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Phase II multicenter trial of anthracycline rechallenge with pegylated liposomal doxorubicin plus cyclophosphamide for first-line therapy of metastatic breast cancer previously treated with adjuvant anthracyclines
Journal of Clinical Oncology, 10/30/09

Trudeau ME et al. – Anthracyclines are a component of breast cancer chemotherapy regimens in both adjuvant and metastatic settings. Anthracycline rechallenge for metastatic disease, for those previously exposed to adjuvant anthracyclines, may not be considered because of concerns about efficacy, tolerability, and cumulative cardiotoxicity. PLD plus cyclophosphamide is effective and well tolerated in patients with metastatic breast cancer who have received prior adjuvant anthracycline-containing chemotherapy. The majority of patients experienced a clinical benefit without any significant impact on cardiac function

Methods

Prospective, multicenter, single-arm, phase II trial
Examined efficacy and safety of pegylated liposomal doxorubicin (PLD) 35 mg/m2 plus cyclophosphamide 600 mg/m2 as first-line therapy
Delivered every 3 weeks, in 70 patients who developed metastatic disease more than 12 months after completion of an adjuvant anthracycline-containing regimen
7 patients discontinued treatment early and excluded from efficacy analysis

Results

After median of 6 cycles, objective response rate was 38%
Additional 33% of patients achieved stable disease lasting more than 6 months
Overall clinical benefit rate 71%
Estimated median time to progression 12.2 mos
Clinical response was equally robust in patients with and without prior taxane exposure
Treatment well tolerated
Most common grade 3 to 4 toxicities palmar-plantar erythrodysesthesia , dyspnea , and neutropenia
1 of 70 patients discontinued treatment as result of PPE
No symptomatic cardiac events observed