Table 2.
Adverse Events | Grade 1 | Grade 2 | Grade 3 | Grade 4 |
---|---|---|---|---|
Hematological | ||||
Anemia* | 9 (26%) | 11 (31%) | 11 (31%) | 0 |
Decreased platelets | 9 (26%) | 0 | 0 | 0 |
Decreased leukocytes | 7 (20%) | 4 (11%) | 1 (3%) | 0 |
Decreased lymphocytes | 4 (11%) | 14 (40%) | 7 (20%) | 0 |
Decreased neutrophils | 0 | 3 (9%) | 1 (3%) | 0 |
Gastrointestinal | ||||
Nausea | 16 (46%) | 1 (3%) | 0 | 0 |
Vomit | 12 (34%) | 0 | 0 | 0 |
Diarrhea | 8 (23%) | 1 (3%) | 0 | 0 |
Constipation | 4 (11%) | 0 | 0 | 0 |
GERD | 5 (14%) | 0 | 0 | 0 |
Anorexia | 8 (23%) | 1 (3%) | 0 | 0 |
Proctitis | 0 | 1 (3%) | 0 | 0 |
Endocrinology and Chemistry | ||||
Hypothyroidism | 1 (3%) | 0 | 0 | 0 |
Hyperthyroidism | 2 (6%) | 0 | 0 | 0 |
Increased creatinine | 7 (20%) | 4 (11%) | 0 | 0 |
Increased ALT/AST | 3 (9%) | 0 | 0 | 0 |
Dermatological | ||||
Rash | 2 (6%) | 1 (3%) | 1 (3%) | 0 |
Hyperpigmentation | 2 (6%) | 0 | 0 | 0 |
Erythema multiforme | 1 (3%) | 0 | 0 | 0 |
Other | ||||
Fatigue | 14 (40%) | 5 (14%) | 0 | 0 |
Headache | 2 (6%) | 0 | 0 | 0 |
Insomnia | 1 (3%) | 0 | 0 | 0 |
Arthralgia | 2 (6%) | 0 | 0 | 0 |
Myalgia | 1 (3%) | 0 | 0 | 0 |
Weight loss | 1 (3%) | 0 | 0 | 0 |
Weight gain | 1 (3%) | 0 | 0 | 0 |
Dry eye | 1 (3%) | 0 | 0 | 0 |
Dry mouth | 1 (3%) | 0 | 0 | 0 |
Flushing** | 1 (3%) | 0 | 0 | 0 |
Three patients required olaparib dose reduction because of recurrent anemia. No one had durvalumab dose reduction or discontinuation due to adverse events. No treatment related deaths were recorded.
During durvalumab infusion
Abbreviations: GERD = gastroesophageal reflux disease, ALT = alanine aminotransferase, AST = aspartate aminotransferase