10720 Background: Trastuzumab provides significant clinical benefit in HER2 positive metastatic breast cancer. Gemcitabine and cisplatin (GC) combination is attractive treatment options for anthracyclines-taxanes-pretreated metastatic breast cancer. These agents demonstrated synergistic activity and minimal overlapping toxicity. On the other hand, additional synergistic activity was observed with trastuzumab and GC. Methods: Histologically confirmed metastatic breast cancer patients with FISH positive tumors (HER2/choromosome 17 ≥2) were eligible if they were at least one measurable disease; ≥18 and ≤70 years; life expectancy >3 month; ECOG 0–2; prior anthracyclines and taxanes treatment but no prior trastuzumab therapy; adequate marrow, renal and hepatic function. Treatment schedule was as follows: Gemcitabine 1000 mg/m2 and cisplatin 30 mg/m2 d1, 8 every 3 weeks conjunction with trastuzumab 4 mg/kg d1 and 2 mg/kg for weekly. Chemotherapy was scheduled for up to eight cycles. Treatment was discontinued in case of progression or prohibitive toxicity. After progression additional regimen was administered with trastuzumab. Results: Eleven women were enrolled. All patients were eligible for toxicity and efficacy evaluations. Median age was 48 (range 28–64) years and median ECOG performance status was 0. Ten patients (90.9%) had visceral metastases, most commonly located in the liver (8 pts) and lung (4 pts). Estrogen receptor positivity was 63.6% (7 pts). A total of 80 cycles were delivered with a median of 8 cycles. Objective response rate was 54.5% (6 pts) with 27.2% (3 pts) complete response and 27.2% (3 pts) partial response. Stabile disease was achieved 36.3% (4 pts). Median time to progression and overall survival were 8 (95% CI: 3.97–12.02) and 18 months (95% CI: 15.89–20.10) respectively. Grade 3–4 toxicity was observed in 18.1% (2 pts). Treatment of one patient was discontinued due to grade 4 thrombocytopenia. Dose reductions due to myelotoxicity were performed in 1 (9.0%) patients. Conclusions: Our preliminary data shows that gemcitabine and cisplatin and trastuzumab combination regimen is effective and has manageable toxicity profile. No significant financial relationships to disclose.
Real‐life activity of eribulin mesylate among metastatic breast cancer patients in the multicenter national observational ESME program
