Carboplatin (Page 4 of 7)
ADVERSE REACTIONS
For a comparison of toxicities when carboplatin or cisplatin was given in combination with cyclophosphamide, see CLINICAL STUDIES, Use with Cyclophosphamide for Initial Treatment of Ovarian Cancer, Comparative Toxicity.
First Line Combination Therapy *Percent | Second Line Single Agent Therapy †Percent | ||
| |||
Bone Marrow | |||
Thrombocytopenia | <100,000/mm 3 | 66 | 62 |
<50,000/mm 3 | 33 | 35 | |
Neutropenia | <2,000 cells/mm 3 | 96 | 67 |
<1,000 cells/mm 3 | 82 | 21 | |
Leukopenia | <4,000 cells/mm 3 | 97 | 85 |
<2,000 cells/mm 3 | 71 | 26 | |
Anemia | <11 g/dL | 90 | 90 |
<8g/dL | 14 | 21 | |
Infections | 16 | 5 | |
Bleeding | 8 | 5 | |
Transfusions | 35 | 44 | |
Gastrointestinal | |||
Nausea and vomiting | 93 | 92 | |
Vomiting | 83 | 81 | |
Other GI side effects | 46 | 21 | |
Neurologic | |||
Peripheral neuropathies | 15 | 6 | |
Ototoxicity | 12 | 1 | |
Other sensory side effects | 5 | 1 | |
Central neurotoxicity | 26 | 5 | |
Renal | |||
Serum creatinine elevations | 6 | 10 | |
Blood urea elevations | 17 | 22 | |
Hepatic | |||
Bilirubin elevations | 5 | 5 | |
SGOT elevations | 20 | 19 | |
Alkaline phosphatase elevations | 29 | 37 | |
Electrolytes loss | |||
Sodium | 10 | 47 | |
Potassium | 16 | 28 | |
Calcium | 16 | 31 | |
Magnesium | 61 | 43 | |
Other side effects | |||
Pain | 44 | 23 | |
Asthenia | 41 | 11 | |
Cardiovascular | 19 | 6 | |
Respiratory | 10 | 6 | |
Allergic | 11 | 2 | |
Genitourinary | 10 | 2 | |
Alopecia | 49 | 2 | |
Mucositis | 8 | 1 |
In the narrative section that follows, the incidences of adverse events are based on data from 1,893 patients with various types of tumors who received carboplatin as single agent therapy.
Hematologic Toxicity
Bone marrow suppression is the dose-limiting toxicity of carboplatin. Thrombocytopenia with platelet counts below 50,000/mm 3 occurs in 25% of the patients (35% of pretreated ovarian cancer patients); neutropenia with granulocyte counts below 1,000/mm 3 occurs in 16% of the patients (21% of pretreated ovarian cancer patients); leukopenia with WBC counts below 2,000/mm 3 occurs in 15% of the patients (26% of pretreated ovarian cancer patients). The nadir usually occurs about day 21 in patients receiving single agent therapy. By day 28, 90% of patients have platelet counts above 100,000/mm 3 ; 74% have neutrophil counts above 2,000/mm 3 ; 67% have leukocyte counts above 4,000/mm 3.
Marrow suppression is usually more severe in patients with impaired kidney function. Patients with poor performance status have also experienced a higher incidence of severe leukopenia and thrombocytopenia.
The hematologic effects, although usually reversible, have resulted in infectious or hemorrhagic complications in 5% of the patients treated with carboplatin, with drug related death occurring in less than 1% of the patients. Fever has also been reported in patients with neutropenia.
Anemia with hemoglobin less than 11 g/dL has been observed in 71% of the patients who started therapy with a baseline above that value. The incidence of anemia increases with increasing exposure to carboplatin. Transfusions have been administered to 26% of the patients treated with carboplatin (44% of previously treated ovarian cancer patients).
Bone marrow depression may be more severe when carboplatin is combined with other bone marrow suppressing drugs or with radiotherapy.
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