Pegylated Liposomal Doxorubicin (Caelyx®) as Adjuvant Treatment in Early-Stage Luminal B-like Breast Cancer: A Feasibility Phase II Trial.
Curr Oncol
; 28(6): 5167-5178, 2021 12 07.
Article
em En
| MEDLINE
| ID: mdl-34940072
ABSTRACT
BACKGROUND:
Adjuvant chemotherapy for Luminal B-like breast cancers usually includes anthracycline-based regimens. However, some patients are reluctant to receive chemotherapy because of side-effects, especially alopecia, and ask for a "less intensive" or personalized approach. PATIENTS ANDMETHODS:
We conducted a phase II feasibility trial to evaluate pegylated liposomal doxorubicin (PLD, Caelyx®) as adjuvant chemotherapy. Patients who received surgery for pT1-3, any N, and luminal B-like early-stage breast cancer (EBC) candidates for adjuvant chemotherapy were included. PLD was administered intravenously at 20 mg/m2 biweekly for eight courses. Endocrine therapy was given according to menopausal status. Trastuzumab was administered in HER2-positive disease. The primary endpoint was to evaluate the feasibility of this regimen, defined as the ability of a patient to achieve a relative dose intensity (RDI) of at least 85% of the eight cycles of treatment. Secondary endpoints included adverse events (AEs), tolerability, breast cancer-free survival, disease-free survival, and overall survival.RESULTS:
From March 2016 to July 2018, 63 patients were included in the trial. Median age was 49 years (range 33-76), with mostly pre- and peri-menopausal (65%) and stage I-II (94%). Only 5% of patients had HER2-positive EBC. Median RDI was 100% (range 12.5-100%; interquartile range, IQR 87.5-100%). The proportion of patients meeting the primary endpoint was 84% (95% confidence interval, CI 73-92%). Overall, 55 out of 63 enrolled patients completed treatment (87%, 95% CI 77-94%). Most common AEs were palmar-plantar erythrodysesthesia (12.2%), fatigue (10.4%), and mucositis (8.5%). Only 13% of patients had G3 AEs. None had alopecia. After a median follow-up of 3.9 years (range 0.3-4.7) two distant events were observed, and all patients were alive at the date of last visit.CONCLUSIONS:
The trial successfully met its primary endpoint the regimen was feasible and well tolerated and could be considered for further evaluation as a treatment option for patients with contraindications to standard anthracyclines or requiring a personalized, less intensive approach.Palavras-chave
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Neoplasias da Mama
Limite:
Female
/
Humans
/
Middle aged
Idioma:
En
Revista:
Curr Oncol
Ano de publicação:
2021
Tipo de documento:
Article