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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 StudyType of CancerNo. of Patients: Enrolled; Treated; ControlbStrongest Benefit ReportedcConcurrent TherapydLevel 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)Melanoma29; 21; 8No advantage of vaccine for disease free survival or overall survivalNone1iA
[29]Phase III (adjuvant setting)Colorectal with liver metastases51; 25; 26Planned subgroup analysis, overall and disease free survival advantages in the colon of cancer patientsProtocol therapy was given after complete surgical resection of primary tumor and liver metastases1iiA
[31]Phase IIGlioblastoma35; 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 therapy2A
[15,22]Phase II trialMetastatic colorectal23; 23; Historical controlsImproved disease-free survivalNo3iiA
[23]Phase II trialOvarian82; 24h; NoneImproved disease-free survivalYes3iiDi
[16]Phase II trialAdvanced colorectal57; 48f; Historical controlsImproved overall survivalNo3iiiA
[17]Retrospective analysisEarly breast63; 63; Internal controlsgImproved overall survivalYes3iiiA
[21]Phase II trialMetastatic renal cell40; 40; Historical controlsImproved overall survival, 11 patients with complete/partial responsesYes3iiiA
[19]Phase II trialVarious advanced43; 31; NoneComplete tumor response, 1 patientYes3iiiDiii
[33]Phase IIGastrointestinal tumors, stage IV25; 25; 01 Complete response, 5 partial responses, overall response rate = 24%None described3iiiDiii
[33]Phase IIIColorectal567; 310; 257Higher mean and median survival for vaccination group compared to the resection group aloneNone describedNone describedi
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