Gemcitabine, dexamethasone, and cisplatin in patients with recurrent or refractory aggressive histology B‐cell non‐Hodgkin lymphoma

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Abstract
BACKGROUND Gemcitabine has been shown to have activity as a single agent in lymphoma and, when combined with cisplatin, is effective therapy for a number of solid tumors. The authors wished to determine the response rate and toxicity of gemcitabine, dexamethasone, and cisplatin for recurrent or refractory non‐Hodgkin lymphoma (NHL). METHODS Patients with recurrent or refractory diffuse large B‐cell NHL or variants (REAL classification), measurable disease, and one previous chemotherapy regimen were eligible. Treatment consisted of gemcitabine 1000 mg/m2 intravenously (i.v.) on Days 1 and 8, dexamethasone 40 mg orally on Days 1–4, and cisplatin 75 mg/m2 i.v. on Day 1 (GDP), every 21 days as an outpatient. The primary end point was a response after two cycles. Patients could then proceed to stem cell transplantation (SCT) or receive up to six treatment cycles. RESULTS Fifty‐one eligible patients were evaluable for toxicity and response. The median age of the patients was 57 years (range, 18–84 years) and most had diffuse large‐cell lymphoma. After 2 cycles, there were 8 complete responses (CR; 16%) and 17 partial responses (PR; 33%). There was an overall response rate (RR) of 49% (95% confidence interval = 37–63%). The RR afer completion of all protocol chemotherapy (including those who received > 2 cycles of GDP) was 53% (11 CR, 16 PR). Grade 3 and 4 neutropenia occurred in 33% and 39% of patients, respectively. Grade 3 and 4 thrombocytopenia occurred in 24% and 4% of patients, respectively. Seven patients (14%) experienced febrile neutropenia. Of the 35 patients < 66 years, 22 (63%) proceeded to SCT. CONCLUSIONS GDP is an active regimen in B‐cell NHL and can be administered with acceptable toxicity to outpatients. A Phase III trial comparing GDP with standard cisplatin‐based chemotherapy is now ongoing through the National Cancer Institute of Canada Clinical Trials Group. Cancer 2004. © 2004 American Cancer Society.

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