193.
NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165.[3]
Polovich, M., White, J. M., & Kelleher, L.O. (eds.) 2005. Chemotherapy and biotherapy guidelines and recommendations for practice (2nd. ed.) Pittsburgh, PA: Oncology.
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 Safe Handling and Disposal
Care should be exercised in the handling and preparation of TEMODAR. Vials and capsules should not be opened. If vials or capsules are accidentally opened or damaged, rigorous precautions should be taken with the contents to avoid inhalation or contact with the skin or mucous membranes. The use of gloves and safety glasses is recommended to avoid exposure in case of breakage of the vial or capsules. Procedures for proper handling and disposal of anticancer drugs should be considered1–4. Several guidelines on this subject have been published.
16.2 How Supplied
TEMODAR Capsules:
TEMODAR (temozolomide) Capsules are supplied in amber glass bottles with child-resistant polypropylene caps containing the following capsule strengths:
TEMODAR Capsules 5 mg: have opaque white bodies with green caps. The capsule body is imprinted with two stripes, the dosage strength, and the Schering-Plough logo. The cap is imprinted with "TEMODAR".
They are supplied as follows:
5-count - NDC 0085-3004-02
14-count - NDC 0085-3004-01
TEMODAR Capsules 20 mg: have |
