Skip to main content
. 2017 Dec 16;2017(12):CD011300. doi: 10.1002/14651858.CD011300.pub2
Methods Chinese RCT
Participants Number of participants: 157 (June 2010 to June 2013) Number randomised: Experimental group (GP regimen + DC‑CIK cell immunotherapy): 79 Control group (GP regimen therapy): 78 Number evaluated: Experimental group: 79, average age: 59.6 ± 10.7 years Control group: 78, average age: 58.2 ± 11.2 years Diagnosis: stage Ⅲ NSCLC that had received complete surgery resection Inclusion: eligible patients:
i) Patients were pathologically diagnosed with adenocarcinoma, squamous cell carcinoma or adenosquamous‑mixed NSCLC; ii) patients were at stage ⅢA according to the International Union Against Cancer NSCLC criteria; iii) patients were aged 30 to 78 years; iv) patients exhibited heart symptoms; v) Karnofsky performance status score of the patients was > 60 points; and vi) patients provided a signed informed consent sheet.
Interventions Experimental group: GP chemotherapy and DC‑CIK cell immunotherapy Control group: Gemcitabine (1,000 mg/m²) intravenously infused at Day 1 and Day 8 + 30 mg/m² cisplatin intravenously injected at Days 1 to 3. The treatment cycle was 21 days and each participant underwent four cycles of treatment
Outcomes Duration of follow‐up:The two groups both were followed up for 36 months
postoperative cellular immune function, disease‑free survival time, cumulative recurrence rate and cumulative survival rate were analysed
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not described
Allocation concealment (selection bias) Unclear risk Not described
Blinding of participants and personnel (performance bias) All outcomes High risk Open‐label design
Blinding of outcome assessment (detection bias) All outcomes Unclear risk Not described
Incomplete outcome data (attrition bias) All outcomes Low risk 157 randomised participants were included in analysis (100%)
Selective reporting (reporting bias) High risk Prior protocol was unavailable, and no pre‐specified primary outcome was reported.
Other bias High risk Suvival rates in abstract, full text, and figures were different from each other