Annals of Oncology 14:1762-1767, 2003
© 2003 European Society for Medical Oncology
Original Paper |
Gemcitabine, dexamethasone and cisplatin is an active and non-toxic chemotherapy regimen in relapsed or refractory Hodgkins disease: a phase II study by the National Cancer Institute of Canada Clinical Trials Group
1 National Cancer Institute of Canada Clinical Trials Group, Kingston, Ontario; 2 Eli Lilly, Toronto, Ontario, Canada
Received 24 June 2003; accepted 12 August 2003
Background:
Gemcitabine (difluorodeoxycytidine) is active as a single agent in Hodgkins disease and has been used successfully in combination with cisplatin to treat a variety of solid tumors.
Patients and methods:
We evaluated the combination of gemcitabine/dexamethasone/cisplatin (GDP) as salvage chemotherapy in 23 patients with relapsed or refractory Hodgkins disease (median age 36 years, range 1957). Treatment consisted of gemcitabine 1000 mg/m2 intravenously on days 1 and 8, dexamethasone 40 mg orally days 14 and cisplatin 75 mg/m2 on day 1, every 21 days as an outpatient. Response was assessed following two cycles of treatment.
Results:
There were four complete responses and 12 partial responses for a response rate of 69.5% (95% confidence interval 52% to 87%); the remaining seven patients had stable disease and no patient progressed on treatment. All patients had successful stem cell mobilization and underwent transplantation with a median 10.6 x 106 CD34+ cells/kg. Hematological toxicity from GDP was mild (grade 3 neutropenia 8.6%, grade 3 thrombocytopenia 13%).
Conclusions:
In summary, GDP is an active regimen for patients with relapsed or refractory Hodgkins disease. The response rate is similar to the rates of other current salvage regimens, it can be given to outpatients with tolerable toxicity and it does not inhibit the mobilization of autologous stem cells.
Key words: gemcitabine, Hodgkins disease, salvage chemotherapy
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