Evaluating the effectiveness and safety of venetoclax with dose-adjusted EPOCH-R as initial therapy for patients with aggressive B-cell lymphoma.

This study evaluated the effectiveness and safety of adding venetoclax (Venclexta) to a dose-adjusted EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab) regimen as initial therapy in patients with aggressive B-cell lymphoma. The data showed that venetoclax with dose-adjusted EPOCH-R was effective with manageable side effects in these patients.

B-cell non-Hodgkin lymphomas (NHL) are a group of cancers of white blood cells known as B-cells. The most common variety is diffuse large B-cell lymphoma (DLBCL), which is a fast-growing cancer. DLBCL and other aggressive NHL can be treated with chemotherapy or with targeted therapies. Dose-adjusted EPOCH-R is a front-line treatment for patients with aggressive B-cell lymphomas.

Bcl-2 is a gene that is commonly mutated (abnormally changed) in aggressive B-cell lymphomas. Venetoclax is a targeted therapy. It is a Bcl-2 inhibitor that works by blocking the growth of cancer cells. The effectiveness and safety outcomes of adding venetoclax to dose-adjusted EPOCH-R as initial therapy in patients with aggressive B-cell lymphoma are still unknown.

This study involved 30 patients with aggressive B-cell lymphoma. All patients received six cycles of oral venetoclax (400 mg, 600 mg, or 800 mg) once daily for 10 days per cycle with dose-adjusted EPOCH-R (one cycle every 3 weeks). Patients were followed-up every 3 months for 2 years.

The maximum manageable dose was 800 mg for 10 days. 600 mg was selected as the recommended phase 2 dose due to better management throughout the entire treatment duration.

After 2 years, 79.4% of the patients were estimated to survive. 65% of the patients were estimated to be alive without cancer worsening after 2 years.

Overall, 96.7% of the patients responded to the treatment. 93.3% of the patients had a complete response (complete disappearance of cancer cells) and 3.3% of the patients had a partial response (partial disappearance of cancer cells).

The most common side effects were low blood cell counts and low white blood cell counts with fever. The most common non-blood-related side effects were low levels of phosphorus and potassium in the blood and high blood sugar levels. The most common serious side effects were infection, abdominal pain, and hole in the walls of the small intestine.

This study concluded that venetoclax added to with dose-adjusted EPOCH-R was effective with manageable side effects as initial therapy in patients with aggressive B-cell lymphoma.

This study was funded by Genentech, the manufacturer of venetoclax. The sample size was very small. The follow-up time was too short.