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.

ADVERSE EXPERIENCES IN PATIENTS WITH OVARIAN CANCER
First Line Combination Therapy *Percent Second Line Single Agent Therapy Percent
*
Use with Cyclophosphamide for Initial Treatment of Ovarian Cancer: Data are based on the experience of 393 patients with ovarian cancer (regardless of baseline status) who received initial combination therapy with carboplatin and cyclophosphamide in two randomized controlled studies conducted by SWOG and NCIC (see CLINICAL STUDIES). Combination with cyclophosphamide as well as duration of treatment may be responsible for the differences that can be noted in the adverse experience table.
Single Agent Use for the Secondary Treatment of Ovarian Cancer: Data are based on the experience of 553 patients with previously treated ovarian carcinoma (regardless of baseline status) who received single agent carboplatin.
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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