1.Clinical Efficacy and Safety of Arbekacin against Pneumonia in Febrile Neutropenia: A Retrospective Study in Patients with Hematologic Malignancies
Takashi OHASHI ; Yukiyoshi FUJITA ; Hiroyuki IRISAWA ; Hidemasa NAKAMINAMI ; Takahiro ARAI ; Masumi TAKAHASHI ; Emi MOMIYAMA ; Naoya MURATA ; Kayoko MURAYAMA ; Taeko SAITO
Infection and Chemotherapy 2022;54(1):80-90
Background:
Arbekacin (ABK) is an aminoglycoside that exhibits anti-methicillin-resistant Staphylococcus aureus (MRSA) and anti-Pseudomonas aeruginosa activities. Therefore, for patients with febrile neutropenia (FN) and concurrent pneumonia suspected to be caused by MRSA, ABK may be sufficiently effective even as a single agent.
Materials and Methods:
Patients with hematologic malignancies treated with ABK who met the following criteria were included: 1) fever during neutropenia or functional neutropenia, 2) FN complicated by pneumonia, and 3) possible infection by antimicrobial-resistant Grampositive cocci.
Results:
This study encompassed 22 episodes involving 19 patients, of which, 15 (68.2%) were successfully treated with ABK. Of the nine episodes showing inadequate response to other anti-MRSA drugs, eight were successfully treated with ABK. Grade 2 or worse adverse events included acute kidney injury (13.6%) and increased transaminase levels (9.1%).
Conclusion
The present study demonstrated that ABK is effective and safe in patients with FN and concurrent pneumonia caused by antimicrobial-resistant Gram-positive cocci. ABK may also be effective in patients who are unresponsive to other anti-MRSA drugs. Therefore, ABK may be beneficial in the treatment of pneumonia caused by antimicrobial-resistant Gram-positive cocci in patients with FN.
2.Phase I/II prospective clinical trial for the hybrid of intracavitary and interstitial brachytherapy for locally advanced uterine cervical cancer
Naoya MURAKAMI ; Miho WATANABE ; Takashi UNO ; Shuhei SEKII ; Kayoko TSUJINO ; Takahiro KASAMATSU ; Yumiko MACHITORI ; Tomomi AOSHIKA ; Shingo KATO ; Hisako HIROWATARI ; Yuko KANEYASU ; Tomio NAKAGAWA ; Hitoshi IKUSHIMA ; Ken ANDO ; Masumi MURATA ; Ken YOSHIDA ; Hiroto YOSHIOKA ; Kazutoshi MURATA ; Tatsuya OHNO ; Noriyuki OKONOGI ; Anneyuko I. SAITO ; Mayumi ICHIKAWA ; Takahito OKUDA ; Keisuke TSUCHIDA ; Hideyuki SAKURAI ; Ryoichi YOSHIMURA ; Yasuo YOSHIOKA ; Atsunori YOROZU ; Naonobu KUNITAKE ; Hiroyuki OKAMOTO ; Koji INABA ; Tomoyasu KATO ; Hiroshi IGAKI ; Jun ITAMI
Journal of Gynecologic Oncology 2023;34(3):e24-
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.