censored at next treatment or death
Day from nadir to first count at level of Grade 1 toxicity or baseline
Day from last platelet count ≥50,000/mm3 to day of first platelet count ≥50,000/mm3 following nadir, censored at next treatment or death
Baseline Platelet Count Group 1
(n=270)
≥ 150,000/mm3 Group 2
(n=65 )
100,000 to 149,000/mm3 Study 4
(n=204)
≥ 150,000/mm3
Y-90 Zeva lin Dose 0.4 mCi/kg
(14.8 MBq/kg) 0.3 mCi/kg
(11.1 MBq/kg) 0.4 mCi/kg
(14.8 MBq/kg)
ANC
Median nadir ( per mm3) 800 600 721
Per Patient Incidence
ANC <1000/mm3 57% 74% 65%
Per Patient Incidence
ANC <500/mm3 30% 35% 26%
Median Duration (Days)
ANC <1000/mm3 22 29 29
Median Time to Recovery† 12 13 15
Platelets
Median nadir (per mm3) 41,000 24,000 42,000
Per Patient Incidence
Platelets <50,000/mm3 61% 78% 61%
Per Patient Incidence
Platelets <10,000/mm3 10% 14% 4%
Median Duration (Days)
Platelets <50,000/mm3 24 35 26
Median Time to Recovery† 13 14 14
Cytopenias were more severe and more prolonged among eleven (5%) patients who received Zeva lin after first-line fludarabine or a fludarabine-containing chemotherapy regimen as compared to patients receiving non-fludarabine-containing regimens. Among these eleven patients, the median platelet nadir was 13,000/mm3 with a median duration of platelets below 50,000/mm3 of 56 days and the median time for platelet recovery from nadir to Grade 1 toxicity or baseline was 35 days. The median ANC was 355/mm3, with a median duration of ANC below 1,000/mm3 of 37 days and the median time for ANC recovery from nadir to Grade 1 toxicity or baseline was 20 days.
The median time to cytopenia was similar across patients with relapsed/refractory NHL and those completing first-line chemotherapy, with median ANC nadir at 61-62 days, platelet nadir at 49-53 days, and hemoglobin nadir at 68-69 days after Y-90-Zeva lin administration.
Information on hematopoietic growth factor use and platelet transfusions is based on 211 patients with relapsed/refractory NHL and 206 patients following first-line chemotherapy. Filgrastim was given to 13% of patients and erythropoietin to 8% with relapsed or refractory disease; 14% of patients receiving Zeva lin following first-line chemotherapy received granulocyte-colony stimulating factors and 5% received erythopoiesis-stimulating agents. Platelet transfusions were given to approximately 22% of all Zeva lin-treated patients. Red blood cell transfusions were given to 20% of patients with relapsed or refractory NHL and 2% of patients receiving Zeva lin following first-line chemotherapy.
Infections
In relapsed or refractory NHL patients, infections occurred in 29% of 349 patients during the first 3 months after initiating the Zeva lin therapeutic regimen and 3% developed serious infections (urinary tract infection, febrile neutropenia, sepsis, pneumonia, cellulitis, colitis, diarrhea, osteomyelitis, and upper respiratory tract infection). Life-threatening infections were reported in 2% (sepsis, empyema, pneumonia, febrile neutropenia, fever, and biliary stent-associated cholangitis). From 3 months to 4 years after Zeva lin treatment, 6% of patients developed infections; 2% were serious (urinary tract infection, bacterial or viral pneumonia, febrile neutropenia, perihilar infiltrate, pericarditis, and intrav |
