Case Study 2:
Relapsed Ovarian Cancer (platinum sensitive)
Patient: 41-year-old lab technician
Diagnosis: Stage IIIC ovarian cancer
Treatment History: TAH, BSO, omentectomy with little residual tumor remaining. Received 6 cycles of carboplatin/paclitaxel with complete remission for 7 months. At relapse, therapy with Hycamtin initiated; stable disease after 4 cycles
Side Effect History: Grade 3 peripheral neuropathy and prolonged thrombocytopenia with carboplatin/paclitaxel. Currently experiencing additional grade 3 neutropenia and thrombocytopenia with Hycamtin
Current Status: Patient is feeling well, and is willing to continue on therapy with Hycamtin
Questions for consideration
- How significant is stable disease as the best response in this type
of patient?
- How long would you continue treating this patient with Hycamtin?
- Would you modify the treatment regimen for Hycamtin to manage hematologic toxicity?
—How would you modify treatment if the patient had
moderate renal impairment?
- Do you currently have any patients who might benefit from single-agent therapy that can be sustained over multiple cycles?
- Are 4 cycles of therapy sufficient to evaluate response?
Case Study 1 | Case Study 2 | Case Study 3 | Case Study 4
Important Safety Information
Indications
Hycamtin is indicated for the treatment of metastatic carcinoma of the ovary after failure of initial or subsequent chemotherapy.
Contraindications
Hycamtin is contraindicated in patients who have a history of hypersensitivity reactions to topotecan or to any of its ingredients. Hycamtin should not be used in patients who are pregnant or breast-feeding, or those with severe bone marrow depression.
Warnings
Hycamtin should be used only in patients with adequate bone marrow reserves, including baseline neutrophil counts of at least 1,500 cells/mm³ and platelet counts of at least 100,000/mm³. Frequent monitoring of blood counts should be instituted during treatment with Hycamtin.
Patients should not be treated with subsequent courses of Hycamtin until neutrophils recover to >1,000 cells/mm³, platelets recover to >100,000 cells/mm³, and hemoglobin levels recover to 9.0 g/dL (with transfusion if necessary). Severe myelotoxicity has been reported when 5-day dosing of Hycamtin is used in combination with cisplatin.
Hycamtin may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant during therapy with Hycamtin.
Drug Interactions
Concomitant administration of G-CSF can prolong the duration of neutropenia, so if G-CSF is to be used, it should not be initiated until 24 hours after completion of treatment with Hycamtin.
Myelosuppression was more severe when Hycamtin, at a dose of 1.25 mg/m²/day x 5 days, was given in combination with cisplatin at a dose of 50 mg/m² in phase I studies. In one study, 1 of 3 patients had severe neutropenia for 12 days, and a second patient died with neutropenic sepsis.
Adverse Events
The most common serious adverse event is myelosuppression.
Severe neutropenia, the dose-limiting toxicity for Hycamtin, occurred in 78% of 879 ovarian and small cell lung cancer patients treated. Other hematologic adverse events reported include severe leukopenia (32%), severe thrombocytopenia (27%), and severe anemia (37%).
Frequently reported nonhematologic adverse events associated with use of Hycamtin included nausea (64%), vomiting (45%), diarrhea (32%), alopecia (49%), fatigue (29%), and dyspnea (22%). Most nonhematologic toxicities were grade 1 or 2.
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