All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit the Lymphoma Coalition.
Introducing
Now you can personalise
your Lymphoma Hub experience!
Bookmark content to read later
Select your specific areas of interest
View content recommended for you
Find out moreThe Lymphoma Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the Lymphoma Hub cannot guarantee the accuracy of translated content. The Lymphoma Hub and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.
The Lymphoma & CLL Hub is an independent medical education platform, sponsored by Beigene and Roche, and supported through educational grants from Bristol Myers Squibb, Ipsen Biopharmaceuticals, Pfizer, and Pharmacyclics LLC, an AbbVie Company and Janssen Biotech, Inc., administered by Janssen Scientific Affairs, LLC View funders.
Bookmark this article
On Wednesday 19 June at the International Conference on Malignant Lymphoma, Lugano, CH, Professor Umberto Vitolo, presented the first report of the global ROBUST phase III randomized trial (NCT02285062) of lenalidomide/R-CHOP (R2-CHOP) vs placebo/R-CHOP in previously untreated CD20+ activated B-cell (ABC)-type diffuse large B-cell lymphoma (DLBCL).
In the double-blind trial, investigators sought to determine whether the addition of lenalidomide to R-CHOP could improve outcomes compared with R-CHOP in 570 patients with ABC-type DLBCL. The study did not meet its primary endpoint of progression-free survival (PFS) for R2-CHOP versus placebo/ R-CHOP as frontline therapy in patients with ABC-type DLBCL.
N (%) |
|
R2-CHOP |
Placebo/R2-CHOP |
---|---|---|---|
International Prognostic Index (IPI) score
|
2 |
121 (42) |
120 (42) |
≥3 |
164 (58) |
165 (58) |
|
Bulky disease |
≥7 cm* |
97 (34) |
99 (35) |
Median age, y (range) ≥ 65 y* |
|
65 (21–82) 147 (52) |
65 (28–83) 148 (52) |
Male/female |
|
164 (58)/121 (42) |
143 (50)/142 (50) |
ECOG performance status |
0 |
129 (45) |
111 (39) |
1 |
104 (36) |
118 (41) |
|
2 |
52 (18) |
56 (20) |
|
Ann Arbor disease stage |
II |
37 (13) |
33 (12)† |
III |
80 (28) |
98 (34) |
|
IV |
168 (59) |
154 (54) |
|
Elevated LDH (> 234 U/L) |
|
177 (62) |
176 (62) |
Geographic distribution |
Europe |
124 (44) |
150 (53) |
Asia-Pacific |
111 (39) |
92 (33) |
|
North America |
24 (8) |
23 (8) |
|
Other |
26 (9) |
20 (7) |
Figure 1: Robust study design
The ROBUST trial was the first study to compare R2-CHOP with placebo/R‐CHOP in patients with previously untreated, prospectively selected, CD20+ ABC‐type DLBCL. Prof Vitolo concluded that overall, the ROBUST trial did not meet the PFS primary or key secondary endpoint for R2-CHOP vs placebo/R-CHOP. However, an encouraging trend for PFS supporting R2-CHOP was observed in patients with higher risk IPI ≥ 3. Prof Vitolo emphasized that analyses of ROBUST are still ongoing and future analyses will include the evaluation of pharmacokinetics/dosing, molecular classification, and mutational status.
Future clinical trials will investigate next-generation immunomodulatory agents for DLBCL.
Understanding your specialty helps us to deliver the most relevant and engaging content.
Please spare a moment to share yours.
Please select or type your specialty
Your opinion matters
Subscribe to get the best content related to lymphoma & CLL delivered to your inbox