Abstract
699 Background: At present, there are no predictive markers for different types/scheduling of cytotoxic agents. We have recently shown 5 putative biomarkers dicriminating patients with ER and PgR positive breast cancer with relapses from relapse-free after adjuvant tamoxifen using proteomics with SELDI (ASCO 2004). Aims: The primary objectives were to determine protein profiles discriminating between effect /no effect of weekly paclitaxel measured as objective response (OR), response duration (RD) and time to progression (TTP). Material and Methods: Patients with a documented metastatic BC ≥18 years, ECOG performance status 0–2, life expectance > 3 months, and with a written signed informed consent were accepted for inclusion. Prior treatment with chemotherapy was not required. Patients should have an adequate haematologic function: WBC> 2.5 x 109, platelets > 100 x 109, haemoglobin>100 (post-transfusion allowed), and a normal hepatic and cardiac function. Paclitaxel was given weekly for three weeks followed by one treatment free week (1 course). The study design was approved by the ethical committee of the Karolinska Institute. Protein expression profiles were determined by use of Surface Enhanced Laser Desorption /Ionisation (SELDI) technology. Samples were run in duplicate (2 different ProteinChip arrays); cation exchange ProteinChip array pH 5.0 and anion exchange ProteinChip array pH 5.0, low and high intensity runs. Results: A total of 46 patients age 32 to 79 years, were included from 26 November 2001 through 30 June 2003 at five centres in Sweden. Eleven patients were not evaluable (did not receive the first course (n=1), off-study before first evaluation due to clinical progress (n=7), other disease (n=1) or toxicity (n=2). Preliminary results show an overall response rate (ORR) including stable disease > 24 weeks in 19 of 35 patients (45%). One patient is still on therapy after 33 courses. Results on key-proteins by proteomics discriminating between effect/no effect of therapy will be presented. No significant financial relationships to disclose.
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