Efficacy and safety of ibrutinib in relapsed/refractory CLL and SLL in Japan: a post-marketing surveillance.

Ibrutinib is approved in Japan for the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) based on the results of global and domestic clinical studies. Following approval, we conducted an all-case post-marketing surveillance in Japanese patients with relapsed/refractory CLL/SLL newly initiated on ibrutinib treatment between May 2016-September 2017. Of the 323 patients enrolled, the safety and efficacy analysis sets comprised 289 and 205 patients, respectively. The overall response rate with ibrutinib treatment was 64.4%, and the estimated 52-week progression-free survival (PFS) and overall survival (OS) rates were 71.7 and 79.1%, respectively. No significant difference in the PFS rate was observed among patients with and without del(17p) (P = 0.160); however, PFS was significantly longer in patients who received 1 prior line of therapy versus >1 prior lines of therapy (P = 0.007). Adverse events occurred in 74.0% of patients, and typically occurred early (≤12 weeks) after ibrutinib initiation, followed by a decline in incidence thereafter. The overall rates of infection, bleeding, and arrhythmia were 22.5, 12.8, and 4.8%, respectively. Grade ≥3 bleeding events and atrial fibrillation occurred in 2.4% of patients each. The efficacy and safety profile of ibrutinib treatment in routine clinical practice was consistent with clinical trials and previously reported domestic data.UMIN-CTR Clinical Trials Register ID: UMIN000021963.

End-of-life preferences of the general public: Results from a Japanese national survey.

PURPOSE: To determine under different End-of-Life (EoL) scenarios the preferences of the general public for EoL care setting and Life-sustaining-Treatments (LST), and to develop a new framework to assess these preferences. METHOD: Using a 2-stage, geographical cluster sampling method, we conducted a postal survey across Japan of 2000 adults, aged 20+. Four EoL scenarios were used: cancer, cardiac failure, dementia and persistent vegetative state (PVS). RESULTS: We received 969 valid responses (response rate 48.5%). Preference for EoL care setting varied by illness with those wishing to spend EoL at home only 39% for cancer, 22% for cardiac failure, and 10-11% for dementia and PVS. Preference for LST differed by scenario and treatment type. In cancer, cardiac failure and dementia, about half to two thirds expressed a preference for antibiotics and fluid drip infusion but few for nasogastric (NG) tube feeding, percutaneous endoscopic gastrostomy (PEG), ventilation or cardiopulmonary resuscitation (CPR). Although our models accounted for only 3-9% of the variance, preferences to receive LST were associated with preference to spend EoL in hospital for cancer and cardiac failure but not dementia. CONCLUSIONS: Few people preferred to die at home, while a preference for hospital was largely determined by factors other than preference for LST.