Reply to "Letter to the Editor on Oral ibandronate for the treatment of metastatic bone disease in breast cancer: efficacy and safety results from a randomized, double-blind, placebo-controlled trial", by A. M. Westermann doi:10.1093/annonc/mdi072
The original ibandronate trials were written and initiated beforethe approval and availability of bisphosphonates to preventcomplications of bone metastases. At the time, these drugs wereonly used to treat hypercalcemia (and hypercalcemia was excludedfrom the ibandronate trial). During the course of these trials,results from other bisphosphonate trials did emerge, but onlyfor lytic bone metastases, and the ibandronate trials includedall bone metastases. The oral ibandronate trial opened afterthe intravenous trials, in 1996. Pamidronate was approved forlytic bone metastases in the USA in 1998. However, the ibandronatetrials were also open in countries where these agents were stillnot available, and where they were available, the investigatorsat the individual center (after 1998) could use their discretionas to whom they would enrollfor example, patients withnon-lytic bone metastases. Thus, the whole approach to treatingbone metastases was evolving during the course of this trial.The follow-up, analysis and publication of the trial were longerthan usual since the company that currently holds the licenseto the drug (Roche) acquired this drug from another companyafter the trial was completed.
D Tripathy*
University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, NC8.106, Dallas, TX 75390-8852, USA