Rituximab + ESHAP as Salvage Chemotherapy for Relapsed/Refractory Aggressive Non-Hodgkins Lymphoma: A Phase II Trial.
Bibliographic record
Abstract
Abstract Background: Patients with relapsed or refractory aggressive B-cell lymphoma have a poor prognosis. If sensitive to salvage chemotherapy, high dose therapy followed by autologous stem cell transplant (ASCT) can result in long-term survival for some. Unfortunately, 50% of patients are insensitive to standard salvage regimens and thus are ineligible for ASCT. Hypothesis: Combining Rituximab with ESHAP may improve chemosensitivity and ASCT eligibility, of patients with CD20+, relapsed or refractory aggressive lymphoma, or CD20+ transformed indolent lymphoma. Objectives: The primary outcome was response rate (CR + CRu + PR) to R-ESHAP. Secondary outcomes were toxicity, ability to undergo ASCT, presence of minimal resdidual disease in the stem cell harvest, and progression free and overall survival. Methods: Eligible patients were 16–65 years old, had ECOG performance status 0–2, and had pathologically confirmed CD20+, relapsed/refractory aggressive lymphoma or transformed indolent lymphoma. Patients with refractory disease had a PR with initial anthracycline-based therapy. ESHAP (etoposide 40mg/m2 day 1–4, solumderol 500mg day 1–5, cytosine arabinoside 2g/m2 day 5, cisplatin 25mg/m2 day 1–4) was given every 28 days with GCSF support until < 15% bone marrow involvement was achieved (2–4 cycles). Eight infusions of Rituximab (375mg/m2) were administered weekly concurrent with the first 2 cycles of ESHAP. GCSF mobilized stems cells were collected on day 10 or 11 when < 15% bone marrow involvement was achieved (mainly in cycles 1 or 2). Results: Preliminary results of 14 of 44 planned patients are presented. Median age was 54 years (range 42–64). All pts had CD20+ aggressive lymphoma, 6 had relapsed aggressive lymphoma, 2 had refractory aggressive lymphoma (with PR after initial therapy) and 6 had transformed indolent lymphoma. Twelve of 14 patients were stage III/IV. The response rate to R-ESHAP was 93% (2 CR, 2 CRu, 9 PR, 1 PD). Thirteen of 14 patients proceeded to ASCT. Data on minimal residual disease in the stem cell harvest is pending. Grade 3–4 thrombocytopenia, neutropenia and anemia occurred with 53%, 31%, and 20% of R-ESHAP cycles respectively. Two of 14 patients had febrile neutropenia, one with bacteremia. Two patients had non-neutropenic bacteremia (1 with septic shock). There were no toxic deaths. Median follow-up post-ASCT is 5 months (range 1–18). Two patients progressed 4 and 5 months post-ASCT respectively. There were 3 deaths, 2 lymphoma related and 1 due to accelerated Parkinson’s Disease. Median PFS has not yet been reached. Conclusions: This trial is still accruing patients. However, preliminary results are promising. R-ESHAP appears to be well tolerated with a high response rate. This regimen may enable more patients with relapsed/refractory aggressive lymphoma or transformed indolent lymphoma to proceed to ASCT.
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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 | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 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".