Introduction
Patients and methods
Inclusion and exclusion criteria
Study design and treatment
Level 1 | Level 0 | Level − 1 | |
---|---|---|---|
Irinotecan (mg/m2) | 150 | 120 | 90 |
Ramucirumab (mg/kg) | 8 |
Study assessment
Endpoints and statistical analysis
Results
Patients
Variable |
N
| % |
---|---|---|
Age (years) | ||
Median | 68 | |
Range | 58–80 | |
Sex | ||
Male | 6 | 100 |
Female | 0 | 0 |
ECOG PS | ||
0 | 1 | 17 |
1 | 5 | 83 |
Primary tumor location | ||
Gastric | 6 | 100 |
Gastro-esophageal junction | 0 | 0 |
Histology | ||
Intestinal | 6 | 100 |
Diffuse | 0 | 0 |
Prior gastrectomy | ||
Yes | 3 | 50 |
No | 3 | 50 |
Number of metastatic sites | ||
Single | 3 | 50 |
Multiple | 3 | 50 |
Peritoneal metastasis | ||
Yes | 1 | 17 |
No | 5 | 83 |
Prior antineoplastic drugs | ||
Fluoropyrimidine | 6 | 100 |
Platinum | 5 | 83 |
Taxane | 6 | 100 |
Trastuzumab | 2 | 34 |
Ramucirumab | 1 | 17 |
Prior number of regimens | ||
One | 1 | 17 |
Two | 4 | 67 |
Three | 1 | 17 |
DLT
Toxicity and dose intensity
Adverse event | NCI-CTC grade | |||||
---|---|---|---|---|---|---|
1 | 2 | 3 | 4 | All (%) | 3/4 (%) | |
Hematologic | ||||||
Leukopenia | 1 | 2 | 0 | 0 | 50 | 0 |
Neutropenia | 2 | 1 | 1 | 0 | 67 | 17 |
Anemia | 3 | 2 | 1 | 0 | 100 | 17 |
Thrombocytopenia | 5 | 0 | 0 | 0 | 83 | 0 |
Alanine aminotransferase (ALT) increased | 3 | 0 | 0 | 0 | 50 | 0 |
Aspartate aminotransferase (AST) increased | 3 | 0 | 0 | 0 | 50 | 0 |
Increased bilirubin | 0 | 1 | 0 | 0 | 17 | 0 |
Non-hematologic | ||||||
Anorexia | 2 | 1 | 0 | 0 | 50 | 0 |
Alopecia | 1 | 0 | 0 | 0 | 17 | 0 |
Constipation | 2 | 0 | 0 | 0 | 33 | 0 |
Diarrhea | 4 | 0 | 0 | 0 | 67 | 0 |
Dysgeusia | 1 | 1 | 0 | 0 | 33 | 0 |
Edema | 2 | 0 | 0 | 0 | 33 | 0 |
Epistaxis | 2 | 0 | 0 | 0 | 33 | 0 |
Fatigue | 2 | 1 | 0 | 0 | 50 | 0 |
Febrile neutropenia | – | – | 0 | 0 | 0 | 0 |
Hoarseness | 1 | 0 | 0 | 0 | 17 | 0 |
Hypertension | 1 | 1 | 1 | 0 | 50 | 17 |
Myalgia | 1 | 0 | 0 | 0 | 17 | 0 |
Nausea | 2 | 0 | 0 | 0 | 33 | 0 |
Stomatitis | 1 | 0 | 0 | 0 | 17 | 0 |
Thromboembolic event | 0 | 1 | 0 | 0 | 17 | 0 |