Background: Results from the first 56 pts in this study were the basis for regulatory approval of CAS as salvage therapy of IA. We report an update on all 90 pts enrolled through US approval of CAS in Jan 2001. Methods: Adults with documented IA, R or I to standard antifungal therapy, received CAS IV 70 mg x 1, then 50 mg/day. Efficacy was assessed by signs, symptoms & radiographs. Favorable response [Complete (CR) or Partial (PR)] required significant clinical & radiographic improvement. Diagnosis & outcome were assessed by an independent expert panel. Results: 83/90 pts met the IA definition & received > 1 dose of CAS. Underlying diseases included hematologic malignancy (48%), allo-BMT (25%), organ transplant (11%), & other (16%). Definite IA was confirmed in 64%; 36% had probable pulmonary IA. 71 (86%) were refractory to & 12 (14%) intolerant of prior therapy. CR or PR was noted in 45% (37/83). 5/19 neutropenic pts at baseline (26%) had a favorable outcome; 4 had improved before neutrophil recovery. CAS for 1 - 162 days was generally well tolerated. The only 2 serious drug-related AEs were lung infiltrate & hypercalcemia. 2 pts stopped CAS due to a drug-related AE. Renal & liver toxicity were rarely noted. Conclusion: These data confirm the efficacy of CAS as salvage therapy of IA.
Full conference title:
42nd Interscience Conference on Antimicrobial Agents and Chemotherapy
- ICAAC 42nd