A 72-year-old woman, who had been treated for autoimmune hemolytic anemia with prednisolone and azathioprine since 2002, was found to have mild aortic stenosis in 1994. In December 2003, she suffered congestive heart failure, and was on temporary mechanical ventilation. In February 2004, the maximum pressure gradient between left ventricle and aorta increased to 115.8mmHg on echocardiographic examination. On April 6, aortic valve replacement was carried out with a 19mm bioprosthesis (Carpentier-Edwards PERIMOUNT^®, Edwards Lifesciences, Irvine, California). Preoperative prednisolone administration was continued until the day of the operation. Four packs of washed red blood cells were transfused intraoperatively and four packs of red blood cells were transfused postoperatively. Before transfusion, haptoglobin and water-soluble prednisolone were administrated to prevent hemolysis. Oral prednisolone and azathioprine were reestablished on the third postoperative day. Her postoperative course was uneventful and she did not suffer either infection or hemolysis. She was discharged on the 30th postoperative day.

Objective: The addition of maintenance olaparib to bevacizumab demonstrated a significant progression-free survival (PFS) benefit in patients with newly diagnosed, advanced ovarian cancer in the PAOLA-1/ENGOT-ov25 trial (NCT02477644). We evaluated maintenance olaparib plus bevacizumab in the Japan subset of PAOLA-1. Methods: PAOLA-1 was a randomized, double-blind, phase III trial. Patients received maintenance olaparib tablets 300 mg twice daily or placebo twice daily for up to 24 months, plus bevacizumab 15 mg/kg every 3 weeks for up to 15 months in total. This prespecified subgroup analysis evaluated investigator-assessed PFS (primary endpoint). Results: Of 24 randomized Japanese patients, 15 were assigned to olaparib and 9 to placebo. After a median follow-up for PFS of 27.7 months for olaparib plus bevacizumab and 24.0 months for placebo plus bevacizumab, median PFS was 27.4 versus 19.4 months, respectively (hazard ratio [HR]=0.34; 95% confidence interval [CI]=0.11–1.00). In patients with tumors positive for homologous recombination deficiency, the HR for PFS was 0.57 (95% CI=0.16–2.09). Adverse events in the Japan subset were generally consistent with those of the PAOLA-1 overall population and with the established safety and tolerability profiles of olaparib and bevacizumab. Conclusion: Results in the Japan subset of PAOLA-1 support the overall conclusion of the PAOLA-1 trial demonstrating that the addition of maintenance olaparib to bevacizumab provides a PFS benefit in patients with newly diagnosed, advanced ovarian cancer.