Current Oncology (Dec 2021)

Pegylated Liposomal Doxorubicin (Caelyx<sup>®</sup>) as Adjuvant Treatment in Early-Stage Luminal B-like Breast Cancer: A Feasibility Phase II Trial

  • Silvia Dellapasqua,
  • Pamela Trillo Aliaga,
  • Elisabetta Munzone,
  • Vincenzo Bagnardi,
  • Eleonora Pagan,
  • Emilia Montagna,
  • Giuseppe Cancello,
  • Raffaella Ghisini,
  • Claudia Sangalli,
  • Mara Negri,
  • Manuelita Mazza,
  • Monica Iorfida,
  • Anna Cardillo,
  • Angela Sciandivasci,
  • Nadia Bianco,
  • Ana Paula De Maio,
  • Monica Milano,
  • Giuseppe Maria Campennì,
  • Loredana Sansonno,
  • Giuseppe Viale,
  • Anna Morra,
  • Maria Cristina Leonardi,
  • Viviana Galimberti,
  • Paolo Veronesi,
  • Marco Colleoni

DOI
https://doi.org/10.3390/curroncol28060433
Journal volume & issue
Vol. 28, no. 6
pp. 5167 – 5178

Abstract

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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 and methods: 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.

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