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Results of a clinical phase I dose-escalation study of cytarabine in combination with fixed-dose vinorelbine, paclitaxel, etoposide and cisplatin for the treatment of relapsed/refractory lymphoma.

Abstract：

:Management of relapsed lymphoma depends upon the variables of chemosensitive disease and successful stem cell mobilization. The microtubule specific agents, paclitaxel and vinorelbine, have efficacy in relapsed lymphoma and can enhance stem cell mobilization. We performed a phase I dose-escalation study of cytarabine combined with fixed doses of vinorelbine, paclitaxel, etoposide and cisplatin (VTEPA) for patients with relapsed/refractory lymphoma. The regimen consisted of paclitaxel 175 mg/m2 and vinorelbine 30 mg/m2 on day 1; cisplatin 20 mg/m2 and etoposide 100 mg/m2 over 4 h on days 2 - 5. Cytarabine 2 g m/m2 over 4 h, in successive cohorts on 1, 2, or 3 consecutive days: cohort A day 5; cohort B days 4 - 5; and cohort C days 3 - 5. Sixteen patients (Hodgkin's disease, n = 6; non-Hodgkin's lymphoma, n = 10) were enrolled. Fourteen of 16 patients (88%) had refractory and seven patients (44%) had primary refractory disease. Major toxicities included hematologic toxicity, mucositis and infectious complications. Infectious complications (10/16 patients) included neutropenic fever, sepsis and fungal pneumonia. Dose-limiting toxicity was achieved in cohort C, which received three doses of cytarabine. There were 33% partial responses, 27% stable disease and 40% progressive disease following a single cycle of VTEPA. Two of 16 patients suffered treatment-related mortality. Five patients went on to receive autologous (n = 4) or allogeneic transplant (n = 1), and five out of seven patients in this heavily pretreated group who received VTEPA for mobilization of an autologous graft were successfully collected. The recommended dose of cytarabine for further evaluation in a phase II study is 2 g m/m2 for 2 consecutive days in combination with VTEPA. Treatment of subjects with relapsed/refractory lymphoma using VTEPA as second- or third-line salvage therapy produced remissions in some patients and permitted collection of grafts and subsequent autologous transplantation, supporting a planned phase II trial.

journal_name

Leuk Lymphoma

journal_title

Leukemia & lymphoma

authors

Lonial S,Arellano M,Hutcherson D,Langston A,Flowers C,Heffner LT,Winton E,Jo Lechowicz M,Waller EK

doi

10.1080/10428190600774923

subject

Has Abstract

pub_date

2006-10-01 00:00:00

pages

2155-62

issue

eissn

1042-8194

issn

1029-2403

pii

X71728045356644P

journal_volume

pub_type

杂志文章

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Results of a clinical phase I dose-escalation study of cytarabine in combination with fixed-dose vinorelbine, paclitaxel, etoposide and cisplatin for the treatment of relapsed/refractory lymphoma.