PRO-ACTIVE: Results of a pragmatic phase IV randomized trial comparing the effectiveness of prophylactic swallow intervention for patients receiving radiotherapy for head and neck cancer.
Notice bibliographique
Résumé
LBA12000 Background: Swallowing therapy during radiotherapy (RT) for head and neck cancer (HNC) has gained popularity as a dysphagia mitigation strategy, yet optimal timing and intensity of therapy remains uncertain. The PRO-ACTIVE trial compared the effectiveness of prophylactic and reactive swallowing therapies during RT. We hypothesized that PRO-ACTIVE therapies are more effective than RE-ACTIVE; and, that more intensive PRO-ACTIVE (EAT+EXERCISE) is superior to less intensive PRO-ACTIVE (EAT). Methods: PRO-ACTIVE was an international, multi-site pragmatic phase IV randomized clinical trial (NCT03455608). Eligible, adult patients had functional baseline swallowing and received RT ≥60-Gy for HNC with bilateral neck fields. Prior to RT, patients were randomized 1:2:2 to 1) RE-ACTIVE, 2) PRO-ACTIVE EAT, or 3) PRO-ACTIVE EAT+EXERCISE arms and followed for 1 year. RE-ACTIVE received weekly monitoring with therapy only if/when dysphagic, and PRO-ACTIVE arms received bi-weekly therapy pre- and during RT. The primary endpoint was feeding tube (FT) use in days from the end of RT to 1 year. Secondary endpoints were patient-reported and clinician-graded outcomes. Adjusted linear regression compared FT days per intention-to-treat with a gate-keeper approach to test hypotheses in hierarchical order with 80% power to detect a small effect size (≥.21 SD) with type 1 error probability of 0.5 (two-sided). Results: 952 patients from 13 institutions were randomized to RE-ACTIVE (n=196), PRO-ACTIVE-EAT (n=377) or PRO-ACTIVE-EAT+EXERCISE (n=379). 21 (2.2%) patients exited before intervention, thus, 931 were retained for analysis. The majority had stage I/II disease (552/931, 59.3%), oropharyngeal tumors (647/931, 69.5%), and p16+ and/or HPV+ disease (680/931, 73.0%). Baseline function was excellent (499/931 (53.5%) grade 0 dysphagia, mean [SD] MDADI 86 [14]). All patients received curative intent RT (median 70 Gy), 706/931 (75.8%) with chemotherapy, and 105/931 (11.3%) with primary site surgery. 364 of 931 (39.1%) required a FT with 34.4 (SD 75.9) mean days of use. Adjusted FT days at 12-months did not meaningfully differ by pro- and re-active timing (∆5.4 days, 95% CI -6.5 to 17.2, p=0.37) or EAT versus EAT+exercise intensity (∆5.9 days, 95% CI -3.8 to 17.6, p=0.21). Swallowing-related QOL, diet, weight/BMI, and dysphagia symptoms did not differ meaningfully by arm. Conclusion: FT utilization was lower than expected and secondary measures of swallowing outcomes were favorable across all arms of the PRO-ACTIVE trial reflecting relative effectiveness of EAT and exercise therapies regardless of timing or intensity of therapy delivery during RT for HNC. As a pragmatic trial, we are robustly powered to examine heterogeneous treatment effects in subgroup analyses and image-based swallowing metrics as critical next steps. Clinical trial information: NCT03455608 .
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Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,005 | 0,010 |
| Méta-épidémiologie (sens strict) | 0,002 | 0,001 |
| Méta-épidémiologie (sens large) | 0,003 | 0,004 |
| Bibliométrie | 0,001 | 0,000 |
| Études des sciences et des technologies | 0,001 | 0,002 |
| Communication savante | 0,001 | 0,002 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,003 | 0,003 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,011 | 0,001 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».