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

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Title: Pegylated Liposomal Doxorubicin (Caelyx®) as Adjuvant Treatment in Early-Stage Luminal B-like Breast Cancer: A Feasibility Phase II Trial
Authors: 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
Source: Current Oncology, Vol 28, Iss 6, Pp 5167-5178 (2021)
Publisher Information: MDPI AG, 2021.
Publication Year: 2021
Collection: LCC:Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Subject Terms: adjuvant chemotherapy, early breast cancer, luminal B-like subtypes, pegylated liposomal doxorubicin (PLD), Caelyx®, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
More Details: 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.
Document Type: article
File Description: electronic resource
Language: English
ISSN: 1718-7729
1198-0052
Relation: https://www.mdpi.com/1718-7729/28/6/433; https://doaj.org/toc/1198-0052; https://doaj.org/toc/1718-7729
DOI: 10.3390/curroncol28060433
Access URL: https://doaj.org/article/01c8698cc532419a944449afa4337d24
Accession Number: edsdoj.01c8698cc532419a944449afa4337d24
Database: Directory of Open Access Journals
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  Data: Pegylated Liposomal Doxorubicin (Caelyx®) as Adjuvant Treatment in Early-Stage Luminal B-like Breast Cancer: A Feasibility Phase II Trial
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  Data: <searchLink fieldCode="AR" term="%22Silvia+Dellapasqua%22">Silvia Dellapasqua</searchLink><br /><searchLink fieldCode="AR" term="%22Pamela+Trillo+Aliaga%22">Pamela Trillo Aliaga</searchLink><br /><searchLink fieldCode="AR" term="%22Elisabetta+Munzone%22">Elisabetta Munzone</searchLink><br /><searchLink fieldCode="AR" term="%22Vincenzo+Bagnardi%22">Vincenzo Bagnardi</searchLink><br /><searchLink fieldCode="AR" term="%22Eleonora+Pagan%22">Eleonora Pagan</searchLink><br /><searchLink fieldCode="AR" term="%22Emilia+Montagna%22">Emilia Montagna</searchLink><br /><searchLink fieldCode="AR" term="%22Giuseppe+Cancello%22">Giuseppe Cancello</searchLink><br /><searchLink fieldCode="AR" term="%22Raffaella+Ghisini%22">Raffaella Ghisini</searchLink><br /><searchLink fieldCode="AR" term="%22Claudia+Sangalli%22">Claudia Sangalli</searchLink><br /><searchLink fieldCode="AR" term="%22Mara+Negri%22">Mara Negri</searchLink><br /><searchLink fieldCode="AR" term="%22Manuelita+Mazza%22">Manuelita Mazza</searchLink><br /><searchLink fieldCode="AR" term="%22Monica+Iorfida%22">Monica Iorfida</searchLink><br /><searchLink fieldCode="AR" term="%22Anna+Cardillo%22">Anna Cardillo</searchLink><br /><searchLink fieldCode="AR" term="%22Angela+Sciandivasci%22">Angela Sciandivasci</searchLink><br /><searchLink fieldCode="AR" term="%22Nadia+Bianco%22">Nadia Bianco</searchLink><br /><searchLink fieldCode="AR" term="%22Ana+Paula+De+Maio%22">Ana Paula De Maio</searchLink><br /><searchLink fieldCode="AR" term="%22Monica+Milano%22">Monica Milano</searchLink><br /><searchLink fieldCode="AR" term="%22Giuseppe+Maria+Campennì%22">Giuseppe Maria Campennì</searchLink><br /><searchLink fieldCode="AR" term="%22Loredana+Sansonno%22">Loredana Sansonno</searchLink><br /><searchLink fieldCode="AR" term="%22Giuseppe+Viale%22">Giuseppe Viale</searchLink><br /><searchLink fieldCode="AR" term="%22Anna+Morra%22">Anna Morra</searchLink><br /><searchLink fieldCode="AR" term="%22Maria+Cristina+Leonardi%22">Maria Cristina Leonardi</searchLink><br /><searchLink fieldCode="AR" term="%22Viviana+Galimberti%22">Viviana Galimberti</searchLink><br /><searchLink fieldCode="AR" term="%22Paolo+Veronesi%22">Paolo Veronesi</searchLink><br /><searchLink fieldCode="AR" term="%22Marco+Colleoni%22">Marco Colleoni</searchLink>
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  Data: <searchLink fieldCode="DE" term="%22adjuvant+chemotherapy%22">adjuvant chemotherapy</searchLink><br /><searchLink fieldCode="DE" term="%22early+breast+cancer%22">early breast cancer</searchLink><br /><searchLink fieldCode="DE" term="%22luminal+B-like+subtypes%22">luminal B-like subtypes</searchLink><br /><searchLink fieldCode="DE" term="%22pegylated+liposomal+doxorubicin+%28PLD%29%22">pegylated liposomal doxorubicin (PLD)</searchLink><br /><searchLink fieldCode="DE" term="%22Caelyx®%22">Caelyx®</searchLink><br /><searchLink fieldCode="DE" term="%22Neoplasms%2E+Tumors%2E+Oncology%2E+Including+cancer+and+carcinogens%22">Neoplasms. Tumors. Oncology. Including cancer and carcinogens</searchLink><br /><searchLink fieldCode="DE" term="%22RC254-282%22">RC254-282</searchLink>
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  Data: 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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