Original Title: Venetoclax en leucemia linfocítica crónica recidivante o refractaria

Authors' recommendations: CONCLUSIONS Moderate-quality evidence suggests that venetoclax plus rituximab therapy vs. bendamustine plus rituximab in patients with relapsed or refractory chronic lymphocytic leukemia, achieve a higher overall survival rate at two-year follow-up. The Grade 3-4 adverse events were more common in the venetoclax plus rituximab therapy when compared with bendamustine plus rituximab. No comparative evidence was found on the combination against other therapies No studies were identified comparing venetoclax as monotherapy versus other therapeutic alternatives for the treatment of relapsed or refractory chronic lymphocytic leukemia. Low-quality evidence suggests that, in patients with relapsed or refractory chronic lymphocytic leukemia with 17p chromosome deletion, venetoclax administered as monotherapy might be associated with a partial or better remission rate (overall response rate) of 77% after two years of therapy. Other trials demonstrated that in patients who received idelalisib or ibrutinib as their last therapy, venetoclax administered as monotherapy might achieve overall response rates of 67 and 65%, respectively at 14-month follow-up, independent from the presence of 17p chromosome deletion. The most commonly reported adverse event was neutropenia and, among the serious events, tumor lysis syndrome was higher when compared to its comparators. The economic evaluations assessed from high-income countries suggest that venetoclax therapy as monotherapy might not be a cost-effective option for patients with relapsed or refractory chronic lymphocytic leukemia, although they conclude that this therapy complies with the end of life criteria The clinical practice guidelines identified, from high-income countries, recommend venetoclax therapy in combination with rituximab and venetoclax as monotherapy for the assessed indication, even when there are no mutations, but they have different levels of recommendation as reported in the text. The Argentine Society of Hematology, in its 2017 diagnostic and treatment guideline, recommends the use of venetoclax as monotherapy for the assessed indication in patients with 17p chromosome deletion. In Argentina, the Superintendence of Public Health does not include venetoclax for the assessed indication in the Mandatory Medical Plan and it is not refundable by the Unique Services Reimbursement Program. Three high-income countries cover venetoclax as monotherapy, regardless of the presence of mutations.

Project Status: Completed

Year Published: 2018

URL for published report: https://www.iecs.org.ar/home-ets/

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Argentina

Organisation Name: Institute for Clinical Effectiveness and Health Policy

Contact Address: Dr. Emilio Ravignani 2024, Buenos Aires - Argentina, C1414 CABA

Contact Name: info@iecs.org.ar

Contact Email: info@iecs.org.ar

Copyright: Institute for Clinical Effectiveness and Health Policy (IECS)