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Clinical Therapy Trails-Quality of Life |
Coordinated by the North Central Cancer Treatment Group, Rochester, MN 55905
2 Address correspondence and reprint requests to B.P. O'Neill, M.D., Department of Neurology, Mayo Clinic and Foundation, 200 SW First St., Rochester, MN 55905.
Abstract
Per protocol, patients with primary CNS non-Hodgkin's lymphoma in an intergroup phase II trial conducted by the North Central Cancer Treatment Group and the Eastern Cooperative Oncology Group had their cognitive functions measured using the Folstein and Folstein Mini-Mental Status Examination (MMSE) and their physical functions measured using the Eastern Cooperative Oncology Group Performance Score (PS) at study entry, at each treatment evaluation, and at quarterly intervals thereafter until disease progression or death. Of the 53 eligible participants who began therapy, 46 (87%) had baseline MMSE scores recorded, 36 (68%) had at least one follow-up MMSE, and 32 (60%) had both, while 52 (98%) had baseline PS, 49 (92%) had at least one follow-up PS, and 48 (91%) had both. Patterns of MMSE and PS values over time were studied in each individual, in the group as a whole, in the 20 patients who completed the study regimen, in the 23 who survived more than a year, and in patients who were classified as nonprogressors at each key evaluation. For each patient, all recorded values were plotted versus time, with dates of disease progression and death included, to look for signs of decline in cognitive or physical function preceding adverse events. Long-term declines in scores of both cognitive and physical function were observed in many treated patients with primary CNS non-Hodgkin's lymphoma. Nearly all patients who were alive more than 52 weeks after study entry had a demonstrable decline in cognitive and physical functionality. Such declines may occur before disease progression is documented; they may also occur in some patients who have long-term follow-up without evidence of disease progression. Declining MMSE and PS was a poor predictor of disease progression. There was no association of PS and toxicity. The data from this study demonstrated the considerable difficulties we encountered conducting an ancillary study such as this within a multicenter clinical trial. Firstly, the test instruments written into the protocol were unable to tell if the declines seen were due to disease, treatment, co-morbidity, or other factors. Secondly, the missing data created difficulties in interpreting outcome.
References
Abrey, L.E., DeAngelis, L.M., and Yahalom, J. (1998) Long-term survival in primary CNS lymphoma. J. Clin. Oncol. 16,859 -863.[Abstract]
Allen, J.C., Rosen, G., Mehta, B.M., and Horten, B. (1980) Leukoencephalopathy following high-dose IV methotrexate chemotherapy with leukovorin rescue. Cancer Treat. Rep. 64,1261 -1273.[ISI][Medline]
Blay, J.Y., Conroy, T., Chevreau, C., Thyss, A., Quesnel, N., Eghbali, H., Bouabdallah, R., Coiffier, B., Wagner, J.P., Le Mevel, A., Dramais-Marcel, D., Baumelou, E., Chauvin, F., and Biron, P. (1998) High-dose methotrexate for the treatment of primary cerebral lymphomas: Analysis of survival and late neurologic toxicity in a retrospective series. J. Clin. Oncol. 16,864 -871.[Abstract]
Brada, M., Dearnaley, D., Horwich, A., and Bloom, H.J. (1990) Management of primary cerebral lymphoma with initial chemotherapy: Preliminary results and comparison with patients treated with radiotherapy alone. Int. J. Radiat. Oncol. Biol. Phys. 18,787 -792.[ISI][Medline]
Cote, T.R., Manna, A., Hardy, C.R., Yellin, F.J., and Hartge, P.
(1996) Epidemiology of brain lymphoma among people with or
without acquired immunodeficiency syndrome. J. Natl. Cancer.
Inst. 88,675
-679.
Crossen, J.R., Garwood, D., Glatstein, E., and Neuwelt, E.A. (1994) Neurobehavioral sequalae of cranial irradiation in adults: A review of radiation-induced encephalopathy. J. Clin. Oncol. 12,627 -642.[Abstract]
DeAngelis, L.M., Delattre, J.Y., and Posner, J.B.
(1989) Radiation-induced dementia in patients cured of
metastases. Neurology
39,789
-796.
DeAngelis, L.M., Yahalom, J., Heinemann, M.H., Cirrincione, C.,
Thaler, H.T., and Krol, G. (1990) Primary CNS lymphoma: Combined
treatment with chemotherapy and radiotherapy.
Neurology 40,80
-86.
Eby, N.L., Grufferman, S., Flannelly, C.M., Schold, S.C., Jr., Vogel, F.S., and Burger, P.C. (1988) Increasing incidence of primary brain lymphoma in the U.S. Cancer 62,2461 -2465.[CrossRef][ISI][Medline]
Fisher, R.I., Gaynor, E.R., Dahlberg, S., Oken, M.M., Grogan, T.M.,
Mize, E.M., Glock, J.H., Coltman, C.A., Jr., and Miller, T.P.
(1993) Comparison of a standard regimen (CHOP) with three
intensive chemotherapy regimens for advanced non-Hodgkin's lymphoma.
N. Engl. J. Med. 328,1002
-1006.
Folstein, M.F., Folstein, S.E., and McHugh, P.R. (1975) "Mini-mental state." A practical method for grading the cognitive state of patients for the clinician. J. Psychiatr. Res. 12,189 -198.[CrossRef][ISI][Medline]
Freilich, R.J., Delattre, J.Y., Monjour, A., and DeAngelis, L.M.
(1996) Chemotherapy without radiation therapy as initial
treatment for primary CNS lymphoma in older patients.
Neurology 46,435
-439.
Frick, J.C., Hansen, R.M., Anderson, T., and Ritch, P.S. (1986) Successful high-dose intravenous cytarabine treatment of parenchymal brain involvement from malignant lymphoma. Arch. Intern. Med. 146,791 -792.[Abstract]
Glass, J., Gruber, M.L., Cher, L., and Hochberg, F.H. (1994) Preirradiation methotrexate chemotherapy of primary central nervous system lymphoma: Long-term outcome. J. Neurosurg. 81,188 -195.[ISI][Medline]
Henry, J.M., Heffner, R.R., Jr., Dillard, S.H., Earle, K.M., and Davis, R.L. (1974) Primary malignant lymphomas of the central nervous system. Cancer 34,1293 -1302.[CrossRef][ISI][Medline]
Hochberg, F.H., and Pruitt, A. (1980) Assumptions in
the radiotherapy of glioblastoma. Neurology
30,907
-911.
Hochberg, F.H., and Slotnick, B. (1980)
Neuropsychologic impairment in astrocytoma survivors.
Neurology 30,172
-177.
Kaplan, E.L., and Meier, P. (1958) Nonparametric estimation from incomplete observations. J. Am. Stat. Assoc. 53,457 -481.[CrossRef][ISI]
MacDonald, D.R., Cascino, T.L., Schold, S.C., Jr., and Cairncross, J.G. (1990) Response criteria for phase II studies of supratentorial malignant glioma. J. Clin. Oncol. 8,1277 -1280.[Abstract]
Mantel, N. (1966) Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemother. Rep. Pt. 1 50,163 -170.
Murray, K.J., Nelson, D.F., Scott, C., Fischbach, A.J., Porter, A., Farnan, N., and Curran, W.J., Jr. (1995) Quality-adjusted survival analysis of malignant glioma. Patients treated with twice-daily radiation (RT) and carmustine: A report of Radiation Therapy Oncology Group (RTOG) 83–02. Int. J. Radiat. Oncol. Biol. Phys. 31,453 -459.[CrossRef][ISI][Medline]
Nelson, D.F., Martz, K.L., Bonner, H., Nelson, J.S., Newall, J., Kerman, H.D., Thomson, J.W., and Murray, K.J. (1992) Non-Hodgkin's lymphoma of the brain: Can high dose, large volume radiation therapy improve survival? Report on a prospective trial by the Radiation Therapy Oncology Group (RTOG): RTOG 8315. Int. J. Radiat. Oncol. Biol. Phys. 23,9 -17.[ISI][Medline]
Nesbitt, J.C., Lee, J.S., Komaki, R., and Roth, J.A. (1997) Cancer of the lung. In: Holland, J.F., Bast, R.C., Jr., Morton, D.L., Frei, E., III, Kufe, D.W., Weichselbaum, R.R. (Eds.),Cancer Medicine. Fourth edition . Philadelphia: Williams and Wilkins. pp. 1723-1803.
Neuwelt, E.A., Goldman, D.L., Dahlborg, S.A., Crossen, J., Ramsey, F., Roman-Goldstein, S., Braziel, R., and Dana, B. (1991) Primary CNS lymphoma treated with osmotic blood-brain barrier disruption: Prolonged survival and preservation of cognitve function. J. Clin. Oncol. 9,1580 -1590.[Abstract]
O'Neill, B.P., O'Fallon, J.R., Earle, J.D., Colgan, J.P., Brown, L.D., and Krigel, R.L. (1995) Primary central nervous system non-Hodgkin's lymphoma: Survival advantages with combined initial therapy? Int. J. Radiat. Oncol. Biol. Phys. 33,663 -673.[CrossRef][ISI][Medline]
O'Neill, B.P., and Illig, J. (1989) Primary central nervous system lymphoma. Mayo Clin. Proc. 64,1005 -1020.[ISI][Medline]
O'Neill, B.P., Tomlinson, F.H., O'Fallon, J.R., Scherthauer, B.W., Kurtin, P.J., and O'Neill, D.B. (1993) The continuing increase of primary central nervous system non-Hodgkin's lymphoma (PCNSL). Ann. Neurol. 34,313 .
Poisson, M., Hauw, J.J., Pouillart, P., Bataini, J.P., Mashaly, R., Pertuiset, B.F., and Metzger, J. (1979) Malignant gliomas treated after surgery by combination chemotherapy and delayed radiation therapy. Part II. Tolerance to irradiation after chemotherapy. Acta. Neurochir. (Wien) 51,27 -42.[CrossRef][Medline]
Schiffer, D., Chio, A., Giordana, M.T., Novero, D., Palestro, G., Soffietti, R., and Vasario, E. (1987) Primary lymphomas of the brain: A clinicopathologic review of 37 cases. Tumori 73,585 -592,.[ISI][Medline]
Shibamoto Y., Tsutsui, K., Dodo, Y., Yamabe, H., Shima, N., and Abe, M. (1990) Improved survival rate in primary intracranial lymphoma treated by high-dose radiation and systemic vincristine-doxorubicin-cyclophosphamide-prednisolone chemotherapy. Cancer 65,1907 -1912.[CrossRef][ISI][Medline]
So, N.K., O'Neill, B.P., Frytak, S., Eagan, R.T., Earnest, F., IV,
and Lee, R.E. (1987) Delayed leukoencephalopathy in survivors
with small cell lung cancer. Neurology
37,1198
-1201.
Taylor, B.V., Buckner, J.C., Cascino, T.L., O'Fallon, J.R., Schaefer, P.L., Dinapoli, R.P., and Schomberg, P. (1998) Effects of radiation and chemotherapy on cognitive function in patients with high-grade glioma. J. Clin. Oncol. 16,2195 -2201.[Abstract]
Tomlinson, F.H., Kurtin, P.J., Suman, V.J., Scheithauer, B.W., O'Fallon, J.R., Delly, P.J., Jack, C.R., Jr., and O'Neill, B.P. (1995) Primary intracerebral malignant lymphoma: A clinicopathological study of 89 patients. J. Neurosurg. 82,558 -566.[ISI][Medline]
Tondini, C., Zanini, M., Lombardi, F., Bengala, C., Rocca, A., Giardini, R., Buzzoni, R., Valagussa, P., and Bonadonna, G. (1993) Combined modality treatment with primary CHOP chemotherapy followed by locoregional irradiation in stage I or II histologically aggressive non-Hodgkin's lymphomas. J. Clin. Oncol. 11,720 -725.[Abstract]
Trojanowski, T., Peszynski, J., Turowski, K., Markiewicz, P., Goscinski, I., Bielawski, A., Bendarzewska, B., Szymona, J., Dabrowska, A., and Lopatkiewicz, J. (1989) Quality of survival of patients with brain gliomas treated with postoperative CCNU and radiation therapy. J. Neurosurg. 70,18 -23.[ISI][Medline]
Weitzner, M.A., Meyers, C.A., and Byrne, K. (1996) Psychosocial functioning and quality of life in patients with primary brain tumors. J. Neurosurg. 84, 29-34.[ISI][Medline]
Wilcoxon, F. (1945) Individual comparisons by ranking methods. Biometrics 1,80 -83.[CrossRef][ISI]
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