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Safety and efficacy of everolimus (EVE) plus exemestane (EXE) in postmenopausal women with locally advanced or metastatic breast cancer: final results from EVEREXES |
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| Authors: | Im Young-Hyuck Karabulut Bulent Lee Keun Seok Park Byeong-Woo Adhav Aditya Cinkir Havva Yesil Abdel-Razeq Hikmat Chang Yuan-Ching Aksoy Sercan Im Seock-Ah Jeong Joon Chae Yeesoo Bowles James Slimane Khemaies Xue Hongling Kim Sung-Bae |
| Affiliation: | 1.Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea ;2.Department of Medical Oncology, Faculty of Medicine, Ege University, Izmir, Turkey ;3.Center for Breast Cancer, National Cancer Center, Gyeonggi do, Korea ;4.Department of Surgery, Yonsei University Health System, Severance Hospital, Seoul, Korea ;5.Department of Surgical Oncology, HCG Manavata Cancer Centre, Nashik, India ;6.Department of Medical Oncology, Gaziantep University Medical Faculty, Gaziantep, Turkey ;7.King Hussein Cancer Center, Amman, Jordan ;8.Mackay Memorial Hospital, Taipei, Taiwan ;9.Hacettepe University Medical Faculty, Ankara, Turkey ;10.Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea ;11.Department of Surgery, Gangnam Severance Hospital Yonsei University Health System, Seoul, Korea ;12.Kyungpook National University Hospital, Daegu, Korea ;13.Novartis Pharma AG, Basel, Switzerland ;14.Novartis Asia Pacific Pharmaceuticals Pte Ltd, Singapore, Singapore ;15.Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea ; |
| Abstract: | Background This study was conducted to collect clinical safety, tolerability, and efficacy data with the use of everolimus (EVE) combined with exemestane (EXE) in patients with advanced breast cancer (ABC). MethodsThe EVEREXES trial initiated in 2012, provided early access to the first dual blockade treatment with EVE?+?EXE in patients with HR+, HER2???ABC in Asia and other emerging growth countries. Postmenopausal women with HR+, HER2???ABC who had documented recurrence or progression, following a nonsteroidal aromatase inhibitor therapy, were treated with EVE (10 mg/day)?+?EXE (25 mg/day) orally. ResultsA total of 235 patients received?≥?1 dose of study medication. At the end of the study, all patients ceased the treatment. Disease progression (66.0%) was the primary reason of discontinuation. The most common AEs (≥?20%) were stomatitis, decreased appetite, hyperglycemia, rash, aspartate aminotransferase increased, anemia, alanine aminotransferase increased, cough, and fatigue. No new safety concerns were identified in the current study. Median progression-free survival (PFS) in the Asian subset was similar to that of the overall population (9.3 months in both groups). Confirmed overall response rate (ORR) was achieved for 19.6% of the patients. Efficacy of EVE?+?EXE across subgroups (prior CT, line of treatment, and presence of visceral metastases) was maintained. ConclusionThe safety and efficacy results from EVEREXES trial are consistent to data previously reported in BOLERO-2. These results support that EVE?+?EXE could be a viable treatment option for the postmenopausal women with HR+, HER2???ABC in Asian region. |
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