Study objective

To compare the efficacy of paclitaxel plus platinum-based chemotherapy vs conventional platinum-based chemotherapy in patients with ovarian cancer who had relapsed following platinum-based chemotherapy.

Study results

Findings suggested a beneficial effect for paclitaxel plus platinum-based chemotherapy for overall survival, and progression-free survival in patients with relapsed platinum-sensitive ovarian cancer.

Response rates

54% (69/128) of patients in the conventional platinum-based chemotherapy group had a complete or partial response
66% (78/119) of patients in the paclitaxel plus platinum-based chemotherapy group had a complete or partial response

ICON4/AGO-OVAR-2.2 Trial Conclusions

Paclitaxel in combination with platinum has a beneficial effect on survival and progression-free survival in patients with relapsed platinum-sensitive ovarian cancer
No clear evidence the effect of paclitaxel plus platinum is larger or smaller in any subgroup (particularly in patients treated with taxanes first line, or whose disease relapsed <12 months)

Potential ICON4/AGO-OVAR-2.2 Trial Design Limitations

Pooled results from 2 parallel trials with 3 separate protocols
Eligibility criteria and study methods varied
57% (458/802) of patients did not receive a taxane front line

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.

Home | Prescribing Information for Hycamtin

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