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Motoko Tachihara,1 Kayoko Tsujino,2 Takeaki Ishihara,3 Hidetoshi Hayashi,4 Yuki Sato,5 Takayasu Kurata,6 Shunichi Sugawara,7 Isamu Okamoto,8 Shunsuke Teraoka,9 Koichi Azuma,10 Haruko Daga,11 Masafumi Yamaguchi,12 Takeshi Kodaira,13 Miyako Satouchi,14 Mototsugu Shimokawa,15 Nobuyuki Yamamoto,9 Kazuhiko Nakagawa4 On behalf of members of the West Japan Oncology Group (WJOG)1Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe City, Japan; 2Department of Radiation Oncology, Hyogo Cancer Center, Akashi City, Japan; 3Division of Radiation Oncology, Kobe University Graduate School of Medicine, Kobe City, Japan; 4Department of Medical Oncology, Kindai University, Osakasayama City, Japan; 5Department of Respiratory Medicine, Kobe City Medical Center General Hospital, Kobe City, Japan; 6Department of Thoracic Oncology, Kansai Medical University Hospital, Hirakata City, Japan; 7Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai City, Japan; 8Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka City, Japan; 9Internal Medicine III, Wakayama Medical University, Wakayama, Japan; 10Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine, Kurume University School of Medicine, Fukuoka City, Japan; 11Department of Medical Oncology, Osaka City General Hospital, Osaka, Japan; 12Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka City, Japan; 13Departments of Radiation Oncology, Aichi Cancer Center Hospital, Nagoya City, Aichi, Japan; 14Department of Thoracic Oncology, Hyogo Cancer Center, Akashi City, Japan; 15Department of Biostatistics, Yamaguchi University Graduate School of Medicine Yamaguchi, Ube City, JapanCorrespondence: Motoko TachiharaDivision of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe City, 650-0017, JapanTel +81-78-382-5660Fax +81-78-382-5661Email mt0318@med.kobe-u.ac.jpAbstract: Durvalumab (anti-programmed cell death ligand-1) administration after concurrent chemoradiotherapy (cCRT) has improved the survival of patients with unresectable, locally advanced (LA) stage III non-small cell lung cancer (NSCLC). Some patients are unable to complete cCRT and cannot receive immunotherapy due to poor performance status based on adverse events after cCRT. Immunotherapy plays an important role in anti-programmed cell death ligand-1 (PD-L1)-positive advanced NSCLC and is replacing chemotherapy. In addition, radiotherapy and immunotherapy have been reported to have a synergistic effect. This Phase II, multicenter study (DOLPHIN, WJOG11619L, JapicCTI-194840) is designed to assess the efficacy and safety of durvalumab plus concurrent curative radiation therapy for PD-L1-positive unresectable LA-NSCLC without chemotherapy. Unresectable LA stage III NSCLC patients aged 20 years or older with a World Health Organization/Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 and PD-L1 positivity are enrolled. The patients will receive curative radiation therapy (60 Gy) plus durvalumab 10 mg/kg every 2 weeks (q2w) for up to 12 months until there is evidence of disease progression (PD) or unacceptable toxicity. The primary endpoint is the 12-month progression-free survival rate as assessed by an independent central review. The secondary endpoints are progression-free survival, overall survival, objective response rate, treatment completion rate, and safety. Recruitment began in September 2019.Keywords: clinical study, locally advanced non-small cell lung cancer, immunotherapy, programmed cell death ligand-1, durvalumab, radiation

Introduction The albumin-bilirubin (ALBI) grade is a novel indicator of the liver function. Some studies showed that the ALBI grade was a prognostic and predictive biomarker for the efficacy of chemotherapy in cancer patients. The association between the ALBI grade and outcomes in patients with non-small-cell lung cancer (NSCLC) treated with cancer immunotherapy, however, is poorly understood. Methods We retrospectively enrolled 452 patients with advanced or recurrent NSCLC who received anti-programmed cell death protein 1 (PD-1)-based therapy between 2016 and 2019 at three medical centers in Japan. The ALBI score was calculated from albumin and bilirubin measured at the time of treatment initiation and was stratified into three categories, ALBI grade 1-3, with reference to previous reports. We examined the clinical impact of the ALBI grade on the outcomes of NSCLC patients receiving anti-PD-1-based therapy using Kaplan–Meier survival curve analysis with log-rank test and Cox proportional hazards regression analysis. Results The classifications of the 452 patients were as follows: grade 1, n = 158 (35.0%); grade 2, n = 271 (60.0%); and grade 3, n = 23 (5.0%). Kaplan–Meier survival curve analysis showed that the ALBI grade was significantly associated with progression-free survival and overall survival. Moreover, Cox regression analysis revealed that the ALBI grade was an independent prognostic factor for progression-free survival and overall survival. Conclusion The ALBI grade was an independent prognostic factor for survival in patients with advanced or recurrent NSCLC who receive anti-PD-1-based therapy. These findings should be validated in a prospective study with a larger sample size., Highlights • ALBI grade is calculated from albumin and bilirubin. • We evaluated the impact of ALBI grade on survival in NSCLC patients receiving immune checkpoint inhibitors. • ALBI grade was an independent prognostic factor for progression-free survival (PFS) and overall survival (OS). • ALBI grade effectively stratified PFS and OS in patients with performance status 1-3. • ALBI grade was significantly associated with PFS and OS, regardless of programmed death ligand-1.

Toshinobu Hayashi,1,2 Mototsugu Shimokawa,3 Koichi Matsuo,2 Takanori Miyoshi,4 Yoko Toriyama,4 Chiaki Yokota,5 Jun Taniguchi,6 Kiyonori Hanada,7 Kyouichi Tsumagari,8 Noriko Okubo,9 Yoshimichi Koutake,10 Kohei Sakata,11 Yosei Kawamata,12 Takashi Goto,13 Yasufumi Tsurusaki,14 Makiko Koyabu1 1Department of Pharmacy, Clinical Research Institute, National Kyushu Medical Center, Fukuoka, Japan; 2Department of Pharmaceutical and Health Care Management, Faculty of Pharmaceutical Sciences, Fukuoka University, Fukuoka, Japan; 3Cancer Biostatistics Laboratory, Clinical Research Institute, National Kyushu Cancer Center, Fukuoka, Japan; 4Department of Pharmacy, National Hospital Organization Beppu Medical Center, Oita, Japan; 5Department of Pharmacy, National Hospital Organization Nagasaki Medical Center, Nagasaki, Japan; 6Department of Pharmacy, National Hospital Organization Ureshino Medical Center, Saga, Japan; 7Department of Pharmacy, National Hospital Organization Kumamoto Saishunso National Hospital, Kumamoto, Japan; 8Department of Pharmacy, National Hospital Organization Miyakonojo Medical Center, Miyazaki, Japan; 9Department of Pharmacy, National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan; 10Department of Pharmacy, National Hospital Organization Fukuoka National Hospital, Japan; 11Department of Pharmacy, National Hospital Organization Kumamoto South National Hospital, Kumamoto, Japan; 12Department of Pharmacy, National Hospital Organization Kagoshima Medical Center, Kagoshima, Japan; 13Department of Pharmacy, National Hospital Organization Kokura Medical Center, Kitakyushu, Japan; 14Department of Pharmacy, National Hospital Organization Saga National Hospital, Saga, Japan Purpose: Improvement in the control of delayed chemotherapy-induced nausea and vomiting (CINV) is needed. There is limited information on antiemetic prophylaxis for patients undergoing low-emetic-risk chemotherapy (LEC), and the optimal antiemetic treatment is not well understood. Therefore, we analyzed the risk factors for delayed CINV to aid in the development of individualized treatments. Patients and methods: This prospective multicenter study was conducted in 13 hospitals and included patients with solid cancers undergoing LEC. A total of 222 patients were enrolled between September 2013 and November 2014. The participants completed a daily diary for 5 days after the commencement of the first cycle of LEC to describe the daily incidence of CINV (yes/no). Furthermore, the participants described the severity of nausea and the amount of food intake with the help of VAS. Results: Two hundred and ten patients provided their data that were analyzed using multivariate logistic regression to examine the risk factors for delayed CINV. History of CINV, Eastern Cooperative Oncology Group performance status score ≥1, acute CINV, and single-day antiemetic prophylaxis were identified as independent risk factors for delayed CINV. Conclusion: The current use of antiemetic prophylaxis according to the recommended guideline appears to effectively control delayed CINV in patients undergoing LEC. Therefore, patients with the abovementioned risk factors should be carefully observed, and their treatment should be adjusted according to their symptoms. The use of multiple-day dexamethasone may be beneficial for those patients who develop acute CINV, especially when it is accompanied by anorexia. Keywords: adverse effects, antiemetics, prophylaxis, quality of life

くも膜下モルヒネ投与患者の術後嘔気・嘔吐に対して,メチルプレドニゾロンを術中に投与し,その予防効果を検討した.ASA 1～2の婦人科予定手術患者80名に対し,くも膜下モルヒネ0.125mgを投与後全身麻酔を行なった.メチルプレドニゾロン投与群(MP群)では術中にメチルプレドニゾロン500mgを点滴静注した.その結果,術後嘔気を訴えた患者はメチルプレドニゾロン非投与群(C群)の61%に対しMP群では15%に,また嘔吐をきたした患者はC群の34%に対しMP群で8%と,有意に減少した.くも膜下モルヒネ投与患者の術後嘔気・嘔吐に対しメチルプレドニゾロンの予防的投与は副作用もなく有用であるといえる.

ALTHOUGH pulmonary embolism is a rare complication of pregnancy, it is one of the leading causes of maternal mortality It was estimated that two thirds of deaths caused by pulmonary embolism occur during the first hour after the event, and the remainder occurred within 4 to 6 h. 3 Therefore, we believe that early detection and subsequent treatment of pulmonary embolism are important clinical challenges. In this report, we describe a patient with abruptio placenta and preeclampsia who underwent general anesthesia for cesarean section, in which life-threatening pulmonary embolism developed intraoperatively and was treated with recombinant tissue plasminogen activator (rt-PA).