Yuichiro Kikawa1,2, Takeshi Kotake3,4, Shigeru Tsuyuki5, Yookija Kang5, Sachiko Takahara6, Yuri Fujimoto6, Hiroyasu Yamashiro7, Hiroshi Yoshibayashi8, Masahiro Takada3, Rie Yasuoka9, Katsuhiko Nakatsukasa9, Kazuhiko Yamagami10, Hirofumi Suwa11, Toshitaka Okuno12, Ichiro Nakayama13, Tatsushi Kato14, Nobuko Ogura4, Yoshio Moriguchi15, Hiroshi Ishiguro16, Tatsuo Kagimura17, Tetsuya Taguchi9, Tomoharu Sugie18, Masakazu Toi3. 1. Department of Breast Surgery, Kansai Medical University, Hirakata-city, Osaka, 573-1191, Japan. kikaway@hirakata.kmu.ac.jp. 2. Department of Breast Surgery, Kobe City Medical Center General Hospital, Kobe-city, Hyogo, 650-0047, Japan. kikaway@hirakata.kmu.ac.jp. 3. Department of Breast Surgery, Kyoto University Graduate School of Medicine, Kyoto-city, Kyoto, 606-8507, Japan. 4. Department of Breast Surgery, Kansai Electric Power Hospital, Osaka-city, Osaka, 553-0003, Japan. 5. Department of Breast Surgery, Osaka Red Cross Hospital, Osaka-city, Osaka, 543-8555, Japan. 6. Department of Breast Surgery, Tazuke Kofukai Medical Research Institute, Kitano Hospital, Osaka-city, Osaka, 530-8480, Japan. 7. Department of Breast Surgery, Tenri Hospital, Tenri-city, Nara, 632-0018, Japan. 8. Wakayama Breast Clinic, Wakayama-city, Wakayama, 640-8203, Japan. 9. Department of Endocrine and Breast Surgery, Kyoto Prefectural University of Medicine, Kyoto-city, Kyoto, 602-8566, Japan. 10. Department of Breast Surgery, Shinko Hospital, Kobe-city, Hyogo, 651-0072, Japan. 11. Department of Breast Surgery, Hyogo Prefectural Amagasaki General Medical Center, Amagasaki-city, Hyogo, 660-8550, Japan. 12. Department of Breast Surgery, Kobe City Nishi-Kobe Medical Center, Kobe-city, Hyogo, 651-2273, Japan. 13. Department of Breast Surgery, Kyoto Min-Iren Chuo Hospital, Kyoto-city, 616-8147, Japan. 14. Department of Breast Surgery, Yamato Takada Municipal Hospital, Yamatotakada-city, Nara, 635-8501, Japan. 15. Department of Breast Surgery, Kyoto City Hospital, Kyoto-city, Kyoto, 604-8845, Japan. 16. Breast Oncology Service, Saitama Medical University International Medical Center, Hidaka-city, Saitama, 350-1298, Japan. 17. Translational Research Center for Medical Innovation, Foundation for Biomedical Research and Innovation at Kobe, Kobe-city, Hyogo, 650-0047, Japan. 18. Department of Breast Surgery, Kansai Medical University, Hirakata-city, Osaka, 573-1191, Japan.
Abstract
BACKGROUND: The optimal positioning of eribulin treatment remains unclear. This study aimed to investigate the effectiveness of eribulin administration as first- and second-line chemotherapy in patients with endocrine-resistant advanced or metastatic breast cancer (AMBC) in the real-world clinical setting. METHODS: This multi-institutional prospective cohort study enrolled patients with triple-negative AMBC or estrogen receptor-positive AMBC refractory to at least one previous endocrine therapy. The overall survival (OS) from the start of first-line (OS1) and second-line chemotherapy (OS2) was assessed. Data analysis included real-world chemotherapy sequences of first- to third-line chemotherapy regimens. The adjusted hazard ratio (HR) with 95% confidence interval (CI) for treatment regimen comparison was calculated using a stratified proportional hazards model. RESULTS: Among 201 patients enrolled, 180 were included in the final analysis. Eribulin was administered as first- and second-line chemotherapy to 46 (26.6%) and 70 (47.9%) patients, respectively. Median OS1 and OS2 were 2.25 (95% CI 1.07-2.68) and 1.75 (95% CI, 1.28-2.45) years for first- and second-line eribulin, respectively. Oral 5-FU followed by eribulin had a numerically longer OS1 (2.84 years) than the other sequences. Among patients who proceeded to second-line or later chemotherapy, the median OS1 for those treated with anthracycline or taxane as first- or second-line (n = 98) was 2.56 years (95% CI 2.27-2.74), while it was 2.87 years (95% CI 2.20-4.32) for those who avoided anthracycline and taxane as first- and second-line (n = 48) (adjusted HR, 1.20; 95% CI 0.70-2.06). In the exploratory analysis, OS1 was 2.55 (95% CI 2.14-2.75) and 2.91 years (95% CI 2.61-4.32) for those aged < 65 and ≥ 65 years, respectively (adjusted HR of ≥ 65, 0.91; 95% CI 0.56-1.46). CONCLUSIONS: Eribulin or oral 5-FU administration in first- and second-line chemotherapy without anthracycline/taxane was acceptable in the real-world setting. TRIAL REGISTRATION: This study is registered with Clinical Trials.gov (NCT 02,551,263).
BACKGROUND: The optimal positioning of eribulin treatment remains unclear. This study aimed to investigate the effectiveness of eribulin administration as first- and second-line chemotherapy in patients with endocrine-resistant advanced or metastatic breast cancer (AMBC) in the real-world clinical setting. METHODS: This multi-institutional prospective cohort study enrolled patients with triple-negative AMBC or estrogen receptor-positive AMBC refractory to at least one previous endocrine therapy. The overall survival (OS) from the start of first-line (OS1) and second-line chemotherapy (OS2) was assessed. Data analysis included real-world chemotherapy sequences of first- to third-line chemotherapy regimens. The adjusted hazard ratio (HR) with 95% confidence interval (CI) for treatment regimen comparison was calculated using a stratified proportional hazards model. RESULTS: Among 201 patients enrolled, 180 were included in the final analysis. Eribulin was administered as first- and second-line chemotherapy to 46 (26.6%) and 70 (47.9%) patients, respectively. Median OS1 and OS2 were 2.25 (95% CI 1.07-2.68) and 1.75 (95% CI, 1.28-2.45) years for first- and second-line eribulin, respectively. Oral 5-FU followed by eribulin had a numerically longer OS1 (2.84 years) than the other sequences. Among patients who proceeded to second-line or later chemotherapy, the median OS1 for those treated with anthracycline or taxane as first- or second-line (n = 98) was 2.56 years (95% CI 2.27-2.74), while it was 2.87 years (95% CI 2.20-4.32) for those who avoided anthracycline and taxane as first- and second-line (n = 48) (adjusted HR, 1.20; 95% CI 0.70-2.06). In the exploratory analysis, OS1 was 2.55 (95% CI 2.14-2.75) and 2.91 years (95% CI 2.61-4.32) for those aged < 65 and ≥ 65 years, respectively (adjusted HR of ≥ 65, 0.91; 95% CI 0.56-1.46). CONCLUSIONS: Eribulin or oral 5-FU administration in first- and second-line chemotherapy without anthracycline/taxane was acceptable in the real-world setting. TRIAL REGISTRATION: This study is registered with Clinical Trials.gov (NCT 02,551,263).
Authors: George W Sledge; Donna Neuberg; Patricia Bernardo; James N Ingle; Silvana Martino; Eric K Rowinsky; William C Wood Journal: J Clin Oncol Date: 2003-02-15 Impact factor: 44.544
Authors: Peter Schmid; Sylvia Adams; Hope S Rugo; Andreas Schneeweiss; Carlos H Barrios; Hiroji Iwata; Véronique Diéras; Roberto Hegg; Seock-Ah Im; Gail Shaw Wright; Volkmar Henschel; Luciana Molinero; Stephen Y Chui; Roel Funke; Amreen Husain; Eric P Winer; Sherene Loi; Leisha A Emens Journal: N Engl J Med Date: 2018-10-20 Impact factor: 91.245
Authors: Mark Robson; Seock-Ah Im; Elżbieta Senkus; Binghe Xu; Susan M Domchek; Norikazu Masuda; Suzette Delaloge; Wei Li; Nadine Tung; Anne Armstrong; Wenting Wu; Carsten Goessl; Sarah Runswick; Pierfranco Conte Journal: N Engl J Med Date: 2017-06-04 Impact factor: 91.245
Authors: N Katsumata; T Watanabe; H Minami; K Aogi; T Tabei; M Sano; N Masuda; J Andoh; T Ikeda; T Shibata; S Takashima Journal: Ann Oncol Date: 2009-03-02 Impact factor: 32.976
Authors: F Cardoso; S Paluch-Shimon; E Senkus; G Curigliano; M S Aapro; F André; C H Barrios; J Bergh; G S Bhattacharyya; L Biganzoli; F Boyle; M-J Cardoso; L A Carey; J Cortés; N S El Saghir; M Elzayat; A Eniu; L Fallowfield; P A Francis; K Gelmon; J Gligorov; R Haidinger; N Harbeck; X Hu; B Kaufman; R Kaur; B E Kiely; S-B Kim; N U Lin; S A Mertz; S Neciosup; B V Offersen; S Ohno; O Pagani; A Prat; F Penault-Llorca; H S Rugo; G W Sledge; C Thomssen; D A Vorobiof; T Wiseman; B Xu; L Norton; A Costa; E P Winer Journal: Ann Oncol Date: 2020-09-23 Impact factor: 32.976