CVP OR R‐CVP GIVEN AFTER INVOLVED‐FIELD RADIOTHERAPY IMPROVES PROGRESSION FREE SURVIVAL IN STAGE I‐II FOLLICULAR LYMPHOMA: RESULTS OF AN INTERNATIONAL RANDOMIZED TRIAL
Bibliographic record
Abstract
Aim: Curative-intent involved field radiation therapy (IFRT) is a standard treatment for stage I-II follicular lymphoma (FL). It achieves durable local disease control and can produce life-long remissions. However ≥50% of patients relapse, generally outside irradiated volumes. We conducted a randomized controlled trial (RCT) to determine if systemic therapy could improve progression free survival (PFS). Patients and Methods: Patients from Australia, New Zealand and Canada with stage I-II FL of grade 1, 2 or 3a were enrolled after mandatory CT scans and marrow biopsies. PET staging was permitted. 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 50 mg/m2 D1-5 (CVP), stratified by center, stage, age and PET. 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 9.6 years (range, 3.1-15.8). PFS was significantly superior for arm B (IFRT + systemic therapy) compared to arm A [HR 0.57 (0.34-0.95); p = 0.033]. At 10 years PFS was 58% (95% CI 46-74%) for arm B and 41% (95% CI 30-57%) for arm A. Patients randomized to R-CVP had a substantially superior PFS to those contemporaneously randomized to IFRT alone, [HR 0.26 (0.07-0.97); p = 0.045]. In univariate analysis, patients who had ENS (p = 0.02), fewer involved regions (p = 0.047) and PET staging (p = 0.056) also had improved PFS. Transformation to high-grade lymphoma occurred in 4 patients in arm B compared to 10 in arm A (p = 0.1). Overall survival (OS) is not currently significantly different between arms (HR 0.62, p = 0.4); 10 year rates 95 vs 87% for arms B and A respectively. Only 2 patients had isolated in-field relapses, therefore systemic therapy primarily prevented progression outside RT fields. Only 3 cases with grade 3-4 acute and 1 case with grade 3 late radiation toxicities were observed. Systemic therapy was associated with 29 cases of grade 3 toxicity and one of grade 4 (neuropathy). One treatment-associated death occurred per arm. Keywords: Chemotherapy; follicular lymphoma (FL); 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 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 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) | 0.006 | 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".