Case Study 1
Recurrent Cervical Cancer
Patient: 51-year-old, Hispanic kindergarten teacher
Diagnosis: Stage III-B squamous cell carcinoma of the cervix involving the pelvic wall and lower third of the vagina with right-sided hydronephrosis
Treatment History: Received external beam pelvic radiotherapy followed by intracavitary brachytherapy with concomitant weekly cisplatin, delivered over 8 weeks. Complete response
Side Effect History: Grade 3 nausea and vomiting, grade 1 peripheral neuropathy, and a transient rise in her serum creatinine
Current Status: After 24 months in remission, she now presents with a 3-week history of progressive fatigue, anorexia, weight loss, and low back pain. CT scans show 3 small pulmonary nodules and 2 liver nodules; bone scan shows a solitary osteolytic lesion at L4. CT-guided liver biopsy confirms histologic diagnosis of recurrent cervical cancer
Questions for consideration
- Are you familiar with the results of GOG 169, which compared paclitaxel/cisplatin with cisplatin alone in the treatment of recurrent or persistent cervical cancer?
- Are you familiar with the results of GOG 179, which compared Hycamtin/cisplatin with cisplatin alone in the treatment of recurrent or persistent cervical cancer?
- Does your patients’ previous exposure to cisplatin influence your treatment decision now?
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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