A subgroup analysis of small lymphocytic and marginal zone lymphomas in the Eastern Cooperative Oncology Group protocol E4402 (RESORT): A randomized phase III study comparing two different rituximab dosing strategies for low tumor burden indolent non-Hodgkin lymphoma.
Bibliographic record
Abstract
8007 Background: Management of low tumor burden (LTB) indolent lymphoma in the rituximab (R) era is uncertain. We hypothesized that R could delay the need for chemotherapy and that maintenance R (MR) would be superior to R retreatment (RR) at progression. E4402 is a randomized phase III study comparing MR and RR for previously untreated, LTB (by GELF criteria) small lymphocytic lymphoma (SLL), marginal zone lymphoma (MZL) and FL. Results for the FL subset was previously presented (Kahl, et al. Blood 2011; 118(21): LBA 6); we now report outcomes for the non-FL patients (pt). Methods: Pt received R 375 mg/m2 weekly x 4, with responders randomized to MR (1 dose R q 3 mo) or RR (R q wk x 4 at progression), each continued until treatment failure. The primary endpoint, time to treatment failure (TTTF), was defined as progression within 6 mo of last R, no response to RR, initiation of alternative therapy, or inability to complete protocol therapy. Pt were evaluated q 3 mo, with CT scans q 6 mo. Secondary endpoints: time to first cytotoxic therapy (TTCT), quality of life (QOL) and safety. Results: From 11/03 to 9/08,137 non-FL pt were enrolled. Complete or partial response was achieved in 57 (41%), who were randomized to MR (n=32) or RR (n=25). 136 pt were stage III-IV (1 IE), and all had PS 0-1; for MR vs RR, median age 66 vs 64, and M:F 47:53% vs. 28:72%, respectively. The mean no. of R doses/pt (incl. 4 induction doses) was 17.9 (range 5- 30) for MR and 5.8 (range 4-12) for RR. With a median follow-up of 4.3 yr, TTTF was 3.74 yr for MR vs. 1.07 yr for RR (p=.0002; HR 4.95). At 3 yr, 100% of MR vs. 70% of RR pt (p=.0002) remained free of cytotoxic therapy. Grade 3-4 toxicities occurred in 2 MR pt, 1 neutropenia and 1 encephalopathy. Conclusions: A planned subgroup analysis of non-FL pt showed significant benefit in TTTF and TTTC for MR but with 2 grade 4 toxicities. This differs from the FL pt in this trial, for whom response to induction was higher (70 vs. 41%; p<.0001) and where no TTTF benefit was observed with MR. LTB non-follicular indolent lymphoma pt who achieve a CR or PR to induction R benefit from MR therapy.
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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 | 0.006 | 0.005 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.003 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.007 | 0.001 |
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".