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Although approximately 40% of patients with diffuse large B-cell lymphoma (DLBCL) are aged ≥70 years, elderly patients are notoriously underrepresented in clinical trials and have a worse prognosis compared with younger patients in the same setting. This article is one in a series addressing the treatment of lymphoma in elderly patients as an educational theme.
Elderly patients often present with comorbidities, which can limit the use of intensive chemotherapy. With this in mind, attenuated-dose CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone), known as miniCHOP, in combination with rituximab (R-miniCHOP) has been employed in two clinical trials as part of a LYSA study. R-miniCHOP is now considered a suitable option for patients over 80 years old for whom intensive therapy is not an option.1,2
It has been suggested that the addition of lenalidomide to the R-miniCHOP regimen (R2-miniCHOP) may enhance its efficacy, without posing additional toxicity. The phase III SENIOR trial was designed to investigate R2-miniCHOP exclusively in patients ≥80 years, representing the first trial designated to older patients in the DLBCL setting. The Lymphoma Hub is happy to provide a summary of the results here.1
Baseline characteristics of the 249 patients enrolled in the SENIOR trial are presented in Table 1.
Table 1. Patient characteristics*
Characteristic, % |
R-miniCHOP |
R2-miniCHOP |
Total |
---|---|---|---|
Male sex |
44 |
46 |
45 |
Age, years |
|
|
|
Ann Arbor Stage III–IV |
83 |
87 |
85 |
ECOG PS |
|
|
|
IPI 3–5 |
75 |
72 |
73.5 |
CD10 positive† |
38 |
35 |
36.5 |
Phenotype‡§ |
|
|
|
Phenotype‖¶ |
|
|
|
ABC, activated B cell-like; ECOG PS, Eastern Cooperative Oncology Group performance status; GCB, germinal center B cell-like; IPI, International Prognostic Index; R-miniCHOP, rituximab plus attenuated-dose cyclophosphamide, doxorubicin, vincristine, and prednisone; R2-miniCHOP, R-miniCHOP plus lenalidomide. |
Table 2. Efficacy of R-miniCHOP and R2-miniCHOP in patients enrolled in the SENIOR trial*
Patient outcomes |
R-miniCHOP |
R2-miniCHOP |
---|---|---|
2-year outcomes, % (95% CI) |
|
|
ORR, % (95% CI) |
73 (64.6–80.7) |
82 (75–89) |
DoR, months (95% CI) |
NR (40.1–NA) |
36 (26.3–NA) |
CR/CRu, % |
53 |
58 |
CI, confidence interval; CR/CRu, complete response and unconfirmed complete response; EFS, event-free survival; NA, not applicable, NR, not reached; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; R-miniCHOP, rituximab plus attenuated-dose cyclophosphamide, doxorubicin, vincristine, and prednisone; R2-miniCHOP, R-miniCHOP plus lenalidomide. |
Table 3. Grade 3–4 AEs observed in patients enrolled in the SENIOR trial*
AE, % |
R-miniCHOP |
R2-miniCHOP |
---|---|---|
Grade 3–4 |
|
|
Grade 5 (fatal) |
5.6 |
6.8 |
AE, adverse event; DVT, deep vein thrombosis; PE, pulmonary embolism; R-miniCHOP, rituximab plus attenuated-dose cyclophosphamide, doxorubicin, vincristine, and prednisone; R2-miniCHOP, R-miniCHOP plus lenalidomide. |
The SENIOR trial is the first randomized phase III trial to solely enrol patients with DLBCL aged ≥80 years and demonstrated the feasibility for large prospective studies in this setting. R2-miniCHOP did not provide a survival benefit over R-miniCHOP and resulted in higher incidences of AEs.
The study showed that rituximab could be administered safely subcutaneously in elderly patients with DLBCL. Across three studies, R-miniCHOP has induced 2-year OS rates of 59% to 66% in patients aged >80 years with DLBCL, highlighting the need for novel therapeutic approaches in the elderly DLBCL population.
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