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. 2013 May 7;8(5):e62847. doi: 10.1371/journal.pone.0062847

Table 1. Characteristics of included studies.

Reference Methods Patients Interventions Outcomes Phenotypic characteristics of infusion cells
Eligibility Control arm ACI arm
Osband ME, 1990 RCT; stratifiedby ECOG PS mRCC with measurable disease; PS (ECOG) 0∼2; suitable haematological indices (packed cell volume>25%, platelet count<500000/µl, and WBC>3000/µl); and no therapy for at least 6 weeks N = 45; medianage 63 years; PS (0)58%; male 69% N = 45; median age 64 years;PS (0) 60%;male 69% (1) 600 mg oral cimetidine (four times daily) with, or (2) without, autolymphocyte therapy i.v. approximately 109 cells/month for 6 months Adverse events; Tumor response; Survival CD3+ (49.6%); CD4+ (45.6%); CD8+ (18.4%)
Law TM, 1995 Multicenter RCT; stratified by center mRCC with measurable disease; age 18∼70 years; anticipated survival>16 weeks; karnofsky PS≥80%; SCr≤2.0 mg/dl; SGOT≤150 IU or 4×ULN; SB≤1.6 mg/dl; PTT≤1.5 times control; PT≤1.5 times control; hemoglobin≥10.0 g/dl; AGC≥1500/mm3; platelet count≥100000/mm3; serum calcium≤12.0 mg/dl; the signing of ICF; absence of brain metastasis or underlying seizure disorder; no history or evidence of significant cardiac dysfunction; no evidence of clinically significant pulmonary dysfunction, pleural effusions, or ascities; no prior treatment with IL-2; and no BRM, radiotherapy, or chemotherapy within previous 4 weeks of entry onto study N = 36; medianage 53 years;median PS 80;male 86% N = 35; median age 53 years; median PS 90; male 69% (1) IL-2 3.0×106 U/m2/day (9 mU) i.v. on days 1∼5, 13∼17, 21∼24,and 28∼31 with, or (2) without, LAK celltherapy i.v. average26.8×109 cells/day ondays 13∼15 Adverse events; Tumor response; Survival Unknown
Figlin RA, 1999 Multicenter double- blindRCT RCC with resectable primary tumor; measurable metastatic disease; PS (ECOG) 0∼1; age ≥18 years; willingness to undergo surgey, agreement to use contraception; the signing of ICF; no prior IL-2 therapy, immunotherapy, immunosuppressive therapy, radiotherapy, or chemotherapy within 4 weeks of screening; no significant renal dysfunction (ie, SCr≥2.0 mg/dl), no significant hepatic dysfunction (ie, SB>1.6 mg/dl, ALT>4×normal, and PTT>1.5 control); adequate blood counts (ie, hemoglobin count≥8 g/dl, granulocyte count≥1,500 cells/mm3, platelet count≥100,000/mm3); no significant cardiovascular disease (ie, heart failure, ischemia, edema, arrhythmia, myocardial infarction, or hypertension); no CNS disease; no pleural effusions or ascites; no active infection; no active peptic ulcer disease; no antibodies to HIV, hepatitis B surface antigen, or hepatitis C; no only bone or abdominal metastases; no prior history of malignancy within the last 5 years other than basal cell carcinoma or cervical carcinoma-in-situ; serum calcium level ≤12 mg/dl or no symptomatic hypercalcemia; no use of corticosteroids or calcium channel and beta adrenergic blockers; women who were not pregnant and/or nursing; no solitary kidney; insignificant intercurrent illnesses and no New York Heart Association class III or IV N = 79; medianage 55 years;PS (0) 44.3%;male 67.1% N = 81; median age 56 years; PS (0) 46.9%; male 86.4% (1) IL-2 5×106 IU/m2/day i.v. for 4 days for 4 weeks with, or (2) without a single i.v. infusion of (5∼3000)×107 CD8+ TIL cells Adverse events; Tumor response; Survival CD3+ (91.8±17.4%); CD4+ (9.0±17.8%); CD8+ (84.8±23.3%); CD56+ (30.1±22.0%); CD3+CD8+ (76.6±32.8%); CD8+CD56+ (22.3±19.6%)
Liu L, 2012 RCT; stratified by a block method progressive and irresectable metastatic clear cell RCC; anticipated survival>3 months; karnofsky PS>40%; age 18∼80 years; SB and SCr less than 1.25×ULN, and free of congestive heart failure, severe coronary artery disease, cardiac arrhythmias, HIV infection, chronic active hepatitis and concomitant corticosteroid therapy; no chemotherapy or immunotherapy during the previous 4 weeks; and women who were not pregnant and lactating N = 74; medianage 60 years;karnofsky PS(≥80) 43%;male 82% N = 74; median age 59 years; karnofsky PS (≥80) 38%;male 81% (1) IL-2 (10×106 IU/m2/day s.c. on day 1, 3 and5, weeks 1∼4) plusIFN-α-2a (3×106 IU/m2/days.c. on day 1, 3 and 5,weeks 1∼4) versus (2)CIK cell therapy i.v.average 9.7×109 cells/cyclefor at leastone cycle Adverse events; Tumor response; Survival CD3+ (81.06±9.22%); CD3+CD4+ (42.70±6.18%); CD3+CD8+ (36.41±5.19%); CD3+CD56+ (18.21±4.73%); CD25+ (33.13±6.87%)

AGC: absolute granulocyte count, BRM: biologic response modifier, ECOG: Eastern Cooperative Oncology Group, ICF: informed consent forms, PT: prothrombin time, PTT: partial thromboplastin time, PS: performance status, SB: serum bilirubin, SCr: serum creatinine, SGOT: serum glutamic oxaloacetic transaminase, ULN: upper limit of normal, WBC: while blood cell.