Chiyomi Egawa1, Kouichi Hirokaga2, Shintaro Takao2, Kazuhiko Yamagami3, Masaru Miyashita4, Masashi Baba5, Shigetoshi Ichii6, Muneharu Konishi7, Yuichiro Kikawa8, Junya Minohata9, Toshitaka Okuno10, Keisuke Miyauchi11, Kazuyuki Wakita12, Hirofumi Suwa13, Takashi Hashimoto14, Masayuki Nishino15, Takashi Matsumoto16, Toshiharu Hidaka17, Yutaka Konishi18, Yoko Sakoda19, Akihiro Miya20, Masao Mitsunobu21, Hidefumi Nishikawa22, Seishi Kono23, Ikuo Kokufu24, Isao Sakita25, Koushiro Kitatsuji26, Koushi Oh27, Yasuo Miyoshi28. 1. Department of Surgery, Kansai Rosai Hospital, Inaba-so, 3-1-69, Amagasaki, Hyogo, 660-8511, Japan. 2. Department of Breast Surgery, Hyogo Cancer Center, Kitaoji-cho, 13-70, Akashi, Hyogo, 673-8558, Japan. 3. Department of Breast Surgery, Shinko Hospital, Wakinohama-cho, 1-4-47, Chuo-ku, Kobe, Hyogo, 651-0072, Japan. 4. Department of Surgery, Kohnan Hospital, Kamokogahara, 1-5-16, Higashinada-ku, Kobe, Hyogo, 658-0064, Japan. 5. Department of Surgery, Itami City Hospital, Koyaike, 1-100, Itami, Hyogo, 664-8540, Japan. 6. Rokko Island Hospital, Koyochonaka, 2-11, Higashinada-ku, Kobe, Hyogo, 658-0032, Japan. 7. Department of Surgery, Hyogo Prefectural Nishinomiya Hospital, Rokutanji-cho, 13-9, Nishinomiya, Hyogo, 662-0918, Japan. 8. Department of Surgery, Kobe City Medical Center West Hospital, Ichiban-cho, 2-4, Nagata-ku, Kobe, Hyogo, 653-0013, Japan. 9. Department of Surgery, Kobe Kyodo Hospital, Kubo-cho, 2-4-7, Nagata-ku, Kobe, Hyogo, 653-0041, Japan. 10. Nishi-kobe Medical Center, Kojidai, 5-7-1, Nishi-ku, Kobe, Hyogo, 651-2273, Japan. 11. Miyauchi Clinic, Mukonoso, 4-10-5, Amagasaki, Hyogo, 661-0035, Japan. 12. Chayamachi Breast Clinic, Chayamachi, 3-1, Kita-ku, Osaka, Osaka, 530-0013, Japan. 13. Hyogo Prefectural Tsukaguchi Hospital, Minamitsukaguchi-cho, 6-8-17, Amagasaki, Hyogo, 661-0012, Japan. 14. Hashimoto Clinic, Sumiyoshihommachi, 1-7-2, Higashinada-ku, Kobe, Hyogo, 658-0051, Japan. 15. Department of Surgery, Takarazuka Municipal Hospital, Kohama, 4-5-1, Takarazuka, Hyogo, 665-0827, Japan. 16. Department of Surgery, Kinki Central Hospital, Kurumazuka, 3-1, Itami, Hyogo, 664-8533, Japan. 17. Kobe Century Memorial Hospital, Misaki-cho, 1-9-1, Hyogo-ku, Kobe, Hyogo, 652-0855, Japan. 18. Kobe Urban Breast Clinic, Kumoidori, 4-1-6, Chuo-ku, Kobe, Hyogo, 651-0096, Japan. 19. Department of Breast Surgery, Hyogo Prefectural Kakogawa Medical Center, Kanno-cho Kanno, 203, Kakogawa, Hyogo, 675-8555, Japan. 20. Department of Surgery, Kuma Hospital, Shimoyamatedori, 8-2-35, Chuo-ku, Kobe, Hyogo, 650-0011, Japan. 21. Department of Breast and Endocrine Surgery, Meiwa Hospital, Agenaruo-cho, 4-31, Nishinomiya, Hyogo, 663-8186, Japan. 22. Nishikawa Clinic, Nishidaimotsu-cho, 12-41, Amagasaki, Hyogo, 660-0827, Japan. 23. Department of Breast and Endocrine Surgery, Kobe University School of Medicine, Kusunoki-cho, 7-5-2, Chuo-ku, Kobe, Hyogo, 650-0017, Japan. 24. Kokufu Breast Clinic, Nakayamadera, 1-10-6, Takarazuka, Hyogo, 665-0861, Japan. 25. Sakita Clinic, Wajo-cho, 2-35-101, Nishinomiya, Hyogo, 662-0971, Japan. 26. Kitatsuji Clinic, Nishitachibana-cho, 3-1-1, Amagasaki, Hyogo, 660-0054, Japan. 27. Kobe Adventist Hospital, Arinodai, 8-4-1, Kita-ku, Kobe, Hyogo, 651-1321, Japan. 28. 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.
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. PATIENTS AND 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. CONCLUSION: 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.
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. PATIENTS AND 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. CONCLUSION: 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.
Entities:
Keywords:
Aromatase inhibitor; Breast cancer; Joint symptoms; Patient-reported outcomes
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