Rhode Island Hospital, Providence, RI
Eric S. Winer , Howard Safran , Boguslawa Karaszewska , Donald A. Richards , Lee Hartner , Frederic Forget , Rodryg Ramlau , Kirushna Kumar , Bhabita Mayer , Brendan Mark Johnson , Conrad A. Messam , Yasser Mostafa Mostafa Kamel
Gema |
Gem + Cis/Carboa |
|||
---|---|---|---|---|
Pbo N=4 |
Epag N=10 |
Pbo N=3 |
Epag N=9 |
|
Any AEs, n (%) | 3 (75) | 10 (100) | 3 (100) | 9 (100) |
Tx-related | 1 (25) | 5 (50) | 2 (67) | 3 (33) |
≥ Grade 3 | 2 (50) | 3 (30) | 2 (67) | 6 (67) |
Liver AEs | 0 | 1 (10) | 0 | 2 (22) |
Renal AEs | 2 (50) | 0 | 0 | 3 (33) |
Thromboembolic eventsb | 0 | 1 (10) | 0 | 2 (22) |
SAEs | 1 (25) | 2 (20) | 1 (33) | 5 (56) |
Deaths, n (%)c | 2 (50) | 4 (40)< | 1 (33) | 3 (33) |
Plts: Cycles 2-6, mean (n) | ||||
Pre ctx Day 1 | 309 (4) | 443 (9) | 314 (3) | 442 (9) |
Pre ctx Day 8 | 204 (4) | 355 (10) | 239 (2) | 270 (9) |
Pre ctx Day 15 | 75 (3) | 164 (10) | - | - |
Nadir | 103 (4) | 143 (10) | 53 (2) | 113 (9) |
Grade 3/4 thrombocytopenia: Cycle 2-6, n (%) | 1 (25) | 0 | 2 (67) | 3 (33) |
a 7/33 randomized pts never received epag/pbo. b None were considered related to epag and all resolved. One event occurred after stopping epag and following disease progression (PD). cAll deaths were from PD; three additional patients died prior to receiving epag or pbo.
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