Response rates for initial therapy with FCM and R-FCM for patients with FLs and MCLs
. | All patients . | . | . | Patients with FL . | . | . | Patients with MCL . | . | . | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
. | Rnd FCM . | Rnd R-FCM . | Add R-FCM . | Rnd FCM . | Rnd R-FCM . | Add R-FCM . | Rnd FCM . | Rnd R-FCM . | Add R-FCM . | ||||||
| N | 65 | 68 | 134 | 31 | 37 | 65 | 26 | 24 | 56 | ||||||
| CR, % | 12 | 34 | 25 | 23 | 41 | 34 | 0 | 29 | 20 | ||||||
| PR, % | 46 | 46 | 60 | 48 | 54 | 63 | 46 | 29 | 59 | ||||||
| MR/SD, % | 12 | 6 | 6 | 13 | 0 | 2 | 4 | 13 | 5 | ||||||
| PD, % | 25 | 12 | 5 | 16 | 3 | 2 | 38 | 29 | 11 | ||||||
| EX, % | 5 | 3 | 3 | 0 | 3 | 0 | 12 | 0 | 5 | ||||||
| PR + CR, % | 58 | 79 | 86 | 71 | 95 | 97 | 46 | 58 | 79 | ||||||
. | All patients . | . | . | Patients with FL . | . | . | Patients with MCL . | . | . | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
. | Rnd FCM . | Rnd R-FCM . | Add R-FCM . | Rnd FCM . | Rnd R-FCM . | Add R-FCM . | Rnd FCM . | Rnd R-FCM . | Add R-FCM . | ||||||
| N | 65 | 68 | 134 | 31 | 37 | 65 | 26 | 24 | 56 | ||||||
| CR, % | 12 | 34 | 25 | 23 | 41 | 34 | 0 | 29 | 20 | ||||||
| PR, % | 46 | 46 | 60 | 48 | 54 | 63 | 46 | 29 | 59 | ||||||
| MR/SD, % | 12 | 6 | 6 | 13 | 0 | 2 | 4 | 13 | 5 | ||||||
| PD, % | 25 | 12 | 5 | 16 | 3 | 2 | 38 | 29 | 11 | ||||||
| EX, % | 5 | 3 | 3 | 0 | 3 | 0 | 12 | 0 | 5 | ||||||
| PR + CR, % | 58 | 79 | 86 | 71 | 95 | 97 | 46 | 58 | 79 | ||||||
For the randomized comparison of FCM versus R-FCM, R-FCM was superior in both lymphoma subtypes. In FL, the overall response rate (CR and PR) was 95% versus 71% (P = .01); in MCL, it was 58% versus 46% (P = .282). After the termination of the FCM arm all subsequent patients received R-FCM. The response rates from the first part of the study were unanimously confirmed.
Ran indicates randomized; Add, added; MR indicates minor response; SD, stable disease; PD, progressive disease; and EX, death.