Case Study 1:
Relapsed Small Cell Lung Cancer (SCLC)
Patient: 57-year-old businessman
Diagnosis: Extensive-stage SCLC 11 months ago, with pulmonary nodules, contralateral adenopathy, and retroperitoneal adenopathy
Treatment History: Received 6 cycles of cisplatin/etoposide. In remission and off therapy for 5 months when he developed cough, dyspnea on exertion, fatigue, and anorexia
Side Effect History: Grade 2/3 peripheral neuropathy and grade 2 thrombocytopenia
Current Status: Relapsed 5 months after initial therapy, CT scans show multiple liver nodules and brain metastases. Extensive-stage, PS1, platinum-sensitive disease
Questions for consideration
- Would symptom palliation play a major role in your treatment decision?
- What is the value of disease stabilization in this patient?
- Would you treat this patient to progression?
- What kind of response would you expect in this patient?
- Should he receive a platinum doublet or a single agent?
- If your patient wants to remain active, what would your treatment
goals be?
Case Study 1 | Case Study 2
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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