A phase I study of the PD-L1 inhibitor, durvalumab, in combination with a PARP inhibitor, olaparib, and a VEGFR1–3 inhibitor, cediranib, in recurrent women’s cancers with biomarker analyses

Table 3 Treatment related adverse events by maximum grade per patient

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	1^a	0
DVT	0	1^b	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