Phase 1 dose-escalation study of the antiplacental growth factor monoclonal antibody RO5323441 combined with bevacizumab in patients with recurrent glioblastoma

Neuro-Oncology

Volumn 17, Issue 7, 2015, Pages 1007-1015

  Lassen, Ulrik ^a   Chinot, Olivier L ^c   McBain, Catherine ^d   Mau Sørensen, Morten ^a   Larsen, Vibeke Andree ^b   Barrie, Maryline ^c   Roth, Patrick ^e   Krieter, Oliver ^f   Wang, Ka ^g   Habben, Kai ^f   Tessier, Jean ^h   Lahr, Angelika ^f   Weller, Michael ^e  

^a Department of Oncology ^*  (Denmark)

^b Rigshospitalet   (Denmark)

^c AIX MARSEILLE UNIVERSITY   (France)

^d CHRISTIE HOSPITAL   (United Kingdom)

^e UNIVERSITY HOSPITAL ZURICH   (Switzerland)

^f ROCHE DIAGNOSTICS GMBH   (Germany)

^g HOFFMANN LA ROCHE INC   (United States)

^h F HOFFMANN LA ROCHE LTD   (Switzerland)

Author keywords

Bevacizumab; dose escalation study; glioblastoma; placental growth factor; RO5323441

Indexed keywords

BEVACIZUMAB; CORTICOSTEROID; MONOCLONAL ANTIBODY; PLACENTAL GROWTH FACTOR; RO 5323441; UNCLASSIFIED DRUG; VASCULOTROPIN A; VASCULOTROPIN RECEPTOR 3; ANGIOGENESIS INHIBITOR; ANTINEOPLASTIC AGENT; PLACENTA PROTEIN; TB-403 MONOCLONAL ANTIBODY;

ADULT; AGED; ARTHRALGIA; ARTICLE; ASTHENIA; BRAIN EDEMA; BRAIN INFARCTION; CANCER COMBINATION CHEMOTHERAPY; CANCER RECURRENCE; CLINICAL ARTICLE; COHORT ANALYSIS; CONFUSION; CONSTIPATION; CONTINUOUS INFUSION; CONTRAST ENHANCEMENT; DEEP VEIN THROMBOSIS; DENMARK; DIFFUSION WEIGHTED IMAGING; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG EXPOSURE; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPHONIA; EPISTAXIS; FATIGUE; FEMALE; FRANCE; GLIOBLASTOMA; HEADACHE; HUMAN; HYPERTENSION; LIQUORRHEA; LUNG EMBOLISM; MALE; MAXIMUM TOLERATED DOSE; MENINGITIS; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE DRUG DOSE; NAUSEA; OPEN STUDY; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PHARMACODYNAMICS; PHASE 1 CLINICAL TRIAL; PNEUMONIA; PROGRESSION FREE SURVIVAL; PROTEIN BLOOD LEVEL; RECOMMENDED DRUG DOSE; RECURRENT DISEASE; RHINOPHARYNGITIS; SEPSIS; SURVIVAL TIME; SWITZERLAND; TOOTH ABSCESS; TREATMENT RESPONSE; UNITED KINGDOM; UPPER ABDOMINAL PAIN; URINARY TRACT INFECTION; VOLUME OF DISTRIBUTION; BLOOD; BRAIN NEOPLASMS; CLINICAL TRIAL; IMMUNOLOGY; KAPLAN MEIER METHOD; MIDDLE AGED; MORTALITY; TREATMENT OUTCOME; TUMOR RECURRENCE;

ADULT; AGED; ANGIOGENESIS INHIBITORS; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BEVACIZUMAB; BRAIN NEOPLASMS; FEMALE; GLIOBLASTOMA; HUMANS; KAPLAN-MEIER ESTIMATE; MALE; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; PREGNANCY PROTEINS; TREATMENT OUTCOME;

EID: 84936797491     PISSN: 15228517     EISSN: 15235866     Source Type: Journal    
DOI: 10.1093/neuonc/nov019     Document Type: Article

References (38)

1. Hanahan D, Weinberg RA. Hallmarks of cancer: The next generation. Cell. 2011;144(5):646-674.
2. Olsson AK, Dimberg A, Kreuger J, et al. VEGF receptor signalling-in control of vascular function. Nat Rev Mol Cell Biol. 2006;7(5): 359-371.
3. Carmeliet P, Moons L, Luttun A, et al. Synergism between vascular endothelial growth factor and placental growth factor contributes to angiogenesis and plasma extravasation in pathological conditions. Nat Med. 2001;7(5):575-583.
4. Fischer C, Mazzone M, Jonckx B, et al. FLT1 and its ligands VEGFB and PlGF: Drug targets for anti-angiogenic therapy?. Nat Rev Cancer. 2008;8(12):942-956.
5. Escudero-Esparza A, Martin TA, Davies ML, et al. PGF isoforms, PLGF-1 and PGF-2, in colorectal cancer and the prognostic significance. Cancer Genomics Proteomics. 2009;6(4):239-246.
6. Cheng SJ, Lee JJ, Kok SH, et al. Expression of placenta growth factor: An independent factor for prediction of progression and prognosis of oral cancer. Head Neck. 2010;32(10):1363-1369.
7. Escudero-Esparza A, Martin TA, Douglas-Jones A, et al. PGF isoforms, PLGF-1 and PGF-2 and the PGF receptor, neuropilin, in human breast cancer: Prognostic significance. Oncol Rep. 2010; 23(2):537-544.
8. Jain R. Perfusion CT imaging of brain tumors: An overview. AJNR Am J Neuroradiol. 2011;32(9):1570-1577.
9. Wong ET, Brem S. Antiangiogenesis treatment for glioblastoma multiforme: Challenges and opportunities. J Natl Compr Canc Netw. 2008;6(5):515-522.
10. Friedman HS, Prados MD, Wen PY, et al. Bevacizumab alone and in combination with irinotecan in recurrent glioblastoma. J Clin Oncol. 2009;27(28):4733-4740.
11. Kreisl TN, Kim L, Moore K, et al. Phase II trial of single-agent bevacizumab followed by bevacizumab plus irinotecan at tumor progression in recurrent glioblastoma. J Clin Oncol. 2009;27(5): 740-745.
12. Cohen MH, Shen YL, Keegan P, et al. FDA drug approval summary: Bevacizumab (Avastinw) as treatment of recurrent glioblastoma multiforme. Oncologist. 2009;14(11):1131-1138.
13. Soda Y, Myskiw C, Rommel A, et al. Mechanisms of neovascularization and resistance to anti-angiogenic therapies in glioblastoma multiforme. J Mol Med (Berl). 2013;91(4): 439-448.
14. Bagley RG, Ren Y, Weber W, et al. Placental growth factor upregulation is a host response to antiangiogenic therapy. Clin Cancer Res. 2011;17(5):976-988.
15. Batchelor TT, Sorensen AG, di Tomaso E, et al. AZD2171, a pan-VEGF receptor tyrosine kinase inhibitor, normalizes tumor vasculature and alleviates edema in glioblastoma patients. Cancer Cell. 2007;11(1):83-95.
16. Fischer C, Jonckx B, Mazzone M, et al. Anti-PlGF inhibits growth of VEGF(R)-inhibitor-resistant tumors without affecting healthy vessels. Cell. 2007;131(3):463-475.
17. Coenegrachts L, Maes C, Torrekens S, et al. Anti-placental growth factor reduces bone metastasis by blocking tumor cell engraftment and osteoclast differentiation. Cancer Res. 2010; 70(16):6537-6547.
18. Martinsson-Niskanen T, Riisbro R, Larsson L, et al. Monoclonal antibody TB-403: A first-in-human, Phase I, double-blind, dose escalation study directed against placental growth factor in healthy male subjects. Clin Ther. 2011;33(9):1142-1149.
19. Lassen U, Nielsen DL, Sørensen M, et al. A phase I, dose-escalation study of TB-403, a monoclonal antibody directed against PlGF, in patients with advanced solid tumours. Br J Cancer. 2012;106(4): 678-684.
20. US Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE). Version 4.0. 2010.
21. Lu JF, Bruno R, Eppler S, et al. Clinical pharmacokinetics of bevacizumab in patients with solid tumors. Cancer Chemother Pharmacol. 2008;62(5):779-786.
22. Wen PY, Macdonald DR, Reardon DA, et al. Updated response assessment criteria for high-grade gliomas: Response assessment in neuro-oncology working group. J Clin Oncol. 2010;28(11): 1963-1972.
23. Ng CS, Raunig DL, Jackson EF, et al. Reproducibility of perfusion parameters in dynamic contrast-enhanced MRI of lung and liver tumors: Effect on estimates of patient sample size in clinical trials and on individual patient responses. AJR Am J Roentgenol. 2010;194(2):W134-W140.
24. Gil-Gil MJ, Mesia C, Rey M, Bruna J, et al. Bevacizumab for the treatment of glioblastoma. Clin Med Insights Oncol. 2013;7: 123-135.
25. De Bruyne S, Van Damme N, Smeets P, et al. Value of DCE-MRI and FDG-PET/CT in the prediction of response to preoperative chemotherapy with bevacizumab for colorectal liver metastases. Br J Cancer. 2012;106(12):1926-1933.
26. Norden AD, Young GS, Setayesh K, et al. Bevacizumab for recurrent malignant gliomas: Efficacy, toxicity, and patterns of recurrence. Neurology. 2008;70(10):779-787.
27. Vredenburgh JJ, Cloughesy T, Samant M, et al. Corticosteroid use in patients with glioblastoma at first or second relapse treated with bevacizumab in the BRAIN study. Oncologist. 2010;15(12): 1329-1334.
28. Tabouret E, Boudouresque F, Barrie M, et al. Association of matrix metalloproteinase 2 plasma level with response and survival in patients treated with bevacizumab for recurrent high-grade glioma. Neuro Oncol. 2013;16(3):392-399.
29. Loges S, Schmidt T, Carmeliet P. Mechanisms of resistance to anti-angiogenic therapy and development of third-generation anti-angiogenic drug candidates. Genes Cancer. 2010;1(1):12-25.
30. Willett CG, Duda DG, di Tomaso E, et al. Efficacy, safety, and biomarkers of neoadjuvant bevacizumab, radiation therapy, and fluorouracil in rectal cancer: A multidisciplinary phase II study. J Clin Oncol. 2009;27(18):3020-3026.
31. Wedam SB, Low JA, Yang SX, et al. Antiangiogenic and antitumor effects of bevacizumab in patients with inflammatory and locally advanced breast cancer. J Clin Oncol. 2006;24(5): 769-777.
32. Park JE, Chen HH, Winer J, et al. Placenta growth factor. Potentiation of vascular endothelial growth factor bioactivity, in vitro and in vivo, and high affinity binding to Flt-1 but not to Flk-1/KDR. J Biol Chem. 1994;269(41):25646-25654.
33. Tammela T, Enholm B, Alitalo K, et al. The biology of vascular endothelial growth factors. Cardiovasc Res. 2005;65(3):550-563.
34. Taal W, Oosterkamp HM, Walenkamp AM, et al. Single-agent bevacizumab or lomustine versus a combination of bevacizumab plus lomustine in patients with recurrent glioblastoma (BELOB trial): A randomised controlled phase 2 trial. Lancet Oncol. 2014;15(9):943-953.
35. Field KM, Simes J, Wheeler H, et al. A randomized phase II study of carboplatin and bevacizumab in recurrent glioblastoma multiforme (CABARET). J Clin Oncol. 2013;31:(Suppl):118s.
36. Bais C, Wu X, Yao J, et al. PlGF blockade does not inhibit angiogenesis during primary tumor growth. Cell. 2010;141(1): 166-177.
37. Van de Veire S, Stalmans I, Heindryckx F, et al. Further pharmacological and genetic evidence for the efficacy of PlGF inhibition in cancer and eye disease. Cell. 2010;141(1):178-190.
38. de Groot JF, Lamborn KR, Chang SM, et al. Phase II study of aflibercept in recurrent malignant glioma: A North American Brain Tumor Consortium study. J Clin Oncol. 2011;29(19):2689-2695.