END OF TREATMENT <scp>PET‐CT</scp> PREDICTS PROGRESSION‐FREE SURVIVAL IN <scp>DLBCL</scp> AFTER FIRST‐LINE TREATMENT: RESULTS FROM THE PHASE III <scp>GOYA</scp> STUDY
Bibliographic record
Abstract
Introduction: Establishing a new clinical trial end point, such as end of treatment (EOT) complete response assessed by 18F-FDG-PET (PET-CR), would allow early assessment of therapeutic efficacy. The prognostic value of EOT PET-CR for PFS and OS in DLBCL patients (pts) has been reported in several small studies, but requires confirmation in a large data set. We investigated the prognostic value of EOT PET for PFS in a large pt cohort treated with obinutuzumab (G) or rituximab (R) plus CHOP in the phase III GOYA study (NCT01287741; Vitolo 2016). Methods: Pts aged ≥18 years, with an ECOG performance status ≤2 and IPI score of ≥2, were enrolled, as well as low-risk pts with IPI scores of 1 (not due to age alone) or 0 (with bulky disease). Pts were randomised 1:1 to receive 8 × 21-day cycles of G (1000 mg IV on days [D] 1, 8, and 15, cycle [C] 1 and D1, C2-8) or R (375 mg/m2 IV on D1, C1-8) plus 6 or 8 cycles of CHOP (number of cycles preplanned for all pts at each site). Pts had an EOT PET-CT assessment 6-8 weeks after completion of treatment. PET-CT data were analysed according to Lugano criteria (based on Deauville 5-point scale; JCO 2014) modified in some patients by biopsy findings (m5PS; Table footnote), and revised International Working Group criteria (IWG2007; JCO 2007), at an independent central review facility by 3 radiologists plus a clinical reviewer. PET-CR status, according to each criteria, was compared with PFS. Results: Of 1418 enrolled pts, 1346 had a baseline PET scan, and 1334 had detectable lesions. Baseline clinical characteristics, eg, age, stage and IPI, were similar between treatment arms. There was no statistical difference in PFS between the treatment arms; thus, the entire cohort was analysed as a whole. Results at EOT by m5PS and IWG2007 criteria are presented (Table). After a median follow-up of 29 months, EOT PET-CR was highly predictive of PFS using m5PS or IWG2007; m5PS-based PET-CR yielded a lower hazard ratio (HR 0.27; 95% CI 0.20-0.38; p < 0.001) than IWG2007 (HR 0.34; 95% CI 0.25-0.46; p < 0.001; Figure). 2.5-yr PFS from EOT for m5PS response was 86.1% (95% CI 83.3-88.5) in pts achieving PET-CR vs 58.8% (95% CI 49.3-67.1) in pts who did not. Conclusions: This large prospective study confirms PET-CR as a strong predictor of PFS in DLBCL after 1 L immunochemotherapy, applying m5PS or IWG2007 criteria; m5PS provided a slight advantage. Meta analyses of these data with other prospective studies would be needed to further evaluate the potential surrogacy of PET-CR for PFS as a novel end point for future clinical trials. Keywords: diffuse large B-cell lymphoma (DLBCL); positron emission tomography (PET); prognostic indices
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
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".