ractory, low-grade, follicular or transformed NHL across 5 trials (4 single arm and 1 randomized) and in 206 patients with previously untreated follicular NHL in a randomized trial (Study 4) who received any portion of the Zeva lin therapeutic regimen. The safety data reflect exposure to Zeva lin in 270 patients with relapsed or refractory NHL with platelet counts ≥150,000/ mm3 who received 0.4 mCi/kg (14.8 MBq/kg) of Y-90 Zeva lin (Group 1 in Table 4), 65 patients with relapsed or refractory NHL with platelet counts of 100,000 to 149,000/mm3 who received 0.3 mCi/kg (11.1 MBq/kg) of Y-90 Zeva lin (Group 2 in Table 4), and 204 patients with previously untreated NHL with platelet counts ≥150,000/ mm3 who received 0.4 mCi/kg (14.8 MBq/kg) of Y-90 Zeva lin; all patients received a single course of Zeva lin.
Table 2 displays selected adverse reaction incidence rates in patients who received any portion of the Zeva lin therapeutic regimen (n=206) or no further therapy (n=203) following first-line chemotherapy (Study 4).
Table 2. Per-Patient Incidence (%) of Selected* Adverse Reactions Occurring in ≥ 5% of Patients with Previously Untreated Follicular NHL Treated with the Zeva lin Therapeutic Regimen *
Between-group difference of ≥5%
NCI CTCAE version 2.0
Zeva lin (n=206) Observation (n=203)
All Grades† Grade† 3-4 All Grades† Grade† 3-4
% % % %
Gastrointestinal Disorders
Abdominal pain 17 2 13 <1
Diarrhea 11 0 3 0
Nausea 18 0 2 0
Body as a Whole
Asthenia 15 1 8 <1
Fatigue 33 1 9 0
Influenza-like illness 8 0 3 0
Pyrexia 10 3 4 0
Musculoskeletal
Myalgia 9 0 3 0
Metabolism
Anorexia 8 0 2 0
Respiratory, Thoracic & Media
Cough 11 <1 5 0
Pharyngolaryngeal pain 7 0 2 0
Epistaxis 5 2 <1 0
Nervous System
Dizziness 7 0 2 0
Vascular
Hypertension 7 3 2 <1
Skin & Subcutaneous
Night sweats 8 0 2 0
Petechiae 8 2 0 0
Pruritus 7 0 1 0
Rash 7 0 <1 0
Infections & Infestations
Bronchitis 8 0 3 0
Nasopharyngitis 19 0 10 0
Rhinitis 8 0 2 0
Sinusitis 7 <1 <1 0
Urinary tract infection 7 <1 3 0
Blood and Lymphatic System
Thrombocytopenia 62 51 1 0
Neutropenia 45 41 3 2
Anemia 22 5 4 0
Leukopenia 43 36 4 1
Lymphopenia 26 18 9 5
Table 3 shows hematologic toxicities in 349 Zeva lin-treated patients with relapsed or refractory, low-grade, follicular or transformed B-cell NHL. Grade 2-4 hematologic toxicity occurred in 86% of Zeva lin-treated patients.
Table 3. Per-Patient Incidence (%) of Hematologic Adverse Reactions in Patients with Relapsed or Refractory Low-grade, Follicular or Transformed B-cell NHL* (N = 349)
Occurring within the 12 weeks following the first rituximab infusion of the Zeva lin therapeutic regimen
All Grades
% Grade 3-4
%
Thrombocytopenia 95 63
Neutropenia 77 60
Anemia 61 17
Ecchymosis 7 <1
Prolonged and Severe Cytopenias
Patients in clinical studies were not permitted to receive hematopoietic growth factors beginning 2 weeks prior to administration of the Zeva lin therapeutic regimen.
The incidence and duration of severe hematologic toxicity in previously treated NHL patients (N=335) and in previously untreated patients (Study 4) receiving Y-90 Zeva lin are shown in Table 4.
Table 4. Severe Hematologic Toxicity in Patients Receiving Zeva lin *
Day from last ANC ≥1000/mm3 to first ANC ≥1000/mm3 following nadir, |
