SYSTEMIC THERAPY AFTER RADIATION THERAPY IN STAGE I‐II FOLLICULAR LYMPHOMA: FINAL RESULTS OF AN INTERNATIONAL RANDOMIZED TRIAL TROG 99.03
Bibliographic record
Abstract
Aim: The first analysis of the TROG 99.03 randomized controlled trial of curative-intent involved-field radiotherapy (IFRT) with or without systemic therapy reported improved progression–free survival (PFS) by the addition of systemic therapy, especially with rituximab. We present the final analysis of that study. Patients and Methods: Patients from Australia, New Zealand and Canada with stage I-II FL of grade 1, 2 or 3a were enrolled after CT scans and bone marrow biopsies. Patients were randomized to either; Arm A: 30Gy IFRT alone or Arm B: IFRT followed by 6 cycles of cyclophosphamide 1000 mg/m2 IV D1, vincristine 1.4 mg/m2 D1 and prednisolone 50mg/m2 D1-5 (CVP), stratified by center, stage, age and use of PET staging (which was not mandatory). A protocol amendment in 2006 added Rituximab 375 mg/m2 D1 to arm B (R-CVP). Results: Between February 2000 and July 2012, 150 patients were recruited: 75 per arm: 44 arm B patients were allocated CVP and 31 R-CVP. Median age was 57 (range 30-79) years, 52% were male, 75% had stage 1 and 48% were PET-staged. Only 8% had an extranodal site (ENS). Median potential follow-up was 11.3 years for this analysis. PFS remained significantly superior for arm B (IFRT + systemic therapy) compared to arm A [HR 0.60 (0.37-0.98); p = 0.043]. At 10 years PFS was 60% for arm B and 43% for arm A. Patients who received R-CVP had substantially superior PFS compared to those who received IFRT alone or with CVP (no rituximab) (83.1% (se = 6.9%) vs 50.4%% (se = 4.8%) at 8 years, P = 0.013). In univariable analysis, patients with ENS (p = 0.041), fewer involved nodal regions (p = 0.018) and PET staging (p = 0.086) had improved PFS. When analysis of PFS was confined to 72 PET-staged patients the difference between arms A and B increased (HR 0.38 P = 0.027), whereas analysis confined to 78 non-PET staged patients showed weak evidence of a difference between arms (HR 0.78, P = 0.42). More deaths (Figure) occurred in arm A (13 versus 6), with 10-year overall survival rates of 95.3% (se = 2.7%) and 84.4% (se = 4.9%) for arms B and A respectively (HR 0.45, p = 0.11). One possible and 5 definite transformations to aggressive lymphoma occurred in arm B versus 11 in arm A. Keywords: follicular lymphoma (FL); positron emission tomography (PET); rituximab.
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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 | 0.004 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.003 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.005 | 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".