Investigation of the Safety and Effectiveness of Metronidazole Gel (Rozex® gel 0.75%) on Sterilization and Reduction of Odor at Cancerous Skin Ulcer (Drug Use-results Survey)

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.

Differences in age at diagnosis of ovarian cancer for each BRCA mutation type in Japan: optimal timing to carry out risk-reducing salpingo-oophorectomy / 부인종양

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.

Development an original reporting system ; from trial to the clinic / 医薬品情報学

  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.

Clinical efficacy of the external preparation Metronidazole in the treatment of malodor associated with advanced and recurrent breast cancer

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.