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Journal of Clinical Oncology, Vol 17, Issue 8 (August), 1999: 2572
© 1999 American Society for Clinical Oncology

Outcomes and Prognostic Factors in Recurrent Glioma Patients Enrolled Onto Phase II Clinical Trials

Eric T. Wong, Kenneth R. Hess, Mary Jo Gleason, Kurt A. Jaeckle, Athanassios P. Kyritsis, Michael D. Prados, Victor A. Levin, W.K. Alfred Yung

From the Departments of Neuro-Oncology and Biomathematics, The University of Texas M.D. Anderson Cancer Center, Houston, TX; and Department of Neurological Surgery, University of California, San Francisco, CA.

Address reprint requests to W.K. Alfred Yung, MD, Department of Neuro-Oncology, Box 100, The University of Texas, M.D. Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030.

PURPOSE: To determine aggregate outcomes and prognostic covariates in patients with recurrent glioma enrolled onto phase II chemotherapy trials.

PATIENTS AND METHODS: Patients from eight consecutive phase II trials included 225 with recurrent glioblastoma multiforme (GBM) and 150 with recurrent anaplastic astrocytoma (AA). Their median age was 45 years (range, 15 to 82 years) and their median Karnofsky performance score was 80 (range, 60 to 100). Prognostic covariates were analyzed with respect to tumor response, progression-free survival (PFS), and overall survival (OS) by multivariate logistic and Cox proportional hazards regression analyses.

RESULTS: Overall, 34 (9%) had complete or partial response, whereas 80 (21%) were alive and progression-free at 6 months (APF6). The median PFS was 10 weeks and median OS was 30 weeks. Histology was a robust prognostic factor across all outcomes. GBM patients had significantly poorer outcomes than AA patients. The APF6 proportion was 15% for GBM and 31% for AA, whereas the median PFS was 9 weeks for GBM and 13 weeks for AA. Results were also significantly poorer for patients with more than two prior surgeries or chemotherapy regimens.

CONCLUSION: Histology is a dominant factor in determining outcome in patients with recurrent glioma enrolled onto phase II trials. Future trials should be designed with separate histology strata.

Presented in part at the Thirty-Second Annual Meeting of the American Society of Clinical Oncology, Philadelphia, PA, May 18-21, 1996.


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A. A. Brandes, A. Tosoni, U. Basso, M. Reni, F. Valduga, S. Monfardini, P. Amista, L. Nicolardi, G. Sotti, and M. Ermani
Second-Line Chemotherapy With Irinotecan Plus Carmustine in Glioblastoma Recurrent or Progressive After First-Line Temozolomide Chemotherapy: A Phase II Study of the Gruppo Italiano Cooperativo di Neuro-Oncologia (GICNO)
J. Clin. Oncol., December 1, 2004; 22(23): 4779 - 4786.
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V. K. Puduvalli, W.K. A. Yung, K. R. Hess, J. G. Kuhn, M. D. Groves, V. A. Levin, J. Zwiebel, S. M. Chang, T. F. Cloughesy, L. Junck, 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., November 1, 2004; 22(21): 4282 - 4289.
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A. A. Brandes, A. Tosoni, P. Amista, L. Nicolardi, D. Grosso, F. Berti, and M. Ermani
How effective is BCNU in recurrent glioblastoma in the modern era?: A phase II trial
Neurology, October 12, 2004; 63(7): 1281 - 1284.
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W. Wick, J. P. Steinbach, W. M. Kuker, J. Dichgans, M. Bamberg, and M. Weller
One week on/one week off: A novel active regimen of temozolomide for recurrent glioblastoma
Neurology, June 8, 2004; 62(11): 2113 - 2115.
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A. A. Brandes, U. Basso, M. Reni, F. Vastola, A. Tosoni, G. Cavallo, L. Scopece, A. J. Ferreri, M. G. Panucci, S. Monfardini, et al.
First-Line Chemotherapy With Cisplatin Plus Fractionated Temozolomide in Recurrent Glioblastoma Multiforme: A Phase II Study of the Gruppo Italiano Cooperativo di Neuro-Oncologia
J. Clin. Oncol., May 1, 2004; 22(9): 1598 - 1604.
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D. A. Reardon, J. A. Quinn, J. N. Rich, S. Gururangan, J. Vredenburgh, J. H. Sampson, J. M. Provenzale, A. Walker, M. Badruddoja, S. Tourt-Uhlig, et al.
Phase 2 trial of BCNU plus irinotecan in adults with malignant glioma
Neuro-oncol, April 1, 2004; 6(2): 134 - 144.
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R. J. Weil
Potential Confounding Features in p53 Gene Therapy of Recurrent Glioma
J. Clin. Oncol., April 1, 2004; 22(7): 1344 - 1345.
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F. F. Lang and W.K. Alfred Yung
In Reply:
J. Clin. Oncol., April 1, 2004; 22(7): 1345 - 1345.
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M. D. Prados, W.K. A. Yung, H. A. Fine, H. S. Greenberg, L. Junck, S. M. Chang, M. K. Nicholas, H. I. Robins, M. P. Mehta, K. L. Fink, et al.
Phase 2 study of BCNU and temozolomide for recurrent glioblastoma multiforme: North American Brain Tumor Consortium study
Neuro-oncol, January 1, 2004; 6(1): 33 - 37.
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S. L. Chua, M. A. Rosenthal, S. S. Wong, D. M. Ashley, A.-m. Woods, A. Dowling, and L. M. Cher
Phase 2 study of temozolomide and Caelyx in patients with recurrent glioblastoma multiforme
Neuro-oncol, January 1, 2004; 6(1): 38 - 43.
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M. J. Vos, O. S. Hoekstra, F. Barkhof, J. Berkhof, J. J. Heimans, C. J. van Groeningen, W. P. Vandertop, B. J. Slotman, and T. J. Postma
Thallium-201 Single-Photon Emission Computed Tomography As an Early Predictor of Outcome in Recurrent Glioma
J. Clin. Oncol., October 1, 2003; 21(19): 3559 - 3565.
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The Neuro-Oncology Working Group of the German Can
Neuro-Oncology Working Group 01 Trial of Nimustine Plus Teniposide Versus Nimustine Plus Cytarabine Chemotherapy in Addition to Involved-Field Radiotherapy in the First-Line Treatment of Malignant Glioma
J. Clin. Oncol., September 1, 2003; 21(17): 3276 - 3284.
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F. F. Lang, J. M. Bruner, G. N. Fuller, K. Aldape, M. D. Prados, S. Chang, M. S. Berger, M. W. McDermott, S. M. Kunwar, L. R. Junck, et al.
Phase I Trial of Adenovirus-Mediated p53 Gene Therapy for Recurrent Glioma: Biological and Clinical Results
J. Clin. Oncol., July 1, 2003; 21(13): 2508 - 2518.
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H. A. Fine, P. Y. Wen, E. A. Maher, E. Viscosi, T. Batchelor, N. Lakhani, W. D. Figg, B. W. Purow, and C. B. Borkowf
Phase II Trial of Thalidomide and Carmustine for Patients With Recurrent High-Grade Gliomas
J. Clin. Oncol., June 15, 2003; 21(12): 2299 - 2304.
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K. A. Jaeckle, K. R. Hess, W.K. A. Yung, H. Greenberg, H. Fine, D. Schiff, I. F. Pollack, J. Kuhn, K. Fink, M. Mehta, et al.
Phase II Evaluation of Temozolomide and 13-cis-Retinoic Acid for the Treatment of Recurrent and Progressive Malignant Glioma: A North American Brain Tumor Consortium Study
J. Clin. Oncol., June 15, 2003; 21(12): 2305 - 2311.
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M.J. Vos, B.M.J. Uitdehaag, F. Barkhof, J.J. Heimans, H.C. Baayen, W. Boogerd, J.A. Castelijns, P.H.M. Elkhuizen, and T.J. Postma
Interobserver variability in the radiological assessment of response to chemotherapy in glioma
Neurology, March 11, 2003; 60(5): 826 - 830.
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L. S. Lashford, P. Thiesse, A. Jouvet, T. Jaspan, D. Couanet, P. D. Griffiths, F. Doz, J. Ironside, K. Robson, R. Hobson, et al.
Temozolomide in Malignant Gliomas of Childhood: A United Kingdom Children's Cancer Study Group and French Society for Pediatric Oncology Intergroup Study
J. Clin. Oncol., December 15, 2002; 20(24): 4684 - 4691.
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A. A. Brandes, S. Turazzi, U. Basso, L. M. Pasetto, B. Guglielmi, L. Volpin, P. Iuzzolino, P. Amista, G. Pinna, R. Scienza, et al.
A multidrug combination designed for reversing resistance to BCNU in glioblastoma multiforme
Neurology, June 25, 2002; 58(12): 1759 - 1764.
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H. I. Robins, S. M. Chang, M. D. Prados, W.K. A. Yung, K. Hess, D. Schiff, H. Greenberg, K. Fink, K. Nicolas, J. G. Kuhn, et al.
A phase II trial of thymidine and carboplatin for recurrent malignant glioma: A North American Brain Tumor Consortium Study
Neuro-oncol, April 1, 2002; 4(2): 109 - 114.
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M. D. Groves, V. K. Puduvalli, K. R. Hess, K. A. Jaeckle, P. Peterson, W.K. Alfred Yung, and V. A. Levin
Phase II Trial of Temozolomide Plus the Matrix Metalloproteinase Inhibitor, Marimastat, in Recurrent and Progressive Glioblastoma Multiforme
J. Clin. Oncol., March 1, 2002; 20(5): 1383 - 1388.
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D. A. Reardon, G. Akabani, R. Edward Coleman, A. H. Friedman, H. S. Friedman, J. E. Herndon II, I. Cokgor, R. E. McLendon, C. N. Pegram, J. M. Provenzale, et al.
Phase II Trial of Murine 131I-Labeled Antitenascin Monoclonal Antibody 81C6 Administered Into Surgically Created Resection Cavities of Patients With Newly Diagnosed Malignant Gliomas
J. Clin. Oncol., March 1, 2002; 20(5): 1389 - 1397.
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R. B. Khan, J. J. Raizer, M. G. Malkin, K. A. Bazylewicz, and L. E. Abrey
A phase II study of extended low-dose temozolomide in recurrent malignant gliomas
Neuro-oncol, January 1, 2002; 4(1): 39 - 43.
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A.C. Kappelle, T.J. Postma, M.J.B. Taphoorn, G.J. Groeneveld, M.J. van den Bent, C.J. van Groeningen, B.A. Zonnenberg, K.C.A. Sneeuw, and J.J. Heimans
PCV chemotherapy for recurrent glioblastoma multiforme
Neurology, January 9, 2001; 56(1): 118 - 120.
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K. R. Hess, E. T. Wong, K. A. Jaeckle, A. P. Kyritsis, V. A. Levin, M. D. Prados, and W. K. A. Yung
Response and progression in recurrent malignant glioma
Neuro-oncol, October 1, 1999; 1(4): 282 - 288.
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