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• W2588762735 abstract "Background: The combination of Trastuzumab (T) and Vinorelbina (VRL) is wildly administered in metastatic HER2 + ve breast cancer. This combination is associated to a high incidence of grade 3-4 neutropenia compared to taxane-based treatment. Recent data demonstrated that scT is not-inferior to ivT in terms of efficacy, with a similar pharmacokinetic and safety profile. In a previous study (VICTOR-1), we tested the metronomic administration (low-dose, continuing schedule) of VRL, demonstrating an incidence of grade 3-4 toxicities below 5%. The easier schedule of mVRL, together with the preference for scT by pts, suggest the possibility to combine these two schedules in HER2+ pts. Here we present the preliminary results of toxicity in an unselected group of HER2+ pts, as a pivotal experience for a Phase II study. Materials and methods: HER2+ ABC pts were treated with VRL 40 mg thrice a week continuously + scT 600 mg fixed dose every 3 weeks, until progression or unacceptable toxicity. Drug-related toxicity was collected at the beginning of each scT administration. Tumor radiological assessment has been planned every 3 cycles (1 cycle = 3 weeks), according to the clinical practice. Results: From August 2014 to March 2016, 10 pts entered this pivotalstudy. At the moment of the present analysis, a total of 93 cycles are evaluable for toxicity. Median age of the pts was 69 years; 9 pts have been previously treated with taxanes; 2 patients received mVRL + scT as 1stline,4 pts as 2nd, 2 pts as 3rd and 2 pts as 4th line of treatment. Table 1 summarizes the incidence of side effects. Grade 3 toxicity was observed in 3.2% of the cycles; no Grade 4 toxicity has been reported. Results regarding efficacy are too early at the moment to be presented. Conclusion: In this pilot evaluation, scT and mVRL combination seems to be feasible with a low incidence of toxicity, in comparison to what observed in the TRAVIOTA Trial. Further evaluation of a greater number of cycles is needed to confirm these preliminary results.Table: F44G1G2G3G4Nausea1310Diarrhoea2000Vomiting0100Abdominal pain1000Myalgia1100Neuropathy2000Neutropenia0310Asthenia2010Total9830 Open table in a new tab" @default.
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• W2588762735 date "2016-09-01" @default.
• W2588762735 modified "2023-09-26" @default.
• W2588762735 title "Subcutaneous Trastuzumab (scT) and metronomic oral Vinorelbine (mVRL) combination in HER2 + ve advanced breast cancer (ABC) patients (pts): a pilot evaluation of toxicity. Preliminary results of the VICTOR-4 study" @default.
• W2588762735 doi "https://doi.org/10.1093/annonc/mdw337.44" @default.
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