Hydromorphone is known for its low bioavailability. Currently, there is no recommended conversion ratio when changing from injectable to oral hydromorphone for patients with hepatic impairment. Its overdose may result in serious side effects, particularly respiratory depression, necessitating careful attention to dosage. In the present case, a patient with hepatic impairment developed respiratory depression following a switch from continuous subcutaneous administration of hydromorphone to an oral extended-release form. The prescribed oral dose of hydromorphone was four times higher than the injectable dosage, based on the standard conversion ratio typically considered equivalent in drug potency. However, increased bioavailability due to hepatic impairment is believed to have caused the patient’s respiratory depression. Therefore, in such cases, it is imperative to cautiously monitor dosage due to significant fluctuations in the conversion ratio, which varies based on individual circumstances.

Objective: To evaluate the long-term efficacy and safety of niraparib in Japanese women with heavily pretreated ovarian cancer. Methods: This was the follow-up analysis of a phase 2, multicenter, open-label, single-arm study in Japanese women with homologous recombination-deficient, platinum-sensitive, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who had completed 3–4 lines of chemotherapy and were poly(ADP-ribose) polymerase inhibitor naïve. Participants received niraparib (starting dose, 300 mg) once daily in continuous 28-day cycles until objective disease progression, unacceptable toxicity, or consent withdrawal. The primary endpoint was confirmed objective response rate (ORR), as assessed using Response Evaluation Criteria in Solid Tumors version 1.1. Safety evaluations included treatment-emergent adverse events (TEAEs). Results: 20 patients were enrolled in the study and included in both efficacy and safety analyses. Median total study duration was 759.5 days. Median dose intensity was 201.3 mg/ day. Confirmed ORR was 60.0% (90% confidence interval [CI]=39.4–78.3); 2 patients had complete response and 10 patients had partial response. Median duration of response was 9.9 months (95% CI=3.9–26.9) and the disease control rate was 90.0% (95% CI=68.3–98.8).The most common TEAEs were anemia (n=15), nausea (n=12), and decreased platelet count (n=11). TEAEs leading to study drug dose reduction, interruption, or discontinuation were reported in 16 (80.0%), 15 (75.0%), and 2 patients (10.0%), respectively. Conclusion The long-term efficacy and safety profile of niraparib was consistent with previous findings in the equivalent population in non-Japanese patients. No new safety signals were identified.

Objective: To evaluate the long-term efficacy and safety of niraparib in Japanese women with heavily pretreated ovarian cancer. Methods: This was the follow-up analysis of a phase 2, multicenter, open-label, single-arm study in Japanese women with homologous recombination-deficient, platinum-sensitive, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who had completed 3–4 lines of chemotherapy and were poly(ADP-ribose) polymerase inhibitor naïve. Participants received niraparib (starting dose, 300 mg) once daily in continuous 28-day cycles until objective disease progression, unacceptable toxicity, or consent withdrawal. The primary endpoint was confirmed objective response rate (ORR), as assessed using Response Evaluation Criteria in Solid Tumors version 1.1. Safety evaluations included treatment-emergent adverse events (TEAEs). Results: 20 patients were enrolled in the study and included in both efficacy and safety analyses. Median total study duration was 759.5 days. Median dose intensity was 201.3 mg/ day. Confirmed ORR was 60.0% (90% confidence interval [CI]=39.4–78.3); 2 patients had complete response and 10 patients had partial response. Median duration of response was 9.9 months (95% CI=3.9–26.9) and the disease control rate was 90.0% (95% CI=68.3–98.8).The most common TEAEs were anemia (n=15), nausea (n=12), and decreased platelet count (n=11). TEAEs leading to study drug dose reduction, interruption, or discontinuation were reported in 16 (80.0%), 15 (75.0%), and 2 patients (10.0%), respectively. Conclusion The long-term efficacy and safety profile of niraparib was consistent with previous findings in the equivalent population in non-Japanese patients. No new safety signals were identified.

Objective: To evaluate the long-term efficacy and safety of niraparib in Japanese women with heavily pretreated ovarian cancer. Methods: This was the follow-up analysis of a phase 2, multicenter, open-label, single-arm study in Japanese women with homologous recombination-deficient, platinum-sensitive, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who had completed 3–4 lines of chemotherapy and were poly(ADP-ribose) polymerase inhibitor naïve. Participants received niraparib (starting dose, 300 mg) once daily in continuous 28-day cycles until objective disease progression, unacceptable toxicity, or consent withdrawal. The primary endpoint was confirmed objective response rate (ORR), as assessed using Response Evaluation Criteria in Solid Tumors version 1.1. Safety evaluations included treatment-emergent adverse events (TEAEs). Results: 20 patients were enrolled in the study and included in both efficacy and safety analyses. Median total study duration was 759.5 days. Median dose intensity was 201.3 mg/ day. Confirmed ORR was 60.0% (90% confidence interval [CI]=39.4–78.3); 2 patients had complete response and 10 patients had partial response. Median duration of response was 9.9 months (95% CI=3.9–26.9) and the disease control rate was 90.0% (95% CI=68.3–98.8).The most common TEAEs were anemia (n=15), nausea (n=12), and decreased platelet count (n=11). TEAEs leading to study drug dose reduction, interruption, or discontinuation were reported in 16 (80.0%), 15 (75.0%), and 2 patients (10.0%), respectively. Conclusion The long-term efficacy and safety profile of niraparib was consistent with previous findings in the equivalent population in non-Japanese patients. No new safety signals were identified.

Background: The anti-programmed death 1 (PD-1) antibody has led to durable clinical responses in a wide variety of human tumors. We have previously developed the caninized anti-canine PD-1 antibody (ca-4F12-E6) and evaluated its therapeutic properties in dogs with advance-staged oral malignant melanoma (OMM), however, their therapeutic effects on other types of canine tumors remain unclear. Objective: The present clinical study was carried out to evaluate the safety profile and clinical efficacy of ca-4F12-E6 in dogs with advanced solid tumors except for OMM. Methods: Thirty-eight dogs with non-OMM solid tumors were enrolled prospectively and treated with ca-4F12-E6 at 3 mg/kg every 2 weeks of each 10-week treatment cycle. Adverse events (AEs) and treatment efficacy were graded based on the criteria established by the Veterinary Cooperative Oncology Group. Results: One dog was withdrawn, and thirty-seven dogs were evaluated for the safety and efficacy of ca-4F12-E6. Treatment-related AEs of any grade occurred in 13 out of 37 cases (35.1%).Two dogs with sterile nodular panniculitis and one with myasthenia gravis and hypothyroidism were suspected of immune-related AEs. In 30 out of 37 dogs that had target tumor lesions, the overall response and clinical benefit rates were 6.9% and 27.6%, respectively. The median progression-free survival and overall survival time were 70 days and 215 days, respectively. Conclusions The present study demonstrated that ca-4F12-E6 was well-tolerated in nonOMM dogs, with a small number of cases showing objective responses. This provides evidence supporting large-scale clinical trials of anti-PD-1 antibody therapy in dogs.

A 77-year-old woman underwent endovascular abdominal aortic repair (EVAR) for an abdominal aortic aneurysm (AAA)．Five years after surgery, she visited the hospital with the chief complaint of a fever. Enhanced computed tomography (CT) showed enlargement of the AAA around the stent-graft and a mass, which was suspected to be an abscess, outside the aneurysm. A blood test revealed a high level of inflammatory response. The patient was diagnosed with infectious AAA. She received antibiotics; however, the inflammatory response did not completely improve. A second CT scan revealed that the suspected abscess had a spreading tendency. The patient was referred to our hospital for a highly suspected stent-graft infection. We performed Y-graft replacement using a rifampicin-immersed graft, and as much as possible of the wall around the aortic aneurysm was removed. The inflammatory response improved rapidly after the operation, and the patient was discharged 15 days later. According to the results of a pathological examination, a diagnosis of xanthogranulomatous inflammation and fibrosis was made. Here, we report a rare case of xanthogranulomatous inflammation of the aortic aneurysm wall after EVAR.

We report a case of a 72-year-old woman with a tumor arising from a colostomy site that had been created 25 years earlier when rectal amputation was performed for perforated sigmoid cancer. She was referred to our hospital due to complaints of pain from the colostomy. The diagnosis was carcinoma arising at the colostomy site with lymph node metastasis. Laparoscopic surgery was performed by attaching an Applied Alexis® wound retractor to the incision site of the colostomy. Lymph node dissection was performed and the left hemicolon was resected. Carcinoma arising from a colostomy site is rare. Laparoscopic surgery was considered to be a useful procedure because it allows for lymph node dissection and intestinal mobilization with minimal invasiveness.

Objective: In many medical institutions in Japan, 10% lidocaine gel is prepared as an in-hospital formulation to treat intractable neuropathic pain. Clinical studies have reported the short-term efficacy of topical lidocaine therapy for neuropathic pain, while there are few reports in real-world practice. To clarify the clinical usage and its usefulness, in this study, we investigated the duration of use, amount, effectiveness, and safety of 10% lidocaine gel.Design: We conducted a retrospective study investigating the actual usage of 10% lidocaine gel using electronic medical records.Methods: This study included 74 patients treated with 10% lidocaine gel in Kyoto University Hospital between July 2019 and January 2022. Information about disease (purpose of use), concomitant medications and other background information of the patients were collected. In addition, the duration of use, amount, adverse events, and discontinuation of 10% lidocaine gel were investigated. Effectiveness was determined by physician interviews and the pain visual analogue scale (VAS).Results: Ten percent lidocaine gel was used primarily to treat postherpetic neuralgia and, in some cases, other types of chronic pain for a median duration of use of 3.2 months (0.03-118.5). Pain relief was achieved in 73.3% of patients according to physician interviews, with a significant decrease in the VAS score. Although adverse events were observed in 12 patients (16.2%), including skin problems (12.2%), paralysis (4.1%), and somnolence (1.4%), eight patients continued to use 10% lidocaine gel after their occurrence. Three patients discontinued it due to adverse events, and their symptoms subsequently improved thereafter.Conclusion: The present results suggest that 10% lidocaine gel is effective and safe even when used for a long-time. Although this is a single-center study, it is the first systematic investigation of real-world usage of an in-hospital formulation of 10% lidocaine gel and is expected to assist clinical practice and drug development.

The patient was an 80-year-old man who was diagnosed with cStage IIIB non-small cell lung cancer (NSCLC) and early gastric cancer. The advanced lung cancer was treated with chemotherapy while the gastric cancer was monitored. Immune checkpoint inhibitors were effective against the lung cancer for a long period, but new gastric cancer appeared and progressed to an advanced stage, necessitating total gastrectomy 5 years after the diagnosis of NSCLC. The patient is currently being treated with a molecular targeted agent for progression of the lung cancer after gastrectomy. In the future, the number of cases with multiple primary cancers will increase alongside aging of the population and advances in cancer treatment, and a system for tumor-agnostic treatment selection and medical treatment will be necessary.

We investigated the efficacy of choreitogoshimotsuto for radiation hemorrhagic cystitis. Of the 11 patients who could be followed up, hematuria disappeared in 8 cases. The median time to disappearance of gross hematuria was 74 days. There was no recurrence. Of the 3 ineffective patients, one had urinary diversion, and two had transurethral electrocoagulation and hyperbaric oxygen therapy. There were no adverse events associated with the use of choreitogoshimotsuto. Choreitogoshimotsuto might be effective for radiation hemorrhagic cystitis.