Baseline characteristics for all participants meeting the initial KICS criteria, participants with confirmed KICS, and participants diagnosed with PEL who also met the criteria for KICS
| . | All participants enrolled in KICS protocol N = 73 . | KICS ± KS on KICS protocol N = 35 . | PEL ± KS on KICS protocol N = 20 . | P value . | MCD + KS comparators N = 15 . | P value . | KS-alone comparators N = 15 . | P value . |
|---|---|---|---|---|---|---|---|---|
| Age at study entry, median (IQR), y | 40.6 (31.9-48.3) | 40.6 (31.6-48.1) | 44.5 (33.2-55.5) | .29 | 42.2 (31.3-48.6) | .9 | 48.2 (36.6-52.5) | .16 |
| Sex (%) | ||||||||
| Male | 67 (92) | 30 (86) | 19 (95) | .62 | 12 (80) | .78 | 15 (100) | .40 |
| Female | 6 (8) | 5 (14) | 1 (5) | 3 (20) | — | |||
| Race/Ethnicity (%) | ||||||||
| White | 22 (30) | 5 (14) | 11 (55) | .004 | 5 (33) | .17 | 5 (33) | .27 |
| Black | 37 (50) | 21 (60) | 9 (45) | 8 (53) | 8 (53) | |||
| Asian | — | — | — | 1 (7) | — | |||
| Hispanic | 7 (10) | 4 (11) | — | 1 (7) | 2 (12) | |||
| Unknown | 7 (10) | 5 (14) | — | — | — | |||
| ECOG Performance Status | ||||||||
| 0-2 (%) | 53 (73) | 30 (86) | 9 (45) | .002 | 6 (40) | .002 | 15 (100) | .15 |
| ≥3 (%) | 20 (27) | 5 (14) | 11 (55) | 9 (60) | — | |||
| HIV and CD4 T-cell characteristics | ||||||||
| HIV-positive (%) | 72 (99) | 34 (97) | 20 (100) | 1.00 | 15 (100) | 1.00 | 15 (100) | 1.00 |
| Time from HIV diagnosis, median (IQR), y | 6.0 (0.5-10.9) | 8.2 (1.9-15.2) | 6.4 (1.0-9.8) | .48 | 2.5 (0.3-5.3) | .04 | 6.8 (3.2-14.4) | .92 |
| On ART (%) | 66 (90) | 31 (91) | 19 (95) | 1.00 | 15 (100) | 1.00 | 15 (100) | 1.00 |
| ART duration, median (IQR), y | 0.6 (0.1-6.1) | 0.8 (0.2-6.7) | 0.6 (0.1-7.3) | .65 | 0.5 (0.1-4.3) | .61 | 2.8 (1.9-4.4) | .09 |
| CD4+ T cell count, median (IQR), cells per μL | 89∗ (32.5-184) | 81∗ (29-169) | 90 (29-229) | .73 | 95 (62-197) | .54 | 406 (253-502) | .0001 |
| CD4+ T cell count <200 cells per μL (%) | 55 (75) | 27 (77) | 13 (65) | .36 | 10 (67) | .49 | 3 (20) | <.0001 |
| HIV VL, median (IQR), copies per mL | 86 (24.5-1721) | 75 (<20 to 5999.8) | 122 (38-1160) | .57 | 417 (<50 to 6432) | .32 | <50 (<50 to 52) | .88 |
| KS characteristics | ||||||||
| Concurrent KS diagnosis† (%) | 66 (90) | 34 (97) | 15 (75) | .02 | 15 (100) | 1.00 | NA | NA |
| T1 stage KS with visceral involvement | 48 (66) | 29 (83) | 14 (70) | .32 | 12 (80) | 1.00 | 3 (20) | <.0001 |
| Time from KS diagnosis to other KAD, median (IQR), y‡ | 0.3 (0.1-1.7) | 0.3 (0.1-0.8) | 0.4 (0.1-3.4) | .27 | 0.1 (0-0.4) | .10 | NA | NA |
| Prior KS chemotherapy (% among those with KS) | 34 (52) | 16 (46) | 8 (40)§ | .78 | 2 (13) | .03 | 10 (67) | .22 |
| . | All participants enrolled in KICS protocol N = 73 . | KICS ± KS on KICS protocol N = 35 . | PEL ± KS on KICS protocol N = 20 . | P value . | MCD + KS comparators N = 15 . | P value . | KS-alone comparators N = 15 . | P value . |
|---|---|---|---|---|---|---|---|---|
| Age at study entry, median (IQR), y | 40.6 (31.9-48.3) | 40.6 (31.6-48.1) | 44.5 (33.2-55.5) | .29 | 42.2 (31.3-48.6) | .9 | 48.2 (36.6-52.5) | .16 |
| Sex (%) | ||||||||
| Male | 67 (92) | 30 (86) | 19 (95) | .62 | 12 (80) | .78 | 15 (100) | .40 |
| Female | 6 (8) | 5 (14) | 1 (5) | 3 (20) | — | |||
| Race/Ethnicity (%) | ||||||||
| White | 22 (30) | 5 (14) | 11 (55) | .004 | 5 (33) | .17 | 5 (33) | .27 |
| Black | 37 (50) | 21 (60) | 9 (45) | 8 (53) | 8 (53) | |||
| Asian | — | — | — | 1 (7) | — | |||
| Hispanic | 7 (10) | 4 (11) | — | 1 (7) | 2 (12) | |||
| Unknown | 7 (10) | 5 (14) | — | — | — | |||
| ECOG Performance Status | ||||||||
| 0-2 (%) | 53 (73) | 30 (86) | 9 (45) | .002 | 6 (40) | .002 | 15 (100) | .15 |
| ≥3 (%) | 20 (27) | 5 (14) | 11 (55) | 9 (60) | — | |||
| HIV and CD4 T-cell characteristics | ||||||||
| HIV-positive (%) | 72 (99) | 34 (97) | 20 (100) | 1.00 | 15 (100) | 1.00 | 15 (100) | 1.00 |
| Time from HIV diagnosis, median (IQR), y | 6.0 (0.5-10.9) | 8.2 (1.9-15.2) | 6.4 (1.0-9.8) | .48 | 2.5 (0.3-5.3) | .04 | 6.8 (3.2-14.4) | .92 |
| On ART (%) | 66 (90) | 31 (91) | 19 (95) | 1.00 | 15 (100) | 1.00 | 15 (100) | 1.00 |
| ART duration, median (IQR), y | 0.6 (0.1-6.1) | 0.8 (0.2-6.7) | 0.6 (0.1-7.3) | .65 | 0.5 (0.1-4.3) | .61 | 2.8 (1.9-4.4) | .09 |
| CD4+ T cell count, median (IQR), cells per μL | 89∗ (32.5-184) | 81∗ (29-169) | 90 (29-229) | .73 | 95 (62-197) | .54 | 406 (253-502) | .0001 |
| CD4+ T cell count <200 cells per μL (%) | 55 (75) | 27 (77) | 13 (65) | .36 | 10 (67) | .49 | 3 (20) | <.0001 |
| HIV VL, median (IQR), copies per mL | 86 (24.5-1721) | 75 (<20 to 5999.8) | 122 (38-1160) | .57 | 417 (<50 to 6432) | .32 | <50 (<50 to 52) | .88 |
| KS characteristics | ||||||||
| Concurrent KS diagnosis† (%) | 66 (90) | 34 (97) | 15 (75) | .02 | 15 (100) | 1.00 | NA | NA |
| T1 stage KS with visceral involvement | 48 (66) | 29 (83) | 14 (70) | .32 | 12 (80) | 1.00 | 3 (20) | <.0001 |
| Time from KS diagnosis to other KAD, median (IQR), y‡ | 0.3 (0.1-1.7) | 0.3 (0.1-0.8) | 0.4 (0.1-3.4) | .27 | 0.1 (0-0.4) | .10 | NA | NA |
| Prior KS chemotherapy (% among those with KS) | 34 (52) | 16 (46) | 8 (40)§ | .78 | 2 (13) | .03 | 10 (67) | .22 |
Comparisons were made between participants with KICS with or without KS and those with other KAD at the time of active disease (PEL with or without KS from the KICS protocol and the comparator groups of KS alone and MCD + KS).
IQR, interquartile range; NA, not applicable.
Includes 1 participant with KICS who was HIV-negative but diagnosed with CARD11 mutation at the time of demise.
All concurrent KS is T1 stage.
In all cases, KICS, MCD, or PEL arose in patients with pre-existing KS.
Includes 4 participants treated for PEL and KS with multiagent chemotherapy targeting both KS and PEL.