Table 2. Overall response at the end of induction chemotherapy and at study end (ITT population).
|
After local treatment
|
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|---|---|---|---|---|---|---|---|---|
| After induction chemotherapy | ITT population |
Chemoradiotherapy
|
Radiotherapy alone
|
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| Response, n (%) | Total (n=104) | Total (n=89) | Stage IIIA (n=11) | Stage IIIB (n=32) | Total (n=43) | Stage IIIA (n=11) | Stage IIIB (n=35) | Total (n=46) |
| Overall response (%) | 46 (44) | 47 (53) | 7 (64) | 18 (56) | 25 (58) | 5 (45) | 17 (49) | 22 (48) |
| 95% Confidence interval | — | — | 31–89 | 38–74 | 42–73 | 17–77 | 31–66 | 33–63 |
| Complete response | 0 | 3 (3) | 1 (9) | 1 (3) | 2 (5) | 0 | 1 (3) | 1 (2) |
| Partial response | 46 (44) | 44 (49) | 6 (55) | 17 (53) | 23 (53) | 5 (45) | 16 (46) | 21 (46) |
| No change | 45 (43) | 7 (8) | 1 (9) | 2 (6) | 3 (7) | 0 | 4 (11) | 4 (9) |
| Progressive disease | 9 (9) | 19 (21) | 2 (18) | 5 (16) | 7 (16) | 6 (55) | 6 (17) | 12 (26) |
| Early progressiona | 4 (4) | 8 (9) | 0 | 4 (13) | 4 (9) | 0 | 4 (11) | 4 (9) |
| Nonevaluable | — | 8 (9) | 1 (9) | 3 (9) | 4 (9) | 0 | 4 (11) | 4 (9) |
a
Progression before the first assessment of the response, that is before completion of two cycles of induction chemotherapy (6 weeks) or before completion of local treatment (3 weekly administrations of docetaxel plus 6 weeks of radiation (chemoradiotherapy arm) or at least 6 weeks of radiation (radiotherapy only arm)).