|
|
|
|
|
|
||
|
|
||||
|
|
||||
|
||||
Clinical Therapy Trials - Other |
2a and 13-cis-retinoic acid with radiation treatment for high-grade glioma
Hoag Cancer Center, Newport Beach, CA 92658 (R.O.D., M.S., K.M., N.M.B.); Bloomington Hospital, Bloomington, IN 47402 (D.F.T., B.R.K., M.M.P.); Central Office of the Cancer Biotherapy Research Group Franklin, TN 37068 (C.K.C., C.D.)
3 Address correspondence and reprint requests to Robert O. Dillman, Medical Director, Hoag Cancer Center, One Hoag Drive, Building 41, Newport Beach, CA 92658.
Abstract
Interferon-
(IFN-) has been safely given concurrently with radiation
therapy (RT) in treating gliomas. As single agents, both IFN- and
cis-retinoic acid (CRA) have produced objective tumor regressions in
patients with recurrent gliomas. In vitro, IFN-2a and CRA enhance
radiation therapy effects on glioblastoma cells more than either agent alone.
This trial was conducted to determine the clinical effects of IFN-2a
and CRA when given concurrently with radiation therapy to patients with
high-grade glioma. Newly diagnosed patients with high-grade glioma received
IFN-2a at a dosage of 3 to 6 million IU s.c. 4 times a day for 3 days
per week and 1 mg/kg CRA by mouth 4 times a day for 5 days per week during the
delivery of partial brain radiation therapy at 180 cGy x 33 fractions
for 5 days per week for a total of 59.4 Gy during the 7-week period. Use of
the antiepileptic phenytoin was prohibited after observing that the
combination of IFN-2a, CRA, and phenytoin was associated with a high
rate of dermatologic toxicity not seen in a previous study with concurrent
IFN-2a and radiation therapy. Forty patients (26 men and 14 women) with
a median age of 60 (range, 19 to 81 years) were enrolled between August 1996
and October 1998. Histopathologic diagnoses were glioblastoma multiforme or
grade 4 anaplastic astrocytoma in 36 patients, and grade 3 anaplastic
astrocytoma in 4 patients. Only 4 patients (10%) underwent a gross total
resection of tumor prior to this therapy; 50% were asymptomatic when treatment
was initiated. The planned 7-week course of concurrent therapy was completed
by 75% of patients; 30% completed the 16-week course of IFN- and CRA
alone. At a median follow-up of 36 months, there were 37 deaths, with a median
overall survival of 9.3 months and a 1-year survival rate of 42%. There was no
improvement in survival compared with a similar group of 19 patients treated
with concurrent IFN-2a and radiation therapy in a previous trial. In
the highrisk group of patients in the present study, concurrent treatment with
IFN-2a, CRA, and RT was feasible, but was not associated with a better
outcome compared with a similar patient population treated with radiation
therapy and IFN-2a, or compared with radiation therapy alone in other
trials.
References
Black, P.M. (1991a) Brain tumors. Pt. 1. N. Engl. J. Med. 324,1471 -1476.[Web of Science][Medline]
Black, P.M. (1991b) Brain tumors. Pt. 2. N. Engl. J. Med. 324,1555 -1564.[Web of Science][Medline]
Bruner, J.M. (1994) Neuropathology of malignant gliomas. Semin. Oncol. 21,126 -138.[Web of Science][Medline]
Cooper, J.J., Borok, T.L., Ransohoff, J., and Carella, R.J.
(1982) Malignant glioma: Results of combined modality therapy.
JAMA 248,62
-65.
Daumas-Duport, C., Scheithauer, B., O'Fallon, J., and Kelly, P. (1988) Grading of astrocytomas: A simple and reproducible method. Cancer 62,2152 -2165.[CrossRef][Web of Science][Medline]
Delattre, J.Y., Safai, B., and Posner, J.B. (1988)
Erythema multiforme and Stevens-Johnson syndrome in patients receiving cranial
irradiation and phenytoin. Neurology
38,194
-198.
Dillman, R.O., Wiemann,M., Oldham, R.K., Soori, G., Bury, M.,
Hafer, R., Church, C., and DePreist, C. (1995) Interferon
-2a and externalbeam radiotherapy in the initial management of patients
with glioma: A pilot study of the National Biotherapy Study Group.
Cancer Biother. 10,265
-271.[Web of Science][Medline]
Dillman, R.O., Soori, G., Tai, D.F., Honeycutt, P., DePriest, C.,
and Church, C. (1997) Interferon -2a (IFN) and
cis-retinoic acid (CRA) for the treatment of squamous cell carcinoma (SCC): A
preliminary report. J. Immunother.
20, 404.
(Abstract)
Fine, H.A., Dear, K.B.G., Loef`er, J.S., Black, P.M., and Canellos, G.P. (1993) Meta-analysis of radiation therapy with and without adjuvant chemotherapy for malignant gliomas in adults. Cancer 71,2585 -2597.[CrossRef][Web of Science][Medline]
Green, S.B., Byar, D.P., Walker, M.D., Pistenmaa, D.A., Alexander, E., Jr., Batzdorf, U., Brooks, W.H., Hunt, W.E., Mealy, J., Jr., Odom, G.L., Paoletti, P., Ransohoff, J., II, Robertson, J.T., Selker, R.G., Shapiro, W.R., Smith, K.R, Jr., Wilson, C.B., and Strike, T.A. (1983) Comparisons of carmustine, procarbazine, and high-dose methylprednisolone as additions to surgery and radiotherapy for the treatment of malignant glioma. Cancer Treat. Rep. 67,121 -132.[Web of Science][Medline]
Kaplan, E.L., and Meier, P. (1958) Nonparametric estimation from incomplete observations. J. Am. Stat. Assoc. 53,457 -481.[CrossRef][Web of Science]
Kelley, K.A., Kirkwood, J.M., and Kapp, D.S. (1984) Glioblastoma multiforme: Pathology, natural history, and treatment. Cancer Treat. Rev. 11,1 -26.
Laws, E.R., Jr., and Thapar, K. (1993) Brain tumors. CA Cancer J. Clin. 43,263 -271.[Abstract]
Leibel, S.A., Scott, C.B., and Loef`er, J.S. (1994) Contemporary approaches to the treatment of malignant gliomas with radiation therapy. Semin. Oncol. 21,198 -219.[Web of Science][Medline]
Loeffler, J.S., Alexander, E., III, Shea, W.M., Wen, P.Y., Fine,
H.A., Kooy, H.M., and Black, P.M. (1992) Radiosurgery as part of
the initial management of patients with malignant gliomas. J. Clin.
Oncol. 10,1379
-1385.
Lesser, G.J., and Grossman, S. (1994) The chemotherapy of high-grade astrocytomas. Semin. Oncol. 21,220 -235.[Web of Science][Medline]
Lippman, S.M., Parkinson, D.R., Itri, L.M., Weber, R.S., Schantz,
S.P., Ota, D.M., Schusterman, M.A., Krakoff, I.H., Gutterman, J.U., and Hong,
W.K. (1992) 13-cis-retinoic acid and interferon -2a:
Effective combination therapy for advanced squamous cell carcinoma of the
skin. J. Natl. Cancer Inst.
84,235
-241.
Lippman, S.M., Kavanagh, J.J., Paredes-Espinoza, M.,
Delgadillo-Madrueno, F., Paredes-Casillas, P., Hong, W.K., Massimini, G.,
Holdener, E.E., and Krakoff, I.H. (1993) 13-cis-retinoic acid
plus interferon-2a in locally advanced squamous cell carcinoma of the
cervix. J. Natl. Cancer Inst.
85,499
-500.
Malone, C., Schiltz, P.M., Nayak, S.K., Shea, M.W., and Dillman,
R.O. (1999) Combination interferon-2a and 13-cis-retinoic
acid enhances radiosensitization of human malignant glioma cells in vitro.
Clin. Cancer Res. 5,417
-423.
McVie, J.G. (1993) The therapeutic challenge of gliomas. Eur. J. Cancer 29A,936 -939.[CrossRef]
Morantz, R.A., and Wara, W.M. (1995) Gamma knife radiosurgery in the treatment of brain tumors. Cancer Control 2,300 -307.[Medline]
Phillips, G.L., Wolff, S.N., Fay, J.W., Herzig, R.H., Lazarus,
H.M., Schold, C., and Herzig, G.P. (1986) Intensive
1,3-bis(2-chlorethyl)-1-nitrosourea [BCNU] monochemotherapy and autologous
marrow transplantation for malignant glioma. J. Clin.
Oncol. 4,639
-645.
Ricci, P.E., Karis, J.P., Heiserman, J.E., Fram, E.K., Bice, A.N., and Drayer, B.P. (1998) Differentiating recurrent tumor from radiation necrosis: Time for re-evaluation of positron emission tomography? AJNR Am. J. Neuroradiol. 19,407 -413.[Abstract]
Schwartz, R.B., Holman, B.L., Polak, J.F., Garada, B.M., Schwartz, M.S., Folkerth, R., Carvalho, P.A., Loef`er, J.S., Shrieve, D.C., Black, P.M., and Alexander, E., III (1998) Dual-isotope single-photon emission computerized tomography scanning in patients with glioblastoma multiforme: Association with patient survival and histopathological characteristics of tumor after high-dose radiotherapy. J. Neurosurg. 89, 60-68.[Web of Science][Medline]
Shrieve, D.C., Alexander, E., III, Black, P.M., Wen, P.Y., Fine, H.A., Kooy, H.M., and Loef`er, J.S. (1999) Treatment of patients with primary glioblastoma multiforme with standard postoperative radiotherapy and radiosurgical boost: Prognostic factors and long-term outcome. J. Neurosurg. 90,72 -77.[Web of Science][Medline]
Trotti, A., Byhardt, R., Stetz, J., Gwede, C., Corn, B., Fu, K., Gunderson, L., McCormick, B., Morrisintegral, M., Rich, T., Shipley, W., and Curran, W. (2000) Common toxicity criteria: Version 2.0 an improved reference for grading the acute effects of cancer treatment: Impact on radiotherapy. Int. J. Radiat. Oncol. Phys. 47, 13-47.[CrossRef][Web of Science][Medline]
Weller, M., and Fontana, A. (1995) The failure of current immunotherapy for malignant glioma. Tumor derived TGF-beta, T-cell apoptosis, and the immune privilege of the brain. Brain Res. Brain Res. Rev. 21,128 -151.[CrossRef][Medline]
Werner-Wasik, M., Scott, C.B., Nelson, D.F., Gaspar, L.E., Murray, K.J., Fischbach, J.A., Nelson, J.S., Weinstein, A.S., and Curran, W.J., Jr. (1996) Final report of a phase I/II trial of hyperfractionated and accelerated hyperfractionated radiation therapy with carmustine for adults with supratentorial malignant gliomas: Radiation Therapy Oncology Group Study 83-02. Cancer 77,1535 -1543.[CrossRef][Web of Science][Medline]
Yung, W.K.A., Levin, V.A., Kyritsis, A., Jaeckle, K., Winn, R., Baidas, S., Martuza, R., and Vaickus, L. (1995) Phase II study of rhIFN-ß +/- CRA in recurrent gliomas. Proc. Am. Soc. Clin. Oncol. 14,148 . (Abstract)
CiteULike 
Connotea 
Del.icio.us 
Digg 
Reddit 
Technorati What's this?
This article has been cited by other articles:
|
|
 |
|
  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. [Abstract] [Full Text] [PDF]
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
