Abstract

3212 Background: Trastuzumab (T) and vinorelbine (V) combination has previously shown as a interesting regimen for Her-2 positive metastatic breast cancer (mbc) patients(pts). It is retrospective analysis of the efficacy and safety T/V combination in Her-2 positive mbc treated in two polish centers. Methods: Between February 2002 and May 2004, 45 women were treated with weekly combination of T and V. Median age 50 (range 35–73), median of metastatic sites 2, median of visceral metastases -1. In all pts overexpression Her-2 3+ (39) or FISH positive (6) were confirmed. 14 pts had not received any chemotherapy for metastatic disease (subgroup A), 12 pts were previously treated by 1 line of chemotherapy for mbc (subgroup B), 19 pts by 2 or more line of chth (subgroupC). In 18pts antracycline because of mbc were used. In 24 cases V was administrated as first combination with T, in 21 as second or third (after combination of docetaxel or cisplatin).T and V were administrated weekly (V-30mg/m2 in 19 pts, 25mg/m2 - 26 pts). Pts were assessed for toxicites and reassessed for response every 8 weeks until progression. Results: The overall response was obtained in 17 pts (38%): in subgroup A-5pts, B-4pts, C-8pts. Median time of treatment duration in responders was 23 weeks. There was no significant differences of results in subroups A,B,C. SD was observed in 22pts. We noted 2 cases of PD during treatment. In the median follow-up 29 weeks (r 2–119) PD was noted in22 pts with mTTP 20 weeks (r 3–111).15pts are still receiving treatment. The regimen was well tolerated. WHO 3–4 grade(G) neutropenia was observed in 17 pts (with 2 cases of infections G3), G3 anaemia in 1pt. There was one case of severe cardiotoxicity in our group -congestive heart failure G3 after 9 weeks therapy, required end of treatment with Herceptin. Toxicites (main hematologic) required vinorelbine dose reduction from 30mg/m2 to 25mg/m2 in 89 cycles (11%) and from 25mg/m2 to 20mg/m2 in 48 cycles (6%).There were 71cycles (9%) of V omitted from 823 planed. Conclusions: This analysis confirm that combination of vinorelbine and trastuzumab is active and well tolerated regimen in Her-2 positive mbc pts, even pretreated by one or more line systemic therapy. No significant financial relationships to disclose.

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