Background: We have recently reported safety of HD-CAP (100 mg daily) therapy in 34 cancer patients. In this study, we report feasibility of HD-CAP in additional 70 patients. Methods: Patients who received HD-CAP (2002-2005) at MDACC were evaluated under an existing IRB protocol. Safety was determined in patients who have received > 3 doses and for efficacy > 7 doses of HD-CAP. EORTC/MSG criteria were used to define IFIs. Outcomes were evaluated at the end of therapy. Response was defined as complete or partial response (CR, PR), or stable disease (SD). Results: In 70 patients HD-CAP was associated with no drug-related serious adverse events. The median change in values between start and end of > 4 weeks of HD-CAP therapy (n=11) were as follows: creatinine 0.2 Â± 0.3 mg/dL; total bilirubin 0.5 Â± 1.8 mg/dL; ALT 38 Â± 29 IU/L; and alkaline phosphatase 26 Â± 39 IU/L (p > 0.3). In 47 patients treatment response was evaluated, the age was 48 Â± 14 years. In 68% cancer was refractory. Leukemia was common (66%). In 14 (30%) allogeneic stem cell transplant recipients, 7 patients had GvHD. APACHE II score was 14 Â± 4. During antifungal therapy, 53% of patients remained neutropenic (7 Â± 15 days) and in 36% high-dose corticosteroids were continued. Eighteen patients (38%) had proven IFI including 12 with aspergillosis and 3 with zygomycosis. One patient had probabale hepatosplenic candidiasis. Most patients (78%) received HD-CAP after failure to primary antifungal therapy. HD-CAP was given in combination with voriconazole or posaconazole in 21 patients (45%); a single patient received HD-CAP alone. Response occured in 28 patients (60%) including 16 patients (34%) with CR, 10 with PR (21%) and SD in 2 patients (4%). Deaths attributed to progressive IFI were observed in 9 patients (19%). Conclusions: HD-CAP salvage therapy was well tolerated and appears to provide an alternative in cancer patients who fail primary antifungal therapy.
Full conference title:
47th Interscience Conference on Antimicrobial agents and Chemotherapy
- ICAAC 47th