Important note: Information in this article was accurate in 1991. The state of the art may have changed since the publication date.
A RANDOMIZED TRIAL OF FLUCONAZOLE (FLU) VS AMPHOTERICIN B (AMB) FOR THE TREATMENT OF ESOPHAGEAL CANDIDIASIS (EC) IN THE ADULT CANCER PATIENT (MEETING ABSTRACT)
Proc Annu Meet Am Soc Clin Oncol; 10:A1222 1991. Unique Identifier : AIDSLINE ICDB/91672559 Lake D; Kunzweiler J; St. Michael's Medical Center, Newark, NJ 07102
Abstract:
AMB is considered the standard therapy for EC. Our study randomized 31 adult cancer patients (pts) with endoscopically verified EC to receive FLU 200 mg/day (16 pts) or AMB 0.3-0.6 mg/kg/day (15 pts). Five of the pts were known to be HIV positive. Although none of the pts were felt to have concurrent herpes or CMV esophagitis, cultures were sporadically taken. Thirteen (42%) were neutropenic, (absolute PMN less than 2000 [3]; less than 500 [10]). Treatment duration was a minimum of 1 wk after resolution of symptoms up to 4 wk total. Three pts in each arm were inevaluable (inadequate therapy). Pts were monitored weekly for clinical improvement, toxicities of therapy and laboratory abnormalities. Post-therapy pts were categorized as clinically cured, improved or failed. Six FLU pts and 5 AMB pts received post-treatment endoscopies; no invasive hyphae were found. Of the 13 evaluable FLU pts, 11 were clinically cured, 1 improved and 1 failed. Of the 12 evaluable AMB pts, 6 were clinically cured, 4 improve and 2 failed. The trend approaches statistical significance (p = 0.08) in favor of FLU. Responses in both groups occurred within 7 days post-treatment. FLU in a once daily dosage was well tolerated with no drug-related side effects. Characteristic AMB side effects were noted in 7/10 (70%) of pts. Investigators stopped AMB sooner than FLU; the av duration of therapy was 13 days (AMB) vs 19 (FLU). In conclusion, this randomized trial suggests that FLU is an effective alternative to AMB in this pt population. It is better tolerated and more likely to be continued for a full therapeutic duration.
Keywords: Adult Amphotericin B/*THERAPEUTIC USE Candidiasis/*DRUG THERAPY/ETIOLOGY Comparative Study Esophageal Diseases/*DRUG THERAPY/ETIOLOGY Fluconazole/*THERAPEUTIC USE Human Neoplasms/COMPLICATIONS/*THERAPY ABSTRACT RANDOMIZED CONTROLLED TRIAL CLINICAL TRIAL 911030
M91A1120
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