title: Risk factors for joint symptoms in postmenopausal Japanese breast cancer patients treated with anastrozole: a prospective multicenter cohort study of patient-reported outcomes.
abstract: BACKGROUND
  Endocrine treatment-related adverse events have a strong impact on patients' quality of life and sometimes result in treatment discontinuation. Since joint symptoms are the most frequently recognized side effect of aromatase inhibitors, evaluation of associated risk factors may yield significant findings.
  
  
  METHODS
  A total of 391 postmenopausal Japanese women with estrogen receptor-positive breast cancer and treated with adjuvant anastrozole were enrolled from 28 centers for assessment of patient-reported outcomes (PROs) in this prospective cohort study (SAVS-JP, UMIN000002455). Patients completed the self-report questionnaire at baseline and after 3, 6, 9, and 12 months of treatment for evaluation of frequency of treatment-related joint symptoms (arthralgia, decrease in range of joint motion, and joint stiffness).
  
  
  RESULTS
  We obtained PROs from 362 patients (92.6 %) at baseline and at one or more subsequent points. New or worsening from baseline of joint symptoms were reported by 260 patients (71.8 %). More than 90 % of the symptoms were mild or moderate and nearly 80 % had occurred by 6 months. Multivariate analysis showed that a short time span after menopause [odds ratio (OR) 0.95, 95 % confidence interval (CI) 0.90-0.99; P = 0.02] and adjuvant chemotherapy (OR 2.29, 95 % CI 1.06-4.95; P = 0.03) were significant independent risk factors for joint symptoms. No significant relationships between body mass index (BMI) and joint symptoms were identified. Eighteen patients discontinued treatment during the 1st year and eight of them reported joint symptoms.
  
  
  CONCLUSIONS
  Taking into consideration that PROs may yield higher prevalence rates than physician ratings for symptoms published in pivotal clinical trials, we found that a short time span after menopause and use of adjuvant chemotherapy, but not high BMI, were significantly associated with joint symptoms. These findings might prove useful for counseling before initiating treatment with adjuvant aromatase inhibitors in postmenopausal Japanese women.
authors.affiliation: Department of Surgery, Kansai Rosai Hospital, Inaba-so, 3-1-69, Amagasaki, Hyogo, 660-8511, Japan.
authors.forename: Chiyomi
authors.initials: C
authors.lastname: Egawa
authors.affiliation: Department of Breast Surgery, Hyogo Cancer Center, Kitaoji-cho, 13-70, Akashi, Hyogo, 673-8558, Japan.
authors.forename: Kouichi
authors.initials: K
authors.lastname: Hirokaga
authors.affiliation: Department of Breast Surgery, Hyogo Cancer Center, Kitaoji-cho, 13-70, Akashi, Hyogo, 673-8558, Japan.
authors.forename: Shintaro
authors.initials: S
authors.lastname: Takao
authors.affiliation: Department of Breast Surgery, Shinko Hospital, Wakinohama-cho, 1-4-47, Chuo-ku, Kobe, Hyogo, 651-0072, Japan.
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Yamagami
authors.affiliation: Department of Surgery, Kohnan Hospital, Kamokogahara, 1-5-16, Higashinada-ku, Kobe, Hyogo, 658-0064, Japan.
authors.forename: Masaru
authors.initials: M
authors.lastname: Miyashita
authors.affiliation: Department of Surgery, Itami City Hospital, Koyaike, 1-100, Itami, Hyogo, 664-8540, Japan.
authors.forename: Masashi
authors.initials: M
authors.lastname: Baba
authors.affiliation: Rokko Island Hospital, Koyochonaka, 2-11, Higashinada-ku, Kobe, Hyogo, 658-0032, Japan.
authors.forename: Shigetoshi
authors.initials: S
authors.lastname: Ichii
authors.affiliation: Department of Surgery, Hyogo Prefectural Nishinomiya Hospital, Rokutanji-cho, 13-9, Nishinomiya, Hyogo, 662-0918, Japan.
authors.forename: Muneharu
authors.initials: M
authors.lastname: Konishi
authors.affiliation: Department of Surgery, Kobe City Medical Center West Hospital, Ichiban-cho, 2-4, Nagata-ku, Kobe, Hyogo, 653-0013, Japan.
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Kikawa
authors.affiliation: Department of Surgery, Kobe Kyodo Hospital, Kubo-cho, 2-4-7, Nagata-ku, Kobe, Hyogo, 653-0041, Japan.
authors.forename: Junya
authors.initials: J
authors.lastname: Minohata
authors.affiliation: Nishi-kobe Medical Center, Kojidai, 5-7-1, Nishi-ku, Kobe, Hyogo, 651-2273, Japan.
authors.forename: Toshitaka
authors.initials: T
authors.lastname: Okuno
authors.affiliation: Miyauchi Clinic, Mukonoso, 4-10-5, Amagasaki, Hyogo, 661-0035, Japan.
authors.forename: Keisuke
authors.initials: K
authors.lastname: Miyauchi
authors.affiliation: Chayamachi Breast Clinic, Chayamachi, 3-1, Kita-ku, Osaka, Osaka, 530-0013, Japan.
authors.forename: Kazuyuki
authors.initials: K
authors.lastname: Wakita
authors.affiliation: Hyogo Prefectural Tsukaguchi Hospital, Minamitsukaguchi-cho, 6-8-17, Amagasaki, Hyogo, 661-0012, Japan.
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Suwa
authors.affiliation: Hashimoto Clinic, Sumiyoshihommachi, 1-7-2, Higashinada-ku, Kobe, Hyogo, 658-0051, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Hashimoto
authors.affiliation: Department of Surgery, Takarazuka Municipal Hospital, Kohama, 4-5-1, Takarazuka, Hyogo, 665-0827, Japan.
authors.forename: Masayuki
authors.initials: M
authors.lastname: Nishino
authors.affiliation: Department of Surgery, Kinki Central Hospital, Kurumazuka, 3-1, Itami, Hyogo, 664-8533, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Matsumoto
authors.affiliation: Kobe Century Memorial Hospital, Misaki-cho, 1-9-1, Hyogo-ku, Kobe, Hyogo, 652-0855, Japan.
authors.forename: Toshiharu
authors.initials: T
authors.lastname: Hidaka
authors.affiliation: Kobe Urban Breast Clinic, Kumoidori, 4-1-6, Chuo-ku, Kobe, Hyogo, 651-0096, Japan.
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Konishi
authors.affiliation: Department of Breast Surgery, Hyogo Prefectural Kakogawa Medical Center, Kanno-cho Kanno, 203, Kakogawa, Hyogo, 675-8555, Japan.
authors.forename: Yoko
authors.initials: Y
authors.lastname: Sakoda
authors.affiliation: Department of Surgery, Kuma Hospital, Shimoyamatedori, 8-2-35, Chuo-ku, Kobe, Hyogo, 650-0011, Japan.
authors.forename: Akihiro
authors.initials: A
authors.lastname: Miya
authors.affiliation: Department of Breast and Endocrine Surgery, Meiwa Hospital, Agenaruo-cho, 4-31, Nishinomiya, Hyogo, 663-8186, Japan.
authors.forename: Masao
authors.initials: M
authors.lastname: Mitsunobu
authors.affiliation: Nishikawa Clinic, Nishidaimotsu-cho, 12-41, Amagasaki, Hyogo, 660-0827, Japan.
authors.forename: Hidefumi
authors.initials: H
authors.lastname: Nishikawa
authors.affiliation: Department of Breast and Endocrine Surgery, Kobe University School of Medicine, Kusunoki-cho, 7-5-2, Chuo-ku, Kobe, Hyogo, 650-0017, Japan.
authors.forename: Seishi
authors.initials: S
authors.lastname: Kono
authors.affiliation: Kokufu Breast Clinic, Nakayamadera, 1-10-6, Takarazuka, Hyogo, 665-0861, Japan.
authors.forename: Ikuo
authors.initials: I
authors.lastname: Kokufu
authors.affiliation: Sakita Clinic, Wajo-cho, 2-35-101, Nishinomiya, Hyogo, 662-0971, Japan.
authors.forename: Isao
authors.initials: I
authors.lastname: Sakita
authors.affiliation: Kitatsuji Clinic, Nishitachibana-cho, 3-1-1, Amagasaki, Hyogo, 660-0054, Japan.
authors.forename: Koushiro
authors.initials: K
authors.lastname: Kitatsuji
authors.affiliation: Kobe Adventist Hospital, Arinodai, 8-4-1, Kita-ku, Kobe, Hyogo, 651-1321, Japan.
authors.forename: Koushi
authors.initials: K
authors.lastname: Oh
authors.affiliation: Division of Breast and Endocrine Surgery, Department of Surgery, Hyogo College of Medicine, Mukogawa-cho, 1-1, Nishinomiya, Hyogo, 663-8501, Japan. ymiyoshi@hyo-med.ac.jp.
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Miyoshi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000077384:Anastrozole; D047072:Aromatase Inhibitors / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018270:Carcinoma, Ductal, Breast / Q000188:drug therapy* / Q000473:pathology; D018275:Carcinoma, Lobular / Q000188:drug therapy* / Q000473:pathology; D017024:Chemotherapy, Adjuvant; D005260:Female; D006801:Humans; D007592:Joint Diseases / Q000139:chemically induced* / Q000473:pathology; D008875:Middle Aged; D009367:Neoplasm Staging; D009570:Nitriles / Q000009:adverse effects*; D063868:Patient Outcome Assessment; D017698:Postmenopause; D011379:Prognosis; D011446:Prospective Studies; D011788:Quality of Life; D012307:Risk Factors; D011795:Surveys and Questionnaires; D014230:Triazoles / Q000009:adverse effects*
chemical_list: D047072:Aromatase Inhibitors; D009570:Nitriles; D014230:Triazoles; D000077384:Anastrozole
keywords: Aromatase inhibitor; Breast cancer; Joint symptoms; Patient-reported outcomes