Case Study 4:
Relapsed Ovarian Cancer (platinum resistant/refractory)
Patient: 66-year-old retired flight attendant
Diagnosis: Stage IV ovarian cancer
Treatment History: Received 6 courses of carboplatin and paclitaxel with complete response. Off therapy for 10 months; first relapse. Re-treated with an additional 6 courses of carboplatin/paclitaxel; achieved another complete response
Side Effect History: Total alopecia, grade 3 thrombocytopenia, peripheral neuropathy
Current Status: 4 months off therapy, she now presents with abdominal pain, constipation, and bloating. CT scan shows massive pelvic and abdominal disease
Questions for consideration
- How important is a quick response in this patient?
- How would you characterize the sensitivity of this patient’s disease?
- Should she receive a platinum doublet or a single agent?
- What kind of response are you expecting with this treatment?
- Would you consider stable disease a positive outcome in this patient?
- What kind of side effects are you expecting with this treatment?
- How long are you likely to continue therapy in this patient?
- Will you treat this patient to progression?
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Important Safety Information
ContraindicationsHycamtin 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.
WarningsHycamtin 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).
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 InteractionsConcomitant administration of G-CSF can prolong the duration of neutropenia, so if G-CSF is to be used, it should not be initiated until day 6 of the course of therapy, 24 hours after completion of treatment with Hycamtin.
Myelosuppression was more severe when Hycamtin was given in combination with cisplatin in phase I studies. In a reported study on concomitant administration of cisplatin 50 mg/m² and Hycamtin at a dose of 1.25 mg/m²/day x 5 days, 1 of 3 patients had severe neutropenia for 12 days, and a second patient died with neutropenic sepsis. There are no adequate data to define a safe and effective regimen for Hycamtin and cisplatin in combination.
Adverse EventsFrequently 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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