Methods: The study included patients aged ≥65 years who underwent spinal surgeries. The patients aged ≥85, 75–84, and 65–74 years were categorized into the super-old, old, and pre-old groups, respectively. The differences in perioperative age-related complications were compared among the three groups while matching for surgical procedures and general conditions (study 1). Furthermore, preoperative and intraoperative factors were examined for perioperative complications in the super-old group (study 2). Complications were categorized into surgical site and systemic complications. Results: The analysis included 44 patients from each group. In study 1, the total complication rates were 40.9%, 25%, and 18.2% of the super-old, old, and pre-old groups, respectively. Differences in complication rates were observed between the super-old and pre-old groups (p=0.011). In study 2, 58 patients from the super-old group were analyzed. Surgical site complications were significantly associated with longer surgical duration (p=0.02) and more estimated blood loss (p=0.003). Systemic complications were significantly associated with previous cerebrovascular disease (p=0.014), preoperative motor deficit (p=0.023), and emergency case (p=0.006) and negatively associated with diabetes mellitus (p=0.048). Conclusions Perioperative complications increased with advancing age in the super-old, old, and pre-old groups. The complication type is associated with specific background factors; therefore, determining them may help prevent perioperative complications.

Objective: This study evaluated the long-term safety and efficacy of niraparib in Japanese patients with platinum-sensitive recurrent ovarian cancer. Methods: This was a follow-up analysis of a phase 2, multicenter, open-label, single-arm study in Japanese women with platinum-sensitive, relapsed ovarian cancer. Participants received niraparib (starting dose 300 mg) once daily in continuous 28-day cycles. The primary endpoint was the incidence of Grade 3 or 4 thrombocytopenia-related events (defined as the overall incidence of the MedDRA Preferred Terms “thrombocytopenia” and “platelet count decreased”) occurring in the 30 days after initial administration of niraparib, and secondary endpoints included evaluation of treatment-emergent adverse events and progression-free survival. Results: Nineteen patients (median age, 62 years; median body weight, 53.9 kg) were enrolled. As previously reported, the incidence of Grade 3 or 4 thrombocytopenia-related events during the first 30 days of treatment was 31.6%. At data cutoff, median (range) treatment exposure was 504.0 (56–1,054) days and mean ± standard deviation dose intensity was 154.4±77.5 mg/day. The most common treatment-emergent adverse events were nausea (n=14, 73.7%), decreased platelet count (n=12, 63.2%), decreased neutrophil count (n=11, 57.9%), anemia, vomiting, and decreased appetite (all n=9, 47.4%). One patient was diagnosed with treatment-related leukemia, which resulted in death. Median (95% confidence interval) progression-free survival was 18.0 (5.6–26.7) months. Conclusion Overall, the safety profile of niraparib was considered manageable in this study population of Japanese patients with platinum-sensitive, relapsed ovarian cancer and was consistent with that observed in studies of non-Japanese patients.

Methods: The study included patients aged ≥65 years who underwent spinal surgeries. The patients aged ≥85, 75–84, and 65–74 years were categorized into the super-old, old, and pre-old groups, respectively. The differences in perioperative age-related complications were compared among the three groups while matching for surgical procedures and general conditions (study 1). Furthermore, preoperative and intraoperative factors were examined for perioperative complications in the super-old group (study 2). Complications were categorized into surgical site and systemic complications. Results: The analysis included 44 patients from each group. In study 1, the total complication rates were 40.9%, 25%, and 18.2% of the super-old, old, and pre-old groups, respectively. Differences in complication rates were observed between the super-old and pre-old groups (p=0.011). In study 2, 58 patients from the super-old group were analyzed. Surgical site complications were significantly associated with longer surgical duration (p=0.02) and more estimated blood loss (p=0.003). Systemic complications were significantly associated with previous cerebrovascular disease (p=0.014), preoperative motor deficit (p=0.023), and emergency case (p=0.006) and negatively associated with diabetes mellitus (p=0.048). Conclusions Perioperative complications increased with advancing age in the super-old, old, and pre-old groups. The complication type is associated with specific background factors; therefore, determining them may help prevent perioperative complications.

Objective: This study evaluated the long-term safety and efficacy of niraparib in Japanese patients with platinum-sensitive recurrent ovarian cancer. Methods: This was a follow-up analysis of a phase 2, multicenter, open-label, single-arm study in Japanese women with platinum-sensitive, relapsed ovarian cancer. Participants received niraparib (starting dose 300 mg) once daily in continuous 28-day cycles. The primary endpoint was the incidence of Grade 3 or 4 thrombocytopenia-related events (defined as the overall incidence of the MedDRA Preferred Terms “thrombocytopenia” and “platelet count decreased”) occurring in the 30 days after initial administration of niraparib, and secondary endpoints included evaluation of treatment-emergent adverse events and progression-free survival. Results: Nineteen patients (median age, 62 years; median body weight, 53.9 kg) were enrolled. As previously reported, the incidence of Grade 3 or 4 thrombocytopenia-related events during the first 30 days of treatment was 31.6%. At data cutoff, median (range) treatment exposure was 504.0 (56–1,054) days and mean ± standard deviation dose intensity was 154.4±77.5 mg/day. The most common treatment-emergent adverse events were nausea (n=14, 73.7%), decreased platelet count (n=12, 63.2%), decreased neutrophil count (n=11, 57.9%), anemia, vomiting, and decreased appetite (all n=9, 47.4%). One patient was diagnosed with treatment-related leukemia, which resulted in death. Median (95% confidence interval) progression-free survival was 18.0 (5.6–26.7) months. Conclusion Overall, the safety profile of niraparib was considered manageable in this study population of Japanese patients with platinum-sensitive, relapsed ovarian cancer and was consistent with that observed in studies of non-Japanese patients.

Methods: The study included patients aged ≥65 years who underwent spinal surgeries. The patients aged ≥85, 75–84, and 65–74 years were categorized into the super-old, old, and pre-old groups, respectively. The differences in perioperative age-related complications were compared among the three groups while matching for surgical procedures and general conditions (study 1). Furthermore, preoperative and intraoperative factors were examined for perioperative complications in the super-old group (study 2). Complications were categorized into surgical site and systemic complications. Results: The analysis included 44 patients from each group. In study 1, the total complication rates were 40.9%, 25%, and 18.2% of the super-old, old, and pre-old groups, respectively. Differences in complication rates were observed between the super-old and pre-old groups (p=0.011). In study 2, 58 patients from the super-old group were analyzed. Surgical site complications were significantly associated with longer surgical duration (p=0.02) and more estimated blood loss (p=0.003). Systemic complications were significantly associated with previous cerebrovascular disease (p=0.014), preoperative motor deficit (p=0.023), and emergency case (p=0.006) and negatively associated with diabetes mellitus (p=0.048). Conclusions Perioperative complications increased with advancing age in the super-old, old, and pre-old groups. The complication type is associated with specific background factors; therefore, determining them may help prevent perioperative complications.

Objective: This study evaluated the long-term safety and efficacy of niraparib in Japanese patients with platinum-sensitive recurrent ovarian cancer. Methods: This was a follow-up analysis of a phase 2, multicenter, open-label, single-arm study in Japanese women with platinum-sensitive, relapsed ovarian cancer. Participants received niraparib (starting dose 300 mg) once daily in continuous 28-day cycles. The primary endpoint was the incidence of Grade 3 or 4 thrombocytopenia-related events (defined as the overall incidence of the MedDRA Preferred Terms “thrombocytopenia” and “platelet count decreased”) occurring in the 30 days after initial administration of niraparib, and secondary endpoints included evaluation of treatment-emergent adverse events and progression-free survival. Results: Nineteen patients (median age, 62 years; median body weight, 53.9 kg) were enrolled. As previously reported, the incidence of Grade 3 or 4 thrombocytopenia-related events during the first 30 days of treatment was 31.6%. At data cutoff, median (range) treatment exposure was 504.0 (56–1,054) days and mean ± standard deviation dose intensity was 154.4±77.5 mg/day. The most common treatment-emergent adverse events were nausea (n=14, 73.7%), decreased platelet count (n=12, 63.2%), decreased neutrophil count (n=11, 57.9%), anemia, vomiting, and decreased appetite (all n=9, 47.4%). One patient was diagnosed with treatment-related leukemia, which resulted in death. Median (95% confidence interval) progression-free survival was 18.0 (5.6–26.7) months. Conclusion Overall, the safety profile of niraparib was considered manageable in this study population of Japanese patients with platinum-sensitive, relapsed ovarian cancer and was consistent with that observed in studies of non-Japanese patients.

Methods: The outcomes of 72 patients who underwent BKP for VCFs between 2015 and 2021 were retrospectively investigated. Patients with DISH were assigned to group D (n=21), whereas those without DISH were assigned to group ND (n=51). Back pain, incidence of subsequent adjacent fractures, reoperation rates, and local kyphosis were statistically analyzed. Results: VCFs in group D occurred at the distal end or adjacent vertebra of the fused segments, and no fractures occurred in the midportion of the fused segment. Back pain improved in both groups, with no significant differences between them. Subsequent adjacent fractures were observed in three of the 21 patients in group D and 11 of the 51 patients in group ND, with no significant difference between them. Reoperation was performed in one patient each in groups D and ND, with no significant difference between the groups. Postoperatively, local kyphosis progressed significantly in group D. Conclusions Although local kyphosis is more advanced in patients with DISH, BKP is effective for VCFs at the distal end or adjacent vertebra of the fused segments and may be useful in older patients with high complication rates.

Herein, we describe a novel posterior lumbar interbody fusion (PLIF) technique with annulus fibrosus (AF) release and the use of expandable cages (called “anterior-release PLIF” [ARPLIF]). In this technique, posterior column osteotomy (PCO) and AF release provide excellent intervertebral mobility. AF release involves circumferentially peeling off the AF above or below the endplate between the fixed vertebrae under radiographic guidance without cutting the AF and anterior longitudinal ligament. Subsequently, high-angle variable-angle expandable cages are used to simultaneously expand both sides before inserting the percutaneous pedicle screws and correcting to achieve good local lumbar lordosis. PCO and AF release achieve excellent intervertebral mobility. Intervertebral mobility and simultaneous expansion of both cages disperse the force on the endplates, reducing cage subsidence, and the high-angle cages facilitate high intervertebral angle creation. The novel ARPLIF intervertebral manipulation technique can promote good local lumbar lordosis formation.

Methods: The medical records of patients with intervertebral TLIF from 2012 to 2018 were retrospectively examined. The patients were divided into those with fusion and those with pseudoarthrosis, and the following data were compared: age, sex, DISH, diabetes mellitus, smoking, drinking, albumin levels, body mass index ≥30 kg/m2, and L5/S fixation. Statistical analyses were performed using regression models. Results: In this study, 180 patients (78.6%) had fusion and 49 patients (21.4%) had pseudoarthrosis. The number of patients with DISH was significantly higher in the pseudoarthrosis group than in the fusion group (36.7% and 21.7%, respectively; univariate p=0.031, multivariate p =0.019). No significant differences in age, sex, diabetes mellitus, smoking, drinking, albumin levels, body mass index ≥30 kg/m2, and L5/S fixation were observed between the two groups. The risk factors for bone fusion were statistically analyzed in 57 patients with DISH. DISH with a caudal end below Th11 was an independent risk factor for pseudoarthrosis (univariate p=0.011, multivariate p=0.033). Conclusions DISH is an independent risk factor for pseudoarthrosis after one intervertebral TLIF, and DISH with a caudal end below Th11 is associated with a higher risk of pseudoarthrosis than DISH without a caudal end below Th11.