Oxford University Press, The Oncologist, 5(10), p. 318-319, 2005
DOI: 10.1634/theoncologist.10-5-318
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The burden of suffering associated with metastatic bone disease is so high that we want to be sure that information on effective therapies is reported in the most complete and balanced way. According to Dr. Body, the gastrointestinal (GI) safety profile of oral ibandronate (50 mg) based on the pooled analysis of two randomized placebo-controlled tri- als (1) was misrepresented. Of course this was not our pur- pose; however, if the authors chose not to report the overall incidence of treatment-related GI adverse events, which is an important measure of tolerability for an oral bisphos- phonate, one is left with assumptions. Certainly, the reported incidence of treatment-related abdominal pain, nausea, and esophagitis was two to three times higher in the ibandronate group compared with placebo. Thus, based on the reported incidence of these common upper GI adverse events, the general statement that "patients treated with oral ibandronate were twice as likely to experience treatment- related GI adverse events as those receiving placebo" is consistent with the reported data. This statement is also consistent with the reported incidence of GI adverse events in the dose-finding study (2). Moreover, the reporting of safety data from patients with osteoporosis who received lower doses of oral ibandronate is certainly appropriate in this context. There is no reason to think that these patients would be different from patients with advanced cancer in terms of their risk of developing treatment-related GI