ge; age 65, 69% were male, 69% were white, and 87% had an Eastern CooperativeOncology Group (ECOG) performance status of 0 or 1. The trial required an absolute neutrophilcount ≥1500/µL, platelet count ≥75/µL, creatinine clearance (CLcr) ≥40 mL/min, hepatictransaminases ≤2.5 times ULN, and bilirubin <1.5 times ULN, unless abnormalities were fromthe underlying disease. Patients with Grade 2 or higher peripheral neuropathy or prior allogeneichematopoietic stem cell transplantation (HSCT) were excluded.
Patients treated with POLIVY plus BR received a median of 5 cycles, with 49% receiving6 cycles. Patients treated with BR alone received a median of 3 cycles, with 23% receiving6 cycles.
Fatal adverse reactions occurred in 7% of recipients of POLIVY plus BR within 90 days of lasttreatment. Serious adverse reactions occurred in 64%, most often from infection. Serious adversereactions in ≥5% of recipients of POLIVY plus BR included pneumonia (16%), febrileneutropenia (11%), pyrexia (9%), and sepsis (7%).
In recipients of POLIVY plus BR, adverse reactions led to dose reduction in 18%, doseinterruption in 51%, and permanent discontinuation of all treatment in 31%. The most common
adverse reactions leading to treatment discontinuation were thrombocytopenia and/or
neutropenia.
Table 3 summarizes commonly reported adverse reactions. In recipients of POLIVY plus BR,adverse reactions in ≥20% of patients included neutropenia, thrombocytopenia, anemia,peripheral neuropathy, fatigue, diarrhea, pyrexia, decreased appetite, and pneumonia.
Table 3 Adverse Reactions Occurring in 10% of Patients with Relapsed or RefractoryDLBCL and ≥5% More in the POLIVY Plus Bendamustine and RituximabProduct Group
Adverse Reactions by Body System
POLIVY + BR
n = 45
BR
n = 39
All Grades,
%
Grade 3 or
Higher,
%
All Grades,
%
Grade 3 or
Higher,
%
Blood and Lymphatic System Disorders
Neutropenia 49 42 44 36
Thrombocytopenia 49 40 33 26
Anemia 47 24 28 18
Lymphopenia 13 13 8 8
Nervous System Disorders
Peripheral neuropathy 40 0 8 0
Dizziness 13 0 8 0
Gastrointestinal Disorders
Diarrhea 38 4.4 28 5
Vomiting 18 2.2 13 0
General Disorders
Infusion-related reaction 18 2.2 8 0
Pyrexia 33 2.2 23 0
Decreased appetite 27 2.2 21 0
Infections
Pneumonia 22 16
a 15 2.6b
Upper respiratory tract infection 13 0 8 0
Investigations
Weight decreased 16 2.2 8 2.6
Metabolism and Nutrition Disorders
Hypokalemia 16 9 10 2.6
Hypoalbuminemia 13 2.2 8 0
Hypocalcemia 11 2.2 5 0
The table includes a combination of grouped and ungrouped terms. Events were graded using NCI
CTCAE version 4.
a
Includes 2 events with fatal outcome.
b
Includes 1 event with fatal outcome.
Other clinically relevant adverse reactions (<10% or with a <5% difference) in recipients ofPOLIVY plus BR included:
Blood and lymphatic system disorders: pancytopenia (7%)
Musculoskeletal disorders: arthralgia (7%)
Investigations: hypophosphatemia (9%), transaminase elevation (7%), lipaseincrease (7%)
Respiratory disorders: pneumonitis (4.4%)
Selected treatment-emergent laboratory abnormalities are summarized in Table 4. In recipients ofPOLIVY plus BR, >20% of patients developed Grade 3 or 4 neutropenia, leukopenia, orthrombocytopenia, and >10% developed Grade 4 neutropenia (13%) or Grade 4thrombocytopen |
