Safety and Effectiveness of Trastuzumab Biosimilar SB3 in Korean Patients, a Post-Marketing Surveillance Study.

INTRODUCTION: SB3 is a trastuzumab biosimilar approved in Australia, Brazil, Canada, the European Union, the Republic of Korea, Switzerland, and the United States. This real-world study evaluated safety and effectiveness of SB3 as part of the Korean post approval safety management system. METHODS: This post-marketing surveillance in Korea included patients in line with approved indications, i.e. patients with early or metastatic breast cancer or metastatic gastric cancer. Safety outcomes were adverse events and adverse drug reactions. Effectiveness outcomes were tumor response and event-free survival. RESULTS: 424 patients were evaluated: 366 patients (86%) with early breast cancer, 53 patients (13%) with metastatic breast cancer, and 5 patients (1%) with metastatic gastric cancer. Among patients with breast cancer, adverse events (mostly mild) and adverse drug reactions were reported by 158 (37.7%) and 57 (13.6%) patients, respectively. Most patients with an AE (141, 75.9%) had no change in treatment schedule. Treatment was temporarily suspended in 14 (8.2%) patients with an AE and completely discontinued in 7 (3.7%). Among patients with early and metastatic breast cancer who were evaluated for efficacy, objective response rates were 82.7% and 38.3%, respectively. Pathological complete response was 64.6% in patients with early breast cancer. DISCUSSION/CONCLUSION: Safety and efficacy of SB3 demonstrated in this real-world study were comparable with previous studies of reference trastuzumab.

A case of parathyroid adenoma adjacent to the thoracic spine in a hemodialysis patient.

Ectopic parathyroid glands are detected occasionally, especially in cases of recurrent hyperparathyroidism after initial parathyroidectomy. Their ectopic locations usually result from faulty migration during embryogenesis. Ectopic parathyroid glands can be found within the thyroid gland, thymus, mediastinum, carotid sheath, or retropharynx, which lie along the path of their normal migration. Here we report a rare case of parathyroid adenoma adjacent to the thoracic spine in a hemodialysis patient who had undergone parathyroidectomy previously. A 67-year-old woman on maintenance hemodialysis since 1993 developed hyperparathyroidism. She underwent total parathyroidectomy with autotransplantation in 2007. Histological examination of the parathyroid glands showed hyperplasia in three glands and adenoma in one. Serum parathyroid hormone levels gradually increased after a year. Ultrasonography of the neck and upper limbs was negative, but technetium-99-sestamibi scanning showed focal uptake in the posterior mediastinum. Computed tomography and magnetic resonance imaging confirmed a tumor adjacent to the left costovertebral junction of the third thoracic vertebra. A tumor resection was performed in 2010, and histopathological examination showed a parathyroid adenoma. Parathyroid adenoma adjacent to the thoracic spine has not been reported previously, and our case suggests that technetium-9-sestamibi scanning is useful for the correct preoperative diagnosis of such rare cases of ectopic parathyroid glands.

Survey of the effects of a column for adsorption of ß2-microglobulin in patients with dialysis-related amyloidosis in Japan.

Dialysis-related amyloidosis is a serious complication of long-term hemodialysis. Its pathogenic mechanism involves accumulation of ß2-microglobulin in the blood, which then forms amyloid fibrils and is deposited in tissues, leading to inflammation and activation of osteoclasts. Lixelle, a direct hemoperfusion column for adsorption of ß2-microglobulin, has been available since 1996 to treat dialysis-related amyloidosis in Japan. However, previous studies showing the therapeutic efficacy of Lixelle were conducted in small numbers of patients with specific dialysis methods. Here, we report the results of a nationwide questionnaire survey on the therapeutic effects of Lixelle. Questionnaires to patients and their attending physicians on changes in symptoms of dialysis-related amyloidosis by Lixelle treatment were sent to 928 institutions that had used Lixelle, and fully completed questionnaires were returned from 345 patients at 138 institutions. The patients included 161 males and 184 females 62.9 ± 7.7 years age, who had undergone dialysis for 25.9 ± 6.2 years and Lixelle treatment for 3.5 ± 2.7 years. Based on self-evaluation by patients, worsening of symptoms was inhibited in 84.9-96.5% of patients. Of the patients, 91.3% felt that worsening of their overall symptoms had been inhibited, while attending physicians evaluated the treatment as effective or partially effective for 72.8% of patients. Our survey showed that Lixelle treatment improved symptoms or prevented the progression of dialysis-related amyloidosis in most patients.

Effectiveness of ß(2)-microglobulin adsorption column in treating dialysis-related amyloidosis: a multicenter study.

BACKGROUND/AIMS: The aim of this study was to determine whether treatment with ß(2)-microglobulin adsorption column (Lixelle) affects bone cysts and clinical symptoms in patients with dialysis-related amyloidosis (DRA). METHODS: Radiographic changes in the number and area of bone cysts of the wrist and the hip joint were compared between 39 hemodialysis (HD) patients treated with Lixelle (Lixelle group) and 28 HD patients treated with conventional therapy as retrospective control (HD group). Clinical symptoms of DRA were also evaluated. RESULTS: In the Lixelle group, the number of bone cysts and the cystic area in wrist joints were significantly decreased, although the changes in these parameters in hip joints were not significant. In the HD group, the corresponding parameters in the hip joints even significantly increased. Clinical symptoms notably improved after Lixelle treatment. CONCLUSION: Treatment with Lixelle reduces the radiolucency of bone cysts in the wrist joints, and improves clinical symptoms associated with DRA.

Reversed whole PTH/intact PTH ratio as an indicator of marked parathyroid enlargement: five case studies and a literature review.

Parathyroid hormone (PTH) levels detected by intact PTH assays are generally higher than those detected by the whole PTH assay because the latter does not detect non-(1-84) PTH fragments, mainly PTH (7-84). Rare exceptions to this rule have been reported in patients with severe primary or secondary hyperparathyroidism and parathyroid carcinoma. Overproduction of an N-form of PTH other than PTH (1-84) has been observed in the sera of these patients. We report five additional cases with the reversed whole PTH/intact PTH ratio associated with severe hyperparathyroidism in haemodialysis patients. Three patients demonstrated enlargement of a single hypervascular gland, whereas the other two had undergone surgical parathyroidectomy and later showed recurrent hyperparathyroidism due to progressive autograft hyperplasia. In the case of a single enlarged gland, the pathological pattern and heterogeneous expression of parathyroid adenomatosis 1/cyclin D1 suggested it to be a single nodule of uraemic hyperparathyroidism rather than sporadic primary adenoma. These cases suggested that the reversed whole PTH/intact PTH ratio could be an indicator of marked parathyroid enlargement. Further studies are required to elucidate the clinical significance of the reversed whole PTH/intact PTH ratio in haemodialysis patients.

[2 dialysis cases which came to our clinic for the symptoms caused by hypercalcemia].

We'll report 2 dialysis cases which came to our clinic for the symptoms caused by hypercalcemia. Patients complained of sleeplessness, itching, headache, palpitation, apathy, akinesis, leanness, foot gangrene and so on. Hypercalcemia is one of the complication of vitamin D and calcium carbonate administration in chronic renal failure, though the frequency and risk are not clearly documented. Hypercalcemia aggravates the outcome of patients on dialysis and contributes to vascular calcification in long term. Recently various factors involving cardiovascular calcification are discussed, but first of all we must be very careful for the symptoms of hypercalcemia, and careful monitoring of plasma calcium concentration are recommended.