Recommendations for revised response criteria for malignant lymphoma
Bibliographic record
Abstract
7507 Background: Standardized response criteria are needed to interpret and compare clinical trials, and for approval of new therapeutic agents by regulatory agencies. Methods: The International Working Group (IWG) criteria (Cheson et al, JCO 17:1244, 1999) were widely adopted but were reevaluated because of limitations identified, and recent advances, notably FDG-PET, immunohistochemistry (IHC) and flow cytometry. Results: We propose the following modifications for non-Hodgkin’s lymphoma (NHL) and Hodgkin lymphoma (HL). For predictably PET avid histologies (PA)(e.g., diffuse large B-cell NHL (DLBCL), HL, follicular (FL) and mantle cell lymphoma (MCL), PET pretreatment is strongly encouraged to define sites of disease, but not required. For histologies not predictably PET+ (NPA), PET should only be done if response is an endpoint. Although PET performed after ≥1 cycles of chemotherapy correlates with treatment efficacy, in the absence of data that altering therapy because of PET results improves outcome, mid-treatment PET should only be done in a clinical trial. PET is essential to assess response in DLBCL and HL, but only in FL and MCL if response is the endpoint. For NPA histologic subtypes, PET should only be used if PET+ prior to therapy and response is a major endpoint. Present data are inadequate to recommend PET for routine post-treatment surveillance. The new definition for CR includes: 1) no signs or symptoms of disease; 2) PET- in a PA lymphoma, or negative CT in NPA lymphoma. 3) Normal bone marrow by morphology, or if indeterminate, negative by IHC, flow and/or molecular genetic studies. CR unconfirmed (CRu) is no longer included. PR is defined as 1) ≥ 50% decrease in tumor size, but PET+ at prior PA sites, or 2) ≥ 50% decrease in tumor size, but CT+ and PET- if PET- prior to treatment. Bone marrow is irrelevant if positive pre-treatment. Stable disease is neither PR nor progressive disease, PET+ only at prior sites of disease. Progressive/ relapsed disease requires ≥ 50% increase in disease or new lesions that are PET+ if PA lymphoma. PET does not replace a biopsy before initiating new therapy. Conclusions: We hope these revised recommendations will be adopted by study groups and regulatory agencies to facilitate the development of new and more effective therapies to improve patient outcome. No significant financial relationships to disclose.
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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 | 0.086 | 0.162 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.010 |
| Bibliometrics | 0.010 | 0.007 |
| Science and technology studies | 0.002 | 0.003 |
| Scholarly communication | 0.006 | 0.005 |
| Open science | 0.011 | 0.005 |
| Research integrity | 0.011 | 0.017 |
| Insufficient payload (model declined to judge) | 0.019 | 0.029 |
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".