Dr. Batlevi on Safety With Ibrutinib/Buparlisib in MCL, FL, and DLBCL

Connie Batlevi, MD
Published: Wednesday, Jun 14, 2017



Connie Batlevi, MD, medical oncologist, Memorial Sloan Kettering Cancer Center, discusses safety results of a phase I study evaluating the combination of ibrutinib (Imbruvica) and buparlisib in patients with mantle cell lymphoma (MCL), follicular lymphoma (FL), and diffuse large B-cell lymphoma (DLBCL).

In the phase I study, 13 patients were enrolled and evaluated for toxicity, and 6 patients discontinued treatment for disease progression. The grade 3 or higher hematologic adverse events (AEs) reported were anemia (2), leukocytosis (2), and leukopenia (4).

Non-hematologic AEs of any grade across all patients were fatigue (77%), diarrhea (62%), anorexia (54%), rash (46%), hyperbilirubinemia (46%), gastric reflux (46%), CMV reactivation (31%), mood change (31%), and hypertension (23%). The most common related grade 3/4 toxicity is rash (N = 3). Serious adverse events included grade 2 pleural effusion and grade 2 nausea (N = 1), grade 1 fever with hospitalization (N = 1), grade 2 confusion and grade 4 hyponatremia (N = 1) were unrelated to therapy.


Connie Batlevi, MD, medical oncologist, Memorial Sloan Kettering Cancer Center, discusses safety results of a phase I study evaluating the combination of ibrutinib (Imbruvica) and buparlisib in patients with mantle cell lymphoma (MCL), follicular lymphoma (FL), and diffuse large B-cell lymphoma (DLBCL).

In the phase I study, 13 patients were enrolled and evaluated for toxicity, and 6 patients discontinued treatment for disease progression. The grade 3 or higher hematologic adverse events (AEs) reported were anemia (2), leukocytosis (2), and leukopenia (4).

Non-hematologic AEs of any grade across all patients were fatigue (77%), diarrhea (62%), anorexia (54%), rash (46%), hyperbilirubinemia (46%), gastric reflux (46%), CMV reactivation (31%), mood change (31%), and hypertension (23%). The most common related grade 3/4 toxicity is rash (N = 3). Serious adverse events included grade 2 pleural effusion and grade 2 nausea (N = 1), grade 1 fever with hospitalization (N = 1), grade 2 confusion and grade 4 hyponatremia (N = 1) were unrelated to therapy.



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