Article Figures & Data
Figures
- FIG. 1.
Combined favorable response rates in the caspofungin and amphotericin groups. Patients presenting with either esophageal or oropharyngeal candidiasis were treated with caspofungin (35, 50, and 70 mg) or amphotericin (0.5 mg/kg) daily for 7 to 14 days. Patients were evaluated 3 to 4 days after discontinuation of therapy. Numbers within the columns represent the total number of patients in each group included in the MITT analysis. Error bars represent the 95% confidence intervals.
- FIG. 2.
Combined favorable response rates to caspofungin and amphotericin therapy by baseline CD4 lymphocyte count. CD4 cell counts were measured at screening. Numbers within the columns represent the total number of patients in each group. Error bars represent the 95% confidence intervals. The confidence interval was not calculated for the caspofungin 70-mg dose group having >50 CD4 cells/mm3 because the sample size was only seven patients.
- FIG. 3.
Resolution of esophageal plaques caused by infection with C. albicans in two patients treated with caspofungin. Favorable endoscopic responses are illustrated for two representative patients with high-grade esophagitis 3 to 4 days after the conclusion of caspofungin therapy.
Tables
- TABLE 1.
Baseline patient characteristics by treatment group
Characteristic Value for patients exhibiting characteristica Total patients (n = 140) Caspofungin acetate, 35 mg (n = 34) Caspofungin acetate, 50 mg (n = 34) Caspofungin acetate, 70 mg (n = 37) Amphotericin B, 0.5 mg/kg (n = 35) Stratumb Esophageal (± oropharyngeal) 21 (61.8) 20 (58.8) 24 (64.9) 23 (65.7) 88 (62.9) Oropharyngeal (exclusively) 13 (38.2) 14 (41.2) 13 (35.1) 12 (34.3) 52 (37.1) Substratumc Unresponsive to fluconazole 6 (17.6) 3 (8.8) 7 (18.9) 5 (14.3) 21 (15.0) Responsive to fluconazoled 28 (82.4) 31 (91.2) 30 (81.1) 30 (85.7) 119 (85.0) Stratum-substratume 1 2 (5.9) 1 (2.9) 2 (5.4) 1 (2.9) 6 (4.3) 2 11 (32.4) 13 (38.2) 11 (29.7) 11 (31.4) 46 (32.9) 3 4 (11.8) 2 (5.9) 5 (13.5) 4 (11.4) 15 (10.7) 4 17 (50.0) 18 (52.9) 19 (51.4) 19 (54.3) 73 (52.1) HIV infection Positive 32 (94.1) 33 (97.1) 37 (100.0) 35 (100.0) 137 (97.9) Negative 2 (5.9) 1 (2.9) 0 (0.0) 0 (0.0) 3 (2.1) Baseline esophageal grade 1/2 1 (2.9) 2 (5.9) 2 (5.4) 3 (8.6) 8 (5.7) 1 4 (11.8) 0 (0.0) 2 (5.4) 1 (2.9) 7 (5.0) 2 3 (8.8) 5 (14.7) 7 (18.9) 3 (8.6) 18 (12.9) 3 10 (29.4) 11 (32.4) 9 (24.3) 12 (34.3) 42 (30.0) 4 2 (5.9) 2 (5.9) 4 (10.8) 4 (11.4) 12 (8.6) Baseline oropharyngeal grade 1 6 (17.6) 6 (17.6) 2 (5.4) 4 (11.4) 18 (12.9) 2 3 (8.8) 8 (23.5) 7 (18.9) 4 (11.4) 22 (15.7) 3 4 (11.8) 0 (0.0) 4 (10.8) 4 (11.4) 12 (8.6) CD4 countf No. of patients 31 32 36 34 133 Mean 109.2 72.6 51.9 59.4 72.2 SD 198.1 99.8 102.4 65.9 124.9 Median 48.0 34.0 21.5 29.0 30.0 Range 2-879 0-405 0-561 0-260 0-879 ↵a Results are presented as number (percent) unless otherwise indicated.
↵b Primary site of infection.
↵c Prior response to fluconazole.
↵d Includes patients not previously exposed to fluconazole or other azole antifungal agents.
↵e Stratum-substratum categories: 1, oropharyngeal candidiasis alone and unresponsive to fluconazole; 2, oropharyngeal candidiasis alone and responsive to or not previously exposed to fluconazole; 3, esophageal candidiasis (with or without oropharyngeal candidiasis) and unresponsive to fluconazole; 4, esophageal candidiasis (with or without oropharyngeal candidiasis) and responsive or not previously exposed to fluconazole.
↵f CD4 count tabulations include only those patients with HIV infection. Mean, standard deviation, median, and range are given as number of cells per cubic millimeter.
- TABLE 2.
Summary of adverse experiences
Treatment group No. (%) of patients experiencing adverse event Clinical Laboratory Drug relateda Serious and drug relateda Therapy stopped due to a serious drug-relateda clinical adverse event Died from any cause Drug relateda Serious and drug relateda Therapy stopped due to a serious drug-relateda laboratory adverse event Caspofungin acetate, 35 mg (n = 34) 17 (50)b 0 (0) 0 (0) 3 (9) 16 (48) 0 (0) 0 (0) Caspofungin acetate, 50 mg (n = 34) 12 (35)b 0 (0) 0 (0) 1 (3) 15 (44)c 0 (0) 0 (0) Caspofungin acetate, 70 mg (n = 37) 17 (46)b 0 (0) 0 (0) 3 (8) 13 (35)b 0 (0) 0 (0) Amphotericin B, 0.5 mg/kg (n = 35) 34 (97) 3 (9) 1 (3) 5 (14) 25 (71) 1 (3) 0 (0) All patients (n = 140)d 80 (57) 3 (2) 1 (1) 12 (9) 69 (50) 1 (1) 0 (0) ↵a Determined by the investigator to be possibly, probably, or definitely drug related.
↵b P ≤ 0.01 versus amphotericin B.
↵c P ≤ 0.05 versus amphotericin B.
↵d Only 33 of the 34 patients in the caspofungin, 35 mg, group had follow-up laboratory results and were included in the tabulation of laboratory adverse events.
Symptom Caspofungin acetatec Amphotericin B, 0.5 mg/kg (n = 35) 35 mg (n = 34) 50 mg (n = 34) 70 mg (n = 37) n (%) n (%) n (%) n (%) Chills 1 (2.9)** 1 (2.9)** 1 (2.7)** 28 (80.0) Fever 7 (20.6)** 4 (11.8)** 6 (16.2)** 25 (71.4) Phlebitis 3 (8.8) 1 (2.9) 2 (5.4) 5 (14.3) Diarrhea 1 (2.9) 0 (0.0) 1 (2.7) 5 (14.3) Nausea 3 (8.8)* 1 (2.9)** 1 (2.7)** 11 (31.4) Vomiting 0 (0.0)** 0 (0.0)** 1 (2.7)* 8 (22.9) Rash 3 (8.8) 0 (0.0) 0 (0.0) 1 (2.9) Headache 4 (11.8) 2 (5.9) 2 (5.4)* 8 (22.9)
