Agustin Avilès1, Maria-Jesùs Nambo2, Judith Huerta-Guzmàn2, Sergio Cleto2, Natividad Neri2. 1. Oncology Research Unit, Oncology Hospítal, National Medical Center, IMSS, México, Federal District, Mexico. Electronic address: aamiranda12@gmail.com. 2. Department of Hematology, Oncology Hospítal, National Medical Center, IMSS, México, Federal District, Mexico.
Abstract
BACKGROUND:Bisphosphonates, especially zoledronic acid (ZA), show antitumor effects in multiple myeloma (MM) and other neoplasms. The standard time for ZA administration has been 2 years. However, with improvement in overall survival (OS) in MM with new agents, it unclear whether ZA could be administered for a prolonged time to improve OS. PATIENTS AND METHODS: A total of 170 patients with untreated, symptomatic MM were randomly divided into a group to receive ZA for 4 years, with a control group to receive ZA for 2 years. All patients were treated with the same induction therapy and stem-cell transplantation. RESULTS:Actuarial curves at 5 years, showed that progression-free survival was 75% (95% confidence interval [CI], 64%-82%) and OS was 68% (95% CI, 60%-76%) in the 4-year group, which was not statistically significantly different compared with the control group: 72% (95% CI, 62%-78%) and 68% (95% CI, 60%-75%; P = .67). However, the 4-year group showed reduced skeletal events (21% occurrence rate); this was statistically significant compared with the control group: 43% (P < .001). CONCLUSION: Although ZA did not improve OS in patients with MM; it continued to be useful to reduce skeletal events, and thus improve better quality of life for patients.
RCT Entities:
BACKGROUND:Bisphosphonates, especially zoledronic acid (ZA), show antitumor effects in multiple myeloma (MM) and other neoplasms. The standard time for ZA administration has been 2 years. However, with improvement in overall survival (OS) in MM with new agents, it unclear whether ZA could be administered for a prolonged time to improve OS. PATIENTS AND METHODS: A total of 170 patients with untreated, symptomatic MM were randomly divided into a group to receive ZA for 4 years, with a control group to receive ZA for 2 years. All patients were treated with the same induction therapy and stem-cell transplantation. RESULTS: Actuarial curves at 5 years, showed that progression-free survival was 75% (95% confidence interval [CI], 64%-82%) and OS was 68% (95% CI, 60%-76%) in the 4-year group, which was not statistically significantly different compared with the control group: 72% (95% CI, 62%-78%) and 68% (95% CI, 60%-75%; P = .67). However, the 4-year group showed reduced skeletal events (21% occurrence rate); this was statistically significant compared with the control group: 43% (P < .001). CONCLUSION: Although ZA did not improve OS in patients with MM; it continued to be useful to reduce skeletal events, and thus improve better quality of life for patients.
Authors: Priscila Corraini; Uffe Heide-Jørgensen; Morten Schiødt; Sven Erik Nørholt; John Acquavella; Henrik Toft Sørensen; Vera Ehrenstein Journal: Cancer Med Date: 2017-09-21 Impact factor: 4.452
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