In this report, we introduce the importance of a system for sharing information about cancer molecular-targeted medicines from trial to the clinic by the department of knowledge education research, department of breast surgical oncology, department of cardiovascular internal medicine and department of dermatology at St. Luke’s International Hospital in Japan.  At present, information regarding the side effect(s) of a study drug does not reach doctors who are not members of the department in charge of the clinical trial.  The reason for this is because clinical trials are conducted under the legal constraints of GCP (Good clinical practice), and while safety information about any adverse events (side effects) is reported, it is limited to the level of an Institutional Review Board.  When there was an enquiry about a known side effect that had occurred to patients taking molecular-target medicine from a doctor who was not a member of the department in charge of the clinical trial, it became clear that information regarding the clinical trial medicine and non-approved medicine was not reaching the clinic.  We developed an original reporting system for such information that would offer the information using the same format as the clinical trial itself, as well as the department in which the side effect was treated, to resolve the problem of access to side effect information outside of the clinical trial itself.  We show that the reporting of such information leads to resolution of this problem.  We believe that this will relieve the patient and contribute to the clinical trial as well as to the department that deals with such side effects.

The external preparation Metronidazole (MTZ) is reported to be useful in controlling the malodor associated with advanced and recurrent breast cancer patients. We prepared two different MTZ external preparations, a 1% MTZ Hydrophilic Ointment and a 0.8% MTZ Carbopol Gel. These preparations were then used to control malodor associated with breast cancer and the results were clinically evaluated. Malodor disappeared within 1 week of administration of either preparation and no adverse reactions were observed. These MTZ external preparations were thus found to be useful in the elimination of malodor as part of the treatment of those patients with advanced and recurrent breast cancer.

An investigation on the efficacy of preoperative autologous blood donation in open-heart surgery was made using frozen red blood cells and MAP red blood cells in cooperation with the Red Cross Blood Center. In 109 cases which received the donation, the rate of cases which received no homologous blood transfusion was 93.6% (35.3% in the cases without donation). Even in the cases of redo operation or aortic surgery, in which extensive blood loss is expected, 75% of those given a donation of 1600-2000ml frozen blood required no homologous blood transfusion. The hemoglobin concentration in the cases which received blood donation for more than 4 weeks did not decrease, indicating that safe donation is feasible. The aforementioned frozen and MAP blood preparations can be preserved for a long period so that blood donation can be started even before deciding on the date of operation. Also, its usefulness is not affected by the postponement of the operation. Furthermore, there was no problem in safety with respect to transfer, treatment, and storage of the autologous blood in cooperation with the Red Cross Blood Center, suggesting that this is useful as a preoperative donation method, especially in small- and middle-scale hospitals, which have no separate blood centers. However, there were 2 cases in which aggravated symptoms were noted after blood collection. Therefore, it is important to carefully select cases for autologous blood donation in open-heart surgery and it is desirable to set up appropriate donation schedules.

A 14-year-old women who had a history of aortic root replacement at 7 years old admitted our hospital due to dilatation of aortic arch aneurysm. Loeys-Dietz syndrome was diagnosed when she was 10 years old. Computed tomography showed 70 mm proximal arch aneurysm. Operative findings revealed brachiocephalic artery and left common carotid artery branched from aneurysm. Partial arch replacement was performed and distal anastomosis was made between left common carotid artery and left subclavian artery. Close observation by CT regularly is necessary and undergo aortic repair not to miss the timing of surgery.

Objective: BRCA1 and BRCA2 mutation carriers are recommended to undergo risk-reducing salpingo-oophorectomy (RRSO) by age 40 and 45, respectively. However, the carriers have a different way of thinking about their life plan. We aimed to investigate the distribution of age at diagnosis of ovarian cancer (OC) patients to examine the optimal timing of RRSO in the carriers. Methods: We examined a correlation between age at diagnosis of OC and common mutation types in 3,517 probands that received BRCA genetic testing. Among them, germline BRCA1 mutation (gBRCA1m), germline BRCA2 mutation (gBRCA2 m) and germline BRCA wild-type (gBRCAwt) were found in 185, 42 and 241 OC patients, respectively. Results: The average age at diagnosis of OC in gBRCA1m and gBRCA2 m was 51.3 and 58.3 years, respectively, and the difference from gBRCAwt (53.8 years) was significant. The gBRCA2 m carriers did not develop OC under the age of 40. The average age was 50.1 years for L63X and 52.8 years for Q934X in BRCA1, and 55.1 years for R2318X and 61.1 years for STOP1861 in BRCA2 . The age at diagnosis in L63X or R2318X carriers was relatively younger than other BRCA1 or BRCA2 carriers, however their differences were not significant. With L63X and R2318X carriers, 89.4% (42/47) and 100% (7/7) of women were able to prevent the development of OC, respectively, when RRSO was performed at age 40. Conclusion There appears to be no difference in the age at diagnosis of OC depending on the type of BRCA common mutation. Further analysis would be needed.

Objective: The drug use-results survey of Metronidazole gel (Rozex® gel 0.75%: hereinafter, this is called “this medicine”) was conducted for the purpose of assessing the safety and effectiveness of this medicine in clinical practice including long-term use. Methods: Patients who initiated treatment with this medicine for sterilization and reduction of odor at cancerous skin ulcer for the first time were registered by the central registration method. The longest period of observation was 1 year. Results: The safety analysis set included 301 patients. The incidence proportion of adverse drug reaction was 3.32% (in 10 of 301 patients), with no serious events. The overall improvement rate was 73.7% (in 205 of 278 patients). At the final observation, the improvement rate of odor by physician's assessment was 80.2% (in 203 of 253 patients) and the improvement rate of patient's satisfaction was 70.1% (in 82 of 117 patients), respectively. Conclusion: The present study demonstrated that this medicine is safe and effective for sterilization and reduction of odor at cancerous skin ulcer, and leads to high treatment satisfaction of patients.