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 The PS2 PatientSmall cell lung cancer (SCLC) is highly responsive to chemotherapy and radiation. However, most patients with SCLC will eventually experience disease recurrence or progression and die from their disease. Treatment options at relapse depend on a number of factors including the performance status (PS) of the patient. [16]PS often reflects the extent of the disease and is a powerful predictor of overall survival in patients with SCLC. Unfortunately, patients with poorer PS scores are unable to tolerate chemotherapy due to comorbid conditions and impaired organ function. As such, many receive subtherapeutic doses or supportive care alone. With patients with PS scores ≥2, treatment should provide symptom palliation and quality of life improvements. [16,19] The combination of symptom palliation, antitumor activity, and tolerability of Hycamtin makes it a viable option for treating PS2 patients with relapsed SCLC [16]In an analysis by Treat et al [16] of 5 clinical trials in patients with relapsed SCLC, PS0/1 and PS2 patients experienced similar responses with Hycamtin. Adapted from Treat et al. Oncologist. 2004;9:178. *Intent-to-treat population. OR=overall response; CR=complete response; PR=partial response.
In that same study, time to progression and overall survival were shorter for PS2 patients than for PS0/1 patients, but PS2 patients experienced benefits from treatment with Hycamtin, including symptom improvement and tumor shrinkage. [16]
Time to progression was significantly shorter for PS2 patients (P=0.046)  Adapted from Treat et al. Oncologist. 2004;9:178. Kaplan-Meier chart showing the estimated time to progression in patients with relapsed SCLC treated with Hycamtin. Overall survival was significantly longer for PS0/1 patients (P=0.001)
In the Treat et al [16] study, symptom improvement was similar between PS0/1 patients and PS2 patients  Adapted from Treat et al. Oncologist. 2004;9:179. †Symptom improvement was evaluated in 3 of the 5 registration trials for Hycamtin conducted in patients with chemotherapy-sensitive recurrent SCLC. All patients in studies 065 and 090 had chemosensitive disease. Improvement was defined as 2 consecutive postbaseline assessments lower (ie, better) than the baseline assessment for that symptom. ‡Defined as improvement sustained over at least 2 courses compared with baseline. §Fatigue and interference with daily activity were evaluated only in studies 065 and 090. Hycamtin can be tolerated by both PS0/1 and PS2 patients [16]
 Adapted from Treat et al. Oncologist. 2004;9:176. || P=0.009 between PS0/1 patients and PS2 patients.
 Adapted from Treat et al. Oncologist. 2004;9:178. # P<0.05 between PS0/1 patients and PS2 patients. **Grade 5 was reported for 1 patient. N/A=not assessed. Important Safety InformationIndicationsHycamtin is indicated for the treatment of small cell lung cancer sensitive disease after failure of first-line chemotherapy.*
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). 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 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 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 EventsThe 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. |
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