Table 2.
Summary of Modified Progression-free Survival According to the Independent Review Committee and Concordance with Events Noted by Trial Investigators (Intention-to-Treat Population).
| Events | A+AVD (N = 664) |
ABVD (N = 670) |
Total (N = 1334) |
|---|---|---|---|
| Patients with events per independent review committee — no. | 117 | 146 | 263 |
| Progression — no./total no. (%) | 90/117 (77) | 102/146 (70) | 192/263 (73) |
| Death — no./total no. (%) | 18/117 (15) | 22/146 (15) | 40/263 (15) |
| Positive PET scan and subsequent treatment — no./total no. (%)* | 9/117 (8) | 22/146 (15) | 31/263 (12) |
| Patients with positive PET scan and subsequent treatment — no. | 9 | 22 | 31 |
| Salvage chemotherapy — no./total no. (%)† | 7/9 (78) | 15/22 (68) | 22/31 (71) |
| Met criteria for PFS event | |||
| PFS event or modified event reported by investigator — no. | 7 | 15 | 22 |
| PFS event reported by investigator — no./total no. (%) | 7/7 (100) | 13/15 (87) | 20/22 (91) |
| PFS event reported by independent review committee — no./total no. (%) | 2/7 (29) | 3/15 (20) | 5/22 (23) |
| Deauville score at end of treatment — no./total no. (%)‡ | |||
| 1 | 0 | 0 | 0 |
| 2 | 0 | 0 | 0 |
| 3 | 0 | 2/15 (13) | 2/22 (9) |
| 4 | 3/7 (43) | 4/15 (27) | 7/22 (32) |
| 5 | 4/7 (57) | 9/15 (60) | 13/22 (59) |
| Radiation — no./total no. (%) | 2/9 (22) | 7/22 (32) | 9/31 (29) |
| Met criteria for PFS event | |||
| PFS event or modified event reported by investigator — no. | 2 | 7 | 9 |
| PFS event reported by investigator — no./total no. (%) | 0 | 1/7 (14) | 1/9 (11) |
| PFS event reported by independent review committee — no./total no. (%) | 0 | 1/7 (14) | 1/9 (11) |
| Deauville score at end of treatment — no./total no. (%)‡ | |||
| 1 | 0 | 0 | 0 |
| 2 | 0 | 0 | 0 |
| 3 | 2/2 (100) | 3/7 (43) | 5/9 (56) |
| 4 | 0 | 3/7 (43) | 3/9 (33) |
| 5 | 0 | 1/7 (14) | 1/9 (11) |
There were 58 patients at risk for a modified progression event (end-of-treatment Deauville score ≥3 and no progressive disease at the end of treatment): 19 in the group receiving A+AVD versus 39 in the group receiving ABVD. However, only 9 patients in the A+AVD group and 22 patients in the ABVD group actually had a modified progression event because they received subsequent treatment. PET denotes positron-emission tomography, and PFS progression-free survival.
Salvage chemotherapy included the terms chemotherapy, high-dose chemotherapy plus transplantation, and immunotherapy according to medical review.
The Deauville score is a 5-point scale on which higher scores indicate greater uptake of 18F-fluorodeoxyglucose at involved sites on PET. A score of 1 indicates no uptake, a score of 2 uptake at an initial site that is less than or equal to the uptake at the mediastinum, a score of 3 uptake at an initial site that is greater than uptake at the mediastinum but less than or equal to uptake at the liver, a score of 4 uptake at an initial site that is moderately increased as compared with uptake at the liver, and a score of 5 markedly increased uptake at any site or uptake at a new site of disease. The absence of complete response at the end of primary chemotherapy was defined as a Deauville score of 3, 4, or 5.