Docetaxel plus oblimersen sodium (Bcl-2 antisense oligonucleotide): an EORTC multicenter, randomized phase II study in patients with castration-resistant prostate cancer
| Autor: | C N, Sternberg, H, Dumez, H, Van Poppel, I, Skoneczna, A, Sella, G, Daugaard, T, Gil, J, Graham, P, Carpentier, F, Calabro, L, Collette, D, Lacombe, F, Calais-da-Silva |
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| Přispěvatelé: | CCA -Cancer Center Amsterdam, Urology |
| Rok vydání: | 2009 |
| Předmět: |
Male
Oncology medicine.medical_specialty medicine.medical_treatment Phases of clinical research Docetaxel urologic and male genital diseases Drug Administration Schedule Prostate cancer Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Mucositis Humans Castration Infusions Intravenous neoplasms Aged Aged 80 and over Mitoxantrone Chemotherapy Dose-Response Relationship Drug business.industry organic chemicals Oblimersen Prostatic Neoplasms Hematology Middle Aged Prostate-Specific Antigen Thionucleotides medicine.disease Surgery Prostate-specific antigen Treatment Outcome Taxoids business therapeutics medicine.drug |
| Zdroj: | Annals of oncology, 20(7), 1264-1269. Oxford University Press |
| ISSN: | 0923-7534 |
| DOI: | 10.1093/annonc/mdn784 |
| Popis: | 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.Chemotherapy-naive patients with prostate-specific antigen (PSA) progression and testosteroneor = 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 foror = 12 cycles. Primary end points were confirmed PSA response (Bubley criteria) and major toxic events.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 gradeor = 3 fatigue, mucositis, and thrombocytopenia. Major toxic events were reported in 22.8% and 40.7% of patients with docetaxel and docetaxel-oblimersen, respectively.The primary end points of the study were not met: a rate of confirmed PSA response30% and a major toxic event rate45% were not observed with docetaxel-oblimersen. |
| Databáze: | OpenAIRE |
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