December 2, 2019Scientific ReportsOpen Access

Pegylated liposomal doxorubicin plus cyclophosphamide followed by docetaxel as neoadjuvant chemotherapy in locally advanced breast cancer (registration number: ChiCTR1900023052)

Q: What is the clinical evidence from this study?

Study design: Other. Population: Locally advanced breast cancer (n=112). Intervention: Pegylated liposomal doxorubicin plus cyclophosphamide followed by docetaxel. Primary outcome: Pathological complete response (pCR) rate in the breast (95% CI 11.5-26.0%, p=<0.001).

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Key result

Neoadjuvant chemotherapy with pegylated liposomal doxorubicin plus cyclophosphamide followed by docetaxel achieved a pathological complete response rate of 18.75% in locally advanced breast cancer.

Why the study?

Anthracyclines have significant toxicities including cardiotoxicity at higher doses, while pegylated liposomal doxorubicin offers equivalent efficacy with lower cardiotoxicity.

Does neoadjuvant pegylated liposomal doxorubicin plus cyclophosphamide followed by docetaxel improve pathological complete response in locally advanced breast cancer?

Population

Patients with locally advanced breast cancer

Comparison

PEG-LD plus cyclophosphamide followed by docetaxel

Design

Open-label multicenter single-armed trial

Authors

RLRuoyang LiHebei Medical University FTFuguo TianShanxi Provincial Cancer Hospital YQYixin QiQingdao University

Discussion

Member takes

Implication

Does not warrant practice change; leaves open comparative efficacy versus standard regimens in randomized trials.

Structured PICO

Does neoadjuvant pegylated liposomal doxorubicin plus cyclophosphamide followed by docetaxel improve pathological complete response in locally advanced breast cancer?

Population

112 patients with untreated, histologically confirmed locally advanced breast cancer (stages II-III), median age 47. Key inclusion criteria: age 18-70 years, ECOG performance status 0-2, LVEF >50%, and normal organ function.

Intervention

Neoadjuvant chemotherapy consisting of 4 cycles of pegylated liposomal doxorubicin (PEG-LD) 40 mg/m2 plus cyclophosphamide 600 mg/m2 on day 1 of a 21-day schedule, followed by 4 cycles of docetaxel 85 mg/m2 on day 1 of a 21-day schedule. Trastuzumab was added for HER2-amplified patients if willing.

Outcome

Pathological complete response rate (pCR) in the breastsurrogate

Main Result

p-value: p=<0.001

Neoadjuvant pegylated liposomal doxorubicin plus cyclophosphamide followed by docetaxel achieved an 18.75% pathological complete response rate with no significant cardiotoxicity in locally advanced breast cancer.

Limitations

Single-armed study without a randomized control group
Not strictly designed to assess breast pCR of different molecular subtypes
Slightly higher drop-out rate than anticipated
Lack of a randomized control group

Cite This Study

Li et al. (2019) studied Locally advanced breast cancer (n=112). Pegylated liposomal doxorubicin plus cyclophosphamide followed by docetaxel was evaluated on Pathological complete response (pCR) rate in the breast (95% CI 11.5-26.0%, p=<0.001). Neoadjuvant chemotherapy with pegylated liposomal doxorubicin plus cyclophosphamide followed by docetaxel achieved a pathological complete response rate of 18.75% in locally advanced breast cancer.

synapsesocial.com/papers/6a14e36d253bd9cd3ce626ff https://doi.org/10.1038/s41598-019-54387-5

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Pegylated liposomal doxorubicin plus cyclophosphamide followed by docetaxel as neoadjuvant chemotherapy in locally advanced breast cancer (registration number: ChiCTR1900023052)

Discussion

Member takes

Implication

Structured PICO

Main Result

Limitations

Cite This Study

Pegylated liposomal doxorubicin plus cyclophosphamide followed by docetaxel as neoadjuvant chemotherapy in locally advanced breast cancer (registration number: ChiCTR1900023052)

Discussion

Member takes

Implication

Structured PICO

Main Result

Limitations

Cite This Study

Also Consider

Also Consider