Phase II study of gemcitabine and bexarotene (GEMBEX) in the treatment of cutaneous T-cell lymphoma.
Phase II study of gemcitabine and bexarotene (GEMBEX) in the treatment of cutaneous T-cell lymphoma.
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DOI：
10.1038/bjc.2013.616
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发表时间：
2013-11-12
影响因子：
8.8
通讯作者：
Cowan, R.
中科院分区：
文献类型：
--
作者：
Illidge, T.;Chan, C.;Counsell, N.;Morris, S.;Scarisbrick, J.;Gilson, D.;Popova, B.;Patrick, P.;Smith, P.;Whittaker, S.;Cowan, R.
吉西他滨和贝沙罗汀都是治疗皮肤T细胞淋巴瘤（CTCL）的既定单药。我们在一项单臂II期研究中调查了联合这些药物的可行性和疗效。皮肤T细胞淋巴瘤患者标准皮肤定向治疗失败，既往至少接受过一次全身治疗，给予4个周期的吉西他滨和同时的贝沙罗汀治疗12周。应答者继续接受贝沙罗汀维持治疗，直至疾病进展或出现不可接受的毒性。中位年龄为65岁，IB期（n=5）、IIA期（n=2）、IIB期（n=8）、III期（n=8）和IVA期（n=12），17例患者为红皮病，17例患者为B1，10例患者同时为红皮病和B1。30例（86%）患者完成了四个周期的吉西他滨治疗。尽管12周时的客观疾病缓解率为31%（部分缓解（PR）31%），24周时为14%（PR 14%，疾病稳定（SD）23%，疾病进展（PD）54%，不可评价9%），但80.0%的患者显示改良严重度加权评估工具（mSWAT）评分降低。中位无进展生存期为5.3个月，中位总生存期为21.2个月。联合治疗的总体缓解率未达到进一步治疗的特定目标，并且低于先前报告的吉西他滨单药治疗的总体缓解率。
Both gemcitabine and bexarotene are established single agents for the treatment of cutaneous T-cell lymphoma (CTCL). We investigated the feasibility and efficacy of combining these drugs in a single-arm phase II study. Cutaneous T-cell lymphoma patients who had failed standard skin-directed therapy and at least one prior systemic therapy were given four cycles of gemcitabine and concurrent bexarotene for 12 weeks. Responders were continued on bexarotene maintenance until disease progression or unacceptable toxicity. The median age was 65 years, stage IB (n=5), stage IIA (n=2), stage IIB (n=8), stage III (n=8) and stage IVA (n=12), 17 patients were erythrodermic, 17 patients were B1, and 10 patients were both erythrodermic and B1. Thirty (86%) patients completed four cycles of gemcitabine. In all, 80.0% of patients demonstrated a reduction in modified Severity-Weighted Assessment Tool (mSWAT) score although the objective disease response rate at 12 weeks was 31% (partial response (PR) 31%) and at 24 weeks 14% (PR 14%, stable disease (SD) 23%, progressive disease (PD) 54%, not evaluable 9%). Median progression-free survival was 5.3 months and median overall survival was 21.2 months. The overall response rate of the combination did not reach the specified target to proceed further and is lower than that previously reported for gemcitabine as a single agent.
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影响因子：
50.5
作者：
Zinzani, P. L.;Venturini, F.;Baccarani, M.
通讯作者：
Baccarani, M.
影响因子：
8.4
作者：
Duvic, Madeleine;Dummer, Reinhard;Prince, H. Miles
通讯作者：
Prince, H. Miles
DOI：
10.3816/clm.2006.n.039
发表时间：
2006-07-01
期刊：
CLINICAL LYMPHOMA & MYELOMA
影响因子：
--
作者：
Duvic, Madeleine;Talpur, Rakhshandra;Apisarnthanarax, Narin
通讯作者：
Apisarnthanarax, Narin
影响因子：
6.2
作者：
Marchi, E;Alinari, L;Zinzani, PL
通讯作者：
Zinzani, PL
影响因子：
45.3
作者：
Duvic, M;Hymes, K;Yocum, RC
通讯作者：
Yocum, RC