Table 1. Randomized studies comparing induction treatment followed by surgery with definitive radio(chemo)therapy.
| Trial (Period of Recruitment) |
Inclusion Criteria | Treatment | median OS [mo] | long-term OS | Hazard Ratio | P |
|---|---|---|---|---|---|---|
|
RTOG 89-01 (1990-1994) |
IIIA N2 | [R]* (1) 2x CDDP/VBL (MMC) → S (2) 2x CDDP/VBL (MMC) → RT [64 Gy] |
19.4 17.4 |
22.0% [4Y] 22.0% |
n.g. | 0.46 |
|
NCI Canada (closed 1995) |
IIIA N2 | [R] (1) 2x CDDP/VBL → S (2) ---------------------------- → RT [60 Gy] |
18.7 16.2 |
n.g. | n.g. | NS |
|
MRC (1995-1999) |
IIIA | [R] (1) 4x CDDP/MMC/IFO or VBL → S (2) ----------------------------------------------- → RT [40-60 Gy] |
13.8 11.2 |
n.g. | 0.91 [0.49-1.72] | 0.78 |
|
EORTC 08941 (1994-2002) |
IIIA N2 | (1) 3x CDDP/ 3rd gen drug → [R]° → S [+PORT 56 Gy] (2) 3x CDDP/ 3rd gen drug → RT [60-62.5 Gy] |
16.4 17.5 |
15.7% [5Y] 14.0% |
1.06 [0.84-1.35] | 0.596 |
|
Nordic TOG (1998-2009) |
IIIA N2 | [R] (1) 3x carboplatin/paclitaxel → S [+PORT 60 Gy] (2) 3x carboplatin/paclitaxel → RT [60 Gy] |
17.3 14.9 |
19.0% [5Y] 17.0% |
0.866 | 0.218 |
|
INT 0139 (1994-2001) |
IIIA N2 | [R] (1) 2x CDDP/ETOII45 Gy/1.8 Gy qd → S → 2x CDDP/ETO (2) 2x CDDP/ETOII45 Gy/1.8 Gy qd → RT [61 Gy]→2x CDDP/ETO |
23.6 22.2 |
27.0% [5Y] 20.0% |
0.87 [0.7-1.1] | 0.24 |
|
ESPATUE (2004-2012) |
IIIA N2 selected IIIB |
(1) 3x CDDP/paclitaxel♢ CDDP/VINII45 Gy (AHF)♢[R] → S (2) 3x CDDP/paclitaxel♢ CDDP/VINII45 Gy (AHF) → RT [20-26 Gy♢65-71 Gy] +CDDP/VIN |
49.3 34.8 |
44.0% [5Y] 40.0% |
0.81 [0.5-1.3] | 0.34 |
Abbreviations: [R]: randomisation timepoint, [R]*: only 45 of 73 patients randomised, [R]°: only responders randomised, OS: overall survival, (1): arm 1 – induction treatment plus surgery, (2): arm 2 – conservative treatment: combined radio(chemo)therapy without resection, mo: months, --: no chemotherapy, S: surgery, RT: radiotherapy, CDDP: cisplatin, VBL: vinblastin, IFO: ifosfamide, MMC: mitomycin, ETO: etoposide, VIN: vinorelbine, n.g.: not given, NS: not significant, PORT: postoperative radiotherapy, qd: once daily, II: concurrent, AHF: accelerated hyperfractionation.