Patient-associated risk factors for severe anemia in patients with advanced ovarian or breast cancer receiving olaparib monotherapy: A multicenter retrospective study

Abstract

BackgroundOlaparib-induced anemia is a frequently occurring complication in patients with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer and is associated with a marked deterioration in patients’ health-related quality of life. This study aimed to clarify patient-specific risk factors for severe anemia in patients with advanced ovarian or breast cancer receiving olaparib monotherapy in a real-world setting.MethodsThis multicenter, retrospective, observational study enrolled consecutively presenting patients with advanced ovarian or breast cancer who received olaparib monotherapy as maintenance or palliative treatment between April 2018 and December 2020 at three participating medical institutions in Japan. The primary endpoint was patient-associated risk factors underlying the onset of grade ≥3 anemia from olaparib treatment initiation to 90 days after treatment. Receiver operating characteristic curves were constructed and univariable and multivariable logistic regression analyses were performed to evaluate the association between patient-associated risk factors and grade ≥3 anemia.ResultsOf 113 patients evaluated in this study, 32.7% (n = 37) had grade ≥3 anemia. Multivariable logistic regression analysis revealed that low baseline red blood cell (RBC) count (<3.3 × 106 cells/μL), low baseline hematocrit level (<35%), low baseline hemoglobin level (<11.6 g/dL), and breast cancer susceptibility (BRCA1/2) mutation were significantly associated with the onset of grade ≥3 anemia (adjusted odds ratio [OR], 3.39; 95% confidence interval [CI], 1.28–9.62; P = 0.017, adjusted OR, 3.63; 95% CI, 1.28–11.64; P = 0.021, adjusted OR, 3.89; 95% CI, 1.39–12.21; P = 0.014, and adjusted OR, 4.09; 95% CI, 1.55–11.67; P = 0.006, respectively).ConclusionsOur findings suggest that low baseline RBC count, low baseline hematocrit level, and low baseline hemoglobin level might be the patient-associated risk factors for severe anemia induced by olaparib monotherapy. Additionally, BRCA1/2 mutation was suggested to be a patient-related risk factor for anemia regardless of severity. Therefore, applying these patient-associated risk factors would help classify and screen patients at risk of severe anemia.

Factors for the development of anemia in patients with newly introduced olaparib: A retrospective case-control study

“…[17] Although 22 patients did not undergo BRCA mutation testing in our study, the incidence of anemia was significantly higher in patients with BRCA mutations, consistent with another report. [38] Patients with BRCA1/2 mutations are at risk of Fanconi anemia, which may affect the frequency and severity of olaparib-induced anemia. [39,40] Chemotherapeutic agents can cause DNA damage and olaparib impedes repair.…”

Real-world data in patients with BRCA mutated breast cancer treated with poly (ADP-ribose) polymerase inhibitors

“…The incidence of grade 3+ anemia was 32.7%, while 61.1% of patients developed grade 1+ anemia. On multivariable logistic regression analysis, low baseline red blood cell (RBC) count, low baseline hematocrit, low baseline hemoglobin, and BRCA1/2 mutation were significantly associated with the development of grade 3+ anemia, while high baseline RBC, high baseline hematocrit, high baseline hemoglobin level and BRCA1/2 mutation were significantly associated with grade 1+ anemia [ 41 ].…”