Clinical characteristics of the entire population by treatment arm
. | Arm A: concurrent R-EPOCH . | Arm B: sequential EPOCH → R . | ||||
---|---|---|---|---|---|---|
Preamendment . | Postamendment . | All patients . | Preamendment . | Postaamendment . | All patients . | |
No. treated | 17 | 34 | 51 | 18 | 37 | 55 |
Male sex | 14(82%) | 29(85%) | 43(84%) | 16(89%) | 32(86%) | 48(87%) |
Median age, y | 45 | 44 | 44 | 44 | 43 | 43 |
CD4 count | ||||||
Median, /μL | 295 | 153 | 181 | 212 | 194 | 194 |
Less than 100/μL | 4(24%) | 12(35%) | 16(31%) | 5(28%) | 12(32%) | 17(31%) |
Concurrent ARV | 10(59%) | 26(76%) | 36(71%) | 10(56%) | 29(78%) | 39(71%) |
Local histology | ||||||
Diffuse large cell | 12(71%) | 23(68%) | 35(69%) | 14(78%) | 30(81%) | 44(80%) |
Burkitt/Burkitt-like or other* | 5(29%) | 11(32%) | 16(31%) | 4(22%) | 7(19%) | 11(20%) |
Stage III-IV | 14(82%) | 29(85%) | 43(84%) | 13(72%) | 28(76%) | 41(75%) |
Elevated LDH | 11(65%) | 25(73%) | 36(71%) | 11(61%) | 25(68%) | 36(65%) |
ECOG PS 2 | 6(35%) | 8(24%) | 14(27%) | 2(11%) | 9(24%) | 11(20%) |
Age-adjusted IPI | ||||||
0 or 1 risk factors | 6(35%) | 10(29%) | 16(31%) | 6(33%) | 14(38%) | 20(36%) |
2 or 3 risk factors | 11(65%) | 24(71%) | 35(69%) | 12(67%) | 23(62%) | 35(64%) |
. | Arm A: concurrent R-EPOCH . | Arm B: sequential EPOCH → R . | ||||
---|---|---|---|---|---|---|
Preamendment . | Postamendment . | All patients . | Preamendment . | Postaamendment . | All patients . | |
No. treated | 17 | 34 | 51 | 18 | 37 | 55 |
Male sex | 14(82%) | 29(85%) | 43(84%) | 16(89%) | 32(86%) | 48(87%) |
Median age, y | 45 | 44 | 44 | 44 | 43 | 43 |
CD4 count | ||||||
Median, /μL | 295 | 153 | 181 | 212 | 194 | 194 |
Less than 100/μL | 4(24%) | 12(35%) | 16(31%) | 5(28%) | 12(32%) | 17(31%) |
Concurrent ARV | 10(59%) | 26(76%) | 36(71%) | 10(56%) | 29(78%) | 39(71%) |
Local histology | ||||||
Diffuse large cell | 12(71%) | 23(68%) | 35(69%) | 14(78%) | 30(81%) | 44(80%) |
Burkitt/Burkitt-like or other* | 5(29%) | 11(32%) | 16(31%) | 4(22%) | 7(19%) | 11(20%) |
Stage III-IV | 14(82%) | 29(85%) | 43(84%) | 13(72%) | 28(76%) | 41(75%) |
Elevated LDH | 11(65%) | 25(73%) | 36(71%) | 11(61%) | 25(68%) | 36(65%) |
ECOG PS 2 | 6(35%) | 8(24%) | 14(27%) | 2(11%) | 9(24%) | 11(20%) |
Age-adjusted IPI | ||||||
0 or 1 risk factors | 6(35%) | 10(29%) | 16(31%) | 6(33%) | 14(38%) | 20(36%) |
2 or 3 risk factors | 11(65%) | 24(71%) | 35(69%) | 12(67%) | 23(62%) | 35(64%) |
ARV indicates antiretroviral therapy; ECOG PS, Eastern Cooperative Oncology Group performance status; and IPI, International Prognostic Index (adverse risk factors included stage III or IV disease, elevated serum lactate dehydrogenase above normal, and Easter Cooperative Oncology performance status 2).
For the Burkitt/Burkitt-like/other category, this included 15 of 16 patents with Burkitt or Burkitt-like lymphoma in arm A and 8 of 11 in arm B; other cases included malignant lymphoma, not otherwise specified.