A randomized phase III trial of the impact of a structured exercise program on disease-free survival (DFS) in stage 3 or high-risk stage 2 colon cancer: Canadian Cancer Trials Group (CCTG) CO.21 (CHALLENGE).
Notice bibliographique
Résumé
LBA3510 Background: Multiple observational studies have reported that post-diagnosis physical activity (PA) is associated with reduced recurrence rates in early-stage colon cancer but epidemiologic data is limited by confounding and reporting bias. CCTG CO.21 was designed to test the hypothesis that a meaningful increase in recreational PA after adjuvant therapy is achievable and will improve DFS in stage 3 or high-risk stage 2 colon cancer. Methods: CCTG CO.21 enrolled patients at 55 sites in 6 countries. Patients with resected stage 3 or high-risk stage 2 colon cancer who had received adjuvant chemotherapy were randomized to a structured exercise program (SEP) or health education materials (HEM). HEM participants received education materials promoting PA and healthy nutrition in addition to standard surveillance. SEP participants worked with a PA consultant who delivered an exercise intervention using behavior change methodology over 3 years. The SEP goal was to increase recreational PA by at least 10 MET-hours/week from baseline during the first 6 months and sustain this for 3 years. Participants chose the type, frequency, intensity and duration of aerobic exercise. The primary endpoint is DFS compared by a stratified log-rank test performed on an intention-to-treat basis. Secondary endpoints include overall survival (OS) and patient-reported outcomes (SF-36 physical function scale was primary PRO). Results: Between 2009 and 2024,889 participants were randomized to SEP (n=445) or HEM (n=444); 51% female, median age 61 years, 90% stage 3 disease. Compared to HEM, SEP resulted in statistically significant improvements in recreational PA, predicted VO2max, and 6-minute walk distance, all maintained over the 3-year intervention period. With a median follow-up of 7.9 years, 224 DFS events (93 in SEP and 131 in HEM) and 107 deaths (41 in SEP and 66 in HEM) were observed. 5-year DFS was 80% in SEP and 74% in HEM (HR 0.72; 95% CI 0.55-0.94; p=0.017). 8-year OS was 90% in SEP and 83% in HEM (HR=0.63; 95% CI=0.43-0.94; p=0.022). SF-36 physical function was substantially improved with SEP at 6 months (mean change scores 7.42 vs 1.10, p<0.001) and was sustained to 24 months. In the safety analysis, 19% (79/428) of patients on SEP reported any grade of musculoskeletal adverse event (MSK AE) over the course of the study, compared to 12% (50/433) on HEM. 10% (8/79) of MSK AE on SEP were considered to be related to participation in the PA program. Conclusions: Inpatients with stage 3 and high-risk stage 2 colon cancer, a 3-year structured exercise program initiated shortly after completion of adjuvant chemotherapy improves DFS, OS, patient-reported physical functioning, and health-related fitness. Health systems should incorporate structured exercise programs as standard of care for this patient population. Clinical trial information: NCT00819208 .
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
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 | 0,001 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,002 | 0,000 |
| Méta-épidémiologie (sens large) | 0,002 | 0,002 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,001 | 0,001 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,002 | 0,003 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,007 | 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 ».