A phase II trial (AGO 2.11) in platinum-resistant ovarian cancer: a randomized multicenter trial with sunitinib (SU11248) to evaluate dosage, schedule, tolerability, toxicity and effectiveness of a multitargeted receptor tyrosine kinase inhibitor monotherapy

被引：62

作者：

Baumann, K. H. ^{[1
]}

du Bois, A. ^{[2
]}

Meier, W. ^{[3
]}

Rau, J. ^{[4
]}

Wimberger, P. ^{[5
]}

Sehouli, J. ^{[6
]}

Kurzeder, C. ^{[7
]}

Hilpert, F. ^{[8
]}

Hasenburg, A. ^{[9
]}

Canzler, U. ^{[10
]}

Hanker, L. C. ^{[11
]}

Hillemanns, P. ^{[12
]}

Richter, B. ^{[13
]}

Wollschlaeger, K. ^{[14
]}

Dewitz, T. ^{[15
]}

Bauerschlag, D. ^{[16
]}

Wagner, U. ^{[1
]}

机构：

[1] Univ Marburg, Dept Gynaecol, Marburg, Germany

[2] HSK Wiesbaden & Kliniken Essen Mitte, Dept Gynaecol & Gynaecol Oncol, Essen, Germany

[3] Evangel Hosp, Dept Gynaecol & Obstet, Dusseldorf, Germany

[4] Univ Marburg, Coordinating Ctr Clin Trials, Marburg, Germany

[5] Univ Duisburg Essen, Dept Gynaecol & Obstet, Essen, Germany

[6] Charite, Dept Gynaecol, Berlin, Germany

[7] Univ Ulm, Dept Gynaecol & Obstet, Ulm, Germany

[8] Univ Kiel, Dept Gynaecol & Obstet, Kiel, Germany

[9] Univ Freiburg, Dept Gynaecol & Obstet, D-79106 Freiburg, Germany

[10] Univ Dresden, Dept Gynaecol & Obstet, Dresden, Germany

[11] Goethe Univ Frankfurt, Dept Gynaecol & Obstet, Frankfurt, Germany

[12] Hannover Med Sch, Dept Gynaecol & Obstet, D-3000 Hannover, Germany

[13] Elbland Hosp, Dept Gynaecol & Obstet, Radebeul, Germany

[14] Univ Magdeburg, Dept Gynaecol & Obstet, D-39106 Magdeburg, Germany

[15] Hosp Gifhorn, Dept Gynaecol & Obstet, Gifhorn, Germany

[16] Univ Med Ctr Aachen RWTH, Dept Gynaecol & Obstet, Aachen, Germany

来源：

ANNALS OF ONCOLOGY | 2012年 / 23卷 / 09期

关键词：

angiogenesis inhibitor; ovarian cancer; platinum resistant; sunitinib; RECURRENT EPITHELIAL OVARIAN; ENDOTHELIAL GROWTH-FACTOR; ANTITUMOR-ACTIVITY; INTERGROUP TRIAL; CARCINOMA; PACLITAXEL; CARBOPLATIN; GUIDELINES; CISPLATIN; STANDARD;

D O I：

10.1093/annonc/mds003

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Recurrent platinum-resistant ovarian cancer usually has a poor outcome with conventional chemotherapeutic therapy and new treatment modalities are warranted. This phase II study was conducted to evaluate sunitinib, an oral antiangiogenic multitargeted tyrosin kinase inhibitor, in this setting. The primary end point of this randomized phase II trial was the objective response rate according to RECIST criteria and/or Gynecologic Cancer InterGroup CA125 response criteria to sunitinib in patients with recurrent platinum-resistant ovarian cancer who were pretreated with up to three chemotherapies. A selection design was employed to compare two schedules of sunitinib (arm 1: 50 mg sunitinib daily orally for 28 days followed by 14 days off drug; and arm 2: 37.5 mg sunitinib administered daily continuously). Of 73 patients enrolled, 36 patients were randomly allocated to the noncontinuous treatment arm (arm 1) and 37 patients were randomly allocated to the continuous treatment arm (arm 2). The mean age was 58.8 and 58.5 years, respectively. We observed six responders (complete response + partial response) in arm 1 (16.7%) and 2 responders in arm 2 (5.4%). The median progression-free survival (arm 1: 4.8 [2.9-8.1] months; arm 2: 2.9 [2.9-5.1] months) and the median overall survival (arm 1: 13.6 [7.0-23.2] months; arm 2: 13.7 [8.4-25.6] months) revealed no significant difference. Adverse events included fatigue as well as cardiovascular, gastrointestinal and abdominal symptoms, hematologic and hepatic laboratory abnormalities. Pattern and frequency of adverse events revealed no substantial differences between both treatment groups. Sunitinib treatment is feasible and moderately active in relapsed platinum-resistant ovarian cancer. The noncontinuous treatment schedule should be chosen for further studies in ovarian cancer.

引用

页码：2265 / 2271

页数：7

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