Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2021 Dec 7;28(6):5167-5178.
doi: 10.3390/curroncol28060433.

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

Silvia Dellapasqua  1 , Pamela Trillo Aliaga  1 , Elisabetta Munzone  1 , Vincenzo Bagnardi  2 , Eleonora Pagan  2 , Emilia Montagna  1 , Giuseppe Cancello  1 , Raffaella Ghisini  1 , Claudia Sangalli  1 , Mara Negri  1 , Manuelita Mazza  1 , Monica Iorfida  1 , Anna Cardillo  1 , Angela Sciandivasci  1 , Nadia Bianco  1 , Ana Paula De Maio  1 , Monica Milano  1 , Giuseppe Maria Campennì  1 , Loredana Sansonno  1 , Giuseppe Viale  3 , Anna Morra  4 , Maria Cristina Leonardi  4 , Viviana Galimberti  5 , Paolo Veronesi  5 , Marco Colleoni  1
Affiliations
Clinical Trial

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

Silvia Dellapasqua et al. Curr Oncol. .

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 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.

Keywords: Caelyx®; adjuvant chemotherapy; early breast cancer; luminal B-like subtypes; pegylated liposomal doxorubicin (PLD).

PubMed Disclaimer

Conflict of interest statement

Silvia Dellapasqua—Travel, Accommodations, Expenses: Lilly, Novartis, Pfizer. Emilia Montagna—Consulting or Advisory Role: Pierre Fabre. Giuseppe Viale—Honoraria: MSD Oncology, Pfizer, Daiichi Sankyo Europe GmbH; Consulting or Advisory Role: Dako, Roche/Genentech, Novartis, Bayer; Daiichi Sankyo, MSD Oncology, Menarini; Speakers’ Bureau: Roche/Genentech; Research Funding: Roche/Genentech, Ventana Medical Systems, Dako/Agilent Technologies, Cepheid Recipient; Travel, Accommodations, Expenses: Roche. Marco Colleoni—Research Grant from Roche. The remaining uthors declare no conflict of interest.

Figures

Figure 1
Figure 1
Waterfall plot showing the relative dose intensity (RDI %) by patient (dashed reference line: RDI = 85%).
Figure 2
Figure 2
Breast Cancer-Free Survival (panel A) and Disease-Free Survival (panel B).
See this image and copyright information in PMC

References

    1. Burstein H., Curigliano G., Thürlimann B., Weber W., Poortmans P., Regan M., Senn H., Winer E., Gnant M., Aebi S., et al. Customizing local and systemic therapies for women with early breast cancer: The St. Gallen International Consensus Guidelines for treatment of early breast cancer 2021. Ann. Oncol. 2021;32:1216–1235. doi: 10.1016/j.annonc.2021.06.023. - DOI - PMC - PubMed
    1. Yan X.J., Xu J., Gu Z.H., Pan C.M., Lu G., Shen Y., Shi J.Y., Zhu Y.M., Tang L., Zhang X.W., et al. Breast cancer classification and prognosis based on gene expression profiles from a popula-tion-based study. Proc. Natl. Acad. Sci. USA. 2003;100:10393–10398. doi: 10.1073/pnas.1732912100. - DOI - PMC - PubMed
    1. Goldhirsch A., Wood W.C., Coates A.S., Gelber R.D., Thürlimann B., Senn H.-J. Strategies for subtypes—dealing with the diversity of breast cancer: Highlights of the St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2011. Ann. Oncol. 2011;22:1736–1747. doi: 10.1093/annonc/mdr304. - DOI - PMC - PubMed
    1. Goldhirsch A., Winer E.P., Coates A.S., Gelber R.D., Piccart-Gebhart M., Thürlimann B., Senn H.J., Albain K.S., André F., Bergh J., et al. Personalizing the treatment of women with early breast cancer: Highlights of the St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2013. Ann Oncol. 2013;24:2206–2223. doi: 10.1093/annonc/mdt303. - DOI - PMC - PubMed
    1. Cardoso F., Kyriakides S., Ohno S., Penault-Llorca F., Poortmans P., Rubio I.T., Zackrisson S., Senkus E. Early breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann. Oncol. 2019;30:1194–1220. doi: 10.1093/annonc/mdz173. - DOI - PubMed

Publication types