|
|
|
|
|
|
||
|
|
||||
|
|
||||
|
||||
Clinical Therapy Trials—Outcomes |
Health Technology Assessment Unit (J.B.W.), Multidisciplinary Oncology Centre (S.O., S.L., R.S.), Centre Hospitalier Universitaire Vaudois, University of Lausanne, CH-1011 Lausanne, Switzerland
1 Address correspondence to Jean-Blaise Wasserfallen, University Hospital (CHUV), Rue du Bugnon, 46, CH-1011 Lausanne, Switzerland (Jean-Blaise.Wasserfallen{at}chuv.hospvd.ch).
Abstract
Effectiveness and costs of care and treatment of recurrent malignant
gliomas are largely unknown. In this study, 49 patients (32 males, 17 females;
mean age, 49; age range, 23-79) were treated with temozolomide (TMZ) for
recurrent or progressive malignant gliomas after standard radiation therapy.
Cost assessment (payer's perspective) singled out treatment for first
recurrence and all costs of care until death. We computed personnel costs as
wages; drugs, imaging, and laboratory tests as prices; and hospitalizations as
day rates. Patients were administered a median of five TMZ cycles at
recurrence. Drug acquisition costs amounted to 
2206 per cycle (76% of
total costs). Seven patients showed no second recurrence (two are still
alive), 16 received no further chemotherapy and died after 3.9 months, and 26
received second-line chemotherapy. After the second progression, median
survival was 4.0 months (95% confidence interval, 1.8-6.1). Overall monthly
costs of care varied between 2450 and 3242 among the different
groups, and median cost-effectiveness and cost utility ranged from
28,817 to 38,450 and from 41,167 to 53,369 per life of
year and per quality-adjusted life-year gained, respectively. We conclude that
despite high TMZ drug acquisition costs, care of recurrent malignant gliomas
is comparable to other accepted therapies.
References
Bloor, K., Drummond, M.F., Brada, M., and Rampling, R. (1998) High grade gliomas: Clinical outcomes, resource use and cost of care. Memorandum. University of York, Centre for Health Economics, Heslington, York, U.K.
Brada, M., Hoang-Xuang, K., Rampling, R., Dietrich, P.Y., Dirix,
L.Y., Macdonald, D., Heimans, J.J., Zonnenberg, B.A., Bravo-Marques, J.M.,
Henriksson, R., Stupp, R., Yue, N., Bruner, J., Dugan, M., Rao, S., and
Zaknoen, S. (2001) Multicenter phase II trial of temozolomide in
patients with glioblastoma multiforme at first relapse. Ann.
Oncol. 12,259
-266.
Brock, C.S., Newlands, E.S., Wedge, S.R., Bower, M., Evans, H.,
Colquhoun, I., Roddie, M., Glaser, M., Brampton, M.H., and Rustin, G.J.
(1998) Phase I trial of temozolomide using an extended continuous
oral schedule. Cancer Res.
58,4363
-4367.
Chamberlain, M.C., and Kormanik, P.A. (1998) Practical guidelines for the treatment of malignant gliomas. West. J. Med. 168,114 -120.[Web of Science][Medline]
Dinnes, J., Cave, C., Huang, S., Major, K., and Milne, R. (2001) The effectiveness and cost-effectiveness of temozolomide for the treatment of recurrent malignant glioma: A rapid and systematic review. Health Technol. Assess. 5, 1-73.[Medline]
Fisher, E.S., Wennberg, D.E., Stukel, T.A., Gottlieb, D.J., Lucas,
F.L., and Pinder, E.L. (2003a) The implications of regional
variations in Medicare spending. Part 1: The content, quality, and
accessibility of care. Ann. Intern. Med.
138,273
-287.
Fisher, E.S., Wennberg, D.E., Stukel, T.A., Gottlieb, D.J., Lucas,
F.L., and Pinder, E.L. (2003b) The implications of regional
variations in Medicare spending. Part 2: Health outcomes and satisfaction with
care. Ann. Intern. Med.
138,288
-298.
Goldman, L,. Gordon, D.J., Rifkind, B.M., Hulley, S.B., Detsky, A.S., Goodman, D.W., Kinosian, B., and Weinstein, M.C. (1992) Cost and health implications of cholesterol lowering. Circulation 85,1960 -1968.[Abstract]
Guyatt, G.H., Feeny, D.H., and Patrick, D.L. (1993)
Measuring health-related quality of life. Ann. Intern.
Med. 118,622
-629.
Hillner, B.E., Agarwala, S., and Middleton, M.R.
(2000) Post hoc economic analysis of temozolomide versus
dacarbazine in the treatment of advanced metastatic melanoma. J.
Clin. Oncol. 18,1474
-1480.
Karnofsky, D.A., Abelmann, W.H., Craver, L.F., and Burchenal, J.H. (1948) The use of the nitrogen mustards in the palliative treatment of carcinoma: With particular reference to bronchogenic carcinoma. Cancer 1,634 -656.[CrossRef][Web of Science]
Kristiansen, K., Hagen, S., Kollevold, T., Torvik, A., Holme, I., Nesbakken, R., Hatlevoll, R., Lindgren, M., Brun, A., Lindgren, S., Notter, G., Andersen, A.P., and Elgen, K. (1981) Combined modality therapy of operated astrocytomas grade III and IV. Confirmation of the value of postoperative irradiation and lack of potentiation of bleomycin on survival time: A prospective multicentre trial of the Scandinavian Glioblastoma Study Group. Cancer 47,649 -652.[CrossRef][Web of Science][Medline]
Latif, A.Z., Signorini, D., Gregor, A., and Whittle, I.R. (1998) The costs of managing patients with malignant glioma at a neuro-oncology clinic. Br. J. Neurosurg. 12,118 -122.[CrossRef][Web of Science][Medline]
Levin, V.A., Silver, P., Hannigan, J., Wara, W.M., Gutin, P.H., Davis, R.L., and Wilson, C.B. (1990) Superiority of post-radiotherapy adjuvant chemotherapy with CCNU, procarbazine, and vincristine (PCV) over BCNU for anaplastic gliomas: NCOG 6G61 final report. Int. J. Radiat. Oncol. Biol. Phys. 18,321 -324.[Web of Science][Medline]
Liu, G., Franssen, E., Fitch, M.I., and Warner, E.
(1997) Patient preferences for oral versus intravenous palliative
chemotherapy. J. Clin. Oncol.
15,110
-115.
Mackworth, N., Fobair, P., and Prados, M.D. (1992) Quality of life self-reports from 200 brain tumor patients: Comparisons with Karnofsky performance scores. J. Neurooncol. 14,243 -253.[Medline]
Middleton, M.R., Grob, J.J., Aaronson, N., Fierlbeck, G., Tilgen,
W., Seiter, S., Gore, M., Aamdal, S., Cebon, J., Coates, A., Dreno, B., Henz,
M., Schadendorf, D., Kapp, A., Weiss, J., Fraass, U., Statkevich, P., Muller,
M., and Thatcher, N. (2000) Randomized phase III study of
temozolomide versus dacarbazine in the treatment of patients with advanced
metastatic malignant melanoma. J. Clin. Oncol.
18,158
-166.
MRC Brain Tumour Working Party (2001) Randomized trial
of procarbazine, lomustine, and vincristine in the adjuvant treatment of
high-grade astrocytoma: A Medical Research Council Trial. J. Clin.
Oncol. 19,509
-518.
Osoba, D., Brada, M., Yung, W.K.A., and Prados, M.
(2000a) Health-related quality of life in patients treated with
temozolomide versus procarbazine for recurrent glioblastoma multiforme.
J. Clin. Oncol. 18,1481
-1491.
Osoba, D., Brada, M., Yung, W.K.A., and Prados, M.D. (2000b) Health-related quality of life in patients with anaplastic astrocytoma during treatment with temozolomide. Eur. J. Cancer 36,1788 -1795.
Rodriguez, L.A., and Levin, V.A. (1987) Does chemotherapy benefit the patient with a central nervous system glioma? Oncology 1,29 -36.
Silverstein, M.D., Cascino, T.L., and Harmsen, W.S. (1996) High-grade astrocytomas: Resource use, clinical outcomes and cost of care. Mayo Clin. Proc. 71,936 -944.[Abstract]
Stewart, L.A., Burdett, S., and Souhami, R.L. (2000) Chemotherapy for high-grade glioma: A meta-analysis using individual patient data from randomized clinical trials (RCTs). Proc. Annu. Meet. Am. Soc. Clin. Oncol. 650 (abstract).
Stupp, R., Maeder, P., Maillard, I., Pica, A., Wurm, R., Hungerbühler, H.P., Villemure, J.G., Baumert, B., Büttner, W., de Tribolet, N., Lejeune, F., Mirimanoff, R.O., and Leyvraz, S. (1998) Improved outcome with chemotherapy with temozolomide for recurrent glioblastoma and anaplastic astrocytoma. J. Neurooncol. 39,151 (abstract).
Stupp, R., Dietrich, P.Y., Ostermann Kraljevic, S., Pica, A.,
Maillard, I., Maeder, P., Meuli, R., Janzer, R., Pizzolato, G., Miralbell, R.,
Porchet, F., Regli, L., De Tribolet, N., Mirimanoff, R.O., and Leyvraz, S.
(2002) Promising survival for patients with newly diagnosed
glioblastoma multiforme treated with concomitant radiation plus temozolomide
followed by adjuvant temozolomide. J. Clin. Oncol.
20,1375
-1382.
Verger, E., Salamero, M., and Conill, C. (1992) Can Karnofsky performance status be transformed to the Eastern Cooperative Oncology Group scoring scale and vice versa? Eur. J. Cancer 28 (suppl. A),1328 -1330.[CrossRef]
Walker, M.D., Alexander, E., Jr., Hunt, W.E., MacCarty, C.S., Mahaley, M.S., Jr., Mealey, J., Jr., Norrell, H.A., Owens, G., Ransohoff, J., Wilson, C.B., Gehan, E.A., and Strike, T.A. (1978) Evaluation of BCNU and/or radiotherapy in the treatment of anaplastic gliomas. J. Neurosurg. 49,333 -343.[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. (1999) Outcomes
and prognostic factors in recurrent glioma patients enrolled onto phase II
clinical trials. J. Clin. Oncol.
17,2572
-2578.
Yung, W.K.A., Prados, M.D., Yaya-Tur, R., Rosenfeld, S.S., Brada,
M., Friedman, H.S., Albright, R., Olson, J., Chang, S.M., O'Neill, A.M.,
Friedman, A.H., Bruner, J., Yue, N., Dugan, M., Zaknoen, S., and Levin, V.A.,
for the Temodal Brain Tumor Group (1999) Multicenter phase II
trial of temozolomide in patients with anaplastic astrocytoma or anaplastic
oligo-astrocytoma at first relapse. J. Clin. Oncol.
17,2762
-2771.
Yung, W.K., Albright, R.E., Olson, J., Fredericks, R., Fink, K., Prados, M.D., Brada, M., Spence, A., Hohl, R.J., Shapiro, W., Glantz, M., Greenberg, H., Selker, R.G., Vick, N.A., Rampling, R., Friedman, H., Phillips, P., Bruner, J., Yue, N., Osoba, D., Zaknoen, S., and Levin, V.A. (2000) A phase II study of temozolomide vs. procarbazine in patients with glioblastoma multiforme at first relapse. Br. J. Cancer 83,588 -593.[CrossRef][Web of Science][Medline]
Zubrod, C.G., Schneiderman, M., Frei, E., III, Brindley, C., Gold, G.L., Shnider, B., Oviedo, R., Gorman, J., Jones, R., Jr., Jonsson, U., Colsky, J., Chalmers, T., Ferguson, B., Dederick, M., Holland, J., Selawry, O., Regelson, W., Lasagna, L., and Owens, A. (1960) Appraisal of methods for the study of chemotherapy of cancer in man: Comparative therapeutic trial of nitrogen mustard and triethylene thiophosphoramide. J. Chron. Dis. 11,7 -33.[CrossRef]
CiteULike 
Connotea 
Del.icio.us 
Digg 
Reddit 
Technorati What's this?
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
