Combination of pegylated liposomal doxorubicin and docetaxel as neoadjuvant therapy for breast cancer with axillary lymph node metastasis

Wang, Li; Hong, Yang; Ma, Jie; Han, Meng; Zhang, Shuo; Shan, Baoen; Liu, Yunjiang

doi:10.1177/0300060520944310

Cited by 3 publications

(2 citation statements)

References 33 publications

(130 reference statements)

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“…In this trial, PLD had a favourable safety profile, comparable to the one previously reported in other studies [ 15 , 16 , 17 , 18 , 19 , 20 , 21 ]. In particular, in a phase II preoperative trial, treatment with PLD 20 mg/m 2 given biweekly for eight courses in combination with metronomic cyclophosphamide 50 mg/day orally was well tolerated, with no grade 4 toxicities and with grade 3 skin toxicity in three patients and hand-foot syndrome in four patients [ 20 ].…”

Section: Discussionsupporting

confidence: 87%

“…Furthermore, PLD has been shown to be effective and well tolerated as neoadjuvant CT for patients with locally advanced breast cancer [ 13 , 14 ]. Studies that used a combination of PLD with other agents (e.g., taxanes, gemcitabine, cisplatin, and fluorouracil) obtained a clinical response rate that ranged from 71% to 89% [ 15 , 16 , 17 , 18 , 19 ]. In a phase II trial, in 29 patients with locally advanced breast cancer who were not suitable to receive a standard chemotherapy due to age or comorbidities or who asked for a regimen with low incidence of toxic effects irrespective of age, PLD 20 mg/m 2 biweekly for eight courses was combined with oral metronomic cyclophosphamide 50 mg/day.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2021

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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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