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Yoshimasa Kosaka,1– 3 Toshiaki Saeki,2 Toshimi Takano,4,5 Tomoyuki Aruga,6 Toshinari Yamashita,7 Norikazu Masuda,8,9 Yukio Koibuchi,10 Akihiko Osaki,2 Junichiro Watanabe,11,12 Ryu Suzuki13 1Department of Breast and Endocrine Surgery, Kitasato University School of Medicine, Sagamihara-shi, Kanagawa, Japan; 2Department of Breast Oncology, Saitama Medical University International Medical Center, Hidaka-shi, Saitama, Japan; 3Department of Breast Oncology, Japanese Red Cross Sagamihara Hospital, Sagamihara-shi, Kanagawa, Japan; 4Department of Medical Oncology, Toranomon Hospital, Minato-ku, Tokyo, Japan; 5Breast Medical Oncology Department, Breast Oncology Center, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Koto-ku, Tokyo, Japan; 6Department of Breast Surgery, Tokyo Metropolitan Center and Infectious Diseases Center Komagome Hospital, Bunkyo-ku, Tokyo, Japan; 7Department of Breast and Endocrine Surgery, Kanagawa Cancer Center, Yokohama-shi, Kanagawa, Japan; 8Department of Surgery, Breast Oncology, National Hospital Organization Osaka National Hospital, Osaka-shi, Osaka, Japan; 9Department of Breast and Endocrine Surgery, Nagoya University Graduate School of Medicine, Nagoya-shi, Aichi, Japan; 10Department of Breast and Endocrine Surgery, National Hospital Organization Takasaki General Medical Center, Takasaki-shi, Gunma, Japan; 11Division of Breast Oncology, Shizuoka Cancer Center, Sunto-gun, Shizuoka, Japan; 12Department of Breast Oncology, Juntendo University Graduate School of Medicine, Bunkyo-ku, Tokyo, Japan; 13Pharmaceuticals Group, Nippon Kayaku Co., Ltd, Kita-ku, Tokyo, JapanCorrespondence: Yoshimasa Kosaka, Department of Breast Oncology, Japanese Red Cross Sagamihara Hospital, 256 Nakano, Midori-ku, Sagamihara-shi, Kanagawa, 252-0157, Japan, Tel +81-42-784-1101, Email y-kosaka@med.kitasato-u.ac.jpBackground: NK105 is a paclitaxel (PTX)-incorporating “core-shell-type” polymeric micellar nanoparticle formulation composed of block copolymers (polyethylene glycol and a polyamino acid). The efficacy and safety of NK105 and paclitaxel in advanced or recurrent breast cancer have never been compared at equivalent dose levels.Patients and Methods: Patients were randomly assigned to either NK105 or PTX in a 1:1 ratio. The study drug was administered on Day 1, 8, and 15 of a 28-day cycle with 80 mg/m2. The primary endpoint was overall response rate (ORR), secondary endpoints were progression-free survival (PFS), overall survival (OS), and adverse events.Results: A total of 123 patients (NK105, n=62; PTX, n=61) received one of the two drugs. There was no significant difference in ORR, the median PFS, or OS (NK105 group: 41.9%, 9.1, and 27.5 months, respectively; PTX group: 45.9%, 7.8, and 32.4 months, respectively). Neutropenia occurred more frequently in the NK105 group, but most patients did not require granulocyte-colony stimulating factor or dose-reduction. The median time to onset of peripheral sensory neuropathy (PSN) in the NK105 group was significantly longer than that in the PTX group (p=0.001), and PSN (≥ grade 3) was not observed in the NK105 group.Conclusion: Weekly NK105 administration was well-tolerated. Efficacy was similar in both groups. The PSN profile was better in the NK105 group.Keywords: polymeric micellar nanoparticles, chemotherapy-induced peripheral neuropathy, taxane, anti-polyethylene glycol antibodies, overall response rate

Misa Nakamura,1 Fumie Tazaki,1 Kazuki Nomura,1 Taeko Takano,1 Masashi Hashimoto,1 Hiroshi Hashizume,2 Ichiro Kamei1 1Department of Rehabilitation, Osaka Kawasaki Rehabilitation University, Kaizuka, Osaka, Japan; 2Department of Orthopaedic Surgery, Wakayama Medical University, Wakayama, Japan Abstract: In our worldwide aging society, elderly people should maintain cognitive and physical function to help avoid health problems. Dementia is a major brain disease among elderly people, and is caused by cognitive impairment. The locomotive syndrome (LS) refers to a condition in which people require healthcare services because of problems associated with locomotion. The purpose of this study was to determine the association between cognitive impairment and LS. Study participants were 142 healthy elderly female volunteers living in a rural area in Japan. Cognitive function was assessed using the Mini-Mental State Examination (MMSE). A score of ≤26 points on the MMSE was used to indicate categorically defined poor cognitive performance (cognitive impairment). The LS was defined by a score ≥16 points, and non-LS as 26 group, the ≤26 group was significantly older, had a higher percentage of body fat, and a higher GLFS-25 score. Those with LS were significantly older, had a higher body mass index, a higher percentage of body fat, and a lower MMSE score. Participants in the LS group had higher odds of cognitive impairment than those without LS [odds ratio (OR) =3.08] by logistic regression analysis adjusted for age. Furthermore, participants with GLFS-25 scores ≥6 had higher odds of cognitive impairment than those with a GLFS-25 score