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Clin Cancer Res. 2010 Nov 15;16(22):5564-72. doi: 10.1158/1078-0432.CCR-10-1233. Epub 2010 Oct 6.

REO-10: a phase I study of intravenous reovirus and docetaxel in patients with advanced cancer.

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  • 1Oncology, Postgraduate Medical School, University of Surrey, Daphne Jackson Road, Manor Park, Guildford, Surrey, United Kingdom.

Abstract

PURPOSE:

REOLYSIN (Oncolytics Biotech) consists of a wild-type oncolytic reovirus, which has selective cytotoxicity for tumor cells while sparing normal cells. In a phase I study as a single agent, repeated infusions of reovirus were safe with evidence of antitumor activity. Preclinical studies indicate potential for synergy between reovirus and chemotherapeutic agents. A multicenter, phase I dose escalation study was designed to assess the safety of combining reovirus with docetaxel chemotherapy in patients with advanced cancer.

EXPERIMENTAL DESIGN:

Patients received 75 mg/m(2) docetaxel (day 1) and escalating doses of reovirus up to 3 × 10(10) TCID(50) (days 1-5) every 3 weeks.

RESULTS:

Twenty-five patients were enrolled, and 24 patients were exposed to treatment, with 23 completing at least one cycle and 16 suitable for response assessment. Dose-limiting toxicity of grade 4 neutropenia was seen in one patient, but the maximum tolerated dose was not reached. Antitumor activity was seen with one complete response and three partial responses. A disease control rate (combined complete response, partial response, and stable disease) of 88% was observed. Immunohistochemical analysis of reovirus protein expression was observed in posttreatment tumor biopsies from three patients.

CONCLUSION:

The combination of reovirus and docetaxel is safe, with evidence of objective disease response, and warrants further evaluation in a phase II study at a recommended schedule of docetaxel (75 mg/m(2), three times weekly) and reovirus (3 × 10(10) TCID(50), days 1-5, every 3 weeks).

PMID:
20926400
[PubMed - indexed for MEDLINE]
PMCID:
PMC3934355
Free PMC Article
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