Oxycodone controlled-release (CR) tablets are used as a first-line opioid analgesic for cancer pain. However, use of oxycodone CR tablets is associated with toxicities such as drowsiness and constipation, leading to deterioration of the quality of life (QOL), especially in patients with gynecologic cancer. In contrast, fentanyl has a superior toxicity profile while still showing a strong analgesic effect. Although fentanyl has been approved for switching from opioid, there have been no Japanese studies of patients with gynecologic cancer who were switched to transdermal fentanyl after experiencing toxicity during therapy with oxycodone CR. More importantly early introduction of palliative therapy for pain has not been adopted routinely in the management of gynecologic cancer. Thus, it appears that treatment for patients with gynecologic cancer remains unsatisfactory at present. We conducted research into improvement of the toxicity profile and pain control with the aim of improving QOL for patients with gynecologic cancer. We showed that pain, drowsiness, and constipation could be significantly improved in gynecologic cancer patients as a result of switching to transdermal fentanyl therapy at an early stage.

Objective: The purposes of this trial were to demonstrate the feasibility and effectiveness of the hybrid of intracavitary and interstitial brachytherapy (HBT) for locally advanced cervical cancer patients in the phase I/II prospective clinical trial. Methods: Patients with FIGO stage IB2-IVA uterine cervical cancer pretreatment width of which was ≥5 cm measured by magnetic resonance imaging were eligible for this clinical trial. The protocol therapy included 30–30.6 Gy in 15–17 fractions of whole pelvic radiotherapy concurrent with weekly CDDP, followed by 24 Gy in 4 fractions of HBT and pelvic radiotherapy with a central shield up to 50–50.4 Gy in 25–28 fractions. The primary endpoint of phase II part was 2-year pelvic progression-free survival (PPFS) rate higher than historical control of 64%. Results: Between October 2015 and October 2019, 73 patients were enrolled in the initial registration and 52 patients proceeded to the secondary registration. With the median follow-up period of 37.3 months (range, 13.9–52.9 months), the 2- PPFS was 80.7% (90% confidence interval [CI]=69.7%–88%). Because the lower range of 90% CI of 2-year PPFS was 69.7%, which was higher than the historical control ICBT data of 64%, therefore, the primary endpoint of this study was met. Conclusion The effectiveness of HBT were demonstrated by a prospective clinical study. Because the dose goal determined in the protocol was lower than 85 Gy, there is room in improvement for local control. A higher dose might have been needed for tumors with poor responses.

Objectives: A refill-prescription system startedin April, 2022 in Japan. Refill-prescriptions can be usedrepeatedly, but pharmacists are required to check patients' medication and determine whether refills are appropriate. This study aimed to clarify the actual status of community pharmacies' treatment of prescription refills and pharmacists’ concerns about them.Design: Questionnaire survey.Methods: A self-administered questionnaire survey was conducted for pharmacists at community pharmacies from June to July, 2022, shortly after the refill-prescription system was launched, focusing on handling of prescription refills in community pharmacies, and concerns and challenges about refill-prescriptions.Results: Responses were obtainedfrom 377 pharmacists in 34 prefectures throughout Japan. Among them, 30.8% had received refill-prescriptions. Many pharmacists checked medical histories, changes in patients' symptoms, and medication and medical examination status when determining the appropriateness of refills, but few reviewed past laboratory values or laboratory values measuredby patients themselves at the time of their pharmacy visit. Moreover, 34.8% of the pharmacies had internal rules for dealing with refills, and 39.8% had equipment to measure laboratory values. Many pharmacists were concerned about how to share patients’ information with other pharmacies. Challenges that were identified included “Determining whether the refill is appropriate for the patient” and “Establishment of a pharmacy system to receive refill-prescriptions”.Conclusion: This study clarified the actual status of community pharmacies handling of prescription refills, and pharmacists' concerns or challenges about them. Potential improvements include increasing the number of devices that can measure laboratory values at pharmacies, improving home-use measuring devices, creating guidelines to determine the appropriateness of prescription refills and improving pharmacists' skills.