Sayaka Fujii

Safety and efficacy of gemcitabine and trastuzumab in HER2-directed therapy pretreated patients with HER2-positive metastatic breast cancer: SBP-01 study.

142 Background: Prognosis of HER2-positive metastatic breast cancer (MBC) has been dramatically improved by trastuzumab (Tmab). More recently, newer anti-HER2 agents such as lapatinib, pertuzumab and T-DM1 have prolonged survival. Despite the efficacy of these drugs, most patients develop progressive disease during or after treatment, and alternative anti-HER2 agents plus chemotherapies are required in subsequent lines of treatment. However, there are few evidence on efficacy of Tmab-containing regimens after disease progression. Gemcitabine (GEM) is non-cross resistant to anthracycline and taxane. Preclinical studies have shown that the combination of Tmab and GEM has synergistic effect against HER2-positive breast cancer cell lines. SBP-01 study assessed the efficacy and safety of the combination of Tamb and GEM in patients with HER2-positive MBC previously treated with anti-HER2 therapy. METHODS SBP-01 study included patients treated with one or more anti-HER2 directed regimens for MBC. Patients were administered with GEM 1250 mg/m2 on days 1 and 8 of each 21-day cycle and Tmab 4mg/kg loading dose and then 2mg/kg weekly. The primary endpoint was objective response rate (ORR). Secondary endpoints included progression free survival (PFS), overall survival, and safety. RESULTS Between June 2011 and June 2014, 35 patients were enrolled. Patients had ER positive tumor (37.1%), a median of 2 metastatic organ sites, visceral metastasis (80.0%), prior (neo) adjuvant Tmab (22.9%) and a median of 2 prior chemotherapy regimens for MBC. Previous HER2-directed drugs included Tmab (94.3%), lapatinib (37.1%), T-DM1 (8.6%) and pertuzumab (2.9%). ORR was 22.9% (95% CI, 8.6%-36.8%). Median PFS was 146 days. Patients with stable disease response received a median of 7 cycles (6-28 cycles) of treatment. Grade3/4 leukopenia (20.0%) and neutropenia (48.6%) were observed. All non-hematological toxicities were less than grade3. CONCLUSIONS The Combination Tmab and GEM is effective and well-tolerated regimen for patients previously treated with HER2-directed therapy, and appears to make disease stable for long time period. CLINICAL TRIAL INFORMATION UMIN000005881.

成人鼠径ヘルニア手術症例の臨床的検討：Mesh plug 法と PROLENE hernia system の比較

To compare the results of the PROLENE hernia system (PHS) and mesh-plug technique (MPT), a retrospective study of adult patients with inguinal hernia was performed. The total number of inguinal herniorrhaphies for the past 9 years was 376, and the numbers of operative treatments by PHS, MPT and the Bassini procedure were 79, 291 and 6, respectively. There were no significant differences either in the operating time or the hospitalization days. No postoperative complications were observed in the PHS group; however, 8 complications were found among the 291 cases (2.75 %) of the MPT group (hematoma, 3 ; seroma, 2 ; testitis, 1 ; mesh infection, 2). Out of the total 376 cases, the number of initial and recurrence cases was 355 and 21, respectively, and out of the 21 recurrence cases the number of initial surgeries by Bassini and MPT was 14 and 7, respectively. Among the 21 recurrence cases there were no recurrences after PHS.

A retrospective study of the PROLENE hernia system compared with the mesh‑plug technique

To compare the results of the PROLENE hernia system (PHS) and mesh-plug technique (MPT), a retrospective study of adult patients with inguinal hernia was performed. The total number of inguinal herniorrhaphies for the past 9 years was 376, and the numbers of operative treatments by PHS, MPT and the Bassini procedure were 79, 291 and 6, respectively. There were no significant differences either in the operating time or the hospitalization days. No postoperative complications were observed in the PHS group; however, 8 complications were found among the 291 cases (2.75 %) of the MPT group (hematoma, 3 ; seroma, 2 ; testitis, 1 ; mesh infection, 2). Out of the total 376 cases, the number of initial and recurrence cases was 355 and 21, respectively, and out of the 21 recurrence cases the number of initial surgeries by Bassini and MPT was 14 and 7, respectively. Among the 21 recurrence cases there were no recurrences after PHS.