Sunitinib malate in the treatment of recurrent or persistent uterine leiomyosarcoma: a Gynecologic Oncology Group phase II study.
Sunitinib malate in the treatment of recurrent or persistent uterine leiomyosarcoma: a Gynecologic Oncology Group phase II study.
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DOI：
10.1016/j.ygyno.2009.09.011
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发表时间：
2009-12
影响因子：
4.7
通讯作者：
Gehrig PA
中科院分区：
文献类型：
--
作者：
Hensley ML;Sill MW;Scribner DR Jr;Brown J;Debernardo RL;Hartenbach EM;McCourt CK;Bosscher JR;Gehrig PA
在阿霉素或吉西他滨-多西他赛治疗后进展的转移性子宫平滑肌肉瘤患者需要新的药物。靶向肿瘤血管的药物在平滑肌肉瘤中具有潜在的活性。我们的目的是通过确定无进展存活至少6个月或获得客观肿瘤反应的患者的频率，评估舒尼替尼在既往接受过一种或两种治疗的复发性子宫平滑肌肉瘤患者中的活性。我们还旨在表征舒尼替尼的毒性并估计进展时间。符合条件的子宫平滑肌肉瘤患者每日口服舒尼替尼50mg，治疗4周，休息2周。每6周评估一次肿瘤反应和无进展状态。入选的25名患者中有23名可评估疗效（两种错误的组织学）。周期数的中位数是1。23例患者中有2例获得部分缓解（8.7%，90%双侧，二项置信区间（CI） 1.6 -24.9%）。4例患者在6个月时仍无进展（17.4%，90%双侧，二项置信区间6.2-35.5%）。毒性包括：3级中性粒细胞减少症（17.4%）；3级血小板减少症（13%）；3级贫血（17.4%）；3-4级淋巴细胞减少（8.7%）；3-4级疲劳（30%）；3级呕吐/腹泻（21.7%）；皮疹/手足综合征，2级（13%），3级（4.3%）；高血压，2级（39%），3级（4.3%）；2级心脏射血分数降低（4.3%），3级血栓形成（4.3%）。中位无进展生存期为1.5个月。作为子宫平滑肌肉瘤的二线或三线治疗，舒尼替尼未能达到足够的客观反应或持续的疾病稳定。
New agents are needed for patients with metastatic uterine leiomyosarcoma who progress after treatment with doxorubicin or gemcitabine-docetaxel. Agents targeting tumor vasculature have potential for activity in leiomyosarcoma. We aimed to assess the activity of sunitinib in patients with recurrent uterine leiomyosarcoma who had received one or two prior therapies by determining the frequency of patients who survived progression-free for at least six months or who achieved objective tumor response. We also aimed to characterize the toxicity of sunitinib and to estimate time-to-progression. Eligible patients with uterine leiomyosarcoma were treated with sunitinib 50 mg by mouth daily for four weeks, with two weeks rest. Tumor response and progression-free status were assessed every six weeks. Twenty-three of 25 patients enrolled were evaluable for efficacy (two wrong histologies). The median number of cycles was one. Two of 23 patients achieved a partial response (8.7%, 90% two-sided, binomial confidence interval (CI) 1.6 –24.9%). Four patients remained progression-free at six months (17.4%, 90% two-sided, binomial confidence interval 6.2–35.5%). Toxicities included: grade 3 neutropenia (17.4%); grade 3 thrombocytopenia (13%); grade 3 anemia (17.4%); grade 3–4 lymphopenia (8.7%); grade 3–4 fatigue (30%); grade 3 vomiting/diarrhea (21.7%); skin rash/hand-foot syndrome, grade 2 (13%), grade 3 (4.3%); hypertension, grade 2 (39%), grade 3 (4.3%); grade 2 decrease in cardiac ejection fraction (4.3%), and grade 3 thrombosis (4.3%). Median progression-free survival was 1.5 months. Sunitinib fails to achieve sufficient objective response or sustained disease stabilization as second- or third-line treatment for uterine leiomyosarcoma.
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影响因子：
45.3
作者：
Delaloge, S;Yovine, A;Cvitkovic, E
通讯作者：
Cvitkovic, E
影响因子：
45.3
作者：
Garcia-Carbonero, R;Supko, JG;Demetri, GD
通讯作者：
Demetri, GD
评估紫杉醇对曾接受过治疗的子宫肌层肉瘤的疗效：妇科肿瘤小组的一项研究
影响因子：
4.7
作者：
Gallup, DG;Blessing, JA;Morgan, MA
通讯作者：
Morgan, MA
DOI：
10.1093/jnci/87.16.1237
发表时间：
1995-08-16
期刊：
JOURNAL OF THE NATIONAL CANCER INSTITUTE
影响因子：
--
作者：
GUIDI, AJ;ABUJAWDEH, G;BROWN, LF
通讯作者：
BROWN, LF
影响因子：
45.3
作者：
Motzer, RJ;Michaelson, MD;Rini, BI
通讯作者：
Rini, BI