Comparison of Electronic Surveillance With Routine Monitoring for Patients With Lymphoma at High Risk of Relapse: Prospective Randomized Controlled Phase 3 Trial (Sentinel Lymphoma)
Bibliographic record
Abstract
Background: Relapse is a major event in patients with lymphoma. Therefore, early detection may have an impact on quality of life and overall survival. Patient-reported outcome measures have demonstrated clinical benefits for patients with lung cancer; however, evidence is lacking in patients with lymphoma. We evaluated the effect of a web-mediated follow-up application for patients with lymphoma at high risk of relapse. Objective: This study aims to demonstrate that monitoring patients via a web application enables the detection of at least 30% more significant events occurring between 2 systematic follow-up consultations with the specialist using an electronic questionnaire. Methods: We conducted a prospective, randomized phase 3 trial comparing the impact of web-based follow-up (experimental arm) with a standard follow-up (control arm). The trial was based on a 2-step triangular test and was designed to have a power of 90% to detect a 30% improvement in the detection of significant events. A significant event was defined as a relapse, progression, or a serious adverse event. The study covered the follow-up period after completion of first-line treatment or relapse (24 months). Eligible patients were aged 18 years and older and had lymphoma at a high risk of relapse. In the experimental arm, patients received a 16-symptom questionnaire by email every 2 weeks. An email alert was sent to the medical team based on a predefined algorithm. The primary objective was assessed after the inclusion of the 40th patient. The study was continued for the duration of the analysis. Results: A total of 52 patients were included between July 12, 2017, and April 7, 2020, at 11 centers in France, with 27 in the experimental arm and 25 in the control arm. The median follow-up was 21.3 (range 1.3-25.6) months, and 121 events were reported during the study period. Most events occurred in the experimental arm (83/119, 69.7%) compared with 30.2% (36/119) in the control arm. A median number of 3.5 (range 1-8) events per patient occurred in the experimental arm, and 1.8 (range 1-6) occurred in the control arm (P=.01). Progression and infection were the most frequently reported events. Further, 19 patients relapsed during follow-up: 6 in the experimental arm and 13 in the control arm (P<.001), with a median follow-up of 7.7 (range 2.8-20.6) months and 6.7 (range 1.9-16.4) months (P=.94), respectively. Statistical analysis was conducted after including the 40th patient, which showed no superiority of the experimental arm over the control arm. The study was therefore stopped after the 52nd patient was enrolled. Conclusions: The primary objective was not reached; however, patient-reported outcome measures remain essential for detecting adverse events in patients with cancer, and the electronic monitoring method needs to demonstrate its effectiveness and comply with international safety guidelines.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".