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

2019 ◽  
Author(s):  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Liposomal Doxorubicin ◽  
Pegylated Liposomal Doxorubicin

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

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jin Zhang ◽  
Hongchuan Jiang ◽  
Jian Zhang ◽  
Guoqiang Bao ◽  
Guoqiang Zhang ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Neoadjuvant Chemotherapy ◽  
Lower Limit ◽  
Adjuvant Treatment ◽  
Real World ◽  
Liposomal Doxorubicin ◽  
Pegylated Liposomal Doxorubicin ◽  
Secondary Outcome ◽  
Rate Difference

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.

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

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.

scholarly journals Pegylated liposomal doxorubicin plus carboplatin in patients with metastatic breast cancer: a phase II study

2012 ◽  
Vol 23 (10) ◽  
pp. 2599-2605 ◽  
Author(s):  
R.P. Collea ◽  
F.W. Kruter ◽  
J.E. Cantrell ◽  
T.K. George ◽  
S. Kruger ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Phase Ii ◽  
Liposomal Doxorubicin ◽  
Phase Ii Study ◽  
Metastatic Breast ◽  
Pegylated Liposomal Doxorubicin

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

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.

A phase 1b study of chemoimmunotherapy with pegylated liposomal doxorubicin and pembrolizumab in estrogen receptor-positive, endocrine-resistant breast cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 1049-1049
Author(s):  
Alberto A. Gabizon ◽  
Nathan Cherny ◽  
Rut Isacson ◽  
Areen Abu Remilah ◽  
Alberto Gabizon ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Estrogen Receptor ◽  
Liposomal Doxorubicin ◽  
Safety Information ◽  
Metastatic Breast ◽  
Pegylated Liposomal Doxorubicin ◽  
Skin Toxicity ◽  
Pharmacokinetic Analysis ◽  
Estrogen Receptor Positive ◽  
Phase 1B

1049 Background: This is a single center phase 1b study of a regimen of pembrolizumab (PBZ) and pegylated liposomal doxorubicin (PLD) in endocrine-resistant breast cancer. PLD was chosen as chemotherapy component because it is mildly myelosuppressive and non-immunosuppressive and contains doxorubicin, a strong immunogenic cell death inducer. Methods: Patients with estrogen receptor positive, HER2 negative, metastatic breast cancer, whose disease progressed on hormonal and biological therapy and up to 2 chemotherapy lines were eligible for enrollment. PLD, 30 mg/m2, and PBZ, 200 mg flat dose, were infused on day 1 of every 3-week cycles. The main study objectives were safe dose clearance, characterization of dose-limiting toxicities (DLT), tumor response, and pharmacokinetic analysis of PLD and PBZ during the first 3 cycles of treatment in a 1st cohort of 6 patients and a 2nd confirmatory cohort of 6-9 patients. Patients with partial response (PR) or stable disease (SD) continued on the extended phase of the study consisting of 9 additional cycles during which further safety information was collected. All patients were followed-up for survival. Results: 12 patients were recruited (median age 61 y, range 45-91). 9 patients had received prior doxorubicin treatment. 82 treatments have been administered (median: 7, range 2-13). Overall, treatment was well tolerated. DLT including infusion reactions, grade ≥2 myelosuppression, hair loss and mucocutaneous toxicity were not observed in the first 3 cycles. Subsequently, skin toxicity (grade 2-3 palmar-plantar erythema) was observed forcing treatment delays of 1-2 weeks. Except for 2 cases of subclinical hypothyroidism, there were no other apparent PBZ-related side-effects. There was no evidence of cardiac toxicity. There were 2 early deaths (days 25 and 45) probably related to disease progression. Upon reevaluation on week 9, we observed: 2 patients with PD, 4 with SD, 2 with PR (15+ and 5+ mth), 1 with no measurable disease, and 1 early to evaluate. Three out of 5 patients responded well to post-study chemotherapy with durable improvement or stabilization (range, 5 to 11+ mth). Median follow-up is 14 mth. Median survival has not been reached with 4 deaths and a longest survivor of 19+ mth. Median progression-free survival is 6.0 mth. The clearance of PLD was slow with high Cmax, long T½ and small Vd. There was a significant increase in the AUC of PLD between the 1st and 3rd cycle (median: 2,649 vs 3,422 mg*h/l, p = 0.039). Analysis of PBZ plasma levels is ongoing. Conclusions: The combination of PLD and PBZ is well tolerated and feasible for extended treatment. Dose interval of PLD should be lengthened to 4 weeks after 2-3 cycles to prevent skin toxicity. The late appearance of skin toxicity is probably related to a delay in PLD clearance after 2 treatment cycles with PLD and PBZ. Clinical trial information: NCT03591276 .

scholarly journals Trastuzumab Emtansine Plus Non-Pegylated Liposomal Doxorubicin in HER2-Positive Metastatic Breast Cancer (Thelma): A Single-Arm, Multicenter, Phase Ib Trial

Cancers ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 3509
Author(s):  
Elena López-Miranda ◽  
José Manuel Pérez-García ◽  
Serena Di Cosimo ◽  
Etienne Brain ◽  
Maja Ravnik ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Liposomal Doxorubicin ◽  
Metastatic Breast ◽  
Pegylated Liposomal Doxorubicin ◽  
Maximum Tolerated Dose ◽  
Trastuzumab Emtansine ◽  
Her2 Positive ◽  
Open Label ◽  
Phase Ib

The paper assesses the dose-limiting toxicities and the maximum tolerated dose (MTD) of trastuzumab emtansine (T-DM1) combined with non-pegylated liposomal doxorubicin (NPLD) in HER2-positive (HER2+) metastatic breast cancer (MBC). This single-arm, open-label, phase Ib trial (NCT02562378) enrolled anthracycline-naïve HER2+ MBC patients who had progressed on trastuzumab and taxanes. Patients received a maximum of 6 cycles of NPLD intravenously (IV) at various dose levels (45, 50, and 60 mg/m2) in the “3 plus 3” dose-escalation part. During expansion, they received 60 mg/m2 of NPLD every 3 weeks (Q3W) plus standard doses of T-DM1. The MTD was T-DM1 3.6 mg/kg plus NPLD 60 mg/m2 administered IV Q3W. No clinically relevant worsening of cardiac function was observed. Among all evaluable patients, the overall response rate was 40.0% (95%CI, 16.3–67.7) with a median duration of response of 6.9 months (95%CI, 4.8–9.1). Clinical benefit rate was 66.7% (95%CI, 38.4–88.2) and median progression-free survival was 7.2 months (95%CI, 4.5–9.6). No significant influence of NPLD on T-DM1 pharmacokinetics was observed. The addition of NPLD to T-DM1 is feasible but does not seem to improve the antitumor efficacy of T-DM1 in HER2+ MBC patients.

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