Table 1.
Phase I and II clinical trials of immunotherapy for non-small-cell lung cancer.
| Author | Vaccine | n | Stage | Clinical response | Immunologic response | Safety data | Ref. |
|---|---|---|---|---|---|---|---|
| Barve et al. | Nine class I peptides (from CEA, p53, HER-2/neu, MAGE-2 and -3) with PADRE | 63 | IIIB–IV or recurrent | OS: 17.3 months; 1-year survival: 60% | CTL responses | One grade III fever/chills | [51] |
| Ramlau et al. | Modified Ankara virus containing MUC-1 and IL-2 | 65 | IIIB–IV | Median OS: 12.7 months | CTL responses | Grade III/IV possible/probably related: anemia/rash | [52] |
| Bolonaki et al. | Optimized class I hTERT peptide p572Y and native peptide p572 | 22 | III–IV | SD achieved in 36.4% | CTL responses | One grade II nausea | [53] |
| Hirschowitz et al. | Immature DCs pulsed with apoptotic bodies from NSCLC cell line | 14 | I–IIIB | NED in 64% at 12 months | CTL responses | Mild injection site reactions | [54] |
| Meyer et al. | Seven ras peptides encompassing predicted mutations of codon 12 | 4 | I or IV | No relapse after 1 year in three patients with early-stage disease | DTH responses | One subject with PE | [55] |
| Brunsvig et al. | hTERT class I peptide p611 and class II peptide p540 with GM-CSF | 26 | IIB–IV | SD achieved in 28% | T-cell proliferation | Mild flu-like symptoms, fever and chills | [56] |
| Nemunaitis et al. | L523S gene immunized in a plasmid followed by a viral vector | 13 | IB–IIB | Median OS: 290 days | Humoral responses | Two grade II: neck pain and arm pruritis | [57] |
| Nemunaitis et al. | Autologous tumor cells with K562 cells transfected with GM-CSF | 86 | III–IV | Median OS: 7.0 (5.4)† months; 1-year survival: 31% (22%)† | DTH/humoral responses | Grade III or IV, possibly related: dyspnea, PE, tachycardia, back pain, chest pain | [58] |
| Morse et al. | Dexosomes pulsed with MAGE-A3, -A4, -A10 and -3DPO4 peptides | 12 | IIIB–IV | Survival range: 52–502 days at 2-year follow-up | DTH responses | Grade II or less: injection site reactions, flu-like symptoms | [59] |
| Tsuboi et al. | Class I WT1 peptide p235 | 2 | IV | Decreased tumor markers, one PR | CTL/DTH responses | Mild injection site reactions | [60] |
| Mine et al. | SART-1, -2 and -3, CypB, Lck, and ART-1 and -4 peptides | 10‡ | IV or recurrent | 1-year survival: 60% | CTL/DTH responses | Three grade II injection site reactions, one grade II colitis, one grade II dyspnea | [61] |
| Raez et al.§ | B7.1 and HLA A1- or A2-transfected allogenic NSCLC cell line | 15 | IIIB–IV | Median OS: 18 months; SD in 27% | CTL responses | Mild injection site reactions | [25] |
†
Intention-to-treat numbers are in parentheses.
‡
Includes one patient with small-cell lung cancer.
§
Phase II trial currently enrolling.
CTL: Cytotoxic T lymphocyte; DC: Dendritic cell; DTH: Delayed-type hypersensitivity; GM-CSF: Granulocyte macrophage colony stimulating factor; NED: No evidence of disease; NSCLC: Non-small-cell lung cancer; OS: Overall survival; PE: Pulmonary embolism; PR: Partial response; SD: Stable disease.