Safety of influenza vaccination on adverse birth outcomes among pregnant women: A prospective cohort study in Japan.

BACKGROUND: Pregnant women are in the highest priority group for receiving influenza vaccination. However, they may be reluctant to receive the vaccination due to concerns about the influence of vaccination on the fetuses. METHODS: This prospective cohort study of 10 330 pregnant women examined the safety of influenza vaccination in terms of adverse birth outcomes. Influenza vaccination during pregnancy was determined from questionnaires before and after the 2013/2014 influenza season. All subjects were followed until the end of their pregnancy. Adverse birth outcomes, including miscarriage, stillbirth, preterm birth, low birth weight, and malformation, were assessed by obstetrician reports. RESULTS: Adverse birth outcomes were reported for 641 (10%) of the 6387 unvaccinated pregnant women and 356 (9%) of the 3943 vaccinated pregnant women. Even after adjusting for potential confounders, vaccination during pregnancy showed no association with the risk of adverse birth outcomes (odds ratio 0.90, 95% confidence interval 0.76-1.07). Vaccination during the first or second trimester displayed no association with adverse birth outcomes, whereas vaccination during the third trimester was associated with a decreased risk of adverse birth outcomes (odds ratio 0.70, 95% confidence interval 0.51-0.98). CONCLUSIONS: Influenza vaccination during pregnancy did not increase the risk of adverse birth outcomes, regardless of the trimester in which vaccination was performed, when compared to unvaccinated pregnant women.

[A Case of Recurrent Small Bowel Cancer That Successfully Responded to Chemoradiation Therapy].

Primary small bowel cancer is a rare entity; thus, it is often found in progress. Therefore, the prognosis is often poor. Because of its low frequency, there are few reports concerning the treatment for small bowel cancer; hence, it is important to examine individual cases in detail. In this study, we present a case of recurrent small bowel cancer that successfully responded to chemoradiation therapy. Case: A 48-year-old woman had anemia. Colonoscopy showed a tumor in the terminal ileum. Because of invasion in the ovaries and uterus, ileocecal resection, hysterectomy, and bilateral adnexectomy were performed. The pathological diagnosis was small bowel cancer with lymph node metastasis, and CapeOX therapy was administered as postoperative adjuvant chemotherapy. Since local recurrence was detected in the right lower quadrant 6 months after the surgery, IRIS plus BV was initiated. Radiation therapy(2Gy×25 times, total 50 Gy)was also administered within the same period(only S-1 administration during radiation). After radiation therapy, the tumor decreased significantly in size and showed CR. Currently, the patient is under observation without treatment, but she has had no recurrence for 6 years after the confirmation of recurrence(6 years and 6 months after surgery). It is extremely rare for chemoradiation therapy to be effective for recurrent small bowel cancer; we report such a case with literatures.

[Neoadjuvant Proton Beam Chemoradiotherapy for Locally Advanced Gall Bladder Cancer-A Case Report].

A 67-year-old man visited our hospital due to progressing appetite loss and fever. He presented with a fist-sized palpable mass in his right hypochondrium. Abdominal CT showed a 10 cm diameter tumor that originated from the gall bladder infiltrating the abdominal wall, liver, duodenum, and colon. Blood tests revealed leukocytosis, elevated C-reactive protein level, and severe malnutrition. FDG-PET showed markedly high uptake in the tumor and diffuse uptake in the spine. Owing to the inability of oral intake, he underwent laparoscopic gastrojejunostomy and intraoperative tumor biopsy, which demonstrated pathologically G-CSF-producing carcinoma in the gall bladder. For the rapidly progressive tumor, he underwent proton beam chemoradiotherapy as preoperative treatment. The tumor markedly shrunk with dramatic improvement of his inflammatory and nutritional status. Consequently, R0 resection could be performed by combination surgeries of right hemi-colectomy, pancreatoduodenectomy, and partial liver resection. He received adjuvant chemotherapy and was alive without recurrence 12 months after tumor resection. To our knowledge, this is the first report of the use of neoadjuvant proton beam chemoradiotherapy in biliary cancer.

Protective Effect of Maternal Influenza Vaccination on Influenza in Their Infants: A Prospective Cohort Study.

Background: Infants <6 months of age are too young to receive influenza vaccine, despite being at high risk for severe influenza-related complications. Methods: To examine the effectiveness of maternal influenza vaccination in preventing influenza in their infants, we conducted a prospective cohort study of 3441 infants born at participating hospitals before the 2013-2014 influenza season. At the time of recruitment, their mothers completed a questionnaire about influenza vaccination status for the 2013-2014 season. A follow-up survey was conducted after the end of the 2013-2014 season to collect information regarding influenza diagnosis and hospitalization among infants. Results: During the 2013-2014 influenza season, 71 infants (2%) had influenza diagnosed, and 13 infants (0.4%) were hospitalized with influenza. Maternal influenza vaccination (especially prenatal vaccination) decreased the odds of influenza among infants. The effectiveness of prenatal vaccination was 61% (95% confidence interval, 16%-81%), whereas that of postpartum vaccination was 53% (-28%-83%). Although maternal influenza vaccination was also associated with a decreased odds of influenza-related hospitalization among infants, vaccine effectiveness (73%) did not reach statistical significance, owing to the limited number of infants hospitalized because of influenza. Conclusions: The present findings indicated that pregnant women and postpartum women should receive influenza vaccination to protect their infants.

Estimating influenza disease burden among pregnant women: Application of self-control method.

To evaluate influenza disease burden among pregnant women, an epidemiological study using the self-control method was conducted. Study subjects were 12,838 pregnant women who visited collaborating maternity hospitals and clinics in Osaka Prefecture, Japan, before the 2013/14 influenza season. As a study outcome, hospitalization due to respiratory illnesses between the 2010/11 and 2013/14 seasons was collected from each study subject through a baseline survey at the time of recruitment and a second survey after the 2013/14 season. The hospitalization rates during pregnancy and non-pregnancy periods was calculated separately. To compare the hospitalization rate during pregnancy with that during non-pregnancy within the same single study subject, Mantel-Haenzel rate ratios (RRMH) were calculated. During the four seasons examined in this study, nine and 17 subjects were hospitalized due to respiratory illnesses during pregnancy and non-pregnancy periods, respectively. The hospitalization rate was 2.54 per 10,000 woman-months during pregnancy and 1.08 per 10,000 woman-months during non-pregnancy. The RRMH for the hospitalization rate during pregnancy compared with that during non-pregnancy was 4.30 (95% confidence interval, 1.96-9.41). Our results suggest that during the influenza season, pregnant women have a higher risk than non-pregnant women for hospitalization due to respiratory illnesses. The self-control method appears to be an appropriate epidemiological method for evaluating the disease burden of influenza among pregnant women.

[A Case of Pathological Complete Response Following Neoadjuvant Chemotherapy with Gemcitabine plus Nab-Paclitaxel in Borderline Resectable Pancreatic Cancer].

We report a resected case with a pathological complete response(pCR)after neoadjuvant chemotherapy for borderline resectable pancreatic cancer(BRPC). A 67-year-old woman who had been treated for type 2 diabetes mellitus in our hospital presented with an exacerbation of diabetes. An abdominal CT scan confirmed a hypovascular mass in the pancreas body consistent with BRPC. After 3 courses of chemotherapy with gemcitabine plus nab-paclitaxel(GnP), her elevated DUPAN-2 level normalized. A follow up CT scan revealed that the tumor had decreased in size, and no distant metastasis was detected. Distal pancreatectomy with en-bloc celiac axis resection was performed. Histopathological examination of the resected specimens showed no evidence of residual cancer cells(pCR). The patient remains disease-free 8 months after surgery. Neoadjuvant GnP chemotherapy may be useful for BRPC.

Effectiveness of an influenza A (H1N1) 2009 monovalent vaccine among Japanese pregnant women: a prospective observational study assessing antibody efficacy.

In order to estimate the effectiveness of an influenza A (H1N1) 2009 monovalent vaccine among pregnant women, we prospectively observed 135 Japanese pregnant women who received an influenza A (H1N1) 2009 monovalent vaccine during November 2009. We calculated an index of "antibody efficacy", in which the medical visits for respiratory illnesses were compared between those with and without post-vaccination hemagglutination inhibition (HI) titer ≥1:40. The product of antibody efficacy and achievement rate is theoretically equivalent to the vaccine effectiveness. Among all subjects, an inverse but non-significant relationship during the epidemic period was observed between post-vaccination HI titer ≥1:40 and medical visits for respiratory illnesses. After stratification by trimester at recruitment, a significant inverse association during the epidemic period was found among subjects in the first or second trimester (antibody efficacy: 91%, vaccine effectiveness: 79%). The influenza A (H1N1) 2009 monovalent vaccine administered in the first or second trimester reduced medical visits for respiratory illnesses among Japanese pregnant women.

Immunogenicity of a monovalent 2009 influenza A (H1N1) vaccine among pregnant women: lowered antibody response by prior seasonal vaccination.

BACKGROUND: Pregnant women are a high-risk group for influenza-associated complications and hospitalizations. METHODS: To examine the immunogenicity of a monovalent 2009 influenza A (H1N1) vaccine among pregnant women, a prospective cohort study was performed at 2 medical institutes of obstetrics in Japan. One hundred fifty subjects received 2 subcutaneous doses of vaccine 3 weeks apart. The hemagglutination inhibition antibody titer was measured in serum samples collected at 3 time points: before vaccination, 3 weeks after the first dose, and 4 weeks after the second dose. RESULTS: The first dose of vaccine induced a ≥ 10-fold rise in the average level of antibody. The seroresponse rate (≥4-fold rise) was 91%, and the seroprotection rate (postvaccination titer ≥ 1:40) was 89%. The second dose of vaccine conferred little additional induction of antibodies. Similar immune responses were observed irrespective of body mass index before pregnancy, trimester, or age at vaccination. However, lesser immune response was shown in subjects who had received the 2009-2010 seasonal influenza vaccine before the H1N1 vaccination. CONCLUSIONS: A single dose of vaccine induced an adequately protective level of immunity in pregnant women. The potential interference with seasonal vaccination requires a more thorough investigation to prepare for future influenza pandemics.