Imatinib Long-Term Effects Study: Global Independent Assessment of Imatinib in Chronic Myeloid Leukemia: Results At 8 Years,
Notice bibliographique
Résumé
Abstract Abstract 3766 The independent, multicenter Imatinib Long Term Effects (ILTE) study assessed overall survival, loss of complete cytogenetic remission (CCyR), attainment of negative Philadelphia chromosome hematopoiesis assessed with quantitative polymerase chain reaction (PCR), serious adverse events (SAE), and toxicities not qualifying as SAE (NSAE) but judged by treating physicians as substantially affecting quality of life. The ILTE study also investigated the development of second tumours after at least two years of treatment. Consecutive CML patients, who started imatinib before 2005 and who were in CCyR after two years, were eligible. Overall survival, incidence of the first adverse events, and loss of CCyR were estimated according to the Kaplan-Meier method and compared with the standard log-rank test. Cumulative incidence of death was broken down into incidence related or unrelated to CML, accounting for competing risks. Standardized incidence ratio were calculated based on population rates specific for gender and age classes. The results at December 31st 2008 were published in J Natl Cancer Inst 2011; 103: 553–561. Here we report the results updated at December 31st, 2009, where a total of 832 patients were enrolled with a median treatment duration of 6.7 years. A comparison of the observed mortality rate in CML patients with the rate in the general Italian population showed no excess mortality. Thirty-three deaths were observed (8 CML-related), with a mortality incidence rate of 0.8 per 100 person-years (standardized incidence ratio = 0.85; 95% CI = 0.58 to 1.19). Similar results were obtained when this analysis was restricted to Italian patients. The CML-related death rate was 0.12 per 100 person-years. There were 139 recorded SAE, of which 19.4% were probably related to imatinib. Among the 830 NSAEs (which developed in 57.8% of patients and were possibly related to imatinib in 68.2% of the 830 events), the most frequent ones were muscle cramps, asthenia (observed in 4.9% of patients), edema, skin fragility, diarrhea, conjunctival hemorrhages, osteoarticular pain and tendon or ligament lesions. Nineteen patients (2.3%) discontinued imatinib because of drug-related toxicities. Fifty-three patients lost CCyR, corresponding to a rate of 1.4 per 100 person years (1.1% in patients who received imatinib as first line treatment). Durable (greater than 1 year) Philadelphia negative hematopoiesis, as evaluated by PCR was attained by 125 patients (15%). The onset of second tumours was also evaluated: 34 patients developed second cancers. The overall rate was not significantly different from that of the general population (SIR = 0.9, 95% CI = 0.63 to 1.26), with the exception of prostate cancer (SIR = 2.86; 95% CI = 1.48 to 4.99). In conclusion, CML-related deaths are uncommon in CML patients who are in CCyR two years after starting imatinib. Survival is not statistically significantly different from that of the general population. Side effects are present but generally not serious. A higher incidence of prostate cancer, to be confirmed and further analyzed, was observed. Disclosures: No relevant conflicts of interest to declare.
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 | 0,003 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,000 | 0,001 |
| Intégrité de la recherche | 0,001 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,001 | 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 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 ».