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This multicenter, open-label, phase I study assessed the safety and antitumor activity of acalabrutinib in Japanese patients with relapsed/refractory (r/r) B-cell malignancies. Parts 1 (dose confirmation) and 2 (dose expansion) of this three-part study are reported. Treatment was a single dose of 100 mg acalabrutinib (day 1), followed by a washout period and then twice daily 100 mg acalabrutinib in part 1, or twice daily 100 mg acalabrutinib in part 2. Patients from parts 1 and 2 with r/r chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and r/r mantle cell lymphoma (MCL) were assessed as r/r CLL/SLL and r/r MCL cohorts, respectively. Twenty-five patients received treatment (part 1, n = 6). Median age was 71.0 years. Nine (one patient from part 1) and 13 (two patients from part 1) patients were included in the r/r CLL/SLL and r/r MCL cohorts, respectively. Treatment-related adverse events (AEs) occurred in 88% of patients (grade ≥3, 36%); the most common were headache (28%) and purpura (24%), both grade 1/2. No AEs resulted in treatment discontinuation or death. Median duration of treatment was 31, 20, and 7 months for part 1, r/r CLL/SLL cohort, and r/r MCL cohort, respectively. Overall response rate (ORR) was 89% and 62% for the r/r CLL/SLL and r/r MCL cohorts, respectively. The median progression-free survival (PFS) was not reached for the r/r CLL/SLL cohort and was 7 months for the r/r MCL cohort. Acalabrutinib (100 mg twice daily) was generally safe and well-tolerated in adult Japanese patients with B-cell malignancies., (© 2021 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.)

Background: Renal hemorrhage is the most common adverse effect of SWL, and it has been speculated to be related to the type of lithotripter used., Methods: We investigated the incidence of renal hemorrhage in patients with urinary stones who underwent lithotripsy using either the EDAP LT-01 or the Siemens Lithostar. In addition, we performed in vitro experiments using pressure-sensitive paper in conjunction with gelatin, agar, or porcine tissue models of renal lithotripsy., Results: Thirty-one (16.6%) of 187 kidneys treated with the EDAP LT-01 and 44 (19.6%) of 225 kidneys treated with the Siemens Lithostar showed intrarenal or subcapsular hemorrhage or perinephric hematoma. In particular, the incidence of subcapsular hematoma was significantly higher in the Lithostar-treated patients (P < 0.0001). We discuss our results in light of the patterns of pressure distribution obtained from the two lithotripter units using in vitro models with colorometric, pressure-sensitive paper., Conclusion: It appears that the Siemens Lithostar exerts a greater pressure on the renal capsule, which may account for the higher incidence of subcapsular hematoma.

From 1975 to 1977, a nationwide rubella epidemic occurred in Japan. This epidemic provided the last chance for the observation of natural rubella and its epidemiology without the influence of mass-vaccination for rubella and before changes in the epidemic pattern of rubella in the 1980's in Japan. Epidemiological and clinical data were obtained by questionnaires on school children in 28 selected primary schools and their family members (a total of 80,221 persons) in Fukuoka in southern Japan during the 1976-1977 rubella epidemic. At the end of 1975 the rubella epidemic was mainly in the western part of Fukuoka city and then it spread to the eastern part. After a break during the summer of 1976, the epidemic restarted in 1977 mainly in the eastern part with few cases in the western part. Rubella was identified clinically in 14,322 cases (18%) during the 1976 epidemic, the incidences in various age groups being as follows: children of below 6 years of age, 28%; primary school children, 37%; junior and senior high school students, 30%; adults of 18 to 30 years of age, 8%; adults of over 30 years of age, 1%. The incidence in primary school children in 1977 was 18%. Of the 14,322 cases of clinical rubella in 1976, 3 with encephalitis, 9 with purpura and 1,843 with joint complaints (pain and/or swelling of joints) were recorded. Rubella encephalitis was estimated to have occurred in 1 in 4,700 cases with clinical rubella, and purpura in 1 in 1,500 cases.(ABSTRACT TRUNCATED AT 250 WORDS)