Randomized phase 3 response-adapted studies in adult early-stage (I-II) HL*
| Trial . | Patients . | Enrollment† . | Results . |
|---|---|---|---|
| EORTC/LYSA/FIL H10F41 | Favorable group | 761/761† (381 PET− patients) | 1-y PFS rates 100.0% and 94.9% in standard and experimental arms, respectively; estimated HR = 9.36 (79.6% CI, 2.45-35.73) |
| EORTC/LYSA/FIL H10U41 | Unfavorable/intermediate group | 1191/1191† (519 PET− patients) | 1-y PFS rates 97.3% and 94.7% in standard and experimental arms, respectively; estimated HR = 2.42 (80.4% CI, 1.35-4.36) |
| UK NCRI RAPID42 | Favorable and unfavorable/intermediate groups combined (nonbulky) | 602/602 | 3-y PFS for no RT versus IFRT in PET− patients: 91% versus 95% by ITT (P = .23) and 91% versus 97% by protocol analysis (P = .03); 3-y PFS for PET+ 85% |
| GHSG HD16 (NCT01356680) | Favorable group | 686/1100‡ | NA |
| GHSG HD17 (NCT00736320) | Unfavorable/intermediate group | 283/1100‡ | NA |
| Trial . | Patients . | Enrollment† . | Results . |
|---|---|---|---|
| EORTC/LYSA/FIL H10F41 | Favorable group | 761/761† (381 PET− patients) | 1-y PFS rates 100.0% and 94.9% in standard and experimental arms, respectively; estimated HR = 9.36 (79.6% CI, 2.45-35.73) |
| EORTC/LYSA/FIL H10U41 | Unfavorable/intermediate group | 1191/1191† (519 PET− patients) | 1-y PFS rates 97.3% and 94.7% in standard and experimental arms, respectively; estimated HR = 2.42 (80.4% CI, 1.35-4.36) |
| UK NCRI RAPID42 | Favorable and unfavorable/intermediate groups combined (nonbulky) | 602/602 | 3-y PFS for no RT versus IFRT in PET− patients: 91% versus 95% by ITT (P = .23) and 91% versus 97% by protocol analysis (P = .03); 3-y PFS for PET+ 85% |
| GHSG HD16 (NCT01356680) | Favorable group | 686/1100‡ | NA |
| GHSG HD17 (NCT00736320) | Unfavorable/intermediate group | 283/1100‡ | NA |
LYSA indicates Lymphoma Group and the Lymphoma Study Association; FIL, Fondazione Italiana Linfomi; UK NCRI, United Kingdom National Cancer Research Institute; and NA, not available.
See Figure 3 for study designs.
Interim/early analysis performed and study amended based on these results adding radiation to all arms.
Enrollment as of April 2014.