Results of randomized phase 3 trials in early-stage favorable HL
| . | N/arm . | Clinical characteristic, % . | Treatment . | PFS, % (95% CI) . | OS, % (95% CI) . | Reason for death (%) . | SN, % (95% CI) . | SN SIR (95% CI) . | Reference . |
|---|---|---|---|---|---|---|---|---|---|
| Non–PET-guided therapy | |||||||||
| HD7 | 311 | CS I, 45 CS II, 55 BSs, 6 Bulk/LMM, 0 EN, 0 >60 y, 10 | 30-Gy EFRT + 10-Gy IFRT | 15 y, 52.2 (44.9-59.5) | 15 y, 77.1 (71.2-83.0) | HL (2), SN (5), CVasc (3), respiratory (2) | 15 y, 16 (11-22) | 15 y, 2.7 (1.9-3.6) | 5 |
| 316 | 2×ABVD + 30-Gy EFRT + 10-Gy IFRT | 72.8 (65.6-80.0) | 79.7 (73.9-85.6) | HL (2), SN (6), CVasc (3), respiratory (1) | 14 (9-19) | 3.0 (2.2-4.0) | |||
| H7F | 168 | CS I, NR CS II, NR BSs, 5 Bulk/LMM, 2 EN, NR >60 y, NR | 6×EBVP + 36-Gy IFRT | 10-y EFS, 88 (82-92) | 10 y, 92 (84-95) | HL (1), SN (1) | 2.9 (0.9-9.0) | NR | 17 |
| 165 | 40-Gy STNI | EFS, 78 (70-83) | 92 (85-95) | HL (3), SN (1) | 2.3 (0.7-7.4) | NR | |||
| HD10 | 298 | CS I, 32 CS II, 68 BSs, 8 Bulk/LMM, 0 EN, 0 >60 y, 12 | 4×ABVD + 30-Gy IFRT | 10 y, 87.4 (82.9-91.9) | 10 y, 93.6 (90.5-96.7) | HL (1), SN (2), CVasc (1) | 10 y, 8 (5-12) | 10 y, 2.1 (1.4-3.1) | 5,25 |
| 298 | 4×ABVD + 20-Gy IFRT | NR | NR | HL (1), SN (1) | 6 (3-10) | 1.5 (0.9-2.3) | |||
| 295 | 2×ABVD + 30-Gy IFRT | NR | NR | SN (2), HL (1) | 8 (4-11) | 1.6 (1.0-2.5) | |||
| 299 | 2×ABVD + 20-Gy IFRT | 87.2 [82.9-91.5] | 10 y, 94.1 (91.1-97.1) | HL (1), SN (1), CVasc (1) | 9 (5-13) | 2.1 (1.4-3.2) | |||
| HD13 | 566 | CS I, 32 CS II, 68 BSs, 9 Bulk/LMM, 0 EN, 0 >60 y, 12 | 2×ABVD + 30-Gy IFRT | 5 y, 93.5 (91.1-95.9) | 5 y, 97.6 (96.1-99.1) | SN (1), HL (<1) | NR | NR | 1 |
| 167 | 2×AV + 30-Gy IFRT | 78.9 (72.5-85.3) | 98.1 (96.0-100) | SN (4), HL (1) | NR | NR | |||
| 198 | 2×ABVD + 30-Gy IFRT | 5 y, 82.1 (76.6-87.7) | 94.1 (90.8-97.5) | HL (3), SN (2) | NR | NR | |||
| 571 | 2×AVD + 30-Gy IFRT | 89.6 (86.7-92.5) | 97.6 (96.2-99.0) | SN (1), HL (< 1) | NR | NR | |||
| PET-guided therapy | |||||||||
| RAPID | PET-3−, 209 | CS I, 33; CS II, 67 Favorable, 67.5 Unfavorable, 32.5 BSs, 0 Bulk w/o LMM, 1.2 EN, NR >60 y, NR | 3×ABVD + 30-Gy IFRT | 3 y, 94.6 (91.5-97.7) | 3 y, 97.1 (94.8-99.4) | HL (1.4) | NR | NR | 27 |
| PET-3−, 211 | 3×ABVD + 30-Gy IFRT | 90.8 (86.9-94.8) | 99.0 (97.6-100) | HL (0.9) | NR | NR | |||
| PET-3+, 145 | 4×ABVD + 30-Gy IFRT | 87.6 (NR) | 95.5 (NR) | HL (3.4) | NR | NR | |||
| H10F | PET-2−, 227 | CS I, 27 CS II, 73 BSs, 10.3 Bulk/LMM, 0 EN, NR >60 y, NR | 3×ABVD + 30(+6)-Gy INRT | 5 y, 99.0 (95.9-99.7) | 5 y, 100 (NA) | SN (<1) | 1.3 (NR) | NR | 6,26 |
| PET-2−, 238 | 4×ABVD | 87.1 (82.1-90.8) | 99.6 (97.0-99.9) | Toxicity of second line (<1) | 2.9 (NR) | NR | |||
| 185* | 3×ABVD + 30(+6)-Gy INRT | 3 y, 98.9 (95.6-99.7) | 3 y, 100 (NA) | NA | 0.5 (NR) | NR | |||
| PET-2+, 97 | 3×ABVD or 2×ABVD + 2×BEACOPPesc + 30(+6)-Gy INRT | NR separately; refer to PET-guided therapy for cumulative results of PET+ patients | |||||||
| . | N/arm . | Clinical characteristic, % . | Treatment . | PFS, % (95% CI) . | OS, % (95% CI) . | Reason for death (%) . | SN, % (95% CI) . | SN SIR (95% CI) . | Reference . |
|---|---|---|---|---|---|---|---|---|---|
| Non–PET-guided therapy | |||||||||
| HD7 | 311 | CS I, 45 CS II, 55 BSs, 6 Bulk/LMM, 0 EN, 0 >60 y, 10 | 30-Gy EFRT + 10-Gy IFRT | 15 y, 52.2 (44.9-59.5) | 15 y, 77.1 (71.2-83.0) | HL (2), SN (5), CVasc (3), respiratory (2) | 15 y, 16 (11-22) | 15 y, 2.7 (1.9-3.6) | 5 |
| 316 | 2×ABVD + 30-Gy EFRT + 10-Gy IFRT | 72.8 (65.6-80.0) | 79.7 (73.9-85.6) | HL (2), SN (6), CVasc (3), respiratory (1) | 14 (9-19) | 3.0 (2.2-4.0) | |||
| H7F | 168 | CS I, NR CS II, NR BSs, 5 Bulk/LMM, 2 EN, NR >60 y, NR | 6×EBVP + 36-Gy IFRT | 10-y EFS, 88 (82-92) | 10 y, 92 (84-95) | HL (1), SN (1) | 2.9 (0.9-9.0) | NR | 17 |
| 165 | 40-Gy STNI | EFS, 78 (70-83) | 92 (85-95) | HL (3), SN (1) | 2.3 (0.7-7.4) | NR | |||
| HD10 | 298 | CS I, 32 CS II, 68 BSs, 8 Bulk/LMM, 0 EN, 0 >60 y, 12 | 4×ABVD + 30-Gy IFRT | 10 y, 87.4 (82.9-91.9) | 10 y, 93.6 (90.5-96.7) | HL (1), SN (2), CVasc (1) | 10 y, 8 (5-12) | 10 y, 2.1 (1.4-3.1) | 5,25 |
| 298 | 4×ABVD + 20-Gy IFRT | NR | NR | HL (1), SN (1) | 6 (3-10) | 1.5 (0.9-2.3) | |||
| 295 | 2×ABVD + 30-Gy IFRT | NR | NR | SN (2), HL (1) | 8 (4-11) | 1.6 (1.0-2.5) | |||
| 299 | 2×ABVD + 20-Gy IFRT | 87.2 [82.9-91.5] | 10 y, 94.1 (91.1-97.1) | HL (1), SN (1), CVasc (1) | 9 (5-13) | 2.1 (1.4-3.2) | |||
| HD13 | 566 | CS I, 32 CS II, 68 BSs, 9 Bulk/LMM, 0 EN, 0 >60 y, 12 | 2×ABVD + 30-Gy IFRT | 5 y, 93.5 (91.1-95.9) | 5 y, 97.6 (96.1-99.1) | SN (1), HL (<1) | NR | NR | 1 |
| 167 | 2×AV + 30-Gy IFRT | 78.9 (72.5-85.3) | 98.1 (96.0-100) | SN (4), HL (1) | NR | NR | |||
| 198 | 2×ABVD + 30-Gy IFRT | 5 y, 82.1 (76.6-87.7) | 94.1 (90.8-97.5) | HL (3), SN (2) | NR | NR | |||
| 571 | 2×AVD + 30-Gy IFRT | 89.6 (86.7-92.5) | 97.6 (96.2-99.0) | SN (1), HL (< 1) | NR | NR | |||
| PET-guided therapy | |||||||||
| RAPID | PET-3−, 209 | CS I, 33; CS II, 67 Favorable, 67.5 Unfavorable, 32.5 BSs, 0 Bulk w/o LMM, 1.2 EN, NR >60 y, NR | 3×ABVD + 30-Gy IFRT | 3 y, 94.6 (91.5-97.7) | 3 y, 97.1 (94.8-99.4) | HL (1.4) | NR | NR | 27 |
| PET-3−, 211 | 3×ABVD + 30-Gy IFRT | 90.8 (86.9-94.8) | 99.0 (97.6-100) | HL (0.9) | NR | NR | |||
| PET-3+, 145 | 4×ABVD + 30-Gy IFRT | 87.6 (NR) | 95.5 (NR) | HL (3.4) | NR | NR | |||
| H10F | PET-2−, 227 | CS I, 27 CS II, 73 BSs, 10.3 Bulk/LMM, 0 EN, NR >60 y, NR | 3×ABVD + 30(+6)-Gy INRT | 5 y, 99.0 (95.9-99.7) | 5 y, 100 (NA) | SN (<1) | 1.3 (NR) | NR | 6,26 |
| PET-2−, 238 | 4×ABVD | 87.1 (82.1-90.8) | 99.6 (97.0-99.9) | Toxicity of second line (<1) | 2.9 (NR) | NR | |||
| 185* | 3×ABVD + 30(+6)-Gy INRT | 3 y, 98.9 (95.6-99.7) | 3 y, 100 (NA) | NA | 0.5 (NR) | NR | |||
| PET-2+, 97 | 3×ABVD or 2×ABVD + 2×BEACOPPesc + 30(+6)-Gy INRT | NR separately; refer to PET-guided therapy for cumulative results of PET+ patients | |||||||
BS, B symptom; CS, clinical stage; CVasc, cardiovascular; EBVP, epirubicin, bleomycin, vinblastine, prednisone; EFRT, extended-field RT; EFS, event-free survival; EN, extranodal; esc, escalated; NA, not applicable; NR, not reported; SIR, standardized incidence ratio.
Treated without PET stratification after safety amendment of the H10 trial.