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Bisphosphonates and Osteonecrosis of the jaws (ONJ) : claiming risk factor studies
- Vittorio Fusco, Anna Baraldi , Cinzia Ortega , Michela Donadio , Gabriella Gorzegno (10 October 2006)
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Vittorio Fusco, Medical Oncology Specialist Medical Oncology Unit, Oncology Dept- Azienda Ospedaliera, Anna Baraldi , Cinzia Ortega , Michela Donadio , Gabriella Gorzegno
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On 2003 first reports were published about a possible association between some forms of dental and jaw disturbes (later called osteonecrosis of the jaw, ONJ) and treatment with iv bisphosphonates (a useful class of drugs for hypercalcemia, bone metastases, osteoporosis). In spite of low incidence of the disease, there was an explosion of medical literature on ONJ, recently reviewed (1-2). Due to the widespread use of bisphosphonates, thousands of cases have been up to now reported to Novartis Inc., to the FDA and various national side-effect surveillance systems (3). Probably only a little part of these cases has been collected and published. In a paper recently published in Annals of Oncology, Van den Wyngaert et al. (4) correctly pointed out that available data do not prove definitely a causal link between the use of bisphosphonates and ONJ, because there are no large studies “with control groups where individual exposure can be linked to individual outcome”, demonstrating “consistency, strength of association, specificity and dose-response relantionship”. However, waiting results of claimed cohort and case-control studies, preliminary data are strongly suggestive of a multifactorial disease in which the mechanism of action of bisphosphonates plays a key role (2). The experience of our regional oncology network (at the moment 82 cases)(5) and recent literature (1-2) lead us to affirm that ONJ is not only a “medical literature fashion trend”, but a potential risk for our patients treated with bisphosphonates. Since it has been shown that risk increases with years of treatment and years of follow-up, “long-surviving” bone metastatic patients such as those bearing myeloma, breast cancer, prostate cancer and (occasionally) other primary malignancies have a greater chance to develop this adverse event. The point is that there is a large variability of individual susceptibility, due to different (possible) classes of risk factors: related to the treatment with bisphosphonates (which drug; for how much time; which dose and schedule) (1-2); aspects of renal function and endocrine response to bisphosphonates (2,6); factors related to dental history (precipitating events)(1-2); interactions with other drugs, for example thalidomide (7), taxanes, steroids, etc.; and probably other now unknown risk factors. So that the clear identification of predictive factors is mandatory in order to tailor to each patients drug schedule and treatment duration. The goal is to prevent or to minimize a possible debilitating long-term side effect of a class of drugs (Bisphosphonates) otherwise so useful for our patients. Vittorio Fusco, MD Medical Oncology Unit, Oncology Dept Azienda Ospedaliera “SS.Antonio e Biagio e C.Arrigo” ALESSANDRIA – Italy vittoriofusco1@tin.it Anna Baraldi, MD Hematology Dept Azienda Ospedaliera “SS.Antonio e Biagio e C.Arrigo” ALESSANDRIA - Italy Cinzia Ortega, MD Medical Oncology Unit IRCCS CANDIOLO (Torino) - Italy Michela Donadio, MD Centro Onco-ematologico Subalpino (COES) Azienda Ospedaliera “S.Giovanni Battista-Molinette” TORINO - Italy Gabriella Gorzegno, MD Medical Oncology Unit Azienda Ospedaliera “S.Luigi Gonzaga” ORBASSANO (Torino) - Italy References 1- Woo SB, Hellstein JW, Kalmar JR . Narrative [corrected] review: bisphosphonates and osteonecrosis of the jaws.Ann Intern Med. 2006 May 16;144(10):753-61. Erratum in: Ann Intern Med. 2006 Aug 1;145(3):235. 2- Migliorati CA, Siegel MA, Elting LS . Bisphosphonate-associated osteonecrosis: a long-term complication of bisphosphonate treatment. Lancet Oncol. 2006 Jun;7(6):508-14. Erratum in: Lancet Oncol. 2006 Jul;7(7):533. 3- Kuehn BM . Reports of adverse events from bone drugs prompt caution. JAMA 2006 Jun 28;295(24):2833-6 4- Van den Wyngaert T, Huizing MT, Vermorken JB . Bisphosphonates and osteonecrosis of the jaw: cause and effect or a post hoc fallacy? Ann Oncol. 2006 Aug;17(8):1197-204. 5- Fusco V, Ortega C, Goia F, et al. Bisphosphonates (BP)-related Osteonecrosis of the Jaw (ONJ): clinical experience of the "Rete Oncologica di Piemonte e Valle d'Aosta" network. J Clin Oncol, 2006 ASCO Annual Meeting Proceedings Part I. Vol 24, No. 18S (June 20 Supplement), 2006: 18584 ( www.asco.org ) 6- Ardine M, Generali D, Donadio M, et al . Could the long-term persistence of low serum calcium levels and high serum parathyroid hormone levels during bisphosphonate treatment predispose metastatic breast cancer patients to undergo osteonecrosis of the jaw? Ann Oncol 2006 Aug;17(8):1336-7. Epub 2006 Mar 8. 7- Zervas K, Verrou E, Teleioudis Z, et al. Incidence, risk factors and management of osteonecrosis of the jaw in patients with multiple myeloma: a single-centre experience in 303 patients. Br J Haematol. 2006 Sep;134(6):620-3. Epub 2006 Aug 1. Conflict of Interest:None declared |
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