TypeofStudy:Letters to the editor.
AuthorsConclusions:In the meantime, one has to carefully weigh the major reduction in bony complications consistently demonstrated in large randomized clinical trials that results from use of these agents by cancer patients compared to the unknown risk and its consequence from ONJ and the rare occurrence of clinically significant irreversible renal failure from these agents when patients are properly monitored and treated.
FreeText:Comment on Aredia (The Oncologist 2004; 9:319-329) and reply. The study reported the safety of chronic intravenous (i.v.) administration of the newer bisphosphonates, Aredia and zoledronic acid (Zol) and the convenience of a 15-minute infusion. The comment states that no serious adverse events (renal function impairment) were describe in the study. The author presented other study that Aredia and ZOL can induced avascular necrosis of the jaws. 36 cases were described; 24 of these had been treated with Aredia, 6 had been treated with ZOL, and 6 had received both therapies successively. A recent study reporting the first 3 cases of osteomyelitis of the jaw among myeloma patients chronically treated with both Aredia and ZOL. In Israel alone, 12 more patients with osteomyelitis of the jaw related to bisphosphonate therapy have been reported since publication of these first cases. A comprehensive review on the safety of chronic bisphosphonate therapy should have included all these complications in order to prevent their related potential morbidity and mortality. In reply, the authors of the study stated that renal function impairment from i.v. bisphosphonates has been known since the early reports with clodronate. In large placebo-controlled as well as Aredia-controlled trials involving patients with all types of cancers, it is clear that this risk is extremely low as long as ZOL is infused over 15 minutes every 3-4 weeks. In addition, among the patients in these studies (baseline creatinine <3 mg/dl), there was no clear cut higher risk of renal deterioration among patients enrolled with higher baseline serum creatinine levels. Patients with myeloma and breast cancer showed high incidence of osteonecrosis of the jaw. They are series of anecdotal reports documenting jaw abnormalities among cancer patients receiving either ZOL or Aredia. It is also important to be aware that this condition can vary greatly in severity. Many patients improve with better oral hygiene and intermittent antibiotic therapy, and continue long-term intravenous bisphosphonate treatment without significant sequelae from their jaw problem.
ASJC Scopus subject areas
- Cancer Research