Table 4.
Hemostatic response and effect on tumor perfusion after administration of dDAVP
Group | Hemostatic Responsea | Reduction of tumor perfusionb | |
---|---|---|---|
PR + CR | CR | ||
Dose level 1 Dose level 2 Dose level 3 Dose level 4 Dose level 5 |
3/3 (100) 3/3 (100) 5/6 (83) 5/6 (83) NEc |
2/3 (67) 3/3 (100) 4/6 (67) 5/6 (83) NEc |
2/3 (67) 1/3 (33) 4/6 (67) 4/6 (67) NEc |
Expansion cohort | 11/12 (92) | 7/12 (58) | 8/12 (67) |
Total | 27/30 (90) | 21/30 (70) | 19/30 (63) |
aRectal bleeding was graded as absent, mild, moderate and severe. Responses were evaluated at day 4 after treatment initiation and/or at the last follow-up at day 14, as described in Methods section. bPerfusion of rectal tumors was evaluated by DCE-RMI at day 4 after treatment initiation, considering AUC as the main parameter of reduction. cNot evaluated, since the two patients included in this group rapidly developed SAE and treatment was discontinued. Data presented as n/total (%).