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On 17 May, Emanuele Zucca from the Oncology Institute of Southern Switzerland, Bellinzona, CH, and colleagues, published results from a phase II trial in follicular lymphoma (FL) (NCT01307605), in Blood.1 This trial compared the efficacy and safety of rituximab monotherapy to rituximab plus lenalidomide in patients with previously untreated FL.
Rituximab in combination with chemotherapy is a standard of care treatment for patients with symptomatic advanced stage FL.2 The investigators sought to examine whether in previously untreated patients with FL, rituximab alone or with chemotherapy, is an effective treatment plan.
The primary endpoint of this open-label, randomized, multicentre trial was complete response (CR) rate at around six months following treatment. Secondary endpoints included overall response rate (ORR), CR rate at 30 months post treatment, progression-free survival (PFS), duration of response (DoR), time-to-next treatment (TTNT), overall survival (OS), and safety.
Baseline characteristic |
R arm |
RL arm |
Total cohort |
---|---|---|---|
Ann Arbor stage II III IV |
10% 38% 52% |
14% 38% 48% |
12% 38% 50% |
FLIPI score Low risk Intermediate risk High risk |
19% 34% 47% |
27% 26% 47% |
23% 30% 47% |
FL histological grade 1 2 3a |
23% 60% 17% |
26% 58% 16% |
25% 59% 16% |
Bulky disease < 6 cm ≥ 6 cm |
60% 40% |
58% 42% |
59% 41% |
* P = 0.001 | ||
|
R arm (n = 77) |
RL arm (n = 77) |
---|---|---|
CR & unconfirmed CR (CRu)* |
36% (95% CI, 26−48) |
61% (95% CI, 49−72) |
Partial response (PR) |
21% |
17% |
Stable disease (SD) |
9% |
3% |
Progressive disease (PD) |
4% |
1% |
Not evaluable |
30% |
18% |
Lenalidomide in combination with rituximab led to a significantly better CR/CRu rate, longer PFS and TTNT, when compared to rituximab monotherapy in patients with previously untreated FL. However, there was no significant effect on OS.
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