期刊
CLINICAL CANCER RESEARCH
卷 12, 期 11, 页码 3394-3401出版社
AMER ASSOC CANCER RESEARCH
DOI: 10.1158/1078-0432.CCR-06-0145
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- NCI NIH HHS [CA58236] Funding Source: Medline
Purpose: To determine the toxicity, immunologic, and clinical activity of immunotherapy with irradiated, allogeneic, prostate cancer cells expressing granulocyte macrophage colony-stimulating factor (GM-CSF) in patients with recurrent prostate cancer. Patients and Methods: A single-institution phase I/II trial was done in hormone therapy - naive patients with prostate-specific antigen (PSA) relapse following radical prostatectomy and absence of radiologic metastases. Treatments were administered weekly via intradermal injections of 1.2 x 10(8) GM-CSF gene - transduced, irradiated, cancer cells (6 X 10(7) LNCa P cells and 6 x 10(7) PC-3 cells) for 8 weeks. Results: Twenty-one patients were enrolled and treated. Toxicities included local injection-site reactions, pruritus, and flu-like symptoms. One patient had a partial PSA response of 7-month duration. At 20 weeks post first treatment, 16 of 21 (76%) patients showed a statistically significant decrease in PSA velocity (slope) compared with prevaccination (P < 0.001). Injection site biopsies showed intradermal infiltrates consisting of CD1a(+) dendritic cells and CD68(+) macrophages, similar to previous clinical trials using autologous GM-CSF-transduced cancer cells. Post-treatment, patients developed new oligoclonal antibodies reactive against at least five identified antigens present in LNCa P or PC-3 cells. A high-titer antibody response against a 250-kDa antigen expressed on normal prostate epithelial cells was induced in a patient with partial PSA remission; titers of this antibody decreased when treatment ended, and subsequent PSA relapse occurred. Conclusions: This non-patient-specific prostate cancer immunotherapy has a favorable safety profile and is immunologically active. Continued clinical investigation at higher doses and with longer boosting schedules is warranted.
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