Results of RCTs comparing the efficacy of smaller vs larger radiotherapy field
| Trial . | Intervention control participants . | OS, % . | FFTF, % . | PFS, % . | EFS, % . | Late AE, % . | Response, % . | Median follow-up . | Reference . |
|---|---|---|---|---|---|---|---|---|---|
| GHSG HD8 | Arm A: COPP-ABVD + 30 Gy EF + 10 Gy to bulk (n = 565) | 90.8 vs 92.4 at 5 y (difference: EF − IF = −1.6% (95% CI: −5.6 to 2.5); P = NS | *85.8 vs 84.2 at 5 y (difference of 1.6%, upper boundary, 5.9%); IF was not inferior to EF; margin at 6% | 79.8 vs 80.0 at 10 y (95% CI: −5.2 to 5.6); P = NS | NR | SC: 4.6 vs 2.8 (P = .191) Deaths: 8.1 vs 6.4 (P = .344) | CR: 98.5 vs 97.2 | 55 mo | 8†, 23 |
| Arm B: COPP-ABVD + 30 Gy IF + 10 Gy to bulk (n = 571) | |||||||||
| EORTC GELA H8U (unfavorable) | Arm A: 6 × MOPP-ABV + IFRT (n = 663) | 88 (95% CI: 84-91) vs 85 (95% CI: 78-90) vs 84 (95% CI: 74-90) at 10 y (P = .93) | NR | NR | *82 (95% CI: 77-86) vs 80 (95% CI: 75-85) vs 80 (95% CI: 71-86) at 10 y (P = .80) | SC at 10 y: Arm A: 4.5 (95% CI: 2.5-7.9) Arm B: 7.1 (95% CI: 4.3-11.6) Arm C: 8.8 (95% CI: 4.3-17.3), P = .63 Death: 11 vs 11 vs 10 (P values NR) | CR/Cru at the end of chemotherapy: 69 vs 64 vs 64 CR/Cru at the end of treatment: 83 vs 85 vs 86 | 89 mo | 25 |
| Arm B: 4 × MOPP-ABV + IFRT (n = 333) | |||||||||
| Arm C: 4 × MOPP-ABV + STNI (n = 327) | |||||||||
| INCI | Arm A: ABVD + STNI (n = 66) | 96 (95% CI: 91-100) vs 94 (95% CI: 89-100) at 12 y | NR | 93 (95% CI: 83-100) vs 94 (95% CI: 88-100) at 12 y | 87 (95% CI: 85-98) vs 91 (95% CI: 85-98) at 12 y | NR | CR: 100 vs 97 | 116 mo | 26 |
| Arm B: ABVD + IFRT (n = 70) | |||||||||
| DNHSG | Arm A: MFRT + 6 × MOPP (n = 163) | For patients surviving >15 y, OS was better for arm A than for arm B (P < .02); estimate: 62 vs 50 at 30 y | NR | NR | NR | SC at 20 y: NS | NR | 25 y | 16 |
| Arm B: (S)TNI (n = 164) |
| Trial . | Intervention control participants . | OS, % . | FFTF, % . | PFS, % . | EFS, % . | Late AE, % . | Response, % . | Median follow-up . | Reference . |
|---|---|---|---|---|---|---|---|---|---|
| GHSG HD8 | Arm A: COPP-ABVD + 30 Gy EF + 10 Gy to bulk (n = 565) | 90.8 vs 92.4 at 5 y (difference: EF − IF = −1.6% (95% CI: −5.6 to 2.5); P = NS | *85.8 vs 84.2 at 5 y (difference of 1.6%, upper boundary, 5.9%); IF was not inferior to EF; margin at 6% | 79.8 vs 80.0 at 10 y (95% CI: −5.2 to 5.6); P = NS | NR | SC: 4.6 vs 2.8 (P = .191) Deaths: 8.1 vs 6.4 (P = .344) | CR: 98.5 vs 97.2 | 55 mo | 8†, 23 |
| Arm B: COPP-ABVD + 30 Gy IF + 10 Gy to bulk (n = 571) | |||||||||
| EORTC GELA H8U (unfavorable) | Arm A: 6 × MOPP-ABV + IFRT (n = 663) | 88 (95% CI: 84-91) vs 85 (95% CI: 78-90) vs 84 (95% CI: 74-90) at 10 y (P = .93) | NR | NR | *82 (95% CI: 77-86) vs 80 (95% CI: 75-85) vs 80 (95% CI: 71-86) at 10 y (P = .80) | SC at 10 y: Arm A: 4.5 (95% CI: 2.5-7.9) Arm B: 7.1 (95% CI: 4.3-11.6) Arm C: 8.8 (95% CI: 4.3-17.3), P = .63 Death: 11 vs 11 vs 10 (P values NR) | CR/Cru at the end of chemotherapy: 69 vs 64 vs 64 CR/Cru at the end of treatment: 83 vs 85 vs 86 | 89 mo | 25 |
| Arm B: 4 × MOPP-ABV + IFRT (n = 333) | |||||||||
| Arm C: 4 × MOPP-ABV + STNI (n = 327) | |||||||||
| INCI | Arm A: ABVD + STNI (n = 66) | 96 (95% CI: 91-100) vs 94 (95% CI: 89-100) at 12 y | NR | 93 (95% CI: 83-100) vs 94 (95% CI: 88-100) at 12 y | 87 (95% CI: 85-98) vs 91 (95% CI: 85-98) at 12 y | NR | CR: 100 vs 97 | 116 mo | 26 |
| Arm B: ABVD + IFRT (n = 70) | |||||||||
| DNHSG | Arm A: MFRT + 6 × MOPP (n = 163) | For patients surviving >15 y, OS was better for arm A than for arm B (P < .02); estimate: 62 vs 50 at 30 y | NR | NR | NR | SC at 20 y: NS | NR | 25 y | 16 |
| Arm B: (S)TNI (n = 164) |
ABV, doxorubicin, bleomycin, vinblastine; COPP, cyclophosphamide, vincristine, procarbazine, prednisone; CR, complete response; CRu, complete response unconfirmed; DNHSG, Danish National Hodgkin Study Group; EF, extended field; IF, involved field; INCI, Italian National Cancer Institute; MFRT, mantle-field radiotherapy; MOPP, mechlorethamine, vincristine, procarbazine, prednisone.
Primary outcome.
Source of PFS data.