A randomized phase 2 study of temozolomide and bevacizumab or nab-paclitaxel, carboplatin, and bevacizumab in patients with unresectable stage IV melanoma : a North Central Cancer Treatment Group study, N0775.
A randomized phase 2 study of temozolomide and bevacizumab or nab-paclitaxel, carboplatin, and bevacizumab in patients with unresectable stage IV melanoma : a North Central Cancer Treatment Group study, N0775.
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DOI：
10.1002/cncr.27760
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发表时间：
2013-02-01
期刊：
影响因子：
6.2
通讯作者：
Markovic, Svetomir N.
中科院分区：
文献类型：
--
作者：
Kottschade, Lisa A.;Suman, Vera J.;Perez, Domingo G.;McWilliams, Robert R.;Kaur, Judith S.;Amatruda, Thomas T., III;Geoffroy, Francois J.;Gross, Howard M.;Cohen, Peter A.;Jaslowski, Anthony J.;Kosel, Matthew L.;Markovic, Svetomir N.
关键词：
越来越多的证据表明化疗联合VEGF抑制是转移性黑色素瘤（MM）患者的临床有效治疗方法。二期试验是在化疗天真IV期的MM不可切除的患者被随机分配到temozolomide d。1 - 5 (200 mg / m2)和贝伐单抗(10毫克/公斤4 d。1和15)每28天(方案temozolomide /贝伐单抗(结核病))或nab-paclitaxel (100 mg / m2 (80 mg / m2文章附录5-secondary毒性)天1,8 - 15),贝伐单抗(10毫克/公斤在第1和15天),和卡铂(AUC 6天1 (AUC 5文章附录5))每28天(ABC)方案。应计目标为每个方案41例患者。本研究的主要目的是估计每个方案的6个月无进展生存率（PFS6）。如果一种治疗方案的PFS6率达到60%，就被认为是有希望的。纳入了93例符合条件的患者（42例TB和51例ABC）。大多数患者有M1c疾病（20- TB和26 - ABC）。ABC的中位PFS和总生存期（OS）分别为6.7个月和13.9个月。TB患者的中位PFS时间和中位OS分别为3.8个月和12.3个月。两种方案中最常见的严重毒性（≥3级）是细胞减少、疲劳和血栓形成。在每个方案的前41名患者中，结核病的PFS6率为32.8% (95% CI: 21.1-51.2%)， ABC的PFS6率为56.1% （90% CI: 44.7-70.4%）。尽管存在耐受性问题，但贝伐单抗加入nab-紫杉醇和卡铂显示出有希望的活性。
Increasing evidence shows chemotherapy in combination with VEGF inhibition is a clinically active therapy for patients with metastatic melanoma (MM). A phase II trial was conducted in chemotherapy naïve patients with unresectable stage IV MM who were randomized to temozolomide (200 mg/m2 on d. 1–5) and bevacizumab (10mg/kg IV d. 1 and 15) every 28 days (Regimen temozolomide/bevacizumab [TB]) or nab-paclitaxel (100mg/m2 [80 mg/m2 post addendum 5-secondary to toxicity] days 1, 8 and 15), bevacizumab (10mg/kg on days 1 and 15), and carboplatin (AUC 6 day 1 [ AUC 5 post addendum 5]) every 28 days (Regimen ABC). Accrual goal was 41 patients per regimen. The primary aim of this study was to estimate progression-free survival rate at 6 months (PFS6) in each regimen. A regimen would be considered promising if its PFS6 rate was > 60%. Ninety-three eligible patients (42 TB and 51 ABC) were enrolled. The majority of patients had M1c disease (20- TB & 26 ABC). The median PFS and overall survival (OS) times with ABC were 6.7 months and 13.9 months, respectively. Median PFS time and median OS with TB were 3.8 months and 12.3 months, respectively. The most common severe toxicities (≥grade 3) in both regimens were cytopenias, fatigue, and thrombosis. Among the first 41 patients enrolled onto each regimen, PFS6 rate was 32.8% (95% CI: 21.1–51.2%) for TB and 56.1% (90% CI: 44.7–70.4%) for ABC. The addition of bevacizumab to nab-paclitaxel and carboplatin shows promising activity despite tolerability issues.
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DOI：
10.1056/nejmoa1003466
发表时间：
2010-08-19
期刊：
The New England journal of medicine
影响因子：
--
作者：
Hodi FS;O'Day SJ;McDermott DF;Weber RW;Sosman JA;Haanen JB;Gonzalez R;Robert C;Schadendorf D;Hassel JC;Akerley W;van den Eertwegh AJ;Lutzky J;Lorigan P;Vaubel JM;Linette GP;Hogg D;Ottensmeier CH;Lebbé C;Peschel C;Quirt I;Clark JI;Wolchok JD;Weber JS;Tian J;Yellin MJ;Nichol GM;Hoos A;Urba WJ
通讯作者：
Urba WJ
影响因子：
50.5
作者：
von Moos, R.;Seifert, B.;Dummer, R.
通讯作者：
Dummer, R.
影响因子：
6.2
作者：
Kottschade, Lisa A.;Suman, Vera J.;Amatruda, Thomas, III;McWilliams, Robert R.;Mattar, Bassam I.;Nikcevich, Daniel A.;Behrens, Robert;Fitch, Tom R.;Jaslowski, Anthony J.;Markovic, Svetomir N.
通讯作者：
Markovic, Svetomir N.
血管内皮生长因子在转移性黑色素瘤中的表达增强。
影响因子：
8.8
作者：
Salven P;Heikkilä P;Joensuu H
通讯作者：
Joensuu H
影响因子：
45.3
作者：
Ugurel, S;Rappl, G;Reinhold, U
通讯作者：
Reinhold, U