Novel Algorithm for the Estimation of Cancer Incidence Using Claims Data in Japan: A Feasibility Study.

PURPOSE: We developed algorithms to identify patients with newly diagnosed cancer from a Japanese claims database to identify the patients with newly diagnosed cancer of the sample population, which were compared with the nationwide cancer incidence in Japan to assess the validity of the novel algorithms. METHODS: We developed two algorithms to identify patients with stomach, lung, colorectal, breast, and cervical cancers: diagnosis only (algorithm 1), and combining diagnosis, treatments, and medicines (algorithm 2). Patients with newly diagnosed cancer were identified from an anonymized commercial claims database (JMDC Claims Database) in 2017 with two inclusions/exclusion criteria: selecting all patients with cancer (extract 1) and excluding patients who had received cancer treatments in 2015 or 2016 (extract 2). We estimated the cancer incidence of the five cancer sites and compared it with the Japan National Cancer Registry incidence (calculated standardized incidence ratio with 95% CIs). RESULTS: The number of patients with newly diagnosed cancer ranged from 219 to 17,840 by the sites, algorithms, and exclusion criteria. Standardized incidence ratios were significantly higher in the JMDC Claims Database than in the national registry data for extract 1 and algorithm 1, extract 1 and algorithm 2, and extract 2 and algorithm 1. In extract 2 and algorithm 2, colorectal cancer in male and stomach, lung, and cervical cancers in females showed similar cancer incidence in the JMDC and national registry data. CONCLUSION: The novel algorithms are effective for extracting information about patients with cancer from claims data by using the combined information on diagnosis, procedures, and medicines (algorithm 2), with 2-year cancer-treatment history as an exclusion criterion (extract 2).

The Japanese Guidelines for Breast Cancer Screening.

OBJECTIVE: The incidence of breast cancer has progressively increased, making it the leading cause of cancer deaths in Japan. Breast cancer accounts for 20.4% of all new cancers with a reported age-standardized rate of 63.6 per 100 000 women. METHODS: The Japanese guidelines for breast cancer screening were developed based on a previously established method. The efficacies of mammography with and without clinical breast examination, clinical breast examination and ultrasonography with and without mammography were evaluated. Based on the balance of the benefits and harms, recommendations for population-based and opportunistic screenings were formulated. RESULTS: Five randomized controlled trials of mammographic screening without clinical breast examination were identified for mortality reduction from breast cancer. The overall relative risk for women aged 40-74 years was 0.75 (95% CI: 0.67-0.83). Three randomized controlled trials of mammographic screening with clinical breast examination served as eligible evidence for mortality reduction from breast cancer. The overall relative risk for women aged 40-64 years was 0.87 (95% confidence interval: 0.77-0.98). The major harms of mammographic screening were radiation exposure, false-positive cases and overdiagnosis. Although two case-control studies evaluating mortality reduction from breast cancer were found for clinical breast examination, there was no study assessing the effectiveness of ultrasonography for breast cancer screening. CONCLUSIONS: Mammographic screening without clinical breast examination for women aged 40-74 years and with clinical breast examination for women aged 40-64 years is recommended for population-based and opportunistic screenings. Clinical breast examination and ultrasonography are not recommended for population-based screening because of insufficient evidence regarding their effectiveness.

Is clinical breast examination effective in Japan? Consideration from the age-specific performance of breast cancer screening combining mammography with clinical breast examination.

BACKGROUND: There is controversy about the value of clinical breast examination (CBE) in breast cancer screening programs that include mammography. METHODS: In Fukui Prefecture, a screening combining mammography with CBE was employed on 62,447 women from 2004 to 2009. We examined the sensitivity and specificity of mammography alone, and mammography and CBE together for each age group (40-49, 50-59, 60-69, and 70-79). RESULTS: 167 breast cancers and 49 false-negative cancers were detected during 5 years. For the combined screening, the sensitivities were 73.1, 74.1, 78.3, and 86.5 %, and the specificities were 83.8, 87.5, 89.8, and 90.9 % in the groups of 40-49, 50-59, 60-69, and 70-79 years, respectively. In the mammography-specific analysis, sensitivity decreased to 69.8 % (-3.3 %), 66.7 % (-7.7 %), 77.3 % (-1.0 %), and 83.8 % (-2.7 %) in the groups of 40-49, 50-59, 60-69, and 70-79 years, respectively. There were greater reductions in the groups of 40-49 and 50-59 years than in those of 60-69 and 70-79 years, but there was no statistically significant decrease. Specificity generally increased with increasing age and there was a significant improvement in specificity among all age groups, except that of 70-79 years. CONCLUSIONS: Our findings suggest that there is a trade-off between sensitivity and specificity associated with CBE added to mammography. This tendency is greater in those 40-50 years of age than in those 60-70 years of age. We consider that CBE may be omitted from breast cancer screening among women aged 60 and 70 years. Furthermore, another modality to complement mammography screening in younger Japanese women is expected.

A meta-analysis of mammographic screening with and without clinical breast examination.

Mammographic screening with clinical breast examination has been recommended in Japan since 2000. Although mammographic screening without clinical breast examination has not been recommended, its introduction is anticipated. The efficacies of mammographic screening with and without clinical breast examination were evaluated based on the results of randomized controlled trials. PubMed and other databases for studies published between 1985 and 2014 were searched. The study design was limited to randomized controlled trials to evaluate mortality reduction from breast cancer. Five studies were eligible for meta-analysis of mammographic screening without clinical breast examination. The relative risk for women aged 40-74 years was 0.75 (95% confidence interval, 0.67-0.83). Three studies evaluated the efficacy of mammographic screening with clinical breast examination. The relative risk for women aged 40-64 years was 0.87 (95% confidence interval, 0.77-0.98). The number needed to invite was always lower in mammographic screening without clinical breast examination than in mammographic screening with clinical breast examination. In both screening methods, the number needed to invite was higher in women aged 40-49 years than in women aged 50-70 years. These results suggest that mammographic screening without clinical breast examination can afford higher benefits to women aged 50 years and over. Although evidence of the efficacy of mammographic screening without clinical breast examination was confirmed based on the results of the randomized controlled trials, a Japanese study is needed to resolve local problems.

Harms of screening mammography for breast cancer in Japanese women.

BACKGROUND: The US Preventative Services Task Force assesses the efficacy of breast cancer screening by the sum of its benefits and harms, and recommends against routine screening mammography because of its relatively great harms for women aged 40-49 years. Assessment of the efficacy of screening mammography should take into consideration not only its benefits but also its harms, but data regarding those harms are lacking for Japanese women. METHODS: In 2008 we collected screening mammography data from 144,848 participants from five Japanese prefectures by age bracket to assess the harms [false-positive results, performance of unnecessary additional imaging, fine-needle aspiration cytology (FNA), and biopsy and its procedures]. RESULTS: The rate of cancer detected in women aged 40-49 years was 0.28%. The false-positive rate (9.6%) and rates of additional imaging by mammography (5.8%) and ultrasound (7.3%) were higher in women aged 40-49 years than in the other age brackets. The rates of FNA (1.6%) and biopsy (0.7%) were also highest in women aged 40-49 years. However, they seemed to be lower than the rates reported by the Breast Cancer Surveillance Consortium (BCSC) and other studies in the US. CONCLUSIONS: The results, although preliminary, indicate the possibility that the harms of screening mammography for Japanese women are less than those for American women.

Clinical usefulness of high-dose toremifene in patients relapsed on treatment with an aromatase inhibitor.

BACKGROUND: Aromatase inhibitors (AIs) have been employed as adjuvant therapy or as treatment for recurrent cases. However, when AI treatment fails, it is unclear which endocrine therapy is the most appropriate to introduce at this point and how effective it will be. In this study, we investigated the efficacy and safety of toremifene (TOR, Fareston(®)), a selective estrogen receptor modulator (SERM). METHODS: Patients with recurrent or advanced breast cancer who had measurable or evaluable lesions, and were diagnosed as having progressive disease during AI treatment and subsequently given TOR at 120 mg/day (TOR120) as endocrine therapy were selected and analyzed retrospectively in relation to their medical history. RESULTS: Of a total of 83 cases examined, 80 were evaluable. The objective response rate (ORR) was 15.0% (12/80), the clinical benefit (CB) rate was 45.0% (36/80), and median time to failure (TTF) was 7.8 months. TOR120 was also effective in the progressive disease cases relapsed on AI treatment. When TOR120 was used, as a first-, second- or third-line treatment, the CB rate was 57% (32/56); this fell to 17% (4/24) when TOR120 was used as a fourth-line or later treatment. There was no response in the five estrogen receptor (ER)-negative cases, compared with an ORR of 15% (10/67) in ER-positive cases. In cases with a human epidermal growth factor receptor 2 (HER2) score of 0, 1+, and 2+, the ORR was 11% (7/61), while there was no response in the five cases with scores of 3+. TOR120 was effective in cases previously treated with tamoxifen (TAM), with an ORR and CB rate of 12 and 29%, respectively. The last AI used was anastrozole in 30 cases and examestane in 46; the response rates to TOR120 were similar in both groups. With regard to adverse effects, hot flushes and/or night sweating was observed in 10 and 12 cases, respectively, but all of them were categorized as grade 1, and the treatment was rated excellent in acceptability. CONCLUSIONS: TOR120 was rated excellent in acceptability, and high efficacy was observed when it was used up to third-line treatment for AI-failure cases, although this study may show some selection bias because of the retrospective study. In addition, it was also considered effective for TAM-failure cases.

Inflammatory pseudotumor of the breast in a patient with a high serum IgG4 level: histologic similarity to sclerosing pancreatitis.

The association between IgG4 and inflammatory pseudotumor was first reported with regard to pancreatic pseudotumor, which is well known as sclerosing pancreatitis or autoimmune pancreatitis. In addition, there is increasing evidence that IgG4 is also involved in inflammatory pseudotumor of the extrapancreatic tissue. In this report, we present a case of IgG4-related inflammatory pseudotumor of the breast. A 46-year-old woman presented with an induration in the left breast. Radiologic examination revealed an ill-circumscribed mass measuring 1.6 cm in diameter in the left breast. Breast cancer could not be ruled out radiologically, and excision biopsy was performed for a definite diagnosis. Histologically, this nodule was composed of an irregular proliferation of stromal cells associated with severe lymphoplasmacytic infiltration, obliterative phlebitis, and eosinophils. No atypical feature regarding the stromal cells or lymphocytes was observed. Furthermore, many plasma cells within the lesion were immunohistochemically positive for IgG4, and the serum IgG4 concentration of this patient was elevated on postoperative examination. This case suggests that inflammatory pseudotumor of the breast has a pathogenetic process similar to that of sclerosing pancreatitis. IgG4 might become a useful marker for inflammatory pseudotumor of the breast, and it might benefit from steroid therapy, as does sclerosing pancreatitis.

Remission of severe anemia persisting for over 20 years after eradication of Helicobacter pylori in cases of Ménètrier's disease and atrophic gastritis: Helicobacter pylori as a pathogenic factor in iron-deficiency anemia.

A man with a 20-year history of recurrent iron-deficiency anemia complicated by Helicobacter pylori-positive Ménètrier's disease was observed over a 10-year clinical course, during which time he was successfully treated for the anemia and a gastric Helicobacter pylori (H. pylori) infection through eradication. Considering the satisfactory therapeutic results in this case, we performed eradication therapy on another H. pylori-positive atrophic gastritis case with a 24-year history of iron-deficiency anemia of unknown etiology, and again, complete remission was obtained. The clinical evidence from these two cases suggests that the gastric H. pylori infection was deeply involved in the pathogeneses of the iron-deficiency anemia. We believe that these case reports will provide useful information on H. pylon-involved pathology in the fields of hematology and gastroenterology.

Percutaneous cholecystocholedochostomy for cholecystitis and cystic duct obstruction in gallbladder carcinoma.

Percutaneous cholecystocholedochostomy was performed in a patient with acute cholecystitis caused by cystic duct obstruction by gallbladder carcinoma, but removal of the percutaneous cholecystostomy catheter was unsuccessful because of continuing discharge. After creation of a cholecystocholedochostomy through the cholecystostomy tract with use of a transjugular liver access set and a 21-gauge needle, self-expandable metallic stents were placed in the narrowed common bile duct and the newly created tract between the gallbladder and the common hepatic duct. The external cholecystostomy catheter was successfully removed after the procedure. Jaundice occurred 70 days later as a result of tumor invasion above the segment with the stent, and an additional stent was placed. The patient died of diffuse metastasis 143 days after creation of the cholecystocholedochostomy without recurrence of cholecystitis.