© 1999 by Society
© 1999 by the Society forNeuro-Oncology
Response and progression in recurrent malignant glioma
Departments of Neuro-Oncology (E.T.W., K.A.J., A.P.K.,V.A.L., W.K.A.Y.) and Biomathematics (K.R.H.), TheUniversity of Texas M.D. Anderson Cancer Center, Houston, TX 77030; andthe Department of Neurological Surgery, University ofCalifornia, San Francisco, CA 94143 (M.D.P.)
2 Address correspondence and reprint requests to Kenneth R. Hess, Ph.D.,Department of Biomathematics, Box 237, The University of Texas M.D. AndersonCancer Center, 1515 Holcombe Boulevard, Houston, TX 77030.
In this article we report the results of a study of the relationshipbetween response and progression in 375 patients with recurrent gliomaenrolled in phase II chemotherapy trials. We reviewed the records of patientsfrom 8 consecutive phase II trials, including 225 patients with recurrentglioblastoma multiforme and 150 with recurrent anaplastic astrocytoma. Medianage was 45 years (range, 15–82) and median Karnofsky performance scorewas 80 (range, 60–100). Forty-one patients (11%) had more than two priorresections and/or more than two prior chemotherapy regimens. Best response wascomplete (n = 1) or partial (n = 33) in 34 patients (9%).Median time to response was 14 weeks, and median response duration was 44weeks. Simon-Makuch estimates for 52-week progression-free survival forpatients progression-free at 13 weeks were 48% for response and 28% fornonresponse. When response was treated as a time-dependent covariate in a Coxproportional hazards regression analysis, response was associated withsignificantly lower failure rates (hazard ratio 0.5; 95% confidence interval0.3–0.8; P = 0.0016). This study showed that response inrecurrent glioma is associated with a significant reduction in progressionrates.
Received January 14, 1999; Accepted May 13, 1999
References
-
A'Hern, R.P., Ebbs, S.R., and Baum M.B. (1988) Doeschemotherapy improve survival in advanced breast cancer? A statisticaloverview. Br. J. Cancer57,615-618.[Web of Science][Medline]
Anderson, J.R., Cain, K.C., and Gelber, R.D. (1983)Analysis of survival by tumor response. J. Clin.Oncol. 1,710-719.[Abstract]
Anderson, J.R., Cain, K.C., Gelber, R.D., and Gelman, R.S.(1985) Analysis and interpretation of the comparison of survivalby treatment outcome variables in cancer clinical trials. CancerTreat. Rep. 69,1139-1146.
Bull, K., and Spiegelhalter, D.J. (1997) Survivalanalysis in observational studies. Stat. Med.16,1041-1074.[CrossRef][Web of Science][Medline]
Buyse, M., and Piedbois, P. (1996) On the relationshipbetween response to treatment and survival time. Stat.Med. 15,2797-2812.
Cnaan, A., and Ryan, L. (1989) Survival analysis innatural history studies of disease. Stat. Med.8,1255-1268.[Web of Science][Medline]
Cox, D.R. (1972) Regression models and life tables(with discussion). J. Royal Stat. Soc. B74,187-220.
Eagan, R.T., and Scott, M. (1983) Evaluation ofprognostic factors in chemotherapy of recurrent brain tumors. J.Clin. Oncol. 1,38-44.[Abstract]
Feuer, E.J., Hankey, B.F., Gaynor, J.J., Wesley, M.N., Baker, S.G.,and Meyer, J.S. (1992) Graphical representation of survivalcurves associated with a binary non-reversible time dependent covariate.Stat. Med. 11,455-474.[Web of Science][Medline]
Fine, H.A. (1994) The basis for current treatmentrecommendations for malignant gliomas. J. Neurooncol.20,111-120.[CrossRef][Medline]
Graf, W., Pahlman, L., Bergstrom, R., and Glimelius, B.(1994) The relationship between an objective response tochemotherapy and survival in advanced colorectal cancer. Br. J.Cancer 70,559-563.[Web of Science][Medline]
Grambsch, P.M., and Therneau, T.M. (1994) Proportionalhazards tests and diagnostics based on weighted residuals.Biometrika 81,515-526.
Grant, R., Liang, B.C., Slattery, J., Greenberg, H.S., and Junck,L. (1997) Chemotherapy response criteria in malignant glioma.Neurology 48,1336-1340.
Hess, K.R. (1995) Graphical methods for assessingviolations of the proportional hazards assumptions in Cox regression.Stat. Med. 14,1707-1723.[Web of Science][Medline]
Kaplan, E.L., and Meier, P. (1958) Nonparametricestimation from incomplete observations. J. Am. Stat.Assoc. 53,457-481.
Klein, J.P., and Moeschberger, M.L. (1997)Survival Analysis: Techniques for Censored and TruncatedData. New York: Springer. p. 153, 271,276.
Leventhal, B.G., and Wittes, R.E. (1988)Research Methods in Clinical Oncology. New York: RavenPress. p. 69-70.
Macdonald, D.R., Cascino, T.L., Schold, S.C., Jr., and Cairncross,J.G. (1990) Response criteria for phase II studies ofsupratentorial malignant glioma. J. Clin. Oncol.8,1277-1280.[Abstract]
Pepe, M.S., and Cai, J. (1993) Some graphical displaysand marginal regression analyses for recurrent failure times and timedependent covariates (in theory and methods). J. Am. Stat.Assoc. 88,811-820.
Perry, J.R., DeAngelis, L.M., Schold, S.C., Jr., Burger, P.C.,Brem, H., Brown, M.T., Curran, W.J., Scott, C.B., Prados, M.D., Kaplan, R.,and Cairncross, J.G. (1997) Challenges in the design and conductof phase III brain tumor therapy trials. Neurology49,912-917.
Rajan, B., Ross, G., Lim, C.C., Ashley, S., Goode, D., Traish, D.,and Brada, M. (1994) Survival in patients with recurrent gliomaas a measure of treatment efficacy: Prognostic factors following nitrosoureachemotherapy. Eur. J. Cancer30A,1809-1815.[CrossRef]
Simon, R., and Makuch, R.W. (1984) A non-parametricgraphical representation of the relationship between survival and theoccurrence of an event: Application to responder versus non-responder bias.Statis. Med. 3,35-44.[CrossRef]
Slack, N.H., Mittelman, A., Brady, M.F., and Murphy, G.P.(1980) The importance of the stable category for chemotherapytreated patients with advanced and relapsing prostate cancer.Cancer 46,2393-2402.[CrossRef][Web of Science][Medline]
Torri, V., Simon, R., Russek-Cohen, E., Midthune, D., and Friedman,M. (1992) Statistical model to determine the relationship ofresponse and survival in patients with advanced ovarian cancer treated withchemotherapy. J. Natl. Cancer Inst.84,407-414.
Wand, M.P., and Jones, M.C. (1997) KernelSmoothing. Second edition. New York: Chapman andHall.
Weiss, G.B., Bunce, H., III, and Hokanson, J.A. (1983)Comparing survival of responders and nonresponders after treatment: Apotential source of confusion in interpreting cancer clinical trials.Control. Clin. Trials 4,43-52.[CrossRef][Web of Science][Medline]
Wong, E.T., Hess, K.R., Gleason, M.J., Jaeckle, K.A., Kyritsis,A.P., Prados, M.D., Levin, V.A., and Yung, W.K.A. (1999) Outcomesand prognostic factors in recurrent glioma patients enrolled in phase IIclinical trials. J. Clin. Oncol.17,2572-2578.
CiteULike 
Connotea 
Del.icio.us What's this?
This article has been cited by other articles:
|
|
 |
|
  S. M. Chang, K. R. Lamborn, J. G. Kuhn, W.K. A. Yung, M. R. Gilbert, P. Y. Wen, H. A. Fine, M. P. Mehta, L. M. DeAngelis, F. S. Lieberman, et al. Neurooncology clinical trial design for targeted therapies: Lessons learned from the North American Brain Tumor Consortium Neuro Oncology, August 1, 2008; 10(4): 631 - 642. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 D. A. Hamstra, C. J. Galban, C. R. Meyer, T. D. Johnson, P. C. Sundgren, C. Tsien, T. S. Lawrence, L. Junck, D. J. Ross, A. Rehemtulla, et al. Functional Diffusion Map As an Early Imaging Biomarker for High-Grade Glioma: Correlation With Conventional Radiologic Response and Overall Survival J. Clin. Oncol., July 10, 2008; 26(20): 3387 - 3394. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 J.W. Henson, S. Ulmer, and G.J. Harris Brain Tumor Imaging in Clinical Trials AJNR Am. J. Neuroradiol., March 1, 2008; 29(3): 419 - 424. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 M. E. Loghin, M. D. Prados, P. Wen, L. Junck, F. Lieberman, H. Fine, K. L. Fink, M. Metha, J. Kuhn, K. Lamborn, et al. Phase I Study of Temozolomide and Irinotecan for Recurrent Malignant Gliomas in Patients Receiving Enzyme-Inducing Antiepileptic Drugs: A North American Brain Tumor Consortium Study Clin. Cancer Res., December 1, 2007; 13(23): 7133 - 7138. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
E. T. Wong and S. Brem Taming Glioblastoma: Targeting Angiogenesis J. Clin. Oncol., October 20, 2007; 25(30): 4705 - 4706. [Full Text] [PDF]
|
|
|
|
|
|
K. V. Ballman, J. C. Buckner, P. D. Brown, C. Giannini, P. J. Flynn, B. R. LaPlant, and K. A. Jaeckle 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 Oncology, January 1, 2007; 9(1): 29 - 38. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 W A Tome and S P Howard On the possible increase in local tumour control probability for gliomas exhibiting low dose hyper-radiosensitivity using a pulsed schedule Br. J. Radiol., January 1, 2007; 80(949): 32 - 37. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
E. Galanis, J. C. Buckner, M. J. Maurer, R. Sykora, R. Castillo, K. V. Ballman, B. J. Erickson, and for the North central cancer treatment Group Validation of neuroradiologic response assessment in gliomas: Measurement by RECIST, two-dimensional, computer-assisted tumor area, and computer-assisted tumor volume methods Neuro Oncology, April 1, 2006; 8(2): 156 - 165. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
M. D. Prados, K. Lamborn, W.K.A. Yung, K. Jaeckle, H. I. Robins, M. Mehta, H. A. Fine, P. Y. Wen, T. Cloughesy, S. Chang, et al. A phase 2 trial of irinotecan (CPT-11) in patients with recurrent malignant glioma: A North American Brain Tumor Consortium study Neuro Oncology, April 1, 2006; 8(2): 189 - 193. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 D. A. Hamstra, T. L. Chenevert, B. A. Moffat, T. D. Johnson, C. R. Meyer, S. K. Mukherji, D. J. Quint, S. S. Gebarski, X. Fan, C. I. Tsien, et al. Evaluation of the functional diffusion map as an early biomarker of time-to-progression and overall survival in high-grade glioma PNAS, November 15, 2005; 102(46): 16759 - 16764. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
S. M. Chang, S. L. Reynolds, N. Butowski, K. R. Lamborn, J. C. Buckner, R. S. Kaplan, and D. D. Bigner GNOSIS: Guidelines for neuro-oncology: Standards for investigational studies--reporting of phase 1 and phase 2 clinical trials Neuro Oncology, October 1, 2005; 7(4): 425 - 434. [Abstract] [PDF]
|
|
|
|
|
|
T. F. Cloughesy, J. Kuhn, H. I. Robins, L. Abrey, P. Wen, K. Fink, F. S. Lieberman, M. Mehta, S. Chang, A. Yung, et al. Phase I Trial of Tipifarnib in Patients With Recurrent Malignant Glioma Taking Enzyme-Inducing Antiepileptic Drugs: A North American Brain Tumor Consortium Study J. Clin. Oncol., September 20, 2005; 23(27): 6647 - 6656. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
E. Galanis, J. C. Buckner, M. J. Maurer, J. I. Kreisberg, K. Ballman, J. Boni, J. M. Peralba, R. B. Jenkins, S. R. Dakhil, R. F. Morton, et al. Phase II Trial of Temsirolimus (CCI-779) in Recurrent Glioblastoma Multiforme: A North Central Cancer Treatment Group Study J. Clin. Oncol., August 10, 2005; 23(23): 5294 - 5304. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
M. D. Prados, W.K.A. Yung, K. A. Jaeckle, H. I. Robins, M. P. Mehta, H. A. Fine, P. Y. Wen, T. F. Cloughesy, S. M. Chang, M. K. Nicholas, et al. Phase 1 trial of irinotecan (CPT-11) in patients with recurrent malignantglioma: A North American Brain Tumor Consortium study Neuro Oncology, January 1, 2004; 6(1): 44 - 54. [Abstract] [PDF]
|
|
|
|
|
|
C. A. Meyers and K. R. Hess Multifaceted end points in brain tumor clinical trials: Cognitivedeterioration precedes MRI progression Neuro Oncology, April 1, 2003; 5(2): 89 - 95. [Abstract] [PDF]
|
|
|
|
|
|
F. F. Lang, M. R. Gilbert, V. K. Puduvalli, J. Weinberg, V. A. Levin, W.K. A. Yung, R. Sawaya, G. N. Fuller, and C. A. Conrad Toward better early-phase brain tumor clinical trials: A reappraisal ofcurrent methods and proposals for future strategies Neuro Oncology, October 1, 2002; 4(4): 268 - 277. [Abstract] [PDF]
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||