Table 1.
Phase III clinical trials of neoadjuvant chemotherapy.
| Trial | Size | Stage | Histology No. (%) |
Regimen | ORR | pCR | Complete Resection Induction Chemo vs. Surgery Alone | Median OS Induction Chemo vs. Surgery Alone |
Survival Induction Chemo vs. Surgery Alone |
|---|---|---|---|---|---|---|---|---|---|
| Roth [10] |
60 | IIIA | AD: 30(50) SCC: 22(37) LCC: 6(10) |
Cyclophosphamide Etoposide Cisplatin |
35% | NR | 39% vs. 31% | 64 months vs. 11 months * | OS at 36 months 56% vs. 15% |
| Rosell [11,12] |
60 | IIIA | AD: 14(23) SCC: 42(70) LCC: 4(7) |
Mitomycin Ifosfamide Cisplatin |
60% | 4% | 85% | 22 months vs. 10 months † | OS at 60 months 17% vs. 0% |
| Depierre [13] |
355 | IB–IIIA | AD SCC |
Mitomycin Ifosfamide Cisplatin |
64% | 11% | 92% vs. 86% | 37 months vs. 26 months ‡ | OS at 48 months 43.9% vs. 35.3% |
| Nagai [14] |
62 | IIIA | AD: 41(66) SCC: 15(24) Others: 6(10) |
Cisplatin Vindesine |
28% | 0% | 65% vs. 77% | 17 months vs. 16 months § | OS at 60 months 10% vs. 22% |
| Gilligan [15] |
519 | IB–IIIA | AD: 138(27) SCC: 256(49) Others: 125(24) |
Platinum-based | 49% | 4% | 82% vs. 80% | 54 months vs. 55 months ** | OS at 36 months 44% vs. 45% |
| Pisters [16,17] |
354 | IB–IIIA | AD: 107 SCC: 129 Others: 101 |
Paclitaxel Carboplatin |
41% | NR | 93% vs. 88% | 62 months vs. 41 months †† | OS at 60 months 50% vs. 41% |
| Felip [18] |
413 | IB–IIIA | AD: 128(31) SCC: 212(52) LCC: 42(10) Others: 27(7) |
Paclitaxel Carboplatin |
53.3% | 10.5% | NR | NR | OS at 60 months46.6% vs. 44% II-T3N1: 41.3% vs. 34.5% |
| Scagliotti [19] |
270 | IB–IIIA | AD: 85(31) SCC: 111(31) LCC: 13(1) Others:59(22) |
Gemcitabine Cisplatin |
35.4% | NR | 88% vs. 84% | 93 months vs. 57 months ‡‡ | OS at 36 months67.6% vs. 59.8% SCC: 66.5% vs. 65.6% |
| Mattson [20] |
274 | IIIA- IIIB | AD: 54(20) SCC: 170(62) LCC: 20(7) Others:30(11) |
Docetaxel | 28% | NR | 77% vs. 76% | 14.8 months vs. 12.6 months §§ | OS at 12 months 59.1% vs. 50.5% |
* p = 0.008 by logrank test and p = 0.018 by Wilcoxon test; † 22 months (95% CI, 13.4–30.6) vs. 10 months (95% CI, 7.4–12.6; p = 0.005); ‡ 37 months (95% CI, 26.7–48.3) vs. 26 months (95% CI, 19.8–33.6; p =0.15); § p = 0.5274, not significant; ** HR 2.01, 95% CI 0.80–1.31, p = 0.86, not significant; †† HR 0.79, 95% CI 0.60–1.06, p = 0.11; ‡‡ HR 0.63, 95% CI, 0.43–0.92, p = 0.02; §§ not significant; ORR, objective response rate; OS, overall survival; NR, not reported; AD, adenocarcinoma; SCC, squamous cell carcinoma; LCC, large cell carcinoma.