NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: A randomised phase III trial of a novel treatment modality

European Journal of Cancer

Volumn 48, Issue 14, 2012, Pages 2192-2202

  Stupp, Roger ^a   Wong, Eric T ^b   Kanner, Andrew A ^c   Steinberg, David ^d   Engelhard, Herbert ^e   Heidecke, Volkmar ^f   Kirson, Eilon D ^g   Taillibert, Sophie ^h   Liebermann, Frank ⁱ   Dbalý, Vladimir ^j   Ram, Zvi ^c   Villano, J Lee ^e   Rainov, Nikolai ^f   Weinberg, Uri ^g   Schiff, David ^k   Kunschner, Lara ^l   Raizer, Jeffrey ^m   Honnorat, Jerome ⁿ   Sloan, Andrew ^o   Malkin, Mark ^p   Landolfi, Joseph C ^q   Payer, Franz ^r   Mehdorn, Maximilian ^s   Weil, Robert J ^t   Pannullo, Susan C ^u   Westphal, Manfred ^v   Smrcka, Martin ^w   Chin, Lawrence ^x   Kostron, Herwig ^y   Hofer, Silvia ^z   Bruce, Jeffrey ^aa   Cosgrove, Rees ^ab   Paleologous, Nina ^ac   Palti, Yoram ^g   Gutin, Philip H ^ad   more..

^a LAUSANNE UNIVERSITY HOSPITAL   (Switzerland)

^b BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^c TEL AVIV SOURASKY MEDICAL CENTER   (Israel)

^d TEL AVIV UNIVERSITY   (Israel)

^e UNIVERSITY OF ILLINOIS AT CHICAGO   (United States)

^f Augsburg Clinic   (Germany)

^g Novocure GmbH   (Israel)

^h PITIÉ SALPÊTRIÈRE HOSPITAL   (France)

ⁱ UNIVERSITY OF PITTSBURGH MEDICAL CENTER   (United States)

^j NA HOMOLCE HOSPITAL   (Czech Republic)

^k UNIVERSITY OF VIRGINIA   (United States)

^l Allegheny Neurological Brain Tumor Center   (United States)

^m NORTHWESTERN UNIVERSITY   (United States)

ⁿ UNIVERSITÉ LYON 1   (France)

^o UNIVERSITY HOSPITALS OF CLEVELAND   (United States)

^p MEDICAL COLLEGE OF WISCONSIN   (United States)

^q New Jersey Neuroscience Institute   (United States)

^r UNIVERSITY OF GRAZ   (Austria)

^s UNIVERSITY OF KIEL   (Germany)

^t TAUSSIG CANCER INSTITUTE   (United States)

^u WEILL CORNELL MEDICAL CENTER   (United States)

^v UNIVERSITY OF HAMBURG   (Germany)

^w UNIVERSITY HOSPITAL BRNO   (Czech Republic)

^x BOSTON MEDICAL CENTER   (United States)

^y UNIVERSITY OF INNSBRUCK   (Austria)

^z UNIVERSITY HOSPITAL ZURICH   (Switzerland)

^aa NewYork Presbyterian Hospital   (United States)

^ab LAHEY HOSPITAL AND MEDICAL CENTER   (United States)

^ac NORTHSHORE UNIVERSITY HEALTHSYSTEM   (United States)

^ad MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

more..

Author keywords

Brain tumour; Chemotherapy; Glioblastoma; Randomised trial

Indexed keywords

ABDOMINAL PAIN; ADULT; AGED; ARTICLE; BRAIN EDEMA; CANCER PATIENT; CANCER RADIOTHERAPY; CANCER SURVIVAL; CELL DIVISION; CLINICAL EFFECTIVENESS; COGNITIVE DEFECT; CONTROLLED STUDY; CONVULSION; DEEP VEIN THROMBOSIS; DERMATITIS; DEVICE SAFETY; DIARRHEA; DYSPHASIA; FEMALE; GLIOBLASTOMA; HEADACHE; HEMIANOPIA; HEMIPARESIS; HUMAN; HYPERTENSION; LEUKOPENIA; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALAISE; MALE; MENTAL DISEASE; METABOLIC DISORDER; MUSCULOSKELETAL DISEASE; NAUSEA AND VOMITING; NEUTROPENIA; NUTRITIONAL DISORDER; OVERALL SURVIVAL; PATIENT SAFETY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RASH; RECURRENT CANCER; RESPIRATORY TRACT DISEASE; SURVIVAL RATE; THROMBOCYTOPENIA; TRANSDUCER; TUMOR TREATMENT FIELD THERAPY; UROGENITAL TRACT DISEASE;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; BRAIN NEOPLASMS; DISEASE-FREE SURVIVAL; ELECTRIC STIMULATION THERAPY; EUROPE; FEMALE; GLIOBLASTOMA; HUMANS; ISRAEL; KAPLAN-MEIER ESTIMATE; KARNOFSKY PERFORMANCE STATUS; MAGNETIC RESONANCE IMAGING; MALE; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; PROPORTIONAL HAZARDS MODELS; QUALITY OF LIFE; RISK ASSESSMENT; RISK FACTORS; TIME FACTORS; TREATMENT OUTCOME; UNITED STATES; YOUNG ADULT;

EID: 84865528882     PISSN: 09598049     EISSN: 18790852     Source Type: Journal    
DOI: 10.1016/j.ejca.2012.04.011     Document Type: Article

References (32)

1. R. Stupp, W.P. Mason, and M.J. van den Bent Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma N Engl J Med 352 10 2005 987 996
2. A.A. Brandes, F. Vastola, and S. Monfardini Reoperation in recurrent high-grade gliomas: literature review of prognostic factors and outcome Am J Clin Oncol 22 4 1999 387 390
3. J. Guyotat, F. Signorelli, D. Frappaz, G. Madarassy, A.C. Ricci, and P. Bret Is reoperation for recurrence of glioblastoma justified? Oncol Rep 7 4 2000 899 904
4. E.S. Mandl, C.M. Dirven, D.R. Buis, T.J. Postma, and W.P. Vandertop Repeated surgery for glioblastoma multiforme: only in combination with other salvage therapy Surg Neurol 69 5 2008 506 509 [discussion 509]
5. J.J. Verhoeff, O. van Tellingen, and A. Claes Concerns about anti-angiogenic treatment in patients with glioblastoma multiforme BMC Cancer 9 2009 444
6. W. Wick, M. Weller, M. van den Bent, and R. Stupp Bevacizumab and recurrent malignant gliomas: a European perspective J Clin Oncol 28 12 2010 188 189 [author reply e190-2]
7. W. Wick, V.K. Puduvalli, and M.C. Chamberlain Phase III study of enzastaurin compared with lomustine in the treatment of recurrent intracranial glioblastoma J Clin Oncol 28 7 2010 1168 1174
8. W.K. Yung, R.E. Albright, and J. Olson A phase II study of temozolomide vs. procarbazine in patients with glioblastoma multiforme at first relapse Br J Cancer 83 5 2000 588 593
9. C. Balmaceda, D. Peereboom, and S. Pannullo Multi-institutional phase II study of temozolomide administered twice daily in the treatment of recurrent high-grade gliomas Cancer 112 5 2008 1139 1146
10. S.M. Chang, P. Theodosopoulos, and K. Lamborn Temozolomide in the treatment of recurrent malignant glioma Cancer 100 3 2004 605 611
11. M.H. Cohen, Y.L. Shen, P. Keegan, and R. Pazdur FDA drug approval summary: bevacizumab (Avastin) as treatment of recurrent glioblastoma multiforme Oncologist 14 11 2009 1131 1138
12. H.S. Friedman, M.D. Prados, and P.Y. Wen Bevacizumab alone and in combination with irinotecan in recurrent glioblastoma J Clin Oncol 27 28 2009 4733 4740
13. J.J. Vredenburgh, A. Desjardins, and J.E. Herndon 2nd Bevacizumab plus irinotecan in recurrent glioblastoma multiforme J Clin Oncol 25 30 2007 4722 4729
14. M.A. Rosenthal, M.L. Gruber, and J. Glass Phase II study of combination taxol and estramustine phosphate in the treatment of recurrent glioblastoma multiforme J Neurooncol 47 1 2000 59 63
15. S. Oudard, A. Carpentier, and E. Banu Phase II study of lonidamine and diazepam in the treatment of recurrent glioblastoma multiforme J Neurooncol 63 1 2003 81 86
16. M.C. Chamberlain, and D.D. Tsao-Wei Salvage chemotherapy with cyclophosphamide for recurrent, temozolomide-refractory glioblastoma multiforme Cancer 100 6 2004 1213 1220
17. S. Kesari, D. Schiff, and L. Doherty Phase II study of metronomic chemotherapy for recurrent malignant gliomas in adults Neuro-oncol 9 3 2007 354 363
18. V.K. Puduvalli, W.K. Yung, and K.R. Hess Phase II study of fenretinide (NSC 374551) in adults with recurrent malignant gliomas: a North American Brain Tumor Consortium study J Clin Oncol 22 21 2004 4282 4289
19. P.A. Robe, D.H. Martin, and M.T. Nguyen-Khac Early termination of ISRCTN45828668, a phase 1/2 prospective, randomized study of sulfasalazine for the treatment of progressing malignant gliomas in adults BMC Cancer 9 2009 372
20. H. Brem, S. Piantadosi, and P.C. Burger Placebo-controlled trial of safety and efficacy of intraoperative controlled delivery by biodegradable polymers of chemotherapy for recurrent gliomas. The polymer-brain tumor treatment group Lancet 345 8956 1995 1008 1012
21. M. Brada, K. Hoang-Xuan, and R. Rampling Multicenter phase II trial of temozolomide in patients with glioblastoma multiforme at first relapse Ann Oncol 12 2 2001 259 266
22. J.N. Rich, D.A. Reardon, and T. Peery Phase II trial of gefitinib in recurrent glioblastoma J Clin Oncol 22 1 2004 133 142
23. B. Neyns, J. Sadones, and E. Joosens Stratified phase II trial of cetuximab in patients with recurrent high-grade glioma Ann Oncol 20 9 2009 1596 1603
24. J.R. Perry, K. Belanger, and W.P. Mason Phase II trial of continuous dose-intense temozolomide in recurrent malignant glioma: rescue study J Clin Oncol 28 12 2010 2051 2057
25. Lee S, Wong E, Swanson K. Mitosis interference of cancer cells during anaphase by electric field from NovoTTF-100A. In: Society for Neuro Oncology, 2011, Orange County, CA; 2011. Neuro Oncol 2011;13(Suppl. 3):1-167 [Abstract CB-17].
26. E.D. Kirson, V. Dbaly, and F. Tovarys Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors Proc Natl Acad Sci U S A 104 24 2007 10152 10157
27. E.D. Kirson, Z. Gurvich, and R. Schneiderman Disruption of cancer cell replication by alternating electric fields Cancer Res 64 9 2004 3288 3295
28. E.D. Kirson, R.S. Schneiderman, and V. Dbaly Chemotherapeutic treatment efficacy and sensitivity are increased by adjuvant alternating electric fields (TTFields) BMC Med Phys 9 1 2009 1
29. M. Salzberg, E. Kirson, Y. Palti, and C. Rochlitz A pilot study with very low-intensity, intermediate-frequency electric fields in patients with locally advanced and/or metastatic solid tumors Onkologie 31 7 2008 362 365
30. Kirson ED, Wasserman Y, Izhaki A, Mordechovich D, Gurvich Z, Dbalý V, et al. Modeling tumor growth kinetics and its implications for TTFields treatment planning. In: The 2010 Society of Neuro-Oncology Scientific Meeting and Education Day, Montreal, Canada; 2010. Neuro Oncol 2010;12(Suppl. 4):1-148 [Abstract NO-54].
31. D.R. Macdonald, T.L. Cascino, S.C. Schold Jr., and J.G. Cairncross Response criteria for phase II studies of supratentorial malignant glioma J Clin Oncol 8 7 1990 1277 1280
32. R.S. Schneiderman, E. Shmueli, E.D. Kirson, and Y. Palti TTFields alone and in combination with chemotherapeutic agents effectively reduce the viability of MDR cell sub-lines that over-express ABC transporters BMC Cancer 10 2010 229