Metastatic breast cancer: highly selective post-hoc analyses instead of full publication of quality-of-life data

IQWiG researchers criticize the publication practice of the PALOMA-2 study authors

Thomas Kaiser and two further IQWiG researchers involved in the early benefit assessment of palbociclib wrote a letter to the editor on the analysis of data from the PALOMA-2 study. They were surprised that on the one hand, the study authors reported post-hoc analyses that had not been planned in the study protocol while on the other, important data on the further course of quality of life in affected women after the end of treatment have still not been reported.

In their response, the study authors confirm that one cannot infer a connection between palbociclib and longer-term maintenance of quality of life from their analyses. However, they evidently do not see a reason to provide all of the data collected, but explain that, in their opinion, these data would not allow a conclusion on the impact of palbociclib. Thomas Kaiser notes that this argument is not convincing and raises the suspicion that the data overall do not confirm the postulated advantage of palbociclib.

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