Lenalidomide (Revlimid®) +/− Corticosteroids in Elderly Patients with Relapsed/Refractory Multiple Myeloma.
Bibliographic record
Abstract
Abstract The combination of lenalidomide (Revlimid®) and dexamethasone (dex) is highly effective in multiple myeloma (MM) patients (pts) with relapsed/refractory disease. As MM is a disease of elderly individuals, we evaluated the outcome of pts 65 yrs and older who received Rev-based regimens through Celgene’s Expanded Access Program in Canada which commenced in 12/05; the results were compared with younger pts on this study. Our center has treated 69 pts who progressed after at least 1 prior regimen. Pts were required to have a minimum baseline neutrophil count of 1.0 x 109/L and platelet count of 30 x 109/L; serum creatinine level needed to be ≤220 umol/L unless a waiver was obtained. The median age was 60 yrs (35–79); 24 pts (35%) were 65 or older, 13 (19%) 70 or older and 4 (0.6%) 75 yrs or older. Fifty-two % were male; median baseline creatinine level was 91 umol/L (52–412); median β2-microglobulin was 214 nm/L (114–1420); Ig subtype was IgG in 42, IgA in 12, IgM in 1 and light chain only in 14. Prior therapy included ASCT in 59 pts (86%), thalidomide in 51 (74%), bortezomib in 21 (30%) and oral cyclophosphamide in 52 (75%); the median number of prior regimens was 2 (1–5). Rev was given with pulse dex in 44 pts (64%), prednisone in 7 (10%), dex and prednisone at different time points in 5 (7%) or as a single agent in 13 (19%); pts not receiving dex had a history of significant steroid toxicity. RESULTS: The older and younger pt groups were well-balanced with respect to baseline characteristics, with the exception that fewer older pts had undergone prior ASCT (54% vs. 80%; p=0.04). Rev + dex was given in 54% of the older pts, compared to 69% of the younger pts; 13% vs. 9% received Rev + prednisone, 4% vs. 9% received Rev + both dex and prednisone at different time points, and 29% vs. 13% received Rev alone in older and younger pts, respectively (p= 0.37). Median follow-up is 4 mos (0.5–8). To date, the median number of cycles of Rev +/− steroids was 4 (1–8) in both age groups. Among older pts, 46% remain on Rev +/− steroids; 54% have discontinued the trial due to disease progression (21%), toxicity (12.5%), pt withdrawal (12.5%) or death (8%). In the younger age group, 49% remain on Rev therapy, while 51% have stopped due to progression (31%), toxicity (4%), withdrawal (7%) or death (9%) (p= 0.62). Table 1 summarizes toxicity seen in the 2 age groups. Using standard EBMT criteria, the partial response rate was 58%, including 1 near CR, in the older pt group, compared with 56% in younger pts (p=0.15). The actuarial progression free survival (PFS) was 43% (95% CI 26–60%) and overall survival (OS) 74% (19–65%) in older pts, compared with 43% (26–60%) and 76% (52–87%), respectively, in younger individuals. CONCLUSION: The incidence of higher grade side-effects is not increased in older pts with relapsed/refractory MM treated with Rev +/− steroids; older MM pts achieve comparable response rates (approximately 60%); in this preliminary analysis, the PFS and OS in older vs. younger pts are identical. Table 1 Age N G 3–4 neutropenia G-CSF given Gr 3–4 thrombocytopenia Febrile neutropenia Any infection Gr 3–4 fatigue None of the differences were statistically significant. 65 or older 24 46% 54% 38% 12% 25% 13% Less than 65 45 44% 64% 24% 9% 16% 11%
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".