Table 2

Clinical information of patients from the eligible trials in the meta-analysis

TrialsAgeNumber of ptsOperative methodTumour stageVaccine regimensVaccine formulationClinical efficacy
Alfonso et al1418+89PlaceboIIIB–IV5 immunisations every 2 weeks and reimmunisations every 4 weeks for 1 yearAnti-idiotype vaccine targeting the NeuGcGM3 tumour-associated gangliosideMedian OS: Racotumomab-Alum vs placebo was 8.23 vs 6.80 months (HR 0.63)
Median PFS: Racotumomab-Alum vs placebo was 5.33 vs 3.90 months for placebo (HR 0.73)
The 1-year and 2-year survival rates were 40.2% and 18.4% for the Racotumomab-Alum group vs 22.5% and 6.7% for the placebo group
Butts et al15UK410Chemo+placeboIIIEight consecutive weekly subcutaneous injections, 806 µg lipopeptide or placeboTecemotide (L-BLP25):MUC1 glycoproteinMedian OS: tecemotide vs placebo was 25.6 vs 22.3 months (HR 0.88) Median TTP:tecemotide vs placebo was 10 vs 8.4 months (HR 0.87) The 1-year, 2-year, 3-year survival rates were 77%, 51%, 40% for the tecemotide group vs 75%, 46%, 37% for the placebo group, respectively
Butts et al16UK83BSCIIIB–IVLow dose of cyclophosphamide 3 days before the first L-BLP25, then weekly subcutaneous injection 930 µg L-BLP25L-BLP25:MUC1 glycoproteinMedian OS: L-BLP25 plus BSC vs BSC was 17.2 vs 13.0 months (HR 0.745)
The 3-year survival rate was 31% in L-BLP25 plus BSC and 17% in those receiving BSC
88BSC+ L-BLP25
Butts17M5983BSCIIIB–IVLow dose of cyclophosphamide 3 days before the first L-BLP25, followed by 8 weekly of 1000 µg of L-BLP25L-BLP25:MUC1 glycoproteinMedian OS: L-BLP25 arm vs BSC arm was 17.4 vs13.3 months (HR 0.524)
The 2-year survival rate was 43.2% for the L-BLP25 arm vs 28.9% for the BSC arm
ORR: L-BLP25 arm vs BSC arm was 49/88 vs 45/83
88BSC+ L-BLP25
Manegold et al18M6537ChemoIIIB–IVPF-3512676 was administered via subcutaneous injection at a dose of 0.2 mg/kg on days 8 and 15 of each cyclePF-3512676: mimics the natural ligand of TLR9 (unmethylated CpG motifs)Median OS: PF-3512676 arm vs chemo arm was 12.3 vs 6.8 months
The 1-year survival was 50% for PF-3512676 arm vs 33% for chemo arm
ORR: 38% in the PF-3512676 arm vs19% in chemo arm
Mitchell et al19UK410Chemo+placeboIII–IVSubcutaneous injection tecemotide (806 µg lipopeptide) or placebo, weekly for 8 weeks and then 6 weeklyTecemotide (L-BLP25):MUC1 glycoproteinMedian PFS: tecemotide arm vs placebo was 9.6 vs 7.7 months (HR 0.865)
Nemunaitis et al2027–78
86Tumours harvestedIII–IVEvery 2 weeks for 3–12 vaccinations with 5–80×6 tumour cells/vaccineGVAX: whole tumour cells genetically modified to secrete GM-CSFMedian OS: vaccine arm vs control was 7 vs 5.4 months
Median PFS: vaccine arm vs control was 4.4 vs 3.7 months
The 1-year survival was 30% for vaccine arm vs 22% for control
Nemunaitis et al2132–89
63Tumours harvestedIII–IVEvery 2 weeks for 3–6 vaccinations, contained 5–100×6 cell/doseAd-GM: autologous tumour cells expose to adenoviral vector with GM-CSFMedian OS: vaccine arm vs control was 12 vs 9 monthsMedian PFS: vaccine arm vs control was 4 vs 4 monthsThe 1-year survival was 44% for vaccine arm vs 38% for control
O'Brien et al2230–78
209ChemoIII–IV1 mg SRL172 was given monthlySuspension of killed Mycobacterium vaccaeMedian TTP: SRL172 arm vs chemo arm was 5.7 vs 5 months
The 1-year survival was 88% for the SRL172 arm vs 83% for control
ORR: 37% in the SRL172 arm vs 33% in chemo arm
Quoix et al2335–79
74ChemoIIIB–IV108 plaque forming units/dose, once a week for 6 weeks, then once every 3 weeksTG4010:modified virus with MUC1 and IL-2Median OS: TG4010 arm vs control was 10.7 vs 10.3 months
Median TTP: TG4010 arm vs chemo arm was 5.9 vs 5.2 months
ORR: 42% in the TG4010 arm vs 28% in chemo arm
Vinageras et al2430–78
40BSCIIIB–IVLow dose of cyclophosphamide 3 days before the first EGF vaccine, followed by EGF vaccine on weeklyRecombinant protein EGFMedian OS: EGF vaccine arm vs BSC was 10.7 vs 10.3 months
The 1-year survival was 67.5% for EGF vaccine arm vs32.5% for control
  • The selective data are authors’ names, year of publication, sample size per arm, regimen used, tumour stage, median or mean age of patients, vaccine formulation, information pertaining to study design and main results of clinical efficacy in each arm.

  • BAI, bronchial arterial infusion; BSC, best supportive care; Chemo, chemotherapy; EGF, epidermal growth factor; GM-CSF, granulocyte–macrophage colony-stimulating factor; IL, interleukin; M, median; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; Pts, patients; TLR, toll-like receptor; TTP, time to progression; UK, unknown.