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Annals of Oncology Advance Access originally published online on March 17, 2009
Annals of Oncology 2009 20(7):1264-1269; doi:10.1093/annonc/mdn784
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© The Author 2009. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

urogenital tumors

Docetaxel plus oblimersen sodium (Bcl-2 antisense oligonucleotide): an EORTC multicenter, randomized phase II study in patients with castration-resistant prostate cancer

C. N. Sternberg1,*, H. Dumez2, H. Van Poppel3, I. Skoneczna4, A. Sella5, G. Daugaard6, T. Gil7, J. Graham8, P. Carpentier9, F. Calabro1, L. Collette10, D. Lacombe10 and for the EORTC Genitourinary Tract Cancer Group

1 Department of Medical Oncology, San Camillo and Forlanini Hospitals, Rome, Italy
2 Department of Oncology
3 Department of Urology, Universitair Ziekenhuis Gasthuisberg, Leuven, Belgium
4 Chemotherapy Unit, Department of Urology, Maria Sklodowska–Curie Memorial Cancer Centre, Warsaw, Poland
5 Department of Oncology, Assaf Harofeh Medical Center, Zerifin, Israel
6 Department of Oncology, Rigshospitalet, Copenhagen, Denmark
7 Department of Chemotherapy, Institut Jules Bordet, Brussels, Belgium
8 Beatson West of Scotland Cancer Centre, Gartnavel General Hospital, Glasgow, UK
9 Department of Urology, Onze Lieve Vrouw Ziekenhuis, Aalst, Belgium
10 EORTC Headquarters, Brussels, Belgium

* Correspondence to: Dr C. N. Sternberg, Department of Medical Oncology, San Camillo and Forlanini Hospitals, Nuovi Padiglioni, 4th Floor, Circonvallazione Gianicolense 87, 00152 Rome, Italy. Tel: +39 06 58704356; Fax: +39 06 6630771; E-mail: cstern{at}mclink.it

Background: This randomized, phase II study assessed the activity of oblimersen sodium, a Bcl-2 antisense oligonucleotide, administered before docetaxel (Taxotere) to patients with castration-resistant prostate cancer.

Patients and methods: Chemotherapy-naive patients with prostate-specific antigen (PSA) progression and testosterone ≤0.5 ng/ml received docetaxel 75 mg/m2 on day 1 or oblimersen 7 mg/kg/day continuous i.v. infusion on days 1–7 with docetaxel 75 mg/m2 on day 5 every 3 weeks for ≤12 cycles. Primary end points were confirmed PSA response (Bubley criteria) and major toxic events.

Results: Confirmed PSA response was observed in 46% and 37% of 57 and 54 patients treated with docetaxel and docetaxel–oblimersen, respectively. Partial response (RECIST) was achieved in 18% and 24%, respectively. Oblimersen added to docetaxel was associated with an increase in the incidence of grade ≥3 fatigue, mucositis, and thrombocytopenia. Major toxic events were reported in 22.8% and 40.7% of patients with docetaxel and docetaxel–oblimersen, respectively.

Conclusions: The primary end points of the study were not met: a rate of confirmed PSA response >30% and a major toxic event rate <45% were not observed with docetaxel–oblimersen.

Key words: chemotherapy, castration-resistant prostate cancer, docetaxel, oblimersen sodium, phase II clinical trial, targeted therapy

Received for publication September 11, 2008. Revision received December 3, 2008. Accepted for publication December 15, 2008.


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