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Mahlangu J.,Comprehensive Care | Powell J.S.,University of California at Davis | Ragni M.V.,University of Pittsburgh | Chowdary P.,Katharine Dormandy Haemophilia Center | And 24 more authors.

This phase 3 pivotal study evaluated the safety, efficacy, and pharmacokinetics of a recombinant FVIII Fc fusion protein (rFVIIIFc) for prophylaxis, treatment of acute bleeding, and perioperative hemostatic control in 165 previously treated males aged ≥12 years with severe hemophilia A. The study had 3 treatment arms: arm 1, individualized prophylaxis (25-65 IU/kg every 3-5 days, n = 118); arm 2, weekly prophylaxis (65 IU/kg, n = 24); and arm 3, episodic treatment (10-50 IU/kg, n = 23). a subgroup compared recombinant FVIII (rFVIII) and rFVIIIFc pharmacokinetics. End points included annualized bleeding rate (ABR), inhibitor development, and adverse events. The terminal half-life of rFVIIIFc (19.0 hours) was extended 1.5-foldvsrFVIII (12.4 hours; P <.001). Median ABRs observed in arms 1, 2, and 3 were 1.6, 3.6, and 33.6, respectively. In arm 1, the median weekly dose was 77.9 IU/kg; approximately 30% of subjects achieved a 5-day dosing interval (last 3 months on study). Across arms, 87.3% of bleeding episodes resolved with 1 injection. Adverse events were consistent with those expected in this population; no subjects developed inhibitors. rFVIIIFc was well-tolerated, had a prolonged half-life compared with rFVIII, and resulted in low ABRs when dosed prophylactically 1 to 2 times per week. This trial was registered at www.clinicaltrials.gov as #NCT01181128. © 2014 by The American Society of Hematology. Source

Nakamura S.,Ogikubo Hospital
Hand surgery : an international journal devoted to hand and upper limb surgery and related research : journal of the Asia-Pacific Federation of Societies for Surgery of the Hand

To the best of our knowledge, there are no previous reports on anterior interosseous nerve palsy (AINP) caused by a soft tissue tumor after fracture of the distal radius. We treated a case of giant forearm lipoma that caused AINP one day after internal fixation of a distal radius fracture. Source

Yoshikawa T.,Ogikubo Hospital
Gan to kagaku ryoho. Cancer & chemotherapy

Several technological advances have been made in laparoscopic surgery, and the use of reduced port surgery (RPS)has gradually become widespread. To assess the safety and usefulness of RPS, we compared the short -term outcomes of conventional laparoscopy-assisted total gastrectomy(LATG)and LATG with the RPS approach. From April 2009 to February 2012, 16 cases with gastric cancer underwent conventional LATG with 5 ports as well as minilaparotomy for anastomosis(Conventional group). From February 2012 to November 2012, 12 cases underwent RPS LATG(RPS group). In the RPS group, a multi-instrument port at the umbilicus was used during surgery. This port held 3 trocars and 2 5-mm trocars that were inserted under the right lumbocostal arch. The mean operation time was 333 minutes in the Conventional group, and 370 minutes in the RPS group. The mean postoperative hospital stay was 23 days in the Conventional group, and 17 days in the RPS group. Postoperative mortality was 0% in both groups. Anastomotic leakage occurred in 2 cases in the Conventional group, whereas pancreatic fistula occurred in 2 cases in the RPS group. Due to postoperative bleeding, 1 case in the RPS group underwent redo laparoscopic operation. Anastomotic stenosis was noted in 4 cases in each group. The patients with stenosis required endoscopic balloon dilation several times and the symptom eventually resolved in all cases. By comparing the short-term outcomes for conventional LATG and RPS LATG, we noted that reduced port laparoscopy-assisted total gastrectomy is a feasible procedure. Source

Yabe N.,Ogikubo Hospital
Gan to kagaku ryoho. Cancer & chemotherapy

A 78-year-old man was admitted to Ogikubo Hospital for pancreatic tumors detected by computed tomography (CT). The patient had undergone right nephrectomy for renal cell carcinoma (RCC) 27 years previously. Dynamic CT revealed a hypervascular mass in the pancreatic head and a cystic mass in the pancreatic body that were approximately 35 mm and 20 mm in size, respectively. Total pancreatectomy and splenectomy were performed. Histological examination of the resected specimens revealed metastatic tumors from RCC and they were diagnosed as clear cell type. Metastatic carcinoma of the pancreas is uncommon. Pancreatic metastasis from RCC is rare; however, it could occur many years after the initial diagnosis and treatment of the primary tumor. A long and careful follow-up that includes examination of the pancreas is mandatory after nephrectomy for RCC. In this paper, we discuss a case of RCC metastasis to the pancreas and report it in the literature. Source

A 71-year-old postmenopausal woman was undergoing treatment for depression. She visited the hospital with a chief complaint of fibrosclerosis of the entire left breast 8 years previously. She was diagnosed as having stage IV( T3N1M1b) left breast cancer (papillotubular>scirrhous carcinoma, g+, f+, estrogen receptor [ER]-negative, progesterone receptor [PgR]-negative, and human epidermal growth factor receptor 2[ HER2/neu]-positive[ 3+]). Synchronous bone metastases were detected in the left tenth rib, the eleventh dorsal vertebra, and in the area spanning the lower lumbar to sacral vertebrae. First-line treatment was systemic therapy with 4 cycles of Adriamycin and cyclophosphamide (AC) followed by 4 cycles of trastuzumab and paclitaxel. The breast mass initially observed on clinical imaging disappeared and only calcifications were observed. Bone metastases were detected only in the left tenth rib. As an additional therapy, 3-dimensional radiotherapy( 50 Gy/25 fractions), which irradiated the left mammary gland, axilla, and supraclavicular fossa, was administered. The tumor was well controlled for approximately 3 years. However, a gradual increase in the level of carcinoembryonic antigen( CEA) was accompanied by an increase in the left breast mass and enlargement of left axillary lymph nodes. Modified radical mastectomy (Bt+Ax [level I]) was performed for this condition 3 years ago. Papillotubular-type invasive ductal carcinoma (INF β, ly3, v0, g+, f+, s+, nuclear grade 3 [atypia 3+mitosis 3]) was diagnosed histopathologically. Lymph node metastases were also detected. As histopathological examination of the bone metastatic lesion showed no progression, administration of lapatinib and capecitabine was initiated. After 15 cycles of treatment, enlarged right axillary lymph nodes were observed and local excision was performed. Histopathological examination revealed recurrence of the breast cancer. The patient was diagnosed as having grade 3( atypia 3, mitosis 2) breast cancer( ER-negative, PgR-negative, HER2/neu positive[ 3+], and MIB-1 index 50%). The response to treatment with lapatinib and capecitabine was progressive disease( PD), and therefore, trastuzumab and gemcitabine therapy was selected. Currently, the patient has undergone 30 cycles of this regimen and the tumor is well controlled. This regimen was considered effective for the treatment of patients with HER2-positive metastatic breast cancer. Source

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