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 |
| [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 |
| No. = number; wk = week. | ||||||
| aSee text and the NCI Dictionary of Cancer Terms for additional information and definition of terms. | ||||||
| bNumber 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 studied AND for whom results were reported; historical control subjects are not included in number of patients enrolled. | ||||||
| cThe strongest evidence reported that the treatment under study has anticancer activity or otherwise improves the well-being of cancer patients. | ||||||
| dChemotherapy, radiation therapy, hormonal therapy, or cytokine therapy given/allowed at the same time as vaccine therapy. | ||||||
| eFor information about levels of evidence analysis and an explanation of the level of evidence scores, see Levels of Evidence for Human Studies of Cancer Complementary and Alternative Medicine. | ||||||
| fOnly 48 patients were treated with NDV-infected tumor cell vaccines; the remaining patients were treated with another type of vaccine. | ||||||
| gThe 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. | ||||||
| hThere were 39 evaluable patients in this study, but findings were reported for only 24 patients. | ||||||
| iArticle does not provide enough information. |
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