Pivotal clinical trials with rituximab (R) and chemotherapy in HIV-associated NHL
| . | R-CHOP . | R-CDE . | R-EPOCH . | SC-EPOCH-RR . | ||
|---|---|---|---|---|---|---|
| Kaplan et al56 . | Boué et al57 . | Ribera et al58 . | Spina et al54 . | Sparano et al59 . | Dunleavy et al47 . | |
| No. of patients | 150 (99 R arm) | 61 | 95 | 74 | 106 (51 cR arm) | 33 |
| Study design | Phase 3: R-CHOP-R vs CHOP | Phase 2 | Phase 2 | Pooled 3 phase 2 trials | Phase 2 randomized: R-EPOCH vs EPOCH-R° | Phase 2 |
| CD4 µL median | 130 | 172 | 158 | 161 | 194 | 208 |
| Histology, % | ||||||
| DLCL BL | 81 8 | 72 26 | 81 8 | 72 28 | 80 20 | 100 0 |
| aa-IPI ≥2% | 43 | 48 | 58 | 57 | 64 | 76 |
| Outcome, % | ||||||
| CR rate | 58 vs 47 | 77 | 69 | 70 | 73 vs 55* | 91 |
| PFS | 11.3 vs 9.5 mo | 69 (2 y) | NA | 52 EFS (2 y) | 66 vs 63 (2 y) | 84 (5 y) |
| OS | 28 vs 35 mo | 75 (2 y) | 56 (3 y) | 64 (2 y) | 70 vs 67 (2 y) | 68 (5 y) |
| Infectious deaths, % | 14° vs 2* | 2 | 7 | 7 | 10° vs 7 | 0 |
| . | R-CHOP . | R-CDE . | R-EPOCH . | SC-EPOCH-RR . | ||
|---|---|---|---|---|---|---|
| Kaplan et al56 . | Boué et al57 . | Ribera et al58 . | Spina et al54 . | Sparano et al59 . | Dunleavy et al47 . | |
| No. of patients | 150 (99 R arm) | 61 | 95 | 74 | 106 (51 cR arm) | 33 |
| Study design | Phase 3: R-CHOP-R vs CHOP | Phase 2 | Phase 2 | Pooled 3 phase 2 trials | Phase 2 randomized: R-EPOCH vs EPOCH-R° | Phase 2 |
| CD4 µL median | 130 | 172 | 158 | 161 | 194 | 208 |
| Histology, % | ||||||
| DLCL BL | 81 8 | 72 26 | 81 8 | 72 28 | 80 20 | 100 0 |
| aa-IPI ≥2% | 43 | 48 | 58 | 57 | 64 | 76 |
| Outcome, % | ||||||
| CR rate | 58 vs 47 | 77 | 69 | 70 | 73 vs 55* | 91 |
| PFS | 11.3 vs 9.5 mo | 69 (2 y) | NA | 52 EFS (2 y) | 66 vs 63 (2 y) | 84 (5 y) |
| OS | 28 vs 35 mo | 75 (2 y) | 56 (3 y) | 64 (2 y) | 70 vs 67 (2 y) | 68 (5 y) |
| Infectious deaths, % | 14° vs 2* | 2 | 7 | 7 | 10° vs 7 | 0 |
P < .005; majority of patients with CD4 count <50/µL and without combination antiretroviral therapy.