Pegylated Liposomal Doxorubicin (Caelyx<sup>®</sup>) as Adjuvant Treatment in Early-Stage Luminal B-like Breast Cancer: A Feasibility Phase II Trial
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:...
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| Format: | Article |
| Language: | English |
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MDPI AG
2021-12-01
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| Series: | Current Oncology |
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| Online Access: | https://www.mdpi.com/1718-7729/28/6/433 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Silvia Dellapasqua |
| collection | DOAJ |
| description | 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<sup>®</sup>) 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/m<sup>2</sup> 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. |
| first_indexed | 2024-03-10T04:20:31Z |
| format | Article |
| id | doaj.art-01c8698cc532419a944449afa4337d24 |
| institution | Directory Open Access Journal |
| issn | 1198-0052 1718-7729 |
| language | English |
| last_indexed | 2024-03-10T04:20:31Z |
| publishDate | 2021-12-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Current Oncology |
| spelling | doaj.art-01c8698cc532419a944449afa4337d242023-11-23T07:51:02ZengMDPI AGCurrent Oncology1198-00521718-77292021-12-012865167517810.3390/curroncol28060433Pegylated Liposomal Doxorubicin (Caelyx<sup>®</sup>) as Adjuvant Treatment in Early-Stage Luminal B-like Breast Cancer: A Feasibility Phase II TrialSilvia Dellapasqua0Pamela Trillo Aliaga1Elisabetta Munzone2Vincenzo Bagnardi3Eleonora Pagan4Emilia Montagna5Giuseppe Cancello6Raffaella Ghisini7Claudia Sangalli8Mara Negri9Manuelita Mazza10Monica Iorfida11Anna Cardillo12Angela Sciandivasci13Nadia Bianco14Ana Paula De Maio15Monica Milano16Giuseppe Maria Campennì17Loredana Sansonno18Giuseppe Viale19Anna Morra20Maria Cristina Leonardi21Viviana Galimberti22Paolo Veronesi23Marco Colleoni24Division of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, ItalyDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, ItalyDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, ItalyDepartment of Statistics and Quantitative Methods, University of Milan-Bicocca, 20126 Milan, ItalyDepartment of Statistics and Quantitative Methods, University of Milan-Bicocca, 20126 Milan, ItalyDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, ItalyDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, ItalyDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, ItalyDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, ItalyDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, ItalyDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, ItalyDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, ItalyDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, ItalyDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, ItalyDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, ItalyDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, ItalyDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, ItalyDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, ItalyDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, ItalyDepartment of Pathology, European Institute of Oncology IRCCS and University of Milan, 20141 Milan, ItalyDivision of Radiotherapy, European Institute of Oncology IRCCS, 20141 Milan, ItalyDivision of Radiotherapy, European Institute of Oncology IRCCS, 20141 Milan, ItalyDivision of Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, ItalyDivision of Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, ItalyDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, ItalyBackground: 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<sup>®</sup>) 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/m<sup>2</sup> 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.https://www.mdpi.com/1718-7729/28/6/433adjuvant chemotherapyearly breast cancerluminal B-like subtypespegylated liposomal doxorubicin (PLD)Caelyx<sup>®</sup> |
| spellingShingle | 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 Pegylated Liposomal Doxorubicin (Caelyx<sup>®</sup>) as Adjuvant Treatment in Early-Stage Luminal B-like Breast Cancer: A Feasibility Phase II Trial Current Oncology adjuvant chemotherapy early breast cancer luminal B-like subtypes pegylated liposomal doxorubicin (PLD) Caelyx<sup>®</sup> |
| title | Pegylated Liposomal Doxorubicin (Caelyx<sup>®</sup>) as Adjuvant Treatment in Early-Stage Luminal B-like Breast Cancer: A Feasibility Phase II Trial |
| title_full | Pegylated Liposomal Doxorubicin (Caelyx<sup>®</sup>) as Adjuvant Treatment in Early-Stage Luminal B-like Breast Cancer: A Feasibility Phase II Trial |
| title_fullStr | Pegylated Liposomal Doxorubicin (Caelyx<sup>®</sup>) as Adjuvant Treatment in Early-Stage Luminal B-like Breast Cancer: A Feasibility Phase II Trial |
| title_full_unstemmed | Pegylated Liposomal Doxorubicin (Caelyx<sup>®</sup>) as Adjuvant Treatment in Early-Stage Luminal B-like Breast Cancer: A Feasibility Phase II Trial |
| title_short | Pegylated Liposomal Doxorubicin (Caelyx<sup>®</sup>) as Adjuvant Treatment in Early-Stage Luminal B-like Breast Cancer: A Feasibility Phase II Trial |
| title_sort | pegylated liposomal doxorubicin caelyx sup r sup as adjuvant treatment in early stage luminal b like breast cancer a feasibility phase ii trial |
| topic | adjuvant chemotherapy early breast cancer luminal B-like subtypes pegylated liposomal doxorubicin (PLD) Caelyx<sup>®</sup> |
| url | https://www.mdpi.com/1718-7729/28/6/433 |
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