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一项多中心2期研究,评估含长春瑞滨和吉西他滨的风险调整挽救化疗方案用于复发难治性淋巴瘤的疗效。

A multicenter phase 2 study of risk-adjusted salvage chemotherapy incorporating vinorelbine and gemcitabine for relapsed and refractory lymphoma.

作者信息

Pasricha Sant-Rayn, Grigg Andrew, Catalano John, Leahy Michael, Underhill Craig, Arthur Chris, D'Rozario James, Lowenthal Ray, Reed Kate, Spencer Andrew

机构信息

Malignant Haematology and Stem Cell Transplantation Service, The Alfred Hospital, Melbourne, Australia.

出版信息

Cancer. 2008 Dec 1;113(11):3192-8. doi: 10.1002/cncr.23915.

DOI:10.1002/cncr.23915
PMID:18932253
Abstract

BACKGROUND

Administration of salvage chemotherapy to patients with relapsed or refractory lymphoma is associated with significant toxicity. Vinorelbine and gemcitabine are novel chemotherapeutic agents with minimal overlapping toxicity. We present a phase 2 study of vinorelbine and gemcitabine with or without ifosfamide administered in an ambulatory care setting for relapsed or refractory lymphoma.

METHODS

Ninety patients were enrolled. Group 1 comprised patients with "good" risk disease, Group 2 comprised patients with "high" risk disease, and Group 3 comprised patients relapsing after prior stem cell transplant. Patients in Group 1 and Group 3 received vinorelbine and gemcitabine with filgrastim support (VGF); those in Group 2 received the above regimen with ifosfamide (FGIV). We incorporated a standardized interim evaluation with dose escalation for patients with suboptimal response after 2 cycles.

RESULTS

Toxicities were acceptable. Febrile neutropenia was uncommon: 7% after VGF (7 of 107 cycles) and 19% for FGIV (26 of 148 cycles). Unplanned admissions occurred in 23 of 107 cycles (21%) after VGF and 50 of 148 (34%) after FGIV. Overall response for Groups 1, 2 and 3, respectively was 76%, 39% and 50%, with median overall survival of 28, 9 and 30 months.

CONCLUSIONS

Vinorelbine-based and gemcitabine-based chemotherapy is effective in the salvage setting against lymphoma and can be administered in an ambulatory setting.

摘要

背景

对复发或难治性淋巴瘤患者进行挽救性化疗会带来显著毒性。长春瑞滨和吉西他滨是新型化疗药物,毒性重叠最小。我们开展了一项2期研究,在门诊环境中对复发或难治性淋巴瘤患者使用长春瑞滨和吉西他滨,联合或不联合异环磷酰胺。

方法

纳入90例患者。第1组为“低”风险疾病患者,第2组为“高”风险疾病患者,第3组为先前干细胞移植后复发的患者。第1组和第3组患者接受长春瑞滨、吉西他滨并给予非格司亭支持(VGF);第2组患者接受上述方案并联合异环磷酰胺(FGIV)。我们纳入了标准化的中期评估,对2个周期后反应欠佳的患者进行剂量递增。

结果

毒性可接受。发热性中性粒细胞减少并不常见:VGF组为7%(107个周期中有7个),FGIV组为19%(148个周期中有26个)。VGF组107个周期中有23个(21%)发生非计划住院,FGIV组148个周期中有50个(34%)。第1、2和3组的总体缓解率分别为76%、39%和50%,中位总生存期分别为28个月、9个月和30个月。

结论

以长春瑞滨和吉西他滨为基础的化疗在挽救性治疗淋巴瘤方面有效,且可在门诊进行。

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