Adverse event | Grade 1 | Grade 2 | Grade 3 | Grade 4 |
---|---|---|---|---|
Hematological | ||||
Lymphopenia | 1 | 2 | 3 | 0 |
Anemia | 2 | 1 | 2 | 0 |
Thrombocytopenia | 2 | 0 | 0 | 0 |
Neutropenia | 1 | 1 | 0 | 0 |
Gastrointestinal | ||||
Anorexia | 2 | 0 | 1 | 0 |
Nausea | 5 | 0 | 0 | 0 |
Vomit | 3 | 0 | 0 | 0 |
Diarrhea | 5 | 0 | 0 | 0 |
GERD | 0 | 1 | 0 | 0 |
Dyspepsia | 1 | 1 | 0 | 0 |
Endocrinology and Chemistry | ||||
Increased creatinine | 1 | 2 | 1 | 0 |
Hypothyroidism | 1 | 1 | 0 | 0 |
Proteinuria | 1 | 0 | 0 | 0 |
Increase ALT/AST | 4 | 0 | 0 | 0 |
Increase Alkaline Phosphatase | 2 | 0 | 0 | 0 |
Cardiovascular | ||||
Hypertension | 0 | 3 | 1 | 0 |
Syncope | 0 | 0 | 1a | 0 |
DVT | 0 | 1b | 0 | 0 |
Other | ||||
Fatigue | 6 | 2 | 0 | 0 |
Dyspnea | 1 | 0 | 0 | 0 |
Headache | 1 | 0 | 0 | 0 |
Arthralgia | 2 | 0 | 0 | 0 |
Dizziness | 2 | 0 | 0 | 0 |
Gastric hemorrhage | 0 | 1 | 0 | 0 |
Hoarseness | 1 | 0 | 0 | 0 |
Anemia occurred in 5 of 9 patients, one with grade 3 anemia required olaparib dose reduction. One patient was taken off study treatment for extensive progression of disease after 3 cycles of treatment and developed multifactorial causes for renal failure, grade 3 creatinine elevation and grade 3 anemia at the time. This patient also developed a new-onset DVT in lower extremity after cycle 3 of treatment, thus cediranib was discontinued but other two drugs were continued
Abbreviations: GERD gastroesophageal reflux disease, AST aspartate aminotransferase, ALT alanine aminotransferase, DVT deep venous thrombosis
aUnlikely related to study drugs – determined to be a non-drug related vasovagal episode after extensive cardiovascular investigation including brain imaging
bPossibly related to cediranib and disease, cediranib was discontinued after grade 2 DVT event but durvalumab and olaparib were continued