Quality of life comparison based on testosterone recovery after androgen deprivation therapy in patients cured from high-risk prostate cancer: Long term data from a phase III trial.
Notice bibliographique
Résumé
333 Background: Using data from a randomized Phase III trial and based on testosterone recovery after androgen suppression therapy (ADT), we compared quality of life (QOL) between patients (pts) considered cured of high-risk prostate cancer (HRPC). Methods: 630 pts with HRPC were randomised to pelvic and prostate radiotherapy plus either 36 or 18 months (m) of ADT (10-2000 / 01-2008). Serum testosterone (T) was measured at baseline then at each visit. Abnormal T was defined as below the normal level. We considered cured pts those with a PSA nadir < 2 ng/ml, QOL was assessed by the validated EORTC30 (30 items). Patient-reported outcomes were filled out before treatments, every 6 m during ADT, 4 m after ADT and then once a year for 5 years. The 30 items were regrouped into 9 scales. All items and scales scores were linearly transformed to a 0-100 points scale. We analysed all items and scales scores with general linear model and repeated measures to evaluate changes between pts who did versus those who did not recover normal levels of T over time. Effect of T recovery was adjusted in multivariable model including age, initial normal/abnormal T and ADT duration (18 or 36 m). P-value < 0.01 was considered statistically significant to account for multiple comparisons and a difference in mean scores of ≥ 10 points was considered clinically relevant. Results: We selected those pts considered cured to avoid subsequent T variations due to reintroduction of ADT for recurrence. We excluded 361 pts: not receiving exactly 18 or 36 m of ADT (63), survival < 1 year (15), no T measured at baseline or during follow-up (55), biochemical failure (105) or evidence of metastatic/recurrent disease (92), no QOL questionnaire (31). 269 pts were retained for the analysis. With a median follow-up of 14 years, 140/269 (52%) pts recovered T to a normal level: 94/166 (56.6%) in 18 m and 46/103 (44.7%) in 36 m ADT, p=0.056. Among pts regaining a normal T, the median time to recovery was 3 years (IQR: 2.5 to 3.6) for 18 m vs. 5 years (IQR: 4.5 to 6.0) for 36 m, p<0.001. The global adherence to QOL questionnaires was 83.9% (2649/3156) and it was higher for 36m than for 18 m [86.4% (1255/1452) vs. 81.8% (1394/1704) p<0.001]. When comparing EORTC30 between pts who recovered with those who did not recover T, pts with T recovery had a better QOL: 15/30 items and 6/9 scales were statistically significant principally scale and items related to physical, role, emotional, fatigue, pain, dyspnoea, insomnia, diarrhoea, and financial difficulties. 2 items were also clinically relevant, trouble to take a long walk and feeling tense. Conclusions: In pts cured from HRPC, T recovery is associated with a betterQOL. 18 m of ADT should be the preferred duration since a significantly faster and a higher proportion of pts recover a normal T level with the shorter schedule without detriment in long term outcomes, as previously reported.
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Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,003 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
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 tête enseignante, 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 ».