Thomas Goehler

A multicentric observational trial of pegylated liposomal doxorubicin for metastatic breast cancer

BackgroundPegylated liposomal doxorubicin (PLD) is active in metastatic breast cancer. This observational study evaluated the efficacy and safety of PLD in patients treated during routine clinical practice.MethodsEligible patients had metastatic breast cancer and were treated with PLD according to the dose and schedule determined by their physician as part of routine practice. The primary objectives were to analyze the efficacy and toxicity of PLD therapy.Results125 patients were assessable. Median age was 62 years, 78% had performance status 0-1, and 60% had estrogen-receptor-positive disease. PLD treatment was second- or third-line in 69% of patients. Prior anthracyclines (adjuvant or metastatic) had been used in 56% of patients. The majority of patients (79%) received PLD every 4 weeks at a median dose of 40 mg/m2. Overall response rate was 43% in all patients and 34% in those previously treated with anthracyclines. The most common grade 3/4 adverse events were skin toxicity/hand-foot syndrome (6%), and leukopenia (3%).ConclusionsThis observational study supports the activity and tolerability of PLD in metastatic breast cancer as demonstrated in PLD clinical trials.

Impact of prophylactic treatments of cetuximab-based skin reactions in patients with metastatic colorectal carcinoma (mCRC): Interim analysis of the German noninterventional study ERBITAG.

675 Background: Prophylactic treatments are widely used to ameliorate skin reactions induced by EGFR inhibition. Randomised studies have shown a positive impact of prophylactic antibiotics. Methods: Patients (Pts) with KRAS-wt and later RAS-wt mCRC treated with a first-line chemotherapy regimen plus cetuximab with written informed consent were eligible for this prospective, non-interventional study. Physicians were requested to complete a questionnaire and document any applied prophylactic and reactive skin toxicity treatment for every pt. Different prophylactic treatment regimens were categorized in 5 groups: systemic antibiotics (SA), skin care without antibiotics or corticosteroids (SC), other topical treatments (OT) (e.g. antibiotics or corticosteroids), any prophylaxis (P), and no prophylaxis (NP). Results: Data from 497 pts at 178 centers were finally collected and evaluable at data cut off. For all reported skin reactions the maximum NCI-CTCAE grade per patient and prophylactic treatment group was ...