Table 3.
Summary of Responses in the Intention-to-Treat Population.
| Measure | A+AVD (N = 664) |
ABVD (N = 670) |
Difference (95% CI)* |
|---|---|---|---|
| no. (%) | % | ||
| Complete response at end of randomized regimen† | 488 (73) | 472 (70) | 3.0 (−2.3 to 8.4) |
| Overall response at end of randomized regimen‡ | 569 (86) | 553 (83) | 3.2 (−2.2 to 8.6) |
| Complete response at end of frontline therapy§ | 488 (73) | 474 (71) | 2.7 (−2.6 to 8.1) |
| Deauville score¶ | |||
| ≤3 After completion of frontline therapy) | 570 (86) | 551 (82) | 3.6 (−1.8 to 9.0) |
| ≤2 After completion of frontline therapy | 563 (85) | 537 (80) | 4.6 (−0.8 to 10.0) |
| Summary at cycle 2 | |||
| 1 | 435 (66) | 414 (62) | |
| 2 | 131 (20) | 133 (20) | |
| 3 | 22 (3) | 30 (4) | |
| 4 | 26 (4) | 28 (4) | |
| 5 | 21 (3) | 30 (4) | |
| Unavailable | 29 (4) | 35 (5) | |
| Summary after completion of primary chemotherapy | |||
| 1 | 444 (67) | 425 (63) | |
| 2 | 119 (18) | 112 (17) | |
| 3 | 7 (1) | 14 (2) | |
| 4 | 12 (2) | 20 (3) | |
| 5 | 46 (7) | 45 (7) | |
| Unavailable | 36 (5) | 54 (8) | |
Confidence intervals (CIs) were calculated from the exact confidence interval, have not been adjusted for the multiple comparisons, and should not be used for definitive comparisons.
Complete response at the end of the randomized regimen is defined as the proportion of patients who had complete response20 at the end of treatment with either regimen (A+AVD or ABVD).
Overall response at the end of the randomized regimen is defined as the proportion of patients who had complete or partial response20 at the end of treatment with either regimen (A+AVD or ABVD).
Complete response at the end of frontline therapy is defined as the proportion of patients who had complete response after the completion of either the randomized regimen (A+AVD or ABVD) or alternate frontline therapy.
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.