Shigeto Maeda1, Michiyo Saimura2, Shigeki Minami3, Kaname Kurashita4, Reiki Nishimura5, Yuichiro Kai6, Hiroshi Yano7, Kohjiro Mashino8, Shoshu Mitsuyama2, Mototsugu Shimokawa9, Kazuo Tamura10. 1. Department of Surgery, National Hospital Organization Nagasaki Medical Center, Omura, Nagasaki, Japan. Electronic address: maedash@nagasaki-mc.com. 2. Department of Surgery, Kitakyushu Municipal Medical Center, Kitakyushu, Fukuoka, Japan. 3. Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan. 4. Department of Breast Surgery, Urasoe General Hospital, Urasoe, Okinawa, Japan. 5. Department of Breast and Endocrine Surgery, Kumamoto City Hospital, Kumamoto, Japan. 6. Department of Breast Surgery, Ueo Breast Cancer Hospital, Oita, Japan. 7. Department of Surgical Oncology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan. 8. Department of Surgery, Oita Prefectural Hospital, Oita, Japan. 9. Department of Cancer Information Center, National Hospital Organization Kyusyu Cancer Center, Fukuoka, Japan. 10. Division of Medical Oncology, Hematology and Infectious Disease, Fukuoka University, Fukuoka, Japan.
Abstract
OBJECTIVES: Despite the survival benefit and acceptable tolerability of eribulin for advanced/metastatic breast cancer (MBC) patients pretreated with anthracyclines and taxanes, there is limited evidence of the clinical benefit of early eribulin use. We investigated the efficacy and safety of first- to third-line eribulin use in patients with MBC. MATERIALS AND METHODS: In this phase II, open-label, single-arm study conducted at 14 sites in Kyushu, Japan, women with histologically confirmed human epidermal growth factor receptor 2-negative MBC were enrolled between December 1, 2011 and November 30, 2013 (Data cut-off: November 30, 2014). Objective response rate (ORR; primary endpoint), disease control rate (DCR), progression-free survival (PFS), duration of response (DOR), overall survival (OS), and safety were evaluated. RESULTS: Of 53 recruited patients, 47 were enrolled. The ORR was 17.0% (95% confidence interval, 7.6-30.8), DCR was 66.0% (51.2-77.8), median PFS was 4.9 months (3.5-7.0), DOR was 6.6 months (1.9-14.3), and median OS was 17.4 months (10.1-not evaluable). The common grade 3/4 adverse events were neutropenia (25 patients; 53.2%), leucopenia (16 patients; 42.1%) and febrile neutropenia (4 patients; 8.5%). Toxicity did not increase during the long-term treatment. Subgroup analysis indicated that first-line treatment led to higher ORR and prolonged PFS and OS than second-/third-line treatment and that incidence of adverse events in patients of second-/third-line treatment was not higher than that in patients of first-line treatment. CONCLUSION: Eribulin exhibited efficacy and manageable tolerability in Japanese women with pretreated MBC in first- to third-line use. (ID: UMIN000007121).
OBJECTIVES: Despite the survival benefit and acceptable tolerability of eribulin for advanced/metastatic breast cancer (MBC) patients pretreated with anthracyclines and taxanes, there is limited evidence of the clinical benefit of early eribulin use. We investigated the efficacy and safety of first- to third-line eribulin use in patients with MBC. MATERIALS AND METHODS: In this phase II, open-label, single-arm study conducted at 14 sites in Kyushu, Japan, women with histologically confirmed humanepidermal growth factor receptor 2-negative MBC were enrolled between December 1, 2011 and November 30, 2013 (Data cut-off: November 30, 2014). Objective response rate (ORR; primary endpoint), disease control rate (DCR), progression-free survival (PFS), duration of response (DOR), overall survival (OS), and safety were evaluated. RESULTS: Of 53 recruited patients, 47 were enrolled. The ORR was 17.0% (95% confidence interval, 7.6-30.8), DCR was 66.0% (51.2-77.8), median PFS was 4.9 months (3.5-7.0), DOR was 6.6 months (1.9-14.3), and median OS was 17.4 months (10.1-not evaluable). The common grade 3/4 adverse events were neutropenia (25 patients; 53.2%), leucopenia (16 patients; 42.1%) and febrile neutropenia (4 patients; 8.5%). Toxicity did not increase during the long-term treatment. Subgroup analysis indicated that first-line treatment led to higher ORR and prolonged PFS and OS than second-/third-line treatment and that incidence of adverse events in patients of second-/third-line treatment was not higher than that in patients of first-line treatment. CONCLUSION: Eribulin exhibited efficacy and manageable tolerability in Japanese women with pretreated MBC in first- to third-line use. (ID: UMIN000007121).
Authors: Reva K Basho; Clinton Yam; Michael Gilcrease; Rashmi K Murthy; Thorunn Helgason; Daniel D Karp; Funda Meric-Bernstam; Kenneth R Hess; Vicente Valero; Constance Albarracin; Jennifer K Litton; Mariana Chavez-MacGregor; David Hong; Razelle Kurzrock; Gabriel N Hortobagyi; Filip Janku; Stacy L Moulder Journal: Oncologist Date: 2018-08-23
Authors: Karen A Cadoo; Peter A Kaufman; Andrew D Seidman; Cassandra Chang; Dongyuan Xing; Tiffany A Traina Journal: Clin Breast Cancer Date: 2018-04-07 Impact factor: 3.225