Effectiveness and safety of pegylated liposomal doxorubicin versus epirubicin as neoadjuvant or adjuvant chemotherapy for breast cancer: a real-world study

Abstract Background Pegylated liposomal doxorubicin (PLD) is an improved formulation of doxorubicin with comparable effectiveness but significantly lower cardiotoxicity than conventional anthracycline. This study aimed to evaluate the real-world effectiveness and safety of PLD versus epirubicin as neoadjuvant or adjuvant treatment for breast cancer. Methods Clinical data of invasive breast cancer patients who received neoadjuvant or adjuvant chemotherapy with PLD or epirubicin were retrospectively collected. Propensity score matching (PSM) was performed to reduce the risk of selection bias. The molecular typing of these patients included Luminal A, Luminal B, HER2-positive, and basal-like/triple-negative. The primary outcome was pathological complete response (pCR) rate for neoadjuvant chemotherapy and 3-year disease-free survival (DFS) rate for adjuvant chemotherapy. Noninferiority was suggested if the lower limit of the 95% CI for the 3-year DFS rate difference was greater than − 10%. The secondary outcome was adverse reactions. Results A total of 1213 patients were included (neoadjuvant, n = 274; adjuvant, n = 939). pCR (ypT0/Tis ypN0) rates of patients who received neoadjuvant chemotherapy were 11.6% for the PLD group and 7.0% for the epirubicin group, but the difference was not statistically significant (P = 0.4578). The 3-year DFS rate of patients who received adjuvant chemotherapy was 94.9% [95%CI, 91.1–98.6%] for the PLD group and 95.4% [95%CI, 93.0–97.9%] for the epirubicin group (P = 0.5684). Rate difference between the two groups and its 95% CI was - 0.55 [− 5.02, 3.92]. The lower limit of the 95% CI was − 5.0% > − 10.0%, suggesting that PLD is not be inferior to epirubicin in adjuvant chemotherapy for breast cancer. The incidences of myelosuppression, decreased appetite, alopecia, gastrointestinal reactions, and cardiotoxicity were lower in the PLD group than in the epirubicin group, while the incidence of nausea was higher in the PLD group. Conclusions In the neoadjuvant and adjuvant treatment of breast cancer, effectiveness is similar but toxicities are different between the PLD-containing regimen and epirubicin-containing regimen. Therefore, further study is warranted to explore PLD-based neoadjuvant and adjuvant chemotherapy for breast cancer.

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Efficacy Of Pegylated Liposomal Doxorubicin-based Neoadjuvant Chemotherapy In Breast Cancer: A Single Center Experience

Clinical & Investigative Medicine ◽

10.25011/cim.v44i1.35196 ◽

2021 ◽

Vol 44 (1) ◽

pp. E7-14

Author(s):

I-Chen Tsai ◽

Chih-Chiang Hung Hung

Keyword(s):

Breast Cancer ◽

Neoadjuvant Chemotherapy ◽

Recurrence Rate ◽

Liposomal Doxorubicin ◽

Histological Grade ◽

Therapeutic Option ◽

Pathologic Complete Response ◽

Pegylated Liposomal Doxorubicin ◽

Operable Breast Cancer ◽

Breast Cancer Patients

Purpose: Neoadjuvant chemotherapy using a doxorubicin-based regimen has recently become a common therapeutic option for operable breast cancer. This study aimed to investigate the efficacy of polyethylene glycol-coated liposomal doxorubicin (PLD)-based chemotherapy for breast cancer in neoadjuvant settings. Methods: A total of 227 female operable breast cancer patients who were diagnosed between January 2009 and December 2017 and completed neoadjuvant PLD-based chemotherapy were retrospectively included. The logistic regression analysis was used to determine the associations between pathologic complete response (pCR) and preoperative clinicopathological characteristics. The breast cancer recurrence rate was estimated using the survival analysis. Results: A higher pCR rate was found in the patients with clinically negative lymph nodes and HER2-enriched patients. Moreover, the patients who achieved pCR also had a better prognosis outcome. A recurrence rate of 11.5% (n=26) was observed during a median follow-up of 11.63 months, and the recurrence rate of the pCR group (2.04%; 95% CI = 0.29-13.62) was lower than the non-pCR group (14.62%; 95% CI = 10.12-20.87). Higher histological grade was also associated high pCR rate (52.0% vs 40.0%). Conclusion: The use of PLD-containing chemotherapeutics in neoadjuvant settings might have benefits for non-metastatic operable breast cancer in Taiwanese females.

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Neoadjuvant chemotherapy with a combination of pegylated liposomal doxorubicin (Caelyx®) and paclitaxel in locally advanced breast cancer: a phase II study by the Hellenic Cooperative Oncology Group

Annals of Oncology ◽

10.1093/annonc/mdf284 ◽

2002 ◽

Vol 13 (11) ◽

pp. 1737-1742 ◽

Cited By ~ 46

Author(s):

H. Gogas ◽

C. Papadimitriou ◽

H.P. Kalofonos ◽

D. Bafaloukos ◽

G. Fountzilas ◽

...

Keyword(s):

Breast Cancer ◽

Neoadjuvant Chemotherapy ◽

Advanced Breast Cancer ◽

Phase Ii ◽

Liposomal Doxorubicin ◽

Phase Ii Study ◽

Locally Advanced Breast Cancer ◽

Locally Advanced ◽

Pegylated Liposomal Doxorubicin ◽

Oncology Group

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Pegylated Liposomal Doxorubicin or Epirubicin in Neoadjuvant or Adjuvant Chemotherapy for Breast Cancer.

Case Medical Research ◽

10.31525/ct1-nct03983096 ◽

2019 ◽

Author(s):

Keyword(s):

Breast Cancer ◽

Adjuvant Chemotherapy ◽

Liposomal Doxorubicin ◽

Pegylated Liposomal Doxorubicin

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Comparable efficacy and less toxicity of pegylated liposomal doxorubicin versus epirubicin for neoadjuvant chemotherapy of breast cancer: a case-control study

OncoTargets and Therapy ◽

10.2147/ott.s162003 ◽

2018 ◽

Vol Volume 11 ◽

pp. 4247-4252 ◽

Cited By ~ 5

Author(s):

Minjun Dong ◽

Liang Luo ◽

Xiaogang Ying ◽

Xianqiu Lu ◽

Jianguo Shen ◽

...

Keyword(s):

Breast Cancer ◽

Neoadjuvant Chemotherapy ◽

Liposomal Doxorubicin ◽

Case Control Study ◽

Pegylated Liposomal Doxorubicin ◽

Case Control ◽

Comparable Efficacy ◽

Control Study

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

Current Oncology ◽

10.3390/curroncol28060433 ◽

2021 ◽

Vol 28 (6) ◽

pp. 5167-5178

Author(s):

Silvia Dellapasqua ◽

Pamela Trillo Aliaga ◽

Elisabetta Munzone ◽

Vincenzo Bagnardi ◽

Eleonora Pagan ◽

...

Keyword(s):

Breast Cancer ◽

Adjuvant Chemotherapy ◽

Phase Ii ◽

Primary Endpoint ◽

Liposomal Doxorubicin ◽

Early Stage ◽

Pegylated Liposomal Doxorubicin ◽

Her2 Positive ◽

Free Survival ◽

Luminal B

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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Non-Pegylated Liposomal Doxorubicin-Cyclophosphamide in Sequential Regimens with Taxanes as Neoadjuvant Chemotherapy in Breast Cancer Patients

Journal of Cancer ◽

10.7150/jca.9132 ◽

2014 ◽

Vol 5 (6) ◽

pp. 398-405 ◽

Cited By ~ 5

Author(s):

Patrizia Vici ◽

Laura Pizzuti ◽

Teresa Gamucci ◽

Domenico Sergi ◽

Francesca Conti ◽

...

Keyword(s):

Breast Cancer ◽

Neoadjuvant Chemotherapy ◽

Cancer Patients ◽

Liposomal Doxorubicin ◽

Pegylated Liposomal Doxorubicin ◽

Breast Cancer Patients

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The Efficacy of Pegylated Liposomal Doxorubicin-Based Neoadjuvant Chemotherapy in Breast Cancer: A Retrospective Case-Control Study in Taiwan

Biochemistry Research International ◽

10.1155/2020/5729389 ◽

2020 ◽

Vol 2020 ◽

pp. 1-9

Author(s):

Chih-Chiang Hung ◽

Youngsen Yang ◽

I-Chen Tsai ◽

Chiann-yi Hsu ◽

Chia-Hua Liu ◽

...

Keyword(s):

Breast Cancer ◽

Neoadjuvant Chemotherapy ◽

Cancer Patients ◽

Liposomal Doxorubicin ◽

Case Control Study ◽

Pegylated Liposomal Doxorubicin ◽

Case Control ◽

Breast Cancer Patients ◽

Study Results ◽

Control Study

Breast cancer is a global issue regarding women’s health, and high incident rates remain in the Taiwanese female population. Chemotherapy, using anthracycline-based chemotherapeutic agents in neoadjuvant settings, has been introduced as a promising new therapeutic option for treatment of invasive breast cancer. Set apart from conventional anthracycline regimens such as epirubicin, pegylated liposomal doxorubicin (Lipo-Dox®, PLD) was introduced for providing a justifiable treatment effect, while offering a favorable toxicity profile for breast cancer patients in a metastatic setting. However, the efficacy of PLD in neoadjuvant settings for breast cancer patients has not yet been sufficiently reported. This study aims to investigate the efficacy of PLD-based neoadjuvant chemotherapy in breast cancer patients using a retrospective matched case-control study. A total of 183 PLD cases and 183 epirubicin-based controls were included after a 1 : 1 ratio case-control matching procedure was held, according to the matching criteria. These criteria included the patient’s preoperative clinical stage, molecular subtype, chemotherapy regimen with taxanes prior to surgery, and histological grade. All data were collected according to an institutional review board approved protocol. The study results reported that the PLD and epirubicin groups both obtained similar outcomes in pathologic complete response (pCR), recurrence, and overall survival rate with no statistically significant differences. Overall, the study results demonstrate that PLD-based neoadjuvant chemotherapy offers a similar effect of treatment with a favorable toxicity profile within the study follow-up duration, when compared with conventional epirubicin-based neoadjuvant chemotherapy.

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