Ibrutinib (Imbruvica) in combination therapy for people who have had treatment for CLL and are able to have further chemotherapy
In 2016, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) assessed the advantages and disadvantages of ibrutinib (trade name: Imbruvica) for people who have had treatment for chronic lymphocytic leukemia (CLL) and are able to have further chemotherapy. To answer this question, the researchers analyzed the data of 106 people from one study. These patients had individually optimized therapy using bendamustine and rituximab. Half of the participants had treatment with ibrutinib and bendamustine, while the other half were given a placebo and bendamustine. In addition, all participants received the drug rituximab. The patients had all had treatment at least twice before.
The manufacturer didn't provide any data on patients who had had treatment only once before or whose individually optimized treatment didn't consist of bendamustine and rituximab.
So the following results only apply to the subgroup of people who have had treatment at least twice and whose individually optimized chemotherapy consists of bendamustine and rituximab.
What are the advantages of ibrutinib?
- Life expectancy: The study suggested that ibrutinib combined with bendamustine and rituximab can prolong life longer than bendamustine and rituximab. But it is unclear how great this advantage is.
- Symptoms of the disease and general health: There was no difference between the treatments in terms of symptoms such as exhaustion, nausea, vomiting or pain.
- Health-related quality of life and general health: There was no difference between the two treatments in terms of these aspects.
- Severe side effects: There was no difference here. About 90 out of 100 people were affected by severe side effects in each group.
What remains unanswered?
- Treatment stopped due to side effects: The manufacturer didn't provide any relevant data regarding this question.
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Ibrutinib (chronic lymphocytic leukemia) – Benefit assessment according to §35a Social Code Book V ; Dossier assessment; Commission A16-60. December 28, 2016. (IQWiG reports; Volume 474).
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