Case Studies
Case Study 1

Relapsed Ovarian Cancer (platinum sensitive)


Patient: 62-year-old nursing instructor

Diagnosis: Stage III ovarian cancer

Treatment History: TAH and BSO performed. Small residual peritoneal implants.
Received 6 cycles of carboplatin/paclitaxel with complete remission

Side Effect History: Grade 3 peripheral neuropathy and prolonged thrombocytopenia

Current Status: Relapsed 10 months after completing carboplatin/paclitaxel therapy. Abdominal pain and right shoulder pain; CT shows liver metastases and peritoneal implants, and retroperitoneal and para-aortic adenopathy; bilirubin 2.8 mg/dL

Questions for consideration
  • Would you consider this patient likely to be platinum sensitive?
  • Which regimen would you choose?
  • What response would you expect with this regimen?
  • What comorbidities affect your decision to treat with a doublet
    or a single agent?
  • Are there other considerations that would affect your
    treatment decisions?
  • Do you currently have any patients in first remission or with
    recent relapse?

Case Study 1  |  Case Study 2  |  Case Study 3  |  Case Study 4

Important Safety Information

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).

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 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 Events

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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