Messaggi chiave
- È stata condotta un’analisi degli esiti riferiti dai pazienti (PRO) di monarchE, lo studio di fase 3 che ha valutato abemaciclib + endocrinoterapia (ET) rispetto a ET da sola nel trattamento del carcinoma mammario precoce HR+/HER2-, con linfonodi positivi e ad alto rischio di recidiva.
- Le variazioni medie rispetto al basale sono risultate numericamente simili all’interno e tra i bracci in relazione a tutte le scale di qualità della vita e a tutte le voci individuali, con l’unica eccezione della diarrea (incrementi medi a 3 e 6 mesi rispettivamente pari a 1,19 e 1,03 punti nel braccio sperimentale). Durante il trattamento, la maggior parte della popolazione in studio ha riferito di essere disturbata “poco” o “per nulla” dagli effetti collaterali. Nel follow-up post-trattamento, i PRO sono stati simili al basale in entrambi i bracci.
- In assenza di sintomi attesi correlati alla malattia, è importante che le terapie somministrate nel setting adiuvante non incidano significativamente sulla qualità della vita dei pazienti. L’analisi presentata conferma la tollerabilità e reversibilità del profilo di tossicità di abemaciclib, a ulteriore supporto del suo utilizzo in pazienti con malattia precoce ad alto rischio.
Abstract
Background
- In monarchE, abemaciclib demonstrated a sustained benefit in invasive disease-free survival and a tolerable safety profile at 42-months median follow-up.
- With no expected disease-related symptoms, therapies in the adjuvant setting should preserve quality of life (QoL).
- With all patients off abemaciclib, we report updated patient-reported outcomes (PROs) for the full 2-year treatment period and follow-up.
Methods
- Patients completed PROs including FACT-B, FACT-ES, and FACIT-Fatigue at baseline, 3, 6, 12, 18, and 24 months during treatment, and 1, 6, and 12 months after treatment discontinuation.
- Mixed effects repeated measures model estimated changes from baseline within and between arms for QoL scales and individual items.
- Meaningful changes were prespecified and no statistical testing was performed. Frequencies of responses to items associated with relevant adverse events and treatment bother were summarized.
Results
- At baseline, completion rates for PRO instruments were >96 %. Mean changes from baseline for all QoL scales were numerically similar within and between arms (ie, less than prespecified thresholds).
- The same was observed for all individual items, except diarrhea. Within abemaciclib arm, meaningful differences for diarrhea were observed at 3 and 6 months (mean increases of 1.19 and 1.03 points on 5-point scale, respectively).
- During treatment, most patients in both arms (69-78 %) reported being bothered “a little bit” or “not at all” by side effects.
- Overall, patterns for fatigue were similar between arms.
- During post-treatment follow-up, PROs in both arms were similar to baseline.
Conclusion
- PRO findings confirm a tolerable and reversible toxicity profile for abemaciclib.
- QoL was preserved with the addition of adjuvant abemaciclib to endocrine therapy, supporting its use in patients with HR+, HER2-, high-risk early breast cancer.