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    Newcastle Disease Virus (PDQ®): Complementary and alternative medicine - Health Professional Information [NCI] - Human / Clinical Studies

    Table 3. Studies of NDV-Infected Tumor Cell Vaccines in Which Therapeutic Benefit Was Assesseda

    Reference Citation(s) Type of Study Type of Cancer No. of Patients: Enrolled; Treated; Controlb Strongest Benefit Reportedc Concurrent Therapyd Level of Evidence Scoree
    No. = number; wk = week.
    a Refer to text and theNCI Dictionary of Cancer Termsfor additional information and definition of terms.
    b Number of patients treated plus number of patients control may not equal number of patients enrolled; number of patients enrolled = number of patients initially recruited/considered by the researchers who conducted a study; number of patients treated = number of enrolled patients who were given the treatment being studiedAND for whom results were reported; historical control subjects are not included in number of patients enrolled.
    c The strongest evidence reported that the treatment under study has anticancer activity or otherwise improves the well-being of cancer patients.
    d Chemotherapy, radiation therapy, hormonal therapy, or cytokine therapy given/allowed at the same time as vaccine therapy.
    e For information about levels of evidence analysis and an explanation of the level of evidence scores, refer toLevels of Evidence for Human Studies of Cancer Complementary and Alternative Medicine.
    f Only 48 patients were treated with NDV-infected tumor cell vaccines; the remaining patients were treated with another type of vaccine.
    g The patients were divided into groups that received a high-quality vaccine or a low-quality vaccine; the low-quality vaccine groups served as the controls; 32, 13, and 18 patients with early breast cancer, metastatic breast cancer, and metastatic ovarian cancer, respectively, received high-quality vaccines; the corresponding low-quality vaccine groups contained 31,14, and 13 patients.
    h There were 39 evaluable patients in this study, but findings were reported for only 24 patients.
    i Article does not provide enough information.
    [32] Phase II/III (adjuvant setting) Melanoma 29; 21; 8 No advantage of vaccine for disease free survival or overall survival None 1iA
    [29] Phase III (adjuvant setting) Colorectal with liver metastases 51; 25; 26 Planned subgroup analysis, overall and disease free survival advantages in the colon of cancer patients Protocol therapy was given after complete surgical resection of primary tumor and liver metastases 1iiA
    [31] Phase II Glioblastoma 35; 23; 87 (concurrent controls identified from within same hospital) Median progression-free survival of vaccinated patients was 40 wk (vs. 26 wk in controls; log-rank test,P = .024), median OS of vaccinated patients was 100 wk (vs. 49 wk in controls; log-rank test,P< .001) Protocol therapy after surgical debulking of tumor followed by radiation therapy 2A
    [15,22] Phase II trial Metastatic colorectal 23; 23; Historical controls Improved disease-free survival No 3iiA
    [23] Phase II trial Ovarian 82; 24h; None Improved disease-free survival Yes 3iiDi
    [16] Phase II trial Advanced colorectal 57; 48f; Historical controls Improved overall survival No 3iiiA
    [17] Retrospective analysis Early breast 63; 63; Internal controlsg Improved overall survival Yes 3iiiA
    [21] Phase II trial Metastatic renal cell 40; 40; Historical controls Improved overall survival, 11 patients with complete/partial responses Yes 3iiiA
    [19] Phase II trial Various advanced 43; 31; None Complete tumor response, 1 patient Yes 3iiiDiii
    [33] Phase II Gastrointestinal tumors, stage IV 25; 25; 0 1 Complete response, 5 partial responses, overall response rate = 24% None described 3iiiDiii
    [33] Phase III Colorectal 567; 310; 257 Higher mean and median survival for vaccination group compared to the resection group alone None described None describedi
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