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- W2267994711 abstract "813 Background: PLD and G have recently demonstrated a clinical efficacy in MBC in mono-chemotherapy. We conducted a phase II clinical trial to determine the activity and safety of the two drugs in combination either in untreated or previously treated metastatic breast cancer women. Patients (pts) received PLD 25 mg/m2 i.v on day 1 plus G 800 mg/m2 i.v. on day 1 and 8 of each 21-day cycle. Methods: Twenty-eight pts were entered into the study between January 2003 and December 2003. Median age: 55 years (range 33–71), median PS (WHO): 0 (0–2), predominant metastatic sites: lung (13 pts), liver (8 pts), bone (5 pts) and soft tissues (2 pts). The median number of previous chemotherapies given for metastatic disease was 1 (range 1–2). Fifteen women were chemotherapy naïve. Eleven pts (39%) were treated with anthracycline-containing regimen with a median anthacycline dose of 480 mg/m2. A median of 5 cycles were administered (range 1–8). Results: Twenty-one pts (1 early death, 6 too early) were assessable for response: 10 achieved partial response (47.6%), 5 (23.8%) stable disease, while 6 women (28.6%) experienced progressive disease. Among pretreated with anthacycline, 36% had a response. Among responders, 70% were chemotherapy naïve while 30% had previously received 1st or 2nd line chemotherapy. Median duration of response and time to progression were 6 months (range 4–9) and 5.8 months (range 1–9), respectively. Only grade 3–4 neutropenia was observed in 11 pts (39%); one case (3.5%) of febrile neutropenia occurred. Grade 3 mucositis and peripheral paresthesia were observed in 3 (11%) and 1 (3.5%) pts, respectively; one pt (3.5%) had a grade 2 hand-foot syndrome; seven pts (25 %) complained of moderate/severe asthenia. No case of cardiotoxicity or LVEF reduction was observed, even among pts previously treated with anthacyclines. Conclusions: The combination of PLD and G shows activity and a good tolerability. It seems to be no evidence of cross-resistance between classic anthracyclines and PLD. This regimen seems to be adequate even for heavily treated and elderly women. No significant financial relationships to disclose." @default.
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- W2267994711 date "2004-07-15" @default.
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- W2267994711 title "Pegylated liposomal doxorubicin (PLD) and gemcitabine (G) in metastatic breast cancer (MBC) patients: A phase II study" @default.
- W2267994711 doi "https://doi.org/10.1200/jco.2004.22.90140.813" @default.
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