UK-Based Study Evaluates Outcomes With Idelalisib Plus Rituximab in CLL
Posted: Friday, September 24, 2021
Christopher Fegan, MD, of the University Hospital of Wales, Cardiff, United Kingdom, and colleagues performed a retrospective review on the safety and efficacy of the PI3Kd inhibitor idelalisib plus rituximab in patients with chronic lymphocytic leukemia (CLL). Published in the British Journal of Haematology, these results demonstrated that despite safety profile limitations, this treatment option is, in fact, effective.
The trial collected data from 110 patients with CLL who were administered idelalisib plus rituximab from September 2014 to December 2017 in the UK and Ireland. The median patient age was 72, and most patients (80%) were 65 or older. Participants received a median of one prior therapy line. A TP53 mutation/17p deletion was identified in all 27 patients who received idelalisib plus rituximab as a front-line therapy (25% of the total population).
The clinical overall response rate was 88.2%. The median overall survival was not reached, but the progression-free survival was 29.6 months. Although these findings were not statistically significant, patients younger than 65 years experienced a longer median event-free survival than those 65 and older (22.6 vs. 19.2 months). However, for front-line patients, the clinical overall response rate was 96.3%, and the median event-free survival was 18.7 months.
The event-free survival appeared to decrease with increasing lines of therapy. Patients who received idelalisib plus rituximab in two or more lines had a median survival of 20.3 months. In contrast, those who received the combination in the third or fourth line had even shorter survivals of 17.3 and 15.2 months, respectively. Additionally, 87% of participants discontinued treatment due to adverse events, progressive disease, death and investigator discretion, and patient decision; 41.8% of individuals died during observation.
Severe adverse events affected 73.6% of patients, with pneumonia or lower respiratory tract infection and neutropenic sepsis being the most common. These adverse events were considered treatment-related, along with diarrhea and sepsis.
Disclosure: For full disclosures of the study authors, visit onlinelibrary.wiley.com.
