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- Title
Impact of Age on Clinical Outcomes and Efficacy of Adjuvant Dual Anti-HER2 Targeted Therapy.
- Authors
Lambertini, Matteo; Fielding, Shona; Loibl, Sibylle; Janni, Wolfgang; Clark, Emma; Franzoi, Maria Alice; Fumagalli, Debora; Caballero, Carmela; Arecco, Luca; Salomoni, Sharon; Ponde, Noam F; Poggio, Francesca; Kim, Hee Jeong; Villarreal-Garza, Cynthia; Pagani, Olivia; Paluch-Shimon, Shani; Ballestrero, Alberto; Mastro, Lucia Del; Piccart, Martine; Bines, Jose
- Abstract
<bold>Background: </bold>Young age at breast cancer (BC) diagnosis has historically been a rationale for overtreatment. Limited data with short follow-up exist on the prognostic value of age at diagnosis in HER2-positive BC and the benefit of anti-HER2 therapy in young patients.<bold>Methods: </bold>APHINITY (NCT01358877) is an international, placebo-controlled, double-blind randomized phase III trial in HER2-positive early BC patients investigating the addition of pertuzumab to adjuvant chemotherapy plus trastuzumab. The prognostic and predictive value of age on invasive disease-free survival (IDFS) as continuous and dichotomous variable (aged 40 years or younger and older than 40 years) was assessed. A subpopulation treatment effect pattern plot analysis was conducted to illustrate possible treatment-effect heterogeneity based on age as a continuous factor.<bold>Results: </bold>Of 4804 included patients, 768 (16.0%) were aged 40 years or younger at enrollment. Median follow-up was 74 (interquartile range = 62-75) months. Young age was not prognostic either as dichotomous (hazard ratio [HR] = 1.06, 95% confidence interval [CI] = 0.84 to 1.33) or continuous (HR = 1.00, 95% CI = 1.00 to 1.01) variable. Lack of prognostic effect of age was observed irrespective of hormone receptor status and treatment arm. No statistically significant interaction was observed between age and pertuzumab effect (Pinteraction = 0.61). Adding pertuzumab improved IDFS for patients in the young (HR = 0.86, 95% CI = 0.56 to 1.32) and older (HR = 0.75, 95% CI = 0.62 to 0.92) cohorts. Similar results were observed irrespective of hormone receptor status. Subpopulation treatment effect pattern plot analysis confirmed the benefit of pertuzumab in 6-year IDFS across age subpopulations.<bold>Conclusions: </bold>In patients with HER2-positive early BC treated with modern anticancer therapies, young age did not demonstrate either prognostic or predictive value, irrespective of hormone receptor status.
- Subjects
ADJUVANT chemotherapy; RESEARCH; HORMONES; CLINICAL trials; RESEARCH methodology; CELL receptors; ANTINEOPLASTIC agents; EVALUATION research; TREATMENT effectiveness; COMPARATIVE studies; RANDOMIZED controlled trials; IMPACT of Event Scale; RESEARCH funding; BREAST tumors
- Publication
JNCI: Journal of the National Cancer Institute, 2022, Vol 114, Issue 8, p1117
- ISSN
0027-8874
- Publication type
journal article
- DOI
10.1093/jnci/djac096