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Susan L. Chua, Mark A. Rosenthal, Shirley S. Wong, David M. Ashley, Anne-marie Woods, Anthony Dowling, Lawrence M. Cher, Phase 2 study of temozolomide and Caelyx in patients with recurrent glioblastoma multiforme, Neuro-Oncology, Volume 6, Issue 1, January 2004, Pages 38–43, https://doi.org/10.1215/S1152851703000188
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Abstract
Temozolomide has established activity in the treatment of recurrent glioblastoma multiforme (GBM). Caelyx (liposomal doxorubicin) has established activity in a broad range of tumors but has not been extensively evaluated in the treatment of GBM. Phase 1 data suggest that temozolomide and Caelyx can be combined safely at full dose. In this phase 2 study, combination temozolomide (200 mg/m2 orally, days 1-5) and Caelyx (40 mg/m2 i.v., day 1) was given every 4 weeks to a cohort of 22 patients with recurrent GBM, who received a total of 109 cycles (median 3.5 cycles). The median age of the patients was 55 years (range, 31-80 years), and 17 were male. All patients had received radiotherapy, but only 2 had received prior chemotherapy. One patient (5%) had a complete response, 3 patients (14%) had a partial response, and 11 patients (50%) had stable disease. The median time to progression for the cohort was 3.2 months (range, 1-13 months). Median overall survival was 8.2 months (range, 1-16+ months). Seven patients (32%) were progression free at 6 months. Hematological toxicity included grade 3/4 neutropenia in 4 patients (18%) and grade 3/4 thrombocytopenia in 4 patients (18%). Grade 3 nonhematologic toxicity included rash in 3 patients (14%), nausea and vomiting in 1 patient (4%), hypersensitivity reaction to Caelyx in 3 patients (14%), and palmar-plantar toxicity in 1 patient (4%). We conclude that the combination of temozolomide and Caelyx is well tolerated, results in a modest objective response rate, but has encouraging disease stabilization in the treatment of recurrent GBM.
References
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. (
Britten, C.D., Rowinsky, E.K., Baker, S.D., Agarwala, S.S., Eckardt, J.R., Bar rington, R., Diab, S.G., Hammond, L.A., Johnson, T., Villalona-Calero, M., Fraass, U., Statkevich, P., Von Hoff, D.D., and Eckhardt, S.G. (
Burton, E., and Prados, M. (
Clarke, K., Basser, R.L., Underhill, C., Mitchell, P., Bartlett, J., Cher, L., Findlay, M., Dalley, D., Pell, M., Byrne, M., Geldard, H., Hill, J.S., Maher, D., Fox, R.M., Green, M.D., and Kaye, A.H. (
Fabel, K., Dietrich, J., Hau, P., Wismeth, C., Winner, B., Przywara, S., Stein brecher, A., Ullrich, W., Bogdahn, U. (
Friedman, H.S., Kerby, T., and Calvert, H. (
Gander, M., Leyvraz, S., Decosterd, L., Bonfanti, M., Marzolini, C., Shen, F., Lienard, D., Perey, L., Colella, G., Biollaz, J., Lejeune, F., Yarosh, D., Belanich, M., and D'Incalci, M. (
Harris, M.T., Rosenthal, M.A., Ashley, D.L., and Cher, L. (
Jemal, A., Thomas, A., Murray, T., and Thun, M. (
Kappelle, A.C., Postma, T.J., Taphoorn, M.J.B., Groeneveld, G.J., van den Bent, M.J., van Groeningen, C.J., Zonnenberg, B.A., Sneeuw, K.C.A., and Heimans, J.J. (
Khan, R.B., Raizer, J.J., Malkin, M.G., Bazylewicz, K.A., and Abrey, L.E. (
Koukourakis, M.I., Koukouraki, S., Fezoulidis, I., Kelekis, N., Kyrias, G., Archimandritis, S., and Karkavitsas, N. (
Levin, V.A. (
MacDonald, D.R., Cascino, T.L., Schold, S.C., Jr., and Cairncross, J.G. (
NCI. National Cancer Institute (
Patel, V.J., Elion, G.B., Houghton, P.J., Keir, S., Pegg, A.E., Johnson, S.P., Dolan, M.E., Bigner, D.D., and Friedman, H.S. (
Rosenthal, M.A., Gruber, M.L., Glass, J., Nirenberg, A., Finlay, J., Hochster, H., and Muggia, F.M. (
Sharma, U.S., Sharma, A., Chau, R.I., and Straubinger, R.M. (
Siegal, T., Horowitz, A., and Gabizon A. (
Simon, R. (
Stupp, R., Gander, M., Leyvraz, S., and Newlands, E. (
Surawicz, T.S., McCarthy, B.J., Kupelian, V., Jukich, P.J., Bruner, J.M., and Davis, F.G. (
Uziely, B., Jeffers, S., Isacson, R., Kutsch, K., Wei-Tsao, D., Yehoshua, Z., Lib son, E., Muggia, F.M., and Gabizon, A. (
Volm, M., Oratz, R., Pavlick, A., Farrell, K., Lee, J., and Muggia, F. (
Walker, M.D., Green, S.B., Byar, D.P., Alexander, E., Jr., Batzdorf, U., Brooks, W.H., Hunt, W.E., MacCarty, C.S., Mahaley, M.S., Jr., Mealey, J., Jr., Owens, G., Ransohoff, J., 2nd, Robertson, J.T., Shapiro, W.R., Smith, K.R., Jr., Wilson, C.B., and Strike, T.A. (
Wong, E.T., Hess, K.R, Gleason, M.I., Jaeckle, K.A., Kyritsis, A.P., Prados, M.D., Levin, V.A., and Yung, W.K.A. (
Yung, W.K.A, 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. (
Yung, W.K.A., Prados, M.D., Yaya-Tur, R., Rosenfeld, S.S., Brada, M., Fried man, H.S., Albright, R., Olson, J., Chang, S.M., O'Neil, A.M., Friedman, A.H., Bruner, J., Yue, N., Dugan, M., Zaknoen, S., and Levin, V.A. (
Author notes
Centre for Developmental Cancer Therapeutics, Parkville, Victoria, affiliates: Department of Clinical Haematology and Medical Oncology, Royal Melbourne Hospital, Parkville, Victoria 3050 (S.L.C., M.A.R., S.S.W., A.W.);Department of Medical Oncology, Royal Children's Hospital, Parkville, Victoria 3050 (D.M.A.);Department of Medical Oncology, St. Vincent's Hospital, Fitzroy, Victoria 3065 (A.D.); andDepartment of Medical Oncology, Austin and Repatriation Medical Centre, Heidelberg, Victoria 3184 (L.M.C.); Australia