Characteristics and efficacy outcomes in patients with informative rebiopsy
Patient no. . | Arm . | Stage . | Remission status at first interim restaging* . | SPD reduction at first interim restaging (%) . | DS at first nterim restaging . | Final remission status . | Observation time without PFS event† . |
---|---|---|---|---|---|---|---|
1 | B | IIB | CR | −97.34 | 3 | CR | 20.5 |
2 | B | IIB | PR | −72.31 | 4 | CR | 22.3 |
3 | A | IIA | CR | −100 | 1 | CR | 9.7 |
4 | B | IIA | CR | −72.14 | 3 | CR | 12.7 |
5 | A | IIAE | CR | −84.59 | 2 | CR | 21.0 |
9 | A | IIB | PR | −77.13 | 4 | CR | 19.0 |
10 | B | IIA | CR | −89.49 | 3 | CR | 9.0 |
11 | A | IIA | CR | −75.64 | 1 | CR | 15.1 |
13 | A | IIB | CR | −78.64 | 2 | CR | 13.8 |
14 | A | IIB | CR | −87.72 | 3 | CR | 8.2 |
Patient no. . | Arm . | Stage . | Remission status at first interim restaging* . | SPD reduction at first interim restaging (%) . | DS at first nterim restaging . | Final remission status . | Observation time without PFS event† . |
---|---|---|---|---|---|---|---|
1 | B | IIB | CR | −97.34 | 3 | CR | 20.5 |
2 | B | IIB | PR | −72.31 | 4 | CR | 22.3 |
3 | A | IIA | CR | −100 | 1 | CR | 9.7 |
4 | B | IIA | CR | −72.14 | 3 | CR | 12.7 |
5 | A | IIAE | CR | −84.59 | 2 | CR | 21.0 |
9 | A | IIB | PR | −77.13 | 4 | CR | 19.0 |
10 | B | IIA | CR | −89.49 | 3 | CR | 9.0 |
11 | A | IIA | CR | −75.64 | 1 | CR | 15.1 |
13 | A | IIB | CR | −78.64 | 2 | CR | 13.8 |
14 | A | IIB | CR | −87.72 | 3 | CR | 8.2 |
Treatment arm A received 4xN-AVD + 30-Gy IS-RT. Treatment arm B received 4xnivolumab + 2xN-AVD + 2xAVD + 30-Gy IS-RT.
DS, Deauville score; PFS, progression-free survival; PR, partial response; SPD, sum of product of greatest diameter, as measured by computed tomography scan.
Centrally reviewed first interim restaging after 2xN-AVD or 4xnivolumab in treatment groups A and B, respectively.
No patient experienced disease progression or relapse so far (data cutoff for PFS calculations was 25 October 2019).