ction rates observed cannot be directly compared to rates in other trials and may not reflect the rates observed in clinical practice.
The safety of JEVTANA in combination with prednisone was eva luated in 371 patients with hormone-refractory metastatic prostate cancer treated in a single randomized trial, compared to mitoxantrone plus prednisone.
Deaths due to causes other than disease progression within 30 days of last study drug dose were reported in 18 (5%) JEVTANA-treated patients and 3 (< 1%) mitoxantrone-treated patients. The most common fatal adverse reactions in JEVTANA-treated patients were infections (n=5) and renal failure (n=4). The majority (4 of 5 patients) of fatal infection-related adverse reactions occurred after a single dose of JEVTANA. Other fatal adverse reactions in JEVTANA-treated patients included ventricular fibrillation, cerebral hemorrhage, and dyspnea.
The most common (≥ 10%) grade 1–4 adverse reactions were anemia, leukopenia, neutropenia, thrombocytopenia, diarrhea, fatigue, nausea, vomiting, constipation, asthenia, abdominal pain, hematuria, back pain, anorexia, peripheral neuropathy, pyrexia, dyspnea, dysguesia, cough, arthralgia, and alopecia.
The most common (≥ 5%) grade 3–4 adverse reactions in patients who received JEVTANA were neutropenia, leukopenia, anemia, febrile neutropenia, diarrhea, fatigue, and asthenia.
Treatment discontinuations due to adverse drug reactions occurred in 18% of patients who received JEVTANA and 8% of patients who received mitoxantrone. The most common adverse reactions leading to treatment discontinuation in the JEVTANA group were neutropenia and renal failure. Dose reductions were reported in 12% of JEVTANA-treated patients and 4% of mitoxantrone-treated patients. Dose delays were reported in 28% of JEVTANA-treated patients and 15% of mitoxantrone-treated patients.
Table 2 – Incidence of Reported Adverse Reactions* and Hematologic Abnormalities in ≥ 5% of Patients Receiving JEVTANA in Combination with Prednisone or Mitoxantrone in Combination with Prednisone JEVTANA 25 mg/m2 every 3 weeks with prednisone 10 mg daily
n=371 Mitoxantrone 12 mg/m2 every 3 weeks with prednisone 10 mg daily
n=371
Grade 1–4
n (%) Grade 3–4
n (%) Grade 1–4
n (%) Grade 3–4
n (%)
Graded using NCI CTCAE version 3
Based on laboratory values, cabazitaxel: n =369, mitoxantrone: n = 370.
Includes atrial fibrillation, atrial flutter, atrial tachycardia, atrioventricular block complete, bradycardia, palpitations, supraventricular tachycardia, tachyarrhythmia, and tachycardia.
Includes abdominal discomfort, abdominal pain lower, abdominal pain upper, abdominal tenderness, and GI pain.
Includes gastroesophageal reflux disease and reflux gastritis.
Includes urinary tract infection enterococcal and urinary tract infection fungal.
Includes peripheral motor neuropathy and peripheral sensory neuropathy.
Any Adverse Reaction
Blood and Lymphatic System Disorders
Neutropenia† 347 (94%) 303 (82%) 325 (87%) 215 (58%)
Febrile Neutropenia 27 (7%) 27 (7%) 5 (1%) 5 (1%)
Anemia† 361 (98%) 39 (11%) 302 (82%) 18 (5%)
Leukopenia† 355 (96%) 253 (69%) 343 (93%) 157 (42%)
Thrombocytopenia† 176 (48%) 15 (4%) 160 (43%) 6 (2%)
Cardiac Disorders
Arrhythmia‡ 18 (5%) 4 (1%) 6 (2%) 1 (< |
