Table 1.
Baseline characteristics of 17 patients with symptomatic KSHV-associated MCD treated with R-Dox
| Feature | Result |
|---|---|
| Age, median (range) | 43 (34-55) |
| Sex | |
| Men | 16 (94) |
| Women | 1 (6) |
| Race/Ethnicity | |
| White | 7 (41) |
| African American | 4 (24) |
| African | 3 (18) |
| Hispanic | 3 (18) |
| Kaposi sarcoma (KS), total, n (%) | 12 (71) |
| History of cutaneous KS only | 2 (12) |
| KS at baseline | 10 (59) |
| Cutaneous only | 2 (12) |
| In MCD-affected lymph node only | 4 (24) |
| Cutaneous and in MCD-affected lymph node | 4 (24) |
| Median CD4, cells/μL (range) | 226 (21-858) |
| CD4 <200 cells/μL | 7 (41) |
| Time since HIV diagnosis, median years (range) | 7 (1-22) |
| HAART | 17* |
| Time on HAART, median months (range) | 25 (0-11 y) |
| Protease inhibitor–based | 10 (59) |
| Non-nucleoside reverse-transcriptase inhibitor based | 6 (35) |
| Integrase stand transfer inhibitor–based† | 1 (6) |
| Median HIV viral load, copies/mL (range) | <50 (<50-7710) |
| Prior KSHV-MCD therapy | |
| Prior therapy‡ | 14 (82) |
| Median number of therapies (range) | 2 (0-5) |
| Prior KS therapy | |
| Prior therapy | 7 (41) |
| Median number of therapies in treated patients (range) | 2 (1-5) |
| Median KSHV viral load, copies/106 PBMCs§ (range) | 22 222 (0-8.7 million) |
| HIV viral load <50 copies/mL | 11 (65) |
| Clinical symptoms§ | |
| Fever/night sweats | 10 (59) |
| Fatigue | 17 (100) |
| Respiratory symptoms | 9 (53) |
| Gastrointestinal symptoms/anorexia | 11 (65) |
| Biochemical parameters, median (range) | |
| C-reactive protein, mg/dL‖ | 7 (0.4-16.3) |
| Albumin, g/dL | 2.9 (1.2-4) |
| Sodium, mEq/L | 133 (126-138) |
| Platelets, K/µL | 98 (11-567) |
| Hemoglobin, g/dL | 9.3 (6.8-12.8) |
| At least one CTCAE equivalent grade ≥3 symptom/laboratory abnormality or ECOG performance status >2 | 6 (35) |
| Radiographic parameters | |
| Splenomegaly, % (spleen size [cm], range) | 100 (12.5-28) |
| Enlarged lymph nodes, % | 100 |
| Serum immunoglobulins and free light chains‖ | |
| Median IgG, mg/dL (range) | 2680 (1140-5200) |
| Median IgA, mg/dL (range) | 313 (117-1500) |
| Median IgM, mg/dL (range) | 81 (27-167) |
| Median IgE, IU/mL (range) | 240 (70-1940) |
| Median λ free light chains, mg/dL (range) | 7.8 (2-22.6) |
| Median κ free light chains, mg/dL (range) | 6 (1.8-19.8) |
HAART, combination antiretroviral therapy; CTCAE, Common Terminology Criteria for Adverse Events; ECOG, Eastern Cooperative Oncology Group.
Values are n (%) unless otherwise noted.
Two patients had not taken HAART during the few days before entry because they were too sick to take their oral medications.
Two additional patients received integrase strand transfer inhibitors in combination with either a protease inhibitor or a non-nucleoside reverse-transcriptase inhibitor.
In addition, 8 of these patients also received steroids for KSHV-MCD, and 2 were treated for severe cytopenias before KSHV-MCD diagnosis.
Three patients were receiving steroids and 1 patient was taking valganciclovir at the time of baseline evaluation.
Normal ranges (mg/dL unless noted): c-reactive protein <0.4 mg/dL, IgG 642-1730, IgA 91-499, IgM 34-342, IgE 0-90 (IU/mL), λ free light chains 0.66-2.32, κ free light chains 0.57-2.22.