A Randomized Trial Comparing Breast Cancer Incidence and Interval Cancers after Tomosynthesis Plus Mammography versus Mammography Alone.
Journal
Radiology
ISSN: 1527-1315
Titre abrégé: Radiology
Pays: United States
ID NLM: 0401260
Informations de publication
Date de publication:
05 2022
05 2022
Historique:
pubmed:
2
2
2022
medline:
28
4
2022
entrez:
1
2
2022
Statut:
ppublish
Résumé
Background Adding digital breast tomosynthesis (DBT) to digital mammography (DM) improves breast cancer screening sensitivity, but how this impacts mortality and other end points is unknown. Purpose To compare interval and overall breast cancer incidence after screening with DBT plus DM versus DM alone. Materials and Methods In this prospective trial (RETomo), women attending screening were randomized to one round of DBT plus DM (experimental arm) or to DM (control arm). All were then rescreened with DM after 12 months (women aged 45-49 years) or after 24 months (50-69 years). The primary outcome was interval cancer incidence. Cumulative incidence up to the subsequent screening round plus 9 months (21- and 33-month follow-up for women aged 45-49 and 50-69, respectively) was also reported. Ductal carcinomas in situ are included. Subgroup analyses by age and breast density were conducted; 95% CIs computed according to binomial distribution are reported. Results Baseline cancer detection was higher in the DBT plu DM arm than DM arm (101 of 13 356 women vs 61 of 13 521 women; relative detection, 1.7 [95% CI: 1.2, 2.3]). The mean age ± standard deviation for the women in both arms was 55 years ± 7. Interval cancer incidence was similar in the two arms (21 vs 22 cancers; relative incidence, 0.97 [95% CI: 0.53, 1.8]). Cumulative incidence remained higher in the DBT plus DM arm in women over 50 (153 vs 124 cancers; relative incidence, 1.2 [95% CI: 0.99, 1.6]), while it was similar in the two arms in women aged 45-49 (36 vs 41 cancers; relative incidence, 0.89 [95% CI: 0.57, 1.4]). Conclusion In women younger than 50 years, the benefit of early diagnosis seemed to be appreciable, while for women over age 50, the higher sensitivity of tomosynthesis plus mammography was not matched by a subsequent reduction in cancers at the next screening examination or in the intervening interval. Clinical trial registration no. NCT02698202 © RSNA, 2022
Identifiants
pubmed: 35103537
doi: 10.1148/radiol.211132
doi:
Banques de données
ClinicalTrials.gov
['NCT02698202']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
256-266Investigateurs
Carlo Alberto Mori
(CA)
Chiara Coriani
(C)
Manuela Pescarolo
(M)
Gloria Stefanelli
(G)
Giulio Tondelli
(G)
Filippo Beretti
(F)
Sabrina Caffarri
(S)
Vanessa Marchesi
(V)
Luisa Paterlini
(L)
Stefania Caroli
(S)
Laura Canovi
(L)
Marco Colli
(M)
Mirco Boschini
(M)
Marco Bertolini
(M)
Kristina Lang
(K)
Axel Graewingholt
(A)
Fabio Falcini
(F)
Commentaires et corrections
Type : CommentIn