A phase II study of aflibercept in patients with advanced epithelial ovarian cancer and symptomatic malignant ascites

Gynecologic Oncology

Volumn 125, Issue 1, 2012, Pages 42-47

  Colombo, Nicoletta ^a   Mangili, Giorgia ^b   Mammoliti, Serafina ^c   Kalling, Mårten ^d   Tholander, Bengt ^e   Sternas, Lars ^f   Buzenet, Giliane ^g   Chamberlain, Donald ^h  

^a EUROPEAN INSTITUTE OF ONCOLOGY   (Italy)

^b SAN RAFFAELE HOSPITAL   (Italy)

^c UNIVERSITY OF GENOA   (Italy)

^d LUND UNIVERSITY HOSPITAL   (Sweden)

^e KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^f SANOFI   (France)

^g Sanofi Aventis   (United States)

^h NONE   (United States)

Author keywords

Aflibercept; Malignant ascites; Ovarian cancer; Phase II study; VEGF trap

Indexed keywords

AFLIBERCEPT; CARBOPLATIN; DOXORUBICIN; PACLITAXEL; TOPOTECAN;

ADULT; ADVANCED CANCER; AGED; ANEMIA; ANOREXIA; ARTHRALGIA; ARTICLE; ASCITES; BACKACHE; CANCER PATIENT; CANCER SURVIVAL; CLINICAL ARTICLE; CONFIDENCE INTERVAL; CONSTIPATION; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; DYSGEUSIA; DYSPHONIA; FEMALE; HAND FOOT SYNDROME; HEADACHE; HUMAN; HYPERTENSION; HYPOTHESIS; INTESTINE PERFORATION; LOW BACK PAIN; MULTICENTER STUDY; MUSCULOSKELETAL PAIN; NAUSEA; NECK PAIN; OPEN STUDY; OVARY CANCER; PAIN; PARACENTESIS; PERIPHERAL EDEMA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SINUS CONGESTION; SQUAMOUS CELL CARCINOMA; SYMPTOMATOLOGY; UPPER ABDOMINAL PAIN; VOMITING; WEIGHT REDUCTION;

EID: 84858336778     PISSN: 00908258     EISSN: 10956859     Source Type: Journal    
DOI: 10.1016/j.ygyno.2011.11.021     Document Type: Article

References (27)

1. A.T. Byrne, L. Ross, J. Holash, M. Nakanishi, L. Hu, and J.I. Hofmann Vascular endothelial growth factor-trap decreases tumor burden, inhibits ascites, and causes dramatic vascular remodeling in an ovarian cancer model Clin Cancer Res 9 2003 5721 5728 (Pubitemid 37499496)
2. L. Hu, J. Hofmann, J. Holash, G.D. Yancopoulos, A.K. Sood, and R.B. Jaffe Vascular endothelial growth factor trap combined with paclitaxel strikingly inhibits tumor and ascites, prolonging survival in a human ovarian cancer model Clin Cancer Res 11 2005 6966 6971 (Pubitemid 41428755)
3. A. Kraft, K. Weindel, A. Ochs, C. Marth, J. Zmija, and P. Schumacher Vascular endothelial growth factor in the sera and effusions of patients with malignant and nonmalignant disease Cancer 85 1999 178 187 (Pubitemid 29031373)
4. H. Roy, S. Bhardwaj, and S. Yla-Herttuala Biology of vascular endothelial growth factors FEBS Lett 580 2006 2879 2887 (Pubitemid 43729175)
5. B.K. Zebrowski, W. Liu, K. Ramirez, Y. Akagi, G.B. Mills, and L.M. Ellis Markedly elevated levels of vascular endothelial growth factor in malignant ascites Ann Surg Oncol 6 1999 373 378 (Pubitemid 29260800)
6. J. Holash, S. Davis, N. Papadopoulos, S.D. Croll, L. Ho, and M. Russell VEGF-Trap: a VEGF blocker with potent antitumor effects Proc Natl Acad Sci U S A 99 2002 11393 11398 (Pubitemid 34920936)
7. H.M. Verheul, H. Hammers, K. van Erp, Y. Wei, T. Sanni, and B. Salumbides Vascular endothelial growth factor trap blocks tumor growth, metastasis formation, and vascular leakage in an orthotopic murine renal cell cancer model Clin Cancer Res 13 2007 4201 4208 (Pubitemid 47105984)
8. J. Huang, J.S. Frischer, A. Serur, A. Kadenhe, A. Yokoi, and K.W. McCrudden Regression of established tumors and metastases by potent vascular endothelial growth factor blockade Proc Natl Acad Sci U S A 100 2003 7785 7790 (Pubitemid 36760047)
9. N.B. Leighl, L.E. Raez, B. Besse, P.J. Rosen, F. Barlesi, and E. Massarelli A multicenter, phase 2 study of vascular endothelial growth factor trap (Aflibercept) in platinum- and erlotinib-resistant adenocarcinoma of the lung J Thorac Oncol 5 2010 1054 1059
10. A.C. Lockhart, M.L. Rothenberg, J. Dupont, W. Cooper, P. Chevalier, and L. Sternas Phase I study of intravenous vascular endothelial growth factor trap, aflibercept, in patients with advanced solid tumors J Clin Oncol 28 2010 207 214
11. P. Tang, S.J. Cohen, G.A. Bjarnason, C. Kollmannsberger, K. Virik, and M.J. MacKenzie Phase II trial of aflibercept (VEGF-Trap) in previously treated patients with metastatic colorectal cancer (MCRC): a PMH phase II consortium trial J Clin Oncol 26 2008 4027 [Abstract]
12. A.A. Tarhini, S. Christensen, P. Frankel, K. Margolin, C. Ruel, and J. Shipe-Spotloe Phase II study of aflibercept (VEGF trap) in recurrent inoperable stage III or stage IV melanoma of cutaneous or ocular origin J Clin Oncol 25 2009 9028 [Abstract]
13. W.P. Tew, M. Gordon, J. Murren, J. Dupont, S. Pezzulli, and C. Aghajanian Phase 1 study of aflibercept administered subcutaneously to patients with advanced solid tumors Clin Cancer Res 16 2010 358 366
14. P. Therasse, S.G. Arbuck, E.A. Eisenhauer, J. Wanders, R.S. Kaplan, and L. Rubinstein New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada J Natl Cancer Inst 92 2000 205 216
15. I. Vergote, F. Amant, S. Advani, C. Goswani, H. Hirte, and D. Provencher Aflibercept (VEGF Trap) in advanced ovarian cancer patients with recurrent symptomatic malignant ascites: results of a randomized, double-blind, placebo-controlled study 16th International Meeting of the European Society of Gynaecological Oncology, Belgrade, Serbia, Oct 11-14, 2009 Oct 11-14, 2009 Abstract 1428
16. G. Becker, D. Galandi, and H.E. Blum Malignant ascites: systematic review and guideline for treatment Eur J Cancer 42 2006 589 597 (Pubitemid 43343680)
17. D. Seimetz, H. Lindhofer, and C. Bokemeyer Development and approval of the trifunctional antibody catumaxomab (anti-EpCAM × anti-CD3) as a targeted cancer immunotherapy Cancer Treat Rev 36 2010 458 467
18. A. Burges, P. Wimberger, C. Kumper, V. Gorbounova, H. Sommer, and B. Schmalfeldt Effective relief of malignant ascites in patients with advanced ovarian cancer by a trifunctional anti-EpCAM x anti-CD3 antibody: a phase I/II study Clin Cancer Res 13 2007 3899 3905 (Pubitemid 47037597)
19. C.A. Hamilton, G.L. Maxwell, M.R. Chernofsky, S.A. Bernstein, J.H. Farley, and G.S. Rose Intraperitoneal bevacizumab for the palliation of malignant ascites in refractory ovarian cancer Gynecol Oncol 111 2008 530 532
20. T.M. Numnum, R.P. Rocconi, J. Whitworth, and M.N. Barnes The use of bevacizumab to palliate symptomatic ascites in patients with refractory ovarian carcinoma Gynecol Oncol 102 2006 425 428 (Pubitemid 44353660)
21. O. Pichelmayer, B. Gruenberger, C. Zielinski, and M. Raderer Bevacizumab is active in malignant effusion Ann Oncol 17 2006 1853
22. K. El-Shami, A. Elsaid, and Y. El-Kerm Open-label safety and efficacy pilot trial of intraperitoneal bevacizumab as palliative treatment in refractory malignant ascites J Clin Oncol 25 18S 2007 Abstract 9043
23. S. Kobold, S. Hegewisch-Becker, K. Oechsle, K. Jordan, C. Bokemeyer, and D. Atanackovic Intraperitoneal VEGF inhibition using bevacizumab: a potential approach for the symptomatic treatment of malignant ascites? Oncologist 14 2009 1242 1251
24. J.P. Diaz, W.P. Tew, O. Zivanovic, J. Konner, P.J. Sabbatini, and L.A. dos Santos Incidence and management of bevacizumab-associated gastrointestinal perforations in patients with recurrent ovarian carcinoma Gynecol Oncol 116 2010 335 339
25. S. Hapani, D. Chu, and S. Wu Risk of gastrointestinal perforation in patients with cancer treated with bevacizumab: a meta-analysis Lancet Oncol 10 2009 559 568
26. F. Simpkins, J.L. Belinson, and P.G. Rose Avoiding bevacizumab related gastrointestinal toxicity for recurrent ovarian cancer by careful patient screening Gynecol Oncol 107 2007 118 123 (Pubitemid 47464553)
27. D.L. Richardson, F.J. Backes, J.D. Hurt, L.G. Seamon, L.J. Copeland, and J.M. Fowler Which factors predict bowel complications in patients with recurrent epithelial ovarian cancer being treated with bevacizumab? Gynecol Oncol 118 2010 47 51