Impact of imaging measurements on response assessment in glioblastoma clinical trials

Neuro-Oncology

Volumn 16, Issue , 2014, Pages v24-vii35

  Reardon, David A ^a   Ballman, Karla V ^b   Buckner, Jan C ^b   Chang, Susan M ^c   Ellingson, Benjamin M ^d,e  

^a DANA FARBER CANCER INSTITUTE   (United States)

^b MAYO CLINIC   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d UNIVERSITY OF CALIFORNIA   (United States)

^e Engineering IV   (United States)

Author keywords

Clinical trials; Glioblastoma; Imaging; MRI; Response assessment.

Indexed keywords

BRAIN NEOPLASMS; CANCER STAGING; CLINICAL TRIAL (TOPIC); GLIOBLASTOMA; HUMAN; NUCLEAR MAGNETIC RESONANCE IMAGING; NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY; POSITRON EMISSION TOMOGRAPHY; PROCEDURES; TRENDS;

BRAIN NEOPLASMS; CLINICAL TRIALS AS TOPIC; GLIOBLASTOMA; HUMANS; MAGNETIC RESONANCE IMAGING; MAGNETIC RESONANCE SPECTROSCOPY; POSITRON-EMISSION TOMOGRAPHY; RESPONSE EVALUATION CRITERIA IN SOLID TUMORS;

EID: 84965188509     PISSN: 15228517     EISSN: 15235866     Source Type: Journal    
DOI: 10.1093/neuonc/nou286     Document Type: Article

References (74)

1. Ballman KV, Buckner JC, Brown PD, et al. The relationship between six-month progression-free survival and 12-month overall survival end points for phase II trials in patients with glioblastoma multiforme. Neuro Oncol. 2007;9(1):29–38.
2. Wu W, Lamborn KR, Buckner JC, et al. Joint NCCTG and NABTC prognostic factors analysis for high-grade recurrent glioma. Neuro Oncol. 2010;12(2):164–172.
3. Lamborn KR, Yung WK, Chang SM, et al. Progression-free survival: an important end point in evaluating therapy for recurrent high-grade gliomas. Neuro Oncol. 2008;10(2):162–170.
4. Han K, Ren M, Wick W, et al. Progression-free survival as a surrogate endpoint for overall survival in glioblastoma: a literature-based meta-analysis from 91 trials. Neuro Oncol. 2014;16(5):696–706.
5. Blankenberg FG, Teplitz RL, Ellis W, et al. The influence of volumetric tumor doubling time, DNA ploidy, and histologic grade on the survival of patients with intracranial astrocytomas. AJNR Am J Neuroradiol. 1995;16(5):1001–1012.
6. Yamashita T, Kuwabara T. Estimation of rate of growth of malignant brain tumors by computed tomography scanning. Surg Neurol. 1983; 20(6):464 – 470.
7. Tsuboi K, Yoshii Y, Nakagawa K, et al. Regrowth patterns of supratentorial gliomas: estimation from computed tomographic scans. Neurosurgery. 1986;19(6):946–951.
8. Pallud J, Blonski M, Mandonnet E, et al. Velocity of tumor spontaneous expansion predicts long-term outcomes for diffuse low-grade gliomas. Neuro Oncol. 2013;15(5):595–606.
9. Ricard D, Kaloshi G, Amiel-Benouaich A, et al. Dynamic history of low-grade gliomas before and after temozolomide treatment. Ann Neurol. 2007;61(5):484–490.
10. Pallud J, Llitjos JF, Dhermain F, et al. Dynamic imaging response following radiation therapy predicts long-term outcomes for diffuse low-grade gliomas. Neuro Oncol. 2012;14(4):496–505.
11. Lamborn KR, Yung WK, Chang SM, et al. Progression-free survival: An important end point in evaluating therapy for recurrent high-grade gliomas. Neuro Oncol. 2008;10(2):162–170.
12. Robins HI, Chang SM, Prados MD, et al. A phase II trial of thymidine and carboplatin for recurrent malignant glioma: a North American Brain Tumor Consortium Study. Neuro Oncol. 2002;4(2):109–114.
13. Brandes AA, Tosoni A, Amista P, et al. How effective is BCNU in recurrent glioblastoma in the modern era? A phase II trial. Neurology. 2004; 63(7):1281–1284.
14. Prados MD, Yung WK, Fine HA, et al. Phase 2 study of BCNU and temozolomide for recurrent glioblastoma multiforme: North American Brain Tumor Consortium study. Neuro Oncol. 2004; 6(1): 33–37.
15. de Groot JF, Gilbert MR, Aldape K, et al. Phase II study of carboplatin and erlotinib (Tarceva, OSI-774) in patients with recurrent glioblastoma. J Neurooncol. 2008;90(1):89–97.
16. Wick W, Puduvalli VK, Chamberlain MC, et al. Phase III study of enzastaurin compared with lomustine in the treatment of recurrent intracranial glioblastoma. Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology. 2010; 28(7):1168–1174.
17. Batchelor TT, Mulholland P, Neyns B, et al. Phase III randomized trial comparing the efficacy of cediranib as monotherapy, and in combination with lomustine, versus lomustine alone in patients with recurrent glioblastoma. J Clin Oncol. 2013;31(26): 3212–3218.
18. Badruddoja MA, Penne K, Desjardins A, et al. Phase II study of Cloretazine for the treatment of adults with recurrent glioblastoma multiforme. Neuro Oncol. 2007;9(1):70–74.
19. Dresemann G, Weller M, Rosenthal MA, et al. Imatinib in combination with hydroxyurea versus hydroxyurea alone as oral therapy in patients with progressive pretreated glioblastoma resistant to standard dose temozolomide. J Neurooncol. 2010; 96(3):393–402.
20. Santisteban M, Buckner JC, Reid JM, et al. Phase II trial of two different irinotecan schedules with pharmacokinetic analysis in patients with recurrent glioma: North Central Cancer Treatment Group results. J Neurooncol. 2009;92(2):165–175.
21. Friedman HS, Petros WP, Friedman AH, et al. Irinotecan therapy in adults with recurrent or progressive malignant glioma. J Clin Oncol. 1999;17(5):1516–1525.
22. Chamberlain MC. Salvage chemotherapy with CPT-11 for recurrent glioblastoma multiforme. J Neurooncol. 2002;56(2):183–188.
23. Kappelle AC, Postma TJ, Taphoorn MJ, et al. PCV chemotherapy for recurrent glioblastoma multiforme. Neurology. 2001;56(1): 118–120.
24. Schmidt F, Fischer J, Herrlinger U, Dietz K, Dichgans J, Weller M. PCV chemotherapy for recurrent glioblastoma. Neurology. 2006;66(4): 587–589.
25. Yung WK, Albright RE, Olson J, et al. A phase II study of temozolomide vs. procarbazine in patients with glioblastoma multiforme at first relapse. Br J Cancer. 2000;83(5):588–593.
26. Brada M, Hoang-Xuan K, Rampling R, et al. Multicenter phase II trial of temozolomide in patients with glioblastoma multiforme at first relapse. Ann Oncol. 2001;12(2):259–266.
27. Wick A, Felsberg J, Steinbach JP, et al. Efficacy and tolerability of temozolomide in an alternating weekly regimen in patients with recurrent glioma. J Clin Oncol. 2007;25(22):3357–3361.
28. Brandes AA, Tosoni A, Cavallo G, et al. Temozolomide 3 weeks on and 1 week off as first-line therapy for recurrent glioblastoma: phase II study from gruppo italiano cooperativo di neuro-oncologia (GICNO). Br J Cancer. 2006;95(9):1155–1160.
29. Norden AD, Lesser GJ, Drappatz J, et al. Phase 2 study of dose-intense temozolomide in recurrent glioblastoma. Neuro Oncol. 2013;15(7):930–935.
30. Perry JR, Belanger K, Mason WP, et al. Phase II trial of continuous dose-intense temozolomide in recurrent malignant glioma: RESCUE study. J Clin Oncol. 2010;28(12):2051–2057.
31. Groves MD, Puduvalli VK, Chang SM, et al. A North American brain tumor consortium (NABTC 99-04) phase II trial of temozolomide plus thalidomide for recurrent glioblastoma multiforme. J Neurooncol. 2007;81(3):271–277.
32. Wen PY, Schiff D, Cloughesy TF, et al. A phase II study evaluating the efficacy and safety of AMG 102 (rilotumumab) in patients with recurrent glioblastoma. Neuro-oncology. 2011;13(4):437–446.
33. Reardon DA, Fink KL, Mikkelsen T, et al. Randomized phase II study of cilengitide, an integrin-targeting arginine-glycine-aspartic acid peptide, in recurrent glioblastoma multiforme. J Clin Oncol. 2008; 26(34):5610–5617.
34. Levin VA, Giglio P, Puduvalli VK, et al. Combination chemotherapy with 13-cis-retinoic acid and celecoxib in the treatment of glioblastoma multiforme. J Neurooncol. 2006;78(1):85–90.
35. Van den Bent MJ, Brandes AA, Rampling R, et al. Randomized phase II trial of erlotinib versus temozolomide or carmustine in recurrent glioblastoma: EORTC brain tumor group study 26034. J Clin Oncol. 2009;27(8):1268–1274.
36. Yung WK, Vredenburgh JJ, Cloughesy TF, et al. Safety and efficacy of erlotinib in first-relapse glioblastoma: a phase II open-label study. Neuro Oncol. 2010;12(10):1061–1070.
37. Reardon DA, Desjardins A, Vredenburgh JJ, et al. Phase 2 trial of erlotinib plus sirolimus in adults with recurrent glioblastoma. J Neurooncol. 2010;96(2):219–230.
38. Puduvalli VK, Yung WK, Hess KR, et al. Phase II study of fenretinide (NSC 374551) in adults with recurrent malignant gliomas: A North American Brain Tumor Consortium study. J Clin Oncol. 2004; 22(21):4282–4289.
39. Rich JN, Reardon DA, Peery T, et al. Phase II trial of gefitinib in recurrent glioblastoma. J Clin Oncol. 2004;22(1):133–142.
40. Wen PY, Yung WK, Lamborn KR, et al. Phase I/II study of imatinib mesylate for recurrent malignant gliomas: North American Brain Tumor Consortium Study 99-08. Clin Cancer Res. 2006;12(16): 4899–4907.
41. Raymond E, Brandes AA, Dittrich C, et al. Phase II study of imatinib in patients with recurrent gliomas of various histologies: a European Organisation for Research and Treatment of Cancer Brain Tumor Group Study. J Clin Oncol. 2008;26(28):4659–4665.
42. Reardon DA, Egorin MJ, Quinn JA, et al. Phase II study of imatinib mesylate plus hydroxyurea in adults with recurrent glioblastoma multiforme. J Clin Oncol. 2005;23(36):9359–9368.
43. Reardon DA, Desjardins A, Vredenburgh JJ, et al. Metronomic chemotherapy with daily, oral etoposide plus bevacizumab for recurrent malignant glioma: a phase II study. Br J Cancer. 2009; 101(12):1986–1994.
44. Dresemann G, Weller M, Rosenthal MA, et al. Imatinib in combination with hydroxyurea versus hydroxyurea alone as oral therapy in patients with progressive pretreated glioblastoma resistant to standard dose temozolomide. J Neurooncol. 2010; 96(3):393–402.
45. Thiessen B, Stewart C, Tsao M, et al. A phase I/II trial of GW572016 (lapatinib) in recurrent glioblastoma multiforme: clinical outcomes, pharmacokinetics and molecular correlation. Cancer Chemotherapy and Pharmacology. 2010;65(2):353–361.
46. Galanis E, Buckner JC, Maurer MJ, et al. Phase II trial of temsirolimus (CCI-779) in recurrent glioblastoma multiforme: a North Central Cancer Treatment Group Study. J Clin Oncol. 2005;23(23): 5294–5304.
47. Cloughesy TF, Wen PY, Robins HI, et al. Phase II trial of tipifarnib in patients with recurrent malignant glioma either receiving or not receiving enzyme-inducing antiepileptic drugs: a North American Brain Tumor Consortium Study. J Clin Oncol. 2006;24(22):3651–3656.
48. Galanis E, Jaeckle KA, Maurer MJ, et al. Phase II trial of vorinostat in recurrent glioblastoma multiforme: a north central cancer treatment group study. J Clin Oncol. 2009;27(12):2052–2058.
49. Blanche P, Dartigues JF, Jacqmin-Gadda H. Estimating and comparing time-dependent areas under receiver operating characteristic curves for censored event times with competing risks. Stat Med. 2013;32(30):5381–5397.
50. 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.
51. Young RJ, Gupta A, Shah AD, et al. Potential utility of conventional MRI signs in diagnosing pseudoprogression in glioblastoma. Neurology. 2011;76(22):1918–1924.
52. Brandes AA, Franceschi E, Tosoni A, et al. MGMT promoter methylation status can predict the incidence and outcome of pseudoprogression after concomitant radiochemotherapy in newly diagnosed glioblastoma patients. J Clin Oncol. 2008;26(13): 2192–2197.
53. Chamberlain MC, Glantz MJ, Chalmers L, et al. Early necrosis following concurrent Temodar and radiotherapy in patients with glioblastoma. J Neurooncol. 2007;82(1):81–83.
54. de Wit MC, de Bruin HG, Eijkenboom W, et al. Immediate post-radiotherapy changes in malignant glioma can mimic tumor progression. Neurology. 2004;63(3):535–537.
55. Taal W, Brandsma D, de Bruin HG, et al. Incidence of early pseudo-progression in a cohort of malignant glioma patients treated with chemoirradiation with temozolomide. Cancer. 2008; 113(2):405–410.
56. Mangla R, Singh G, Ziegelitz D, et al. Changes in relative cerebral blood volume 1 month after radiation-temozolomide therapy can help predict overall survival in patients with glioblastoma. Radiology. 2010;256(2):575–584.
57. Gerstner ER, McNamara MB, Norden AD, et al. Effect of adding temozolomide to radiation therapy on the incidence of pseudoprogression. J Neurooncol. 2009;94(1):97–101.
58. Sanghera P, Perry J, Sahgal A, et al. Pseudoprogression following chemoradiotherapy for glioblastoma multiforme. Can J Neurol Sci. 2010;37(1):36–42.
59. Clarke JL, Abrey LE, Karimi S, et al. Pseudoprogression (PsPr) after concurrent radiotherapy (RT) and temozolomide (TMZ) for newly diagnosed glioblastoma multiforme (GBM) [abstract]. J Clin Oncol. 2008;26:2025.
60. Chu HH, Choi SH, Ryoo I, et al. Differentiation of true progression from pseudoprogression in glioblastoma treated with radiation therapy and concomitant temozolomide: Comparison study of standard and high-b-value diffusion-weighted imaging. Radiology. 2013; 269(3):831–840.
61. Jefferies S, Burton K, Jones P, et al. Interpretation of early imaging after concurrent radiotherapy and temozolomide in glioblastoma. Clin Oncol (R Coll Radiol). 2007;19:S33.
62. Chaskis C, Neyns B, Michotte A, et al. Pseudoprogression after radiotherapy with concurrent temozolomide for high-grade glioma: clinical observations and working recommendations. Surg Neurol. 2009;72(4):423–428.
63. Kumar AJ, Leeds NE, Fuller GN, et al. Malignant gliomas: MR imaging spectrum of radiation therapy- and chemotherapy-induced necrosis of the brain after treatment. Radiology. 2000;217(2):377–384.
64. Jackson A, O’Connor JP, Parker GJ, et al. Imaging tumor vascular heterogeneity and angiogenesis using dynamic contrast-enhanced magnetic resonance imaging. Clin Cancer Res. 2007;13(12):3449–3459.
65. Chinot O, Wick W, Mason W, et al. Phase III trial of bevacizumab added to standard radiotherapy and temozolomide for newly diagnosed glioblastoma: Final progression-free survival and interim overall survival results in AVAglio. Paper presented at: Society for Neuro-Oncology 2012; Washington, D.C.
66. Macdonald DR, Cascino TL, Schold SC Jr, et al. Response criteria for phase II studies of supratentorial malignant glioma. J Clin Oncol. 1990;8(7):1277–1280.
67. Pazdur R. Endpoints for assessing drug activity in clinical trials. Oncologist. 2008;13(Suppl 2):19–21.
68. Federman N, Brien EW, Narasimhan V, et al. Giant cell tumor of bone in childhood: clinical aspects and novel therapeutic targets. Paediatr Drugs. 2014;16(1):21–28.
69. Wood L. Sunitinib malate for the treatment of renal cell carcinoma. Expert Opin Pharmacother. 2012;13(9):1323–1336.
70. Ma P, Mumper RJ. Paclitaxel Nano-Delivery Systems: A Comprehensive Review. J Nanomed Nanotechnol. 2013;4(2):1000164.
71. Axelson M, Liu K, Jiang X, et al. U.S. food and drug administration approval: vismodegib for recurrent, locally advanced, or metastatic basal cell carcinoma. Clin Cancer Res. 2013;19(9):2289–2293.
72. Ibrahim A, Hirschfeld S, Cohen MH, et al. FDA drug approval summaries: oxaliplatin. Oncologist. 2004;9(1):8–12.
73. Cairncross JG, Macdonald DR. Successful chemotherapy for recurrent malignant oligodendroglioma. Ann Neurol. 1988;23(4): 360–364.
74. Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228–247.