Bevacizumab in patients with nonsquamous non-small cell lung cancer and asymptomatic, untreated brain metastases (BRAIN): A nonrandomized, phase II study

Clinical Cancer Research

Volumn 21, Issue 8, 2015, Pages 1896-1903

  Besse, Benjamin ^a   Le Moulec, Sylvestre ^b   Mazières, Julien ^c   Senellart, Hélène ^d   Barlesi, Fabrice ^e   Chouaid, Christos ^f   Dansin, Eric ^g   Bérard, Henri ^h   Falchero, Lionel ⁱ   Gervais, Radj ^j   Robinet, Gilles ^k   Ruppert, Anne Marie ^l   Schott, Roland ^m   Léna, Hervé ⁿ   Clément Duchêne, Christelle ^o   Quantin, Xavier ^p   Souquet, Pierre Jean ^q   Trédaniel, Jean ^r   Moro Sibilot, Denis ^s   Pérol, Maurice ^t   Madroszyk, Anne Catherine ^u   Soria, Jean Charles ^a   more..

^a UNIVERSITÉ PARIS SACLAY   (France)

^b University of Paris Descartes   (France)

^c SERVICE DE PNEUMOLOGIE   (France)

^d UMR INSERM U892 CNRS 6299   (France)

^e AIX MARSEILLE UNIVERSITY   (France)

^f CHI Crétiel   (France)

^g CENTRE RENÉ GAUDUCHEAU   (France)

^h Military Hospital   (France)

ⁱ L'Hôpital Nord Ouest ^*  (France)

^j CENTRE FRANÇOIS BACLESSE   (France)

^k CHU MORVAN   (France)

^l HÔPITAL TENON   (France)

^m CENTRE PAUL STRAUSS   (France)

ⁿ PONTCHAILLOU UNIVERSITY HOSPITAL   (France)

^o CHU NANCY BRABOIS   (France)

^p MONTPELLIER UNIVERSITY HOSPITAL   (France)

^q CENTRE HOSPITALIER LYON SUD   (France)

^r SAINT JOSEPH HOSPITAL   (France)

^s HÔPITAL MICHALLON   (France)

^t CENTRE LÉON BÉRARD   (France)

^u INSTITUT PAOLI CALMETTES   (France)

more..

Author keywords

[No Author keywords available]

Indexed keywords

BEVACIZUMAB; CARBOPLATIN; EPIDERMAL GROWTH FACTOR RECEPTOR KINASE INHIBITOR; ERLOTINIB; PACLITAXEL; PEMETREXED; ANGIOGENESIS INHIBITOR; ANTINEOPLASTIC AGENT;

ADULT; AGED; ARTERIAL THROMBOEMBOLISM; ARTICLE; ASYMPTOMATIC DISEASE; BRAIN HEMORRHAGE; BRAIN METASTASIS; BRAIN RADIATION; CANCER COMBINATION CHEMOTHERAPY; CANCER RADIOTHERAPY; CANCER SURGERY; CANCER SURVIVAL; COHORT ANALYSIS; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; HUMAN; HYPERTENSION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; NON SMALL CELL LUNG CANCER; OPEN STUDY; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROSPECTIVE STUDY; PROTEINURIA; SURVIVAL RATE; SURVIVAL TIME; THROMBOCYTOPENIA; VENOUS THROMBOEMBOLISM; BRAIN NEOPLASMS; CANCER STAGING; CARCINOMA, NON-SMALL-CELL LUNG; CLINICAL TRIAL; CONTROLLED STUDY; KAPLAN MEIER METHOD; LUNG NEOPLASMS; METASTASIS; MIDDLE AGED; MORTALITY; PATHOLOGY; RANDOMIZED CONTROLLED TRIAL; RETREATMENT; SECONDARY; TREATMENT OUTCOME; TUMOR RECURRENCE;

ADULT; AGED; ANGIOGENESIS INHIBITORS; ANTINEOPLASTIC AGENTS; BEVACIZUMAB; BRAIN NEOPLASMS; CARCINOMA, NON-SMALL-CELL LUNG; FEMALE; HUMANS; KAPLAN-MEIER ESTIMATE; LUNG NEOPLASMS; MALE; MIDDLE AGED; NEOPLASM METASTASIS; NEOPLASM RECURRENCE, LOCAL; NEOPLASM STAGING; RETREATMENT; TREATMENT OUTCOME;

EID: 84927655714     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-14-2082     Document Type: Article

References (34)

1. Langer CJ, Mehta MP. Current management of brain metastases, with a focus on systemic options. J Clin Oncol 2005;23:6207-19.
2. Nayak L, Lee EQ, Wen PY. Epidemiology of brain metastases. Curr Oncol Rep 2012;14:48-54.
3. Ding X, Dai HH, Hui ZG, Ji W, Liang J, Lv J, et al. Risk factors of brain metastases in completely resected pathological stage IIIA-N2 non-small cell lung cancer. Radiat Oncol 2012;7:119.
4. Tsao MN, Lloyd N, Wong RKS, Chow E, Rakavitch E, Laperriere N. Whole brain radiotherapy for the treatment of newly diagnosed multiple brain metastases. Cochrane Database Syst Rev 2012;4:CD003869.
5. Yoo H, Jung E, Gwak HS, Shin SH, Lee SH. Surgical outcomes of hemorrhagic metastatic brain tumors. Cancer Res Treat 2011;43:102-7.
6. Sperduto PW, Chao ST, Sneed PK, Luo X, Suh J, Roberge D, et al. Diagnosis-speci fi c prognostic factors, indexes, and treatment outcomes for patients with newly diagnosed brain metastases: a multi-institutional analysis of 4,259 patients. Int J Radiat Oncol Biol Phys 2010;77:655-61.
7. Gaspar L, Scott C, Rotman M, Asbell S, Phillips T, Wasserman T, et al. Recursive partitioning analysis (RPA) of prognostic factors in three radiation therapy oncology group (RTOG) brain metastases trials. Int J Radiat Oncol Biol Phys 1997;37:745-51.
8. Nieder C, Nestle U, Motaref B, Walter K, Niewald M, Schnabel K. Prognostic factors in brain metastases: should patients be selected for aggressive treatment according to recursive partitioning analysis (RPA) classes? Int J Radiat Oncol Biol Phys 2000;46:297-302.
9. Chaubet-Houdu M, Besse B, Le Pechoux C, Le Chevalier T. Management of brain metastases in non-small cell lung cancer. Cancer Chemother Rev 2012;7.
10. Videtic GM, Reddy CA, Chao ST, Rice TW, Adelstein DJ, Barnett GH, et al. Gender, race, and survival: a study in non-small-cell lung cancer brain metastases patients utilizing the radiation therapy oncology group recursive partitioning analysis classification. Int J Radiat Oncol Biol Phys 2009;75:1141-7.
11. Sperduto PW, Berkey B, Gaspar LE, Mehta M, Curran W. A new prognostic index and comparison to three other indices for patients with brain metastases: an analysis of 1,960 patients in the RTOG database. Int J Radiat Oncol Biol Phys 2008;70:510-4.
12. Ricciardi S, de Marinis F. Multimodality management of non-small cell lung cancer patients with brain metastases. Curr Opin Oncol 2010;22: 86-93.
13. Tsao MN, Rades D, Wirth A, Lo SS, Danielson BL, Gaspar LE, et al. Radiotherapeutic and surgical management for newly diagnosed brain metastasis(es): an American Society for Radiation Oncology evidence-based guideline. Pract Radiat Oncol 2012;2:210-25.
14. Zhang RD, Price JE, Fujimaki T, Bucana CD, Fidler IJ. Differential permeability of the blood-brain barrier in experimental brain metastases produced by human neoplasms implanted into nude mice. Am J Pathol 1992;141:1115-24.
15. Fortin D. The blood-brain barrier: its influence in the treatment of brain tumors metastases. Curr Cancer Drug Targets 2012;12:247-59.
16. Barlesi F, Gervais R, Lena H, Hureaux J, Berard H, Paillotin D, et al. Pemetrexed and cisplatin as first-line chemotherapy for advanced non-small- cell lung cancer (NSCLC) with asymptomatic inoperable brain metastases: a multicenter phase II trial (GFPC 07-01). Ann Oncol 2011;22:2466-70.
17. Robinet G, Thomas P, Breton JL, LénaH, Gouva S, Dabouis G, et al. Results of a phase III study of early versus delayed whole brain radiotherapy with concurrent cisplatin and vinorelbine combination in inoperable brain metastasis of non-small-cell lung cancer: Groupe Français de Pneumo- Cancérologie (GFPC) Protocol 95-1. Ann Oncol 2001;12:59-67.
18. Chaubet-Houdu M, Le Pechoux C, Lanoy E, Bouda D, Besse B. Multimodal strategy may improve survival in non-small cell lung cancer (NSCLC) patients (pt) with brain metastases (BM). Ann Oncol 2012;23(Suppl 9): Abstr 1284P.
19. Sandler A, Gray R, Perry MC, Brahmer J, Schiller JH, Dowlati A, et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med 2006;355:2542-50.
20. Herbst RS, Johnson DH, Mininberg E, Carbone DP, Henderson T, Kim ES, et al. Phase I/II trial evaluating the anti-vascular endothelial growth factor monoclonal antibody bevacizumab in combination with the HER-1/ epidermal growth factor receptor tyrosine kinase inhibitor erlotinib for patients with recurrent non-small-cell lung cancer. J Clin Oncol 2005;23: 2544-55.
21. Herbst RS, Ansari R, Bustin F, Flynn P, Hart L, Otterson GA, et al. Efficacy of bevacizumab plus erlotinibversus erlotinib alone inadvancednon-small-cell lung cancer after failure of standard first-line chemotherapy (BeTa): a doubleblind, placebo-controlled, phase 3 trial. Lancet 2011;377:1846-54.
22. Gordon MS, Margolin K, Talpaz M, SledgeGWJr, Holmgren E, Benjamin R, et al. Phase I safety and pharmacokinetic study of recombinanthuman antivascular endothelial growth factor in patients with advanced cancer. J Clin Oncol 2001;19:843-50.
23. Avastin® Summary of Product Characteristics. 2014. [cited 8 Apr 2014]. Available from: http://www.medicines.org.uk/emc/medicine/15748/SPC/.
24. Besse B, Lasserre SF, Compton P, Huang J, Augustus S, Rohr UP. Bevacizumab safety in patients with central nervous system metastases. Clin Cancer Res 2010;16:269-78.
25. Polley MY, Lamborn KR, Chang SM, Butowski N, Clarke J, Prados M. Six-month progression-free survival as an alternative primary efficacy endpoint to overall survival in newly diagnosed glioblastoma patients receiving temozolomine. Neuro Oncol 2010;12:274-82.
26. Lamborn KR, Yung WK, Chang SM, Wen PY, Cloughesy TF, DeAngelis LM, et al. Progression-free survival: an important end point in evaluating therapy for recurrent high-grade gliomas. Neuro Oncol 2008;10: 162-70.
27. Andrews DW, Scott CB, Sperduto PW, Flanders AE, Gaspar LE, Schell MC, et al. Whole brain radiation therapy with and without stereotactic radiosurgery boost for patients with one to three brain metastases: phase III results of the RTOG 9508 trial. Lancet 2004;363:1665-72.
28. Arroundeau J, Le Pecheoux C, Le Moulec S, Barlesi F, Lesueur P, Besse B. Bevacizumab safety when combined with whole-brain radiotherapy (WBRT). J Thorac Oncol 2014;9 (suppl 1):S49-50.
29. Levy C, Allouache D, Lacroix J, Dugue A, Supiot S, Campone M, et al. REBECA: a phase I study of bevacizumab and whole-brain radiation therapy for treatment of brain metastasis from solid tumours. Ann Oncol 2014;25:2351-6.
30. Dansin E, Cinieri S, Garrido P, Griesinger F, Isla D, Koehler M, et al. MO19390 (SAiL): bleeding events in a phase IV study of first-line bevacizumab with chemotherapy in patients with advanced non-squamous NSCLC. Lung Cancer 2012;76:373-9.
31. Archer V, Reck M, Sandler AB, et al. Risk of symptomatic central nervous system (CNS) progression and secondary hemorrhage in patients with non-squamous non-small cell lung cancer (NSCLC) receiving bevacizumab (BV)-based first-line therapy. J Clin Oncol 2008;26(Suppl):Abstr 8114.
32. Akerley WL, Langer CJ, Oh Y, Strickland DK, Joo Royer S, Xia Q, et al. Acceptable safety of bevacizumab therapy in patientswith brain metastases due to non-small cell lung cancer. J Clin Oncol 2008;26(Suppl 20):Abstr 8043.
33. Sandler A, Hirsh V, Reck M, von Pawel J, Akerley W, Johnson DH. An evidence-based review of the incidence of CNS bleeding with anti-VEGF therapy in non-small cell lung cancer patients with brain metastases. Lung Cancer 2012;78:1-7.
34. Sandler A, Yi J, Dahlberg S, Kolb MM, Wang L, Hambleton J, et al. Treatment outcomes by tumor histology in Eastern Cooperative Group Study E4599 of bevacizumab with paclitaxel/carboplatin for advanced non-small cell lung cancer. J Thorac Oncol 2010;5:1416-23.