. 2015 Apr 14;5(4):e006321. doi: 10.1136/bmjopen-2014-006321

Table 2.

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

Trials	Age	Number of pts	Operative method	Tumour stage	Vaccine regimens	Vaccine formulation	Clinical efficacy
Alfonso et al¹⁴	18+	89	Placebo	IIIB–IV	5 immunisations every 2 weeks and reimmunisations every 4 weeks for 1 year	Anti-idiotype vaccine targeting the NeuGcGM3 tumour-associated ganglioside	Median 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
Alfonso et al¹⁴	18+	87	RacotumomabAlum	IIIB–IV
Butts et al¹⁵	UK	410	Chemo+placebo	III	Eight consecutive weekly subcutaneous injections, 806 µg lipopeptide or placebo	Tecemotide (L-BLP25):MUC1 glycoprotein	Median 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 al¹⁵	UK	829	Chemo+tecemotide	III		Tecemotide (L-BLP25):MUC1 glycoprotein
Butts et al¹⁶	UK	83	BSC	IIIB–IV	Low dose of cyclophosphamide 3 days before the first L-BLP25, then weekly subcutaneous injection 930 µg L-BLP25	L-BLP25:MUC1 glycoprotein	Median 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
Butts et al¹⁶	UK	88	BSC+ L-BLP25	IIIB–IV		L-BLP25:MUC1 glycoprotein
Butts¹⁷	M59	83	BSC	IIIB–IV	Low dose of cyclophosphamide 3 days before the first L-BLP25, followed by 8 weekly of 1000 µg of L-BLP25	L-BLP25:MUC1 glycoprotein	Median 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
Butts¹⁷	M59	88	BSC+ L-BLP25	IIIB–IV		L-BLP25:MUC1 glycoprotein
Manegold et al¹⁸	M65	37	Chemo	IIIB–IV	PF-3512676 was administered via subcutaneous injection at a dose of 0.2 mg/kg on days 8 and 15 of each cycle	PF-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
Manegold et al¹⁸	M65	75	Chemo+PF-3512676	IIIB–IV
Mitchell et al¹⁹	UK	410	Chemo+placebo	III–IV	Subcutaneous injection tecemotide (806 µg lipopeptide) or placebo, weekly for 8 weeks and then 6 weekly	Tecemotide (L-BLP25):MUC1 glycoprotein	Median PFS: tecemotide arm vs placebo was 9.6 vs 7.7 months (HR 0.865)
Mitchell et al¹⁹	UK	829	Chemo+tecemotide	III–IV		Tecemotide (L-BLP25):MUC1 glycoprotein
Nemunaitis et al²⁰	27–78 M59	86	Tumours harvested	III–IV	Every 2 weeks for 3–12 vaccinations with 5–80×6 tumour cells/vaccine	GVAX: whole tumour cells genetically modified to secrete GM-CSF	Median 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 al²⁰	27–78 M59	49	Vaccine	III–IV
Nemunaitis et al²¹	32–89 M64	63	Tumours harvested	III–IV	Every 2 weeks for 3–6 vaccinations, contained 5–100×6 cell/dose	Ad-GM: autologous tumour cells expose to adenoviral vector with GM-CSF	Median 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
Nemunaitis et al²¹	32–89 M64	33	Vaccine	III–IV
O'Brien et al²²	30–78 M61	209	Chemo	III–IV	1 mg SRL172 was given monthly	Suspension of killed Mycobacterium vaccae	Median 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
O'Brien et al²²	30–78 M61	210	Chemo+SRL172	III–IV	1 mg SRL172 was given monthly	Suspension of killed Mycobacterium vaccae
Quoix et al²³	35–79 M58.5	74	Chemo	IIIB–IV	10⁸ plaque forming units/dose, once a week for 6 weeks, then once every 3 weeks	TG4010:modified virus with MUC1 and IL-2	Median 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
Quoix et al²³	35–79 M58.5	74	Chemo+TG4010	IIIB–IV		TG4010:modified virus with MUC1 and IL-2
Vinageras et al²⁴	30–78 M55	40	BSC	IIIB–IV	Low dose of cyclophosphamide 3 days before the first EGF vaccine, followed by EGF vaccine on weekly	Recombinant protein EGF	Median 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
Vinageras et al²⁴	30–78 M55	40	BSC+EGF	IIIB–IV		Recombinant protein EGF

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.