Table 2. Tumour response.
|
FOLFOX arm A (N=47)
|
5FU-cisplatin arm B (N=40)
|
|||
|---|---|---|---|---|
| n (%) | (95% CI) (exact) | n (%) | (95% CI) (exact) | |
| Complete endoscopic response rate assessed by the IDMC | ||||
| CR | 21 (44.7) | (30.2–59.9) | 12 (30) | (15.8–44.2) |
| Squamous cell | 17 (40.5) | (25.6–55.3) | 10 (26.3) | (12.3–40.3) |
| Adenocarcinoma | 4 (36.4) | (10.9–69.2) | 2 (33.3) | (4.3–77.7) |
| No CR | 18 (38.3) | (24.5–53.6) | 21 (51.2) | (35.1–67.1) |
| Not evaluable | 2 (4.3) | (0.5–14.5) | 4 (10) | (0.7–19.3) |
| Not assessed | 6 (12.8) | — | 5 (12.2) | — |
| Overall response rate assessed by the investigator (Tumour response evaluable population)–RECIST criteria | ||||
| CR | 20 (42.6) | (28.3–57.8) | 18 (43.9) | (28.5–60.3) |
| PR | 17 (36.2) | (22.7–51.5) | 10 (24.4) | (12.4–40.3) |
| ORR (CR+PR) | 37 (78.7) | (64.3–89.3) | 28 (68.3) | (51.9–81.9) |
| SD | 2 (4.3) | (0.5–14.5) | 4 (9.8) | (2.7–23.1) |
| PD | 4 (8.5) | (2.4–20.4) | 4 (9.8) | (2.7–23.1) |
| Not evaluable | 0 | (0.0–7.5) | 1 (2.4) | (0.1–12.9) |
| Not assessed | 4 (8.5) | — | 3 (7.3) | — |
| Missing | 0 | — | 1 (2.4) | — |
Abbreviations: CI=confidence interval; CR=complete response; FOLFOX=oxaliplatin, fluorouracil and leucovorin; IDMC=independent data monitoring committee; ORR=objective response rate; PD=progressive disease; RECIST=Response Evaluation Criteria in Solid Tumours; SD=stable disease.