Table 2.
FGF2 status at the baseline and randomisation and secondary efficacy end-points at the end of the lead-in period (week 12).
| Tumour type | Number of FGF2-positive patients/number of assessed patients (%) | |
|---|---|---|
|
|
||
| Baseline | Randomisation | |
|
| ||
| Soft tissue sarcomas | 142/218 (65%) | 53/76 (70%) |
| Ovarian cancer | 97/126 (77%) | 36/39 (92%) |
| Breast cancer | 50/63 (79%) | 9/12 (75%) |
| Pancreatic cancer | 23/29 (79%) | 4/5 (80%) |
| Non-small-cell lung cancer | 27/42 (79%) | 7/11 (64%) |
| Gastric/esophageal carcinoma | 30/31 (97%) | 5/5 (100%) |
| Transitional cell carcinoma | 22/25 (88%) | 4/4 (100%) |
| Overall trial population | 391/510 (77%) | 118/152 (78%) |
| Tumour type | Objective response rate | Disease stabilisation rate | Change in tumour size |
|---|---|---|---|
|
| |||
| Soft tissue sarcomas | 2.8% (95% CI: 0.8–7.1) | 28.9% (95% CI: 21.6–37.1) | 40%a |
| Ovarian cancer | 8.2% (95% CI: 3.6–15.6) | 38.1% (95% CI: 28.5–48.6) | NA |
| Breast cancer | 8.2% (95% CI: 3.1–17.3) | 20.5% (95% CI: 12.0–31.6) | NA |
| Pancreatic cancer | 0 | 13.2% (95% CI: 4.4–28.1) | NA |
| Non-small-cell lung cancer | 0 | 23.8% (95% CI: 12.1–39.5) | NA |
| Gastric/esophageal cancer | 8.8% (95% CI: 1.9–23.7) | 8.8% (95% CI: 1.9–23.7) | 75%b |
| Transitional cell carcinoma | 0 | 16.1% (95% CI: 5.5–33.7) | NA |
FGF, fibroblast growth factor; CI, confidence interval.
a
FGF2-positive treated patients.
b
All but one patient was FGF2 positive.