Table 2. Anti tumour activity by dose levels.
| DL | Pt. no. | Gender/age (yrs) | Primary tumour | Previous no. of regimens | Previous anthracyclines/ best response | NGR–TNF dose (μg m−2)/no. of cycles | Doxorubicin dose (mg m−2)/no. of cycles | Best response | Duration of PR or SD (months) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 1 | M/58 | Head and neck | 2 | No | 0.2/4 | 60/4 | SD | 3 |
| 2 | F/42 | Cervix | 6 | No | 0.2/6 | 60/6 | SD | 4.7 | |
| 3 | F/59 | Colon | 2 | No | 0.2/2 | 60/2 | PD | — | |
| 2 | 4 | F/58 | Ovarian | 5 | Yes/SD | 0.2/8 | 75/5 | SDa | 6.4 |
| 5 | M/56 | Ampulla of Vater | 1 | No | 0.2/15 | 75/8 | SD | 11.9 | |
| 6 | F/31 | Thymoma | 1 | Yes/PD | 0.2/4 | 75/4 | SD | 2.9 | |
| 3 | 7 | M/58 | Thymoma | 1 | Yes/PD | 0.4/3 | 75/3 | PDb | — |
| 8 | M/62 | SCLC | 2 | Yes/PD | 0.4/4 | 75/4 | SD | 3.5 | |
| 9 | M/83 | Angiosarcoma | 3 | Yes/PD | 0.4/6 | 75/4 | SD | 4.2 | |
| 4 | 10 | M/59 | Oesophageal | 2 | No | 0.8/8 | 75/6 | PR | 4.7 |
| 11 | M/54 | Chordoma | 5 | Yes/PD | 0.8/9 | 75/3 | SD | 8.2 | |
| 12 | F/54 | Sarcoma | 2 | Yesc | 0.8/8 | 75/3 | SD | 6.5 | |
| 5 | 13 | M/51 | Hepatocellular | 1 | Yesd | 1.6/8 | 75/6 | SD | 6.7 |
| 14 | M/44 | Melanoma | 2 | No | 1.6/2 | 75/2 | PD | — | |
| 15 | M/69 | Sarcoma | 2 | Yes/PD | 1.6/2 | 75/2 | PDb | — |
Abbreviations: DL, dose level; F, female; M, male; NGR–TNF, asparagine–glycine–arginine–tumour necrosis factor; PR, partial response; SCLC, small cell lung cancer, PD, progressive disease; SD, stable disease.
a
Patient with radiologically documented partial response after the sixth cycle.
b
Patient with radiologically documented stable disease at first tumour restaging carried out after two cycles.
c
Patient treated with epirubicin in adjuvant setting.
d
Patient with radiologically documented stable disease for whom epirubicin treatment was stopped after two cycles because of marked increase of alpha-fetoprotein.