Abemaciclib plus endocrine therapy in high-risk, node-positive early breast cancer in Italian practice: interim analysis of prospective observational IT-PATH study.

@article{visani2026abemaciclib,
  title = {{Abemaciclib plus endocrine therapy in high-risk, node-positive early breast cancer in Italian practice: interim analysis of prospective observational IT-PATH study.}},
  author = {L Visani and A Melaccio and C Vernieri and E Rota Caremoli and C Bengala and V Guarneri and D Palleschi and L Del Mastro and E Munzone and M V Sanò and F M Carfì and P Scavina and A Fabi and F Puglisi and M Ramundo and L Moscetti and A Avitabile and S Baffini and M A Sarno and M De Laurentiis},
  journal = {ESMO real world data and digital oncology},
  year = {2026},
  month = oct,
  doi = {10.1016/j.esmorw.2026.100813},
  url = {https://europepmc.org/article/MED/42999618},
  note = {CC BY-NC-ND},
}

TY  - JOUR
TI  - Abemaciclib plus endocrine therapy in high-risk, node-positive early breast cancer in Italian practice: interim analysis of prospective observational IT-PATH study.
AU  - L Visani
AU  - A Melaccio
AU  - C Vernieri
AU  - E Rota Caremoli
AU  - C Bengala
AU  - V Guarneri
AU  - D Palleschi
AU  - L Del Mastro
AU  - E Munzone
AU  - M V Sanò
AU  - F M Carfì
AU  - P Scavina
AU  - A Fabi
AU  - F Puglisi
AU  - M Ramundo
AU  - L Moscetti
AU  - A Avitabile
AU  - S Baffini
AU  - M A Sarno
AU  - M De Laurentiis
PY  - 2026
DA  - 2026/10/29
JO  - ESMO real world data and digital oncology
DO  - 10.1016/j.esmorw.2026.100813
UR  - https://europepmc.org/article/MED/42999618
AB  - Abemaciclib plus endocrine therapy (ET) is an established adjuvant treatment for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, high-risk early breast cancer (EBC), based on monarchE trial. Prospective real-world data on persistence, adherence, dose management, and patient-reported outcomes (PROs) remain lacking. IT-PATH was designed to address these gaps. IT-PATH is a prospective, multicenter, noninterventional study enrolling patients with HR-positive, HER2-negative high-risk EBC treated with adjuvant abemaciclib + ET at 18 Italian sites. This preplanned interim analysis reports data from the first 100 patients reaching 6-month follow-up. Primary outcome: 6-month treatment persistence and discontinuation rate. Secondary outcomes: adherence [modified medication possession ratio (mMPR)], dose management, safety. Exploratory endpoints (PROs): health-related quality of life (HRQoL), sexual health, and work productivity. Patients were 100% female, with a mean age of 55.4 years; 89.6% had Eastern Cooperative Oncology Group Performance Status 0. Treatment persistence at 3 months was 100% and at 6 months was 98% (median follow-up, 5.6 months). Discontinuation occurred in 2% due to adverse events (AEs). Reductions occurred in 52%; high adherence (mMPR ≥0.8 in 89.8%). AEs ≥ grade 3 were reported in 29% (no grade 4/5). Diarrhea (85%), asthenia (38%), and neutropenia (34%) were the most frequent AEs (any grade). No clinically meaningful changes from baseline were observed across all PROs. This interim analysis provides prospective real-world evidence that, in routine clinical practice, adjuvant abemaciclib + ET demonstrates feasibility and manageable tolerability with high treatment persistence and no clinically meaningful changes in HRQoL during the first 6 months of therapy. These findings support the value of proactive and personalized dose management to sustain treatment exposure and patient well-being.
SN  - 2949-8201
ER  -